ethics in medical research and publication

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Home > Books > Bioethics - Medical, Ethical and Legal Perspectives

Ethical Publications in Medical Research

Submitted: 01 April 2016 Reviewed: 19 July 2016 Published: 29 December 2016

DOI: 10.5772/64947

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Bioethics - Medical, Ethical and Legal Perspectives

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Ethics in medical sciences research may not always translate into ethical publications. Unfortunately due to lack of regulatory bodies, publication misconduct is now a global menace for the scientific community. Publication misconducts are not only restricted to research fraud or data manipulations alone but also seriously include plagiarism, duplicate publications especially on figures and tables, authorship disputes and conflict of interests. As global scientific research is expanding particularly in the field of health sciences hence possibilities of more rise of unethical practices from research to publications are very high, authors suggest a strong peer-reviewing system, use latest technological support, strong publication ethics policies, active monitoring, protection of whistle blowers and more liaisons between journals and research institutions or universities possibly to prevent publication misconduct effectively. This chapter discusses how medical publications might have abused various ethical norms not only while conducting research but also during the publication process. The review also discusses the possible preventive measures against unethical practices of research publications.

• scientific misconduct
• medical journals
• ethical publications

Author Information

Kusal k. das *.

• Laboratory of Vascular Physiology and Medicine, Department of Physiology, BLDE University's Shri B. M. Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka, India

Mallanagoud S. Biradar

• Department of Medicine, BLDE University's Shri B. M. Patil Medical College, Hospital and Research Centre, Vijayapura, Karnataka, India

*Address all correspondence to: [email protected];, [email protected]

1. Introduction

Ethics in medical sciences research may not always translate into ethical publications. As peer pressure rises the ethics of conducting medical research and subsequent writing scientific papers and publications gradually erodes in the last couple of years. This phenomenon so much deeply penetrates into the medical researchers that various professional bodies, universities and governments are forced to press panic button against unethical medical research and publications [ 1 ]. Ethical violations in conducting medical research always promote unethical scientific publications. The most important outcome of any research is its findings and observations and definitely improper research or scientific misconduct will lead to unethical publications. The research misconduct that promotes unethical publication impacts badly on other researchers who follow the steps shown in unethical scientific publications and resulting wrong practices or applications on patients [ 2 ]. Scientific and research misconduct is defined very clearly by the Royal College of Physicians at Edinburgh—‘as any behaviour by a researcher, whether intentional or not, that fails to scrupulously respect high scientific and ethical standards. Various types of research misconduct include fabrication or falsification of data, plagiarism, problematic data presentation or analysis, failure to obtain ethical approval by the Research Ethics Committee or to obtain the subject's informed consent, inappropriate claims of authorship, duplicate publication and undisclosed conflict of interest (COI)’ [ 1 ]. The statement specifically mentioned that research misconduct does not end at the research works level but also extends to the publication level. One must note that research misconduct either is done intentionally or unintentionally—hardly it matters on its impact to the society that includes fellow researchers, authors, reviewers, editors, institutes, universities, nations and above all future students of medicine, professionals and patients as a whole. In the era of ‘publish or perish’ medical fraternity should not focus only on his/her career advancement but also consider the professional ethics including research and publication ethics seriously [ 3 ]. How serious a research misconduct may be the story of South Korean stem cell scientist Woo Suk Hwang is enough to speak to that! Dr. Hwang's revolutionary work on stem cells published in Science (2004 and 2005) and later found that both the papers are fakes [ 4 ].

According to Fanelli, research misconduct should be redefined as ‘any omission or misrepresentation of the information necessary and sufficient to evaluate the validity and significance of research, at the level appropriate to the context in which the research is communicated’ [ 5 ]. Faneli also stated that ‘scientific knowledge is reliable not because scientists are more clever, objective or honest than other people, but because their claims are exposed to criticism and replication’ [ 5 ].

Society and humanity: Wrong procedures, false and fabricated data bring out products, which may be considered unsafe for humanity. Here comes the publication ethics regulation, which perhaps control or prevent these danger.

Fellow researchers: Published data and knowledge derived from research misconduct in medical sciences will mislead fellow medical researchers and that will lead to huge loss of money, funds, times and reputations.

Medical practitioners and students: Medical practitioner also suffers a lot due to unethical research publications as many wrong diagnostic and therapeutic published guidelines lead to professional disaster for them. Medical students might be taught subjects and understanding based on false and fabricated data which will jeopardize the career of future doctors.

Public trust and Government policies: Research misconduct and subsequent unethical publications may destroy public trust on science. Such false information and data may misguide government and lead to implement some erroneous health policies and laws. The ultimate sufferers are common man and society.

Hence, we can say that all the stakeholders from researchers, institutions/universities, government agencies, medical journals or book publishers are going to be devastated by research misconduct, which may also be considered as the most serious scientific assault on human health sciences.

While conducting medical research, researchers are usually careful and take all the precautions against any sort of ethical violation either in human or in animal research as per the guidelines of various apex professional bodies. Institutional Regulatory Body/Institutional Ethical Committee of all the countries function near similar pattern which strictly follow Declaration of Helsinki and other international guidelines. In general, all the institutional ethics committee critically obey all the ethical principles as per the Declaration of Helsinki by World Medical Association (WMA), National Institute of Health (NIH), the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Singapore statement of research integrity, ICMR guidelines, etc. In a nutshell, American Psychological Association comes out with five principles for research ethics: (i) discuss intellectual property frankly, (ii) be conscious of multiple roles, (iii) follow informed consent rules, (iv) respect confidentiality and privacy and (v) tap into ethics resources [ 6 ]. NIH also summarizes the principles of ‘Codes and Policies for Research ethics’ as the following: (i) honesty, (ii) objectivity, (iii) integrity, (iv) carefulness, (v) openness, (vi) respect for intellectual property, (vii) confidentiality, (viii) responsible publication, (ix) responsible mentoring, (x) respect for colleagues, (xi) social responsibility, (xii) nondiscrimination, (xiii) competence, (xiv) legality, (xv) animal care and (xvi) human subject protection [ 7 ]. Unfortunately, such strong and mandatory authority is unavailable in case of research publications.

This review is undertaken to discuss how medical publications might have abused various ethical norms not only while conducting research but also during the publication process. The review also discusses the possible preventive measures against unethical practices of research and publications.

1.2. Manifestations of medical research misconduct

There are several ways in which ethical violation in medical research are noticed, namely altering instrumentation or research procedure, nonreplicable findings, copying ideas, copying results, false study design, inadequate data, falsifying ethical consent, image manipulations, plagiarism, duplicate publication, etc. These unethical practices are taken place at each of the steps in research, that is performing works to disseminating knowledge through scientific publications [ 8 , 9 ]. The most common research misconduct, which is manifested through publications, is falsifications and fabrication of data. As per NIH, ‘fabrication’ means ‘the intentional act of making up data or results and recording or reporting them’ whereas ‘falsification’ is manipulating research materials, equipment or processes, or changing or omitting/suppressing data or results without scientific or statistical justification, such that the research is not accurately represented in the research record [ 10 ]. It is noticed that ‘figures’ and ‘graphics’ where maximum fabrications or falsification take place. The graphical manipulations are mainly through Photoshop and journal editors are struggling hard to fight against these hi-tech manipulations on research data [ 11 , 12 ]. Overall, we can say that research misconduct manifestation is multidimensional. These may be classified as (1) General research misconduct, (2) Research application misconduct, (3) Data generation misconduct, (4) Financial misconduct, (5) Behavioural misconduct and (6) Publication misconduct.

The foremost important manifestation is general research misconduct , which includes fabrication, falsification and plagiarism. These three unethical research practices are very serious offences as it makes research either misrepresented by the facts or underrepresented by the truth. Usually, such unethical practices in research are due to peer pressure and personal gains and pressure from research sponsors. Research application misconduct usually occurs while adopting wrong or poor research design or technical errors during experimental, computational and statistical analysis. Improper uses of human subjects, patients or animals also lead to research misconduct and result in ethical violations. Data generation misconduct includes false data generation, not including real data in research, not sharing true data with colleagues’ especially multicentre studies. Financial misconduct in research usually includes misuse of research funds like unauthorized purchase procedures, use of research funds for personal reasons, disclosure of conflict of interest, etc. Behavioural misconduct covers inappropriate behaviours towards colleagues, research scholars and gender and religious insensitivities on students, colleagues, patients and subjects. Usually, publication misconduct occurs due to authorship dispute, ghost and gifted authorship, plagiarism, duplicate publication and suspicious clinical trials. Study on misconduct in clinical trials found that the most serious forms of research misconduct in clinical trials are selective and biased reporting [ 12 , 13 ].

1.3. Factors that influence research misconduct

Publish or Perish pressure.

Severe competition for funds.

Promotion or career advancement policies.

Pressure from research sponsors to obtain desired results.

Lack of knowledge on research ethics.

Desire to ‘go ahead’.

Personal characters.

In most of the cases, research misconduct is suspected, identified and reported by colleagues. Usually, researchers who work alone and never allow others to observe his or her research works or researchers who are self centric and do not have an attitude to work in a team are primarily prone to do research misconducts. Research findings in medical sciences should be always repetitive at any place and anytime. Failure to repeat research results by one's own laboratory or external laboratories definitely suspect misconduct.

1.4. Questionable research practices in medicine

Failing to retain significant research data for a reasonable period.

Maintaining inadequate research records, especially for results that are published or are relied on by others.

Conferring or requesting authorship on the basis of a specialized service or contribution that is not significantly related to the research reported in the paper.

Refusing to give peers reasonable access to unique research materials or data that could support published papers.

Using inappropriate statistical or other methods of measurement to enhance the significance of research findings.

Inadequately supervising research subordinates or exploiting them.

Misrepresenting speculations as fact or releasing preliminary research results, especially in the public media, without providing sufficient data to allow peers to judge the validity of the results or to reproduce the experiments.

1.5. Reasons for questionable research practices

The reasons for questionable research practices may be due to poor supervision, excessive workloads, poor training in research, lack of interest of researchers and being over ambitious. These can be found in principal investigators, study coordinators, research scholars, administrative staff, technicians and even the research subjects themselves.

1.6. How questionable research misconduct is done?

Dates misrepresented.

Duplicate X-rays: different names.

Blank laboratory reports to fill in.

Fake subjects: obituary names.

Analysis done after subjects died.

Same subject different names.

Nonexistent subjects created.

Dates changed in records to match washout periods.

Consent not signed before entering the study.

Unqualified staff doing research.

Inadequate records.

Failure to get IEC/IRB approval.

Failure to report changes in research.

Bogus laboratory results reported.

Samples study from only a few subjects.

Subjects received prohibited medication while on study.

Failure to report adverse events.

Hence, we can say that from knowledge generation (ethical research) to knowledge dissemination (ethical practices and publications) – medical ethics is a common component of research integrity and medical science research cannot afford to lose this integrity for the interest of the humanity ( Figure 1 ).

Figure 1.

Research integrity through ethical research, practice and publication.

2. Publication ethics

Graf et al. [ 15 ] said that academic publishing depends mainly on ‘trust’. In the system of research publication procedure, editor trusts reviewers, authors trust editors by expecting fair reviewing processes and finally readers trust authors, reviewers and editors for providing honest sciences. In general, common public outside of research community considers physicians and scientists are just demigod with high morale and integrity. ‘Scientists are generally perceived as well-intentioned seekers of truth; universities, as cathedrals of learning and as producers of knowledge vital to the health and welfare of society’ [ 16 ]. Unfortunately, reports of unethical research publications shake the public confidence on medical scientists. Although medical practitioners, teachers and researchers can recognize publication misconduct and ignore that to some extent, chances of un detection of mistakes and doubtful observations are also may lead to serious consequences. Thorough understanding of publication ethics in medical research is need of the hour. World Association of Medical Editors (WAME), International Committee of Medical Journal Editors (ICMJE) and Committee on Publication Ethics (COPE) are the guiding force to interpret ethical publication appropriately [ 14 ]. They have provided guidelines on the publication ethics policies for medical journals on various issues such as study design, authorship, peer review, editorial decisions and plagiarism and also further guided the procedural guidelines to tackle those publication misconduct. These bodies also enlighten editors on various issues such as conflict of interest, authorship disputes, redundant publications, fabrication of data, plagiarism and human and animal rights [ 17 ].

2.1. Ethical issues

2.1.1. why do publication ethics matter.

Published research influences other researchers and establishes credibility for individual or journal. Honest scientific reports build trust among peers and within scientific community. Publication ethics is not confined to one country—it is global by approach and is commonly held throughout the world. Author's seven deadly sin : Table 1 depicts unethical practices of authors.

2.1.2. Plagiarism

In the era of copy and paste, an excessive dependence on search engine make plagiarism a universally popular among the medical scientists who like to prefer a short cut for the way of success in publication. Plagiarism is defined as ‘to copy ideas and passages of text from someone else's work and use them as if they were one's own’ [ 18 ]. The word plagiarism may be further extended to unreferenced use of the ideas of others submitted as a ‘new’ paper by a different author! One must know plagiarism may not be considered always as accidental. The most vulnerable part for plagiarism in any research publication is ‘methods’.

Another form of plagiarism is self-plagiarism where author copy and paste from his/her previous publications including results, tables and figures without providing copyright clearance certificate from publishers. Self-plagiarism is also an equal crime or research misconduct like simple plagiarism. Fortunately, due to the availability of many anti-plagiarism softwares, this menace has cut down notably. Editor must make his/her peer reviewers alert and possibly train them on this issue. Universities, medical institutes and funding authorities should also sensitize its medical researchers and practitioners on it. The best way to avoid plagiarism is to cite other's work always in the research articles, put the cited words in quotation marks and seek permission from appropriate authorities for references to cite tables, figures, etc. COPE has given a very useful guideline through flow chart on plagiarism for both submitted manuscripts and published manuscripts [ 18 ]. The Committee on Publication Ethics (COPE) is a UK-based charitable organization (established 1997) working mainly on research and publication misconduct. COPE has provided some very authentic guidelines addressing publication ethics from authors, reviewers, editors and publishers’ point of views. COPE defines the good practices in publication of research articles, which are really very helpful for authors, readers, editors, peer reviewers, editorial board members and journal and book publishers. COPE is the first organization, which advocates accountability of research institutions for its employee scientist's misdeed [ 19 ]. ICMJE also directs authors and editors to follow COPE guidelines in case of suspected unethical practices on publications or any ethical dispute [ 20 ].

Table 1.

Author's ethical misconduct.

2.1.3. Redundant publications

Data in conference abstract? – No

Same data, different journal? – Yes

Data on website? – May be

Data included in review article? – No if permission is taken

Expansion of published data set? – Yes

There are certain norms that may help clarify further on duplicate publications like if one takes an approval from both the journals and subsequently publishes, it may not be considered as ‘duplicate’. Secondary version for paper intended to different language readers with appropriate permission may not be taken as ‘duplicate’. But in any case secondary version faithfully reflects data and interpretations of the primary version with a clear message that it is the secondary publication for journal ‘y’ based on previously published article (primary) in journal ‘x’ in ‘z’ language. COPE has given some useful guidelines on how to handle suspected redundant (duplicate) publications, especially for journal editors. COPE instructed that at the beginning editor must verify whether it is the case of major or minor redundancy. Major redundancy is always considered with evidence of deliberate duplication such as changes of title and data sheet with identical findings. Minor redundancy is something ‘salami publication’ types with looks of extended follow-up of previously published article. Whatever it may be, editor must contact corresponding author and ask explanation, if satisfied, do not take any action. If it is not found satisfactory, editor has many choices such as inform the incidence to author's superior organizational authority/employer or prompt rejection of manuscript or notice of retraction immediately [ 22 ].

2.1.4. Authorship disputes and ethical misconducts

Probably, one of the most discussed and complex ethical violation in publication in medicine is authorship disputes and ethical misconducts. The difference between ‘disputes’ and ‘misconduct’ may be proclaimed as follows:

Disputes —‘Question of interpretation’ like whether ‘contribution’ by the authors was substantial? Whether authorship criteria were discussed when research was planned ? Or it was decided before submission of manuscript?

Misconduct—Authorship is unethical like ‘gift’ or ‘ghost’ authorship.

Journals must have clear authorship criteria.

Authors should disclose all contributors, regardless of author status and their specific individual contributions and affiliations.

Authors must sign about their contributions details.

Authors should disclose any of his/her conflict of interest and a statement whether they have received any support from medical writers [ 26 ].

Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data.

Drafting the article or revising it critically for important intellectual content.

Examples of publication misconduct are authorship disputes and misconducts, which are very common in the medical professionals. Various studies in this regard showed the nature and execution of such unethical practices among medical professional. Works of Dhingra and Mishra [ 3 ] revealed that majority of respondent on questionnaires confirm publication misconduct especially authorship disputes among Indian biomedical researchers. Another study of Das et al. [ 25 ] observed clear authorship misconduct among medical faculty members of India. In their study, they have found that around 81.4% respondents from medical faculty members confessed authorship disputes in any form among themselves. Further, a comparative study with pharmacy faculty members the dispute level was found to be 29.2%, which further indicates that medical researchers are more vulnerable to authorship misconduct. The study also showed that 74.07% of medical and 68.29% of pharmacy faculty members did not have any discussion on authorship issues at any time before they actually started drafting article for publication. About 88.88% of medical and 36.5% of pharmacy faculty members also mentioned that their professors and head of the departments were included as author although they do not have any contributions or they do not fit in ICMJE authorship criteria. About 81.4% of medical and 29.26% of pharmacy faculty members also mentioned in questionnaires that senior research colleagues interfered while writing manuscript to include their names in the drafted manuscripts. Das et al. further elaborated that even though pharmacy faculty members are better practioners of ethical authorship as compared to their medical counterparts still more sensitization is needed for them to realize ethical authorship [ 25 ]. To regulate authorship disputes and misconduct the role of corresponding author should be considered the most important one although other co-authors are also accountable. Every author must have substantial research contribution to justify their inclusion as author. All authors must take their responsibility on manuscript's every pros and cons. The accuracy of all the data, conflict of interest, disclosure of funding authority and get manuscript checked by all the co-authors are the responsibilities must be put on corresponding or principal author's shoulder [ 9 ].

2.1.5. Conflict of interest

One of the important but less admitted examples of publication misconduct is nondisclosure of conflict of interest. It may be financial (industry sponsor research) or others like personal interest like employment interest, promotion or career advancement interest, patents, personal believes, grant providing, relationship, academic competition or intellectual passion, etc [ 23 , 28 ]. Most of the journals make disclosure of potential conflict of interest mandatory and do not publish articles even after acceptance if COI is not disclosed. It has been reported in a study on five leading medical journals like Annals of Internal Medicine , BMJ , Lancet , JAMA , New England Journal of Medicine that only 52 of total 3642 articles disclosed their potential COI, that is only 1.4% of total [ 29 ]. Another study also showed that one in three lead authors had financial interests in their research by patents, shares or payments for being on advisory boards or as a director, etc [ 30 ]. A study conducted by Das et al. [ 31 ] on awareness of COI among medical scientists/researchers from India showed that only 12% authors understand COI issues correctly and 19 % of medical authors just heard about it. Very interestingly, the authors who had clear knowledge on COI confessed that hardly they provide COI statement to the journal. The study also found that knowledge of COI is equally poor even among peer reviewers (30%) and editorial board members (25%) too! Some peer reviewers even stated that they are biased toward articles submitted by their known colleagues from medical sciences [ 31 ]. Another study also showed that there are no clear guidelines for institution and industries are other cause of COI-related issues [ 32 ]. In the complex scenario of COI issues among medical publications, editor of the journals, peer reviewers, research institutions or universities and grant providers must pay more attention to tackle this unethical issue in publications [ 32 ]. Das suggested COI case comes out even after publication, in which, the publisher and editor may apologize and issue a formal correction and subsequently retract the article [ 33 ].

2.1.6. Fabrication and falsification of data

Fabrication means cooking up data or results (fictitious by nature) as per the hypothesis of research and publishes it in a journal whereas falsification is simply manipulating data or results. It also includes figures or graph distortions. Fabrication also covers selective reporting where authors just report a small number of significant values of the study but hide large number of insignificant observations. Such biasness completely destroys the spirit of science. Normally, both fabrication and falsification of research observations are common for clinical trials (pressure from sponsors) and research activities of medical researchers who have a tendency to go alone instead of working as a research team [ 1 ]. In an interest meta-analysis study, Fanelli [ 9 ] reported that around 2% of studied medical scientists confessed that they had fabricated or falsified research data. Nearly, one-third of the said study group also confessed that they allowed many publication malpractices including ‘dropping data’ results of a study in response to pressures from a funding source [ 9 ]. The issues on fabrication and falsification of data are very serious by nature, and unfortunately, even the world's top medical research institute faculties are also involved in it. Story of John Long, a pathologist at Harvard Medical School was compelled to resign after publication of his false and fake results on molecular immune complexes related to Hodgkin's disease [ 34 ]. Similarly, one Dr. Vijay Soman of Yale University was found an offender on publication ethics because of fabrication and falsification of data from his colleague [ 35 ]. This problem is not only restricted on medical researcher/author, but it is even extended to editor also. Malcolm Pearce who was an Assistant Editor of British Journal of Obstetrics and Gynaecology was found to be a publication ethics defaulter. His false case report based on a patient who had gone under successful delivery after reimplanting an ectopic pregnancy was actually nonexisting. Later, his all papers were retracted from various journals [ 36 ]. One of the classic example of data fabrication is the story of Ram B. Singh between India. Dr. Singh submitted nine papers from 1992 to 1996 on his research on diet and myocardial infarction. The then Editor of BMJ Professor Richard Smith suspected on Dr. Singh's work and asked him to produce raw data. Dr. R. B. Singh failed to produce that and insisted that data were ‘eaten by termites’. It was also found that the institution where he did his research was owned by his family members. BMJ initiated an independent inquiry and published his story [ 37 ].

3. Publication ethics

3.1. best practices.

Based on ICMJE and COPE guidelines for publishers, editors, peer reviewers and authors must practice and train themselves against publication misconduct. One of the most important things to promote ethical publication is to encourage research integrity among medical researchers. COPE advocated for a research integrity officer in each of the research institution to monitor and guide various issues pertaining to research ethics including publication ethics [ 18 ]. Research Institutions share a responsibility with all of its researchers to preserve scientific integrity in research. They bear the primary responsibility for promoting a culture of good scientific conduct among researchers and students and for the prevention, investigation and punishment of scientific misconduct in their midst. One must remember that research integrity requires the highest professional standards by a critical, open-minded approach, frankness and fairness with absolute honesty.

3.1.1. Publishers, editors and peer reviewers

An editor must take into consideration some important points before sending manuscript for reviewing like whether competing interests are cited by authors or reviewers, ensures that reviewer is adequately qualified and can keep confidentiality and also protects the whistle blower in case of reports on publication misconduct. It is suggested that journal editors must provide a link to WAME or COPE or ICMJE for authors, readers or reviewers to get first-hand information on ethics in publication. Editors should encourage peer reviewers to consider ethical issues on research manuscripts while reviewing and may also ask additional information from authors if need arises. Journals editors and publishers must protect confidentiality of research that includes identity of subjects/patients, etc besides identity of reviewers. Editors may also verify institutional review board clearance on each of the research manuscript in medical journal [ 15 ]. Ethical publication also includes timely peer reviewing and publication of the manuscript which is the responsibility of editor and publisher. Authors’ especially medical authors always should be sensitized by editors, publishers and institutions that medicine is a profession based on ‘absolute trust, philanthropy and altruism’. For ethical publication, the great role of peer reviewers must also to be remembered. Reviewer should be competent enough to review the content of manuscript; he/she should not be in hurry, no COI issues, have knowledge on publication ethics. One more important point on best practice for editors is to remain cultural and gender sensitive on any article. They should carefully observe whether any cultural offence is in the content of manuscripts. Language of the authors should not offend anyone among the readers [ 15 ].

3.1.2. Prevention

To regulate appropriately on the issues of ethical publications, institutions or universities should be accountable by the journal publishers for any unethical publication practices authored by the researchers belong to that institution. COPE or ICMJE have given some guidelines but that do not make institutions of author as accountable for any publication misconduct. Institution must have clear and transparent functioning on not only ethical research policy but also on ethical publications. Institution of authors and journal must take a special attention on the clinical trial-based publications. A Strong peer-reviewing system, uses of latest technological support, strong publication ethics policies, active monitoring, protection of whistle blowers and more liaisons between journals and research institutions or universities possibly prevent publication misconduct effectively.

Better education on publication guidelines and ethics.

Introduction of registers for planned and ongoing clinical trials.

Change criteria from quantity to quality when papers are used for assessment of posts or grants.

Punish the culprits but be careful that innocent is not victimized.

Acknowledgments

The authors thank Professor B.G. Mulimani, Chief Adviser and former Vice Chancellor of BLDE University, Vijayapura, India, for his encouragement on ethical practices in all the aspects of life in BLDE University.

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• 28. FACTSHEET Conflict of Interest. Elsevier | Ethics in Research & Publication Available at: https://www.elsevier.com/__data/assets/pdf_file/0010/92476/ETHICS_COI02.pdf . Accessed on 13/05/2016.
• 29. Hussain A, Smith R. Declaring financial competing interests: survey of five general medical journals. BMJ. 2001;323:263–4.
• 30. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. A systematic review. JAMA. 2003;289:454–65.
• 31. Das KK, Vallabha T, Ray J, Murthy PSN. Conflict of interest – serious issue on publication ethics for Indian Medical Journals. J Nepal Med Assoc. 2013;52(190):357–60.
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• 34. Hamblin TJ. Fake. Br Med J (Clin Res Ed). 1981;283:1671–4.
• 35. Altman L, Melcher L. Fraud in science. Br Med J (Clin Res Ed). 1983;286:2003–6.
• 36. Smith R. Research misconduct: the poisoning of the well. J R Soc Med. 2006;99:232–7.
• 37. Smith J, Godlee F. Investigating allegations of scientific misconduct. BMJ. 2005;331:245–6.

© 2016 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution 3.0 License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Ethics in medical research and publication.

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• Masic I | 0000-0002-9080-5456

International Journal of Preventive Medicine , 01 Sep 2014 , 5(9): 1073-1082 PMID: 25317288  PMCID: PMC4192767

Abstract 

Free full text , ethics in medical research and publication.

Department of Family Medicine, Faculty of Medicine, University of Sarajevo, Sarajevo, Bosnia and Herzegovina

Ajla Hodzic

Smaila mulic.

To present the basic principles and standards of Ethics in medical research and publishing, as well as the need for continuing education in the principles and ethics in science and publication in biomedicine. An analysis of relevant materials and documents, sources from the published literature. Investing in education of researches and potential researches, already in the level of medical schools. Educating them on research ethics, what constitutes research misconduct and the seriousness of it repercussion is essential for finding a solution to this problem and ensuring careers are constructed on honesty and integrity.

• INTRODUCTION

Science is a key link in the educational system, it is part of the culture of the nation, further on it contributes to overall well-being and security in everyday life, and represents a source of real knowledge of mankind. In most cases, the scientist is a person of exceptional diligence, which is at the same time, very focused on what it does. If one deals with the scientific work, can significantly improve the human condition; thus, it will make a great effort and sacrifice many daily pleasures.[ 1 ]

• PRINCIPLES OF WRITING A SCIENTIFIC PAPER

Scientific research demands precision.[ 2 , 3 , 4 ] Scientific writing should respect this precision in the form of clarity. Unfortunately, a glance at almost any scientific journal will reveal that the above-stated ideal is often not attained in the real world of scholarly publication.[ 5 , 6 ] Indeed, many of the accusations by nonscientific of “obscurity” and “elitism” within the scientific community probably originate in the sad fact that many scientists are not capable of expressing their hypotheses and conclusions clearly and simply.[ 7 ]

The scientific way of thinking and application of scientific methods require honesty, criticality, trust, creativity and openness, and acceptance of these principles as desirable prerequisites for successful engagement in science by students and young researchers, qualifying research institution that produces competent promoters (initiators) for the future technological cultural and political development of society.[ 1 ]

Defining principles of good scientific and good laboratory practice should encourage the development of standardized principles and guidelines for accurate and quality data in scientific research.[ 1 ]

The text of observational and experimental articles is usually divided into sections in accordance with so-called “IMRAD” structure: Introduction, Methods, Results, and Discussion. Papers related to public health programs and practice might have different than IMRAD structure (drug). There is a key question for each section of the IMRAD structure of the paper, which an author needs to keep in mind, while writing the manuscript.[ 6 ]

Title of the scientific paper contains a brief description of the content. The title should accurately describe the content of the article. There are two types of titles: Indicative title talks about the work that covers and informative title-convey the message of the article and recommended for beginners. A good title should be: (a) Short, (b) correct, (c) a clear, (d) complete, (e) informing, (d) attractive. It should also include: Characteristics of the article, showing what is most important in the work. It is necessary to specify the names of the authors and their affiliations.

Abstract/summary and title can be written in two forms: Reference and Information. It can be written in author's native language and English. The structure of the summary should look like this: Introduction, goal, materials and methods, the location of the study, measuring the outcomes of the study, the results and conclusions.

Summary is the distillate of which will be presented and should show: What has been done, what are the results, what the results means. Writing an introduction has its own rules: A clear definition of a the problem, why exactly this issue was explored, there is no need to explain what can be found in the textbooks, do not need to explain the terms of the title.

Materials and Methods describe how the study was conducted and the characteristics of the sample (experimental group, controls, and their properties). It is necessary to explain what is researched, asked, tested as follows: Sampling (random, consecutive, and representative), the sample size (patient gender, age), the control group, and the criteria for exclusion from the study, the control group if any.

It should be described how the research was done: Type of study (prospective, retrospective or combined), data collection (surveys, inventory or checkup), the technique of measuring results (operative treatment, laboratory tests). It is necessary to specify where the research was conducted. Results are an important part of writing an article.

The research results are usually most carefully read and should be a detailed plan, well-documented at the optimal dose. Discussion is a critical review of the data described in the results. He results should be compared with other findings and discuss the theoretical and practical research outcome. Conclusion should be short, clear and precise. It is necessary to: Make the final statement of what logically follows from the results of the work, list only the most important and give the message. Good conclusions should not surprise attentive reader. The reader should get the impression that he himself had written it. References should be in accordance with the instructions provided by the journal, and otherwise used Vancouver or Harvard citation style.[ 8 ]

Papers related to public health programs and practice might have different than IMRAD structure. Anyhow, the paper should be written in logical order consisting informative or indicative title, an introductory section with description of the subject or public health problem and objectives, the current status or situation, recommended or realized program and activities, lessons learned, experiences, results and recommendations, and finally conclusions and a list of references. Special importance and validity have papers which describe new practice, approach and activities, have clear description, design of the practice, approach and activities, offers possibilities for implementation of the practice, approach and activities in other settings and environments, presents the experiences gained, lessons learned, and recommendations.[ 7 ]

• ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS

The World Medical Association (WMA) has developed the Declaration of Helsinki [ Figure 1 ] as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. Consistent with the mandate of the WMA, the declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles:[ 9 ]

The Declaration of Helsinki. Retrieved from: New edition of Declaration of Helsinki Available: http://www. hopitalmontfort.com/en/new-edition-declaration-helsinki

General principles

The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration”, and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care”.

It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfillment of this duty.

Medical progress is based on research that ultimately must include studies involving human subjects. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures, and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality.

Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this declaration.

Medical research should be conducted in a manner that minimizes possible harm to the environment. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, burdens and benefits

In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation. Measures to minimize the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable groups and individuals

Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a nonvulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific requirements and research protocols

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and as appropriate, animal experimentation. The welfare of animals used for research must be respected. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

The protocol should contain:

A statement of the ethical considerations involved and should indicate how the principles in this declaration have been addressed

Information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

In clinical trials, the protocol must also describe appropriate arrangements for posttrial provisions.

Research ethics committees

The research protocol must be submitted for consideration, comment, guidance and approval to the concerned Research Ethics Committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards, but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this declaration.

The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study's findings and conclusions.

Privacy and confidentiality

Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed consent

Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, poststudy provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject's freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the nonwritten consent must be formally documented and witnessed. All medical research subjects should be given the option of being informed about the general outcome and results of the study.

When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject's dissent should be respected.

Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a Research Ethics Committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorized representative.

The physician must fully inform the patient, which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient's decision to withdraw from the study must never adversely affect the patient-physician relationship.

For medical research using identifiable human material or data, such as research on material or data contained in bio banks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations, the research may be done only after consideration and approval of a Research Ethics Committee.

Use of placebo

The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option.

Posttrial provisions

In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for posttrial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research registration and publication and dissemination of results

Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this declaration should not be accepted for publication.

Unproven interventions in clinical practice

In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgment it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and where appropriate, made publicly available.[ 9 ]

• PUBLICATION ETHICS

Academic publishing depends, to a great extent, on trust. Editors trust peer reviewers to provide fair assessments, authors trust editors to select appropriate peer reviewers, and readers put their trust in the peer-review process. Academic publishing also occurs in an environment of powerful intellectual, financial, and sometimes political interests that may collide or compete. Good decisions and strong editorial processes designed to manage these interests will foster a sustainable and efficient publishing system, which will benefit academic societies, journal editors, authors, research funders, readers, and publishers.

Good publication practices do not develop by chance, and will become established only if they are actively promoted.[ 10 ]

The general principles of publication ethics are:

Transparency

Sources of funding for research or publication should always be disclosed. Editors should state this directly in their editorial policy. Authors should routinely include information about research funding in all papers they prepare for publication. Where a clinical trial registration number is available, this should be included.

Authorship acknowledgment

The International Committee of Medical Journal Editors (ICMJE) provides a definition of authorship that is applicable beyond the medical sector. The ICMJE authorship criteria state ‘authorship credit should be based on:

Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data;

Drafting the article or revising it critically for important intellectual content; and

Final approval of the version to be published.

Authors of research papers should state whether they had complete access to the study data that support the publication. Contributors who do not qualify as authors should also be listed and their particular contribution described. This information should appear as an acknowledgment. Sample authorship description/acknowledgment. Collecting authorship information for research papers, authorship should be decided at the study launch. Policing authorship is beyond the responsibilities of an editor. Editors should demand transparent and complete descriptions of who has contributed to a paper.

Editors should employ appropriate systems to inform contributors about authorship criteria (if used) and/or to obtain accurate information about individuals’ contributions.

Editors should ask authors to submit, as part of their initial submission package, a statement that all individuals listed as authors meet the appropriate authorship criteria, that nobody who qualifies for authorship has been omitted from the list, and that contributors and their funding sources have been properly acknowledged, and that authors and contributors have approved the acknowledgment of their contribution.

Attributing authorship to a group

The ICMJE provides guidance for instances where a number of authors report on behalf of a larger group of investigators.[ 1 ]

This guidance is applicable outside the medical sector.

International Committee of Medical Journal Editors guidance states: “When a large, multi-center group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship defined above… When submitting a group author manuscript, the corresponding author should clearly indicate the preferred citation and should clearly identify all individual authors as well as the group name”. The individual authors who accept direct responsibility for the manuscript should list the members of the larger authorship group in an appendix to their acknowledgment.

Protecting research subjects

Journals should ask authors to state that the study they are submitting was approved by the relevant Research Ethics Committee or Institutional Review Board. If human participants were involved, manuscripts must be accompanied by a statement that the experiments were undertaken with the understanding and appropriate informed consent of each.

Editors should reserve the right to reject papers if there is doubt whether appropriate procedures have been followed. If a paper has been submitted from a country where there is no Ethics Committee, Institutional Review Board, or similar review and approval, editors should use their own experience to judge whether the paper should be published. If the decision is made to publish a paper under these circumstances a short statement should be included to explain the situation.[ 10 ]

• THE MAIN FORMS OF SCIENTIFIC AND PUBLISHING MISCONDUCT

The Oxford English Dictionary describes fraud as “wrongful or criminal deception intended to result in financial or personal gain” and deceit as “the action or practice of deceiving someone by concealing or misrepresenting the truth”.[ 11 ]

Research organizations and the literature have defined these behavioral patterns within the umbrella title of “Research Misconduct”.[ 12 ]

There are three major and most severe forms of scientific fraud, scientific and publishing dishonesty or misconduct, in proposing, conducting or evaluation of research and presentation of the research results:

Inventing data and results (fabrication);

Alteration or changing the results (falsification); and

Plagiarism (plagiarism), including self-plagiarism (self-plagiarism), fragmented, repetitive and double publication (duplicate publication).

Besides these, there are a number of other kinds of misconduct that scientists should know how to recognize and avoid that is, “pathology” of authorship, conflict of interest, conflicts of loyalty, “pathological” science, etc.

In the process of publishing scientific papers, it is important to know how a completed research should be described in a scientific paper.[ 6 ]

Falsification/fabrication of data

The integrity of research depends on the integrity of the data and the data record. As falsification and fabrication call into question the integrity of data and the data record, they represent serious issues in scientific ethics. Falsification is the practice of omitting or altering research materials, equipment, data, or processes in such a way that the results of the research are no longer accurately reflected in the research record. Fabrication is the practice of inventing data or results and recording and/or reporting them in the research record. Both of these schemes are probably among the most serious offenses in scientific research as they challenge the credibility of everyone and everything involved in a research effort.[ 13 ]

However, it is questionable whether a clinical researcher who fabricates data to enroll a terminally ill patient into a trial that ultimately may lead to that individual receiving treatment that may prolong their life should receive the same penalty as someone fabricating data for their own professional gain.[ 14 ]

These offenses make it very difficult for scientists to move forward as it is unclear to anyone what if anything is true and can be trusted-can lead students and colleagues to waste precious time, effort, and resources investigating dead ends.[ 13 ]

The term plagiarism stems from the Latin word plagium, meaning kidnapping a man. It literary means theft, taking material authored by others and presenting as someone else’ Plagiarism is basically intended to deceive the reader's. Izet Masic reminded of the comment of Samuel Johnson, dealing with a manuscript that he sent for evaluation: “Your work is both good and original. Unfortunately the parts that are good are not original, and the parts that are original are not good”.[ 13 ]

Referring to the United States’ Office of Research Integrity (ORI) definition of plagiarism, which is “unattributed textual copying”, many have questioned its applicability in real life situations. One definition of plagiarism suggests it is the repetition of 11 words or the overlap of 30 letter strings, although this is by no means a standard definition. Furthermore, “salami-slicing”-the selective use of research-project results to maximize the number of presentations possible-has also been classed as a type of plagiarism by some, but not by others.[ 14 ]

Plagiarism can be divided into direct (plagiarism of the text); mosaic (the borrowing ideas and opinions from original source and a few verbatim words of phrases without crediting the author) and self-plagiarism (which refers to re-using one's own work without citations).[ 15 ]

Researchers rely on the published data, and have to be skilled to selectively process these data, to incorporate previous knowledge into a new paper, and to distinguish original ideas and research results from already publicized ones. Authors are obliged to follow ethical, moral, and legal regulations acceptable by the scientific community. To do so, they must properly cite relevant publications and quote borrowed published or unpublished ideas and words. Simply, when an author copies others’ text word for word, the borrowed passage should be enclosed in the quotation marks (inverted commas). The reader should be clearly informed over what is original and recycled from other sources.[ 15 ]

Redundant (multiple) publication

Journal instructions should clearly explain what is, and what is not, considered to be prior publication. Journals may choose to accept (i.e. consider “not redundant”) the re-publication of materials that have been accurately translated from an original publication in a different language. Journals that translate and publish material that has been published elsewhere should ensure that they have appropriate permission (s), should indicate clearly that the material has been translated and re-published, and should indicate clearly the original source of the material. Editors may request copies of related publications if they are concerned about overlap and possible redundancy. Re-publishing in the same language as primary publication with the aim of serving different audiences is more difficult to justify when primary publication is electronic and therefore easily accessible, but if editors feel that this is appropriate they should follow the same steps as for translation. Editors should ensure that sub-group analyses, meta-and secondary analyses are clearly identified as analyses of data that have already been published, that they refer directly to the primary source, and that (if available) they include the clinical trial registration number from the primary publication.[ 16 ]

• NATIONAL BODIES

One of the oldest organizations dealing with research misconduct is the ORI in the United States. Set up in 1992, it oversees and directs Public Health Service research integrity activities. With a huge budget of $30 billion, it provides significant funds in the areas of health, research, and development, and oversees bodies such as The National Institute of Health and The Office of Public Health and Science.[ 14 ]

The Committee on Publication Ethics (COPE) was established in 1997 by a small group of medical journal editors in the UK, but now has over 7000 members worldwide from all academic fields. Membership is open to editors of academic journals and others interested in publication ethics. Several major publishers (including Elsevier, Wiley-Blackwell, Springer, Taylor and Francis, Palgrave Macmillan and Wolters Kluwer) have signed up some, if not all, of their journals as COPE members. COPE provides advice to editors and publishers on all aspects of publication ethics and in particular, how to handle cases of research and publication misconduct. It also provides a forum for its members to discuss individual cases. COPE does not investigate individual cases, but encourages editors to ensure that cases are investigated by the appropriate authorities (usually a research institution or employer).[ 17 ]

The UK Research Integrity Office is another body representing the interests of over 50 universities and organizations dedicated to scientific research. Set up in 2006, its aims are to:

Promote the good governance, management, and conduct of academic, scientific, and medical research;

Share good practice on how to address poor practice, misconduct, and unethical behavior; and

Give confidential, independent, and expert advice and guidance about the conduct of academic, scientific, and medical research.[ 18 ]

• CONCLUSIONS

If one wants to create a scientific work, must have on his mind that creating a scientific work requires creativity and openness, honesty, trust, and obeying the ethical principles for writing a scientific paper.

As well an author in medical sciences should always follow the words; “The health of my patient will be my first consideration”, (Declaration of Geneva, Adopted by the 2 nd General Assembly of the WMA, Geneva, Switzerland, September 1948).[ 19 ]

While working on a an biomedical research involving human subjects medical workers should have on mind that it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out.

The subjects should be volunteers-either healthy persons or patients for whom the experimental design is not related to the patient's illness.

The investigator or the investigating team should discontinue the research if in his/her or their judgment it may, if continued, be harmful to the individual.

In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.

Investing in education of researches and potential researches already in the level of medical schools, educating them on research ethics, what constitutes research misconduct and the seriousness of it repercussion is essential for finding a solution to this problem and ensuring careers are constructed on honesty and integrity.

Source of Support: Nil

Conflict of Interest: None declared.

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Ethics in Research

• Samiran Nundy 4 ,
• Atul Kakar 5 &
• Zulfiqar A. Bhutta 6  
• Open Access
• First Online: 24 October 2021

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Ethics is a set of moral principles of ‘what is right?’ and ‘what is wrong?’ or, in simple words, ‘what is good and what is bad?’ When the same principles are applied to medicine, the subject is called medical ethics. It is expected that a doctor should act in a particular way and follow certain rules. Medical ethics are professional standards for physicians. Bioethics is a branch of medical ethics and deals with complex issues like euthanasia, transplant medicine, genetic medicine, assisted reproduction therapy, human cloning, and medical genomics. Medical ethics and bioethics concepts are guides for physicians and to ensure patient safety.

“Wrong is wrong even if everyone is doing it. Right is right even if no one is doing it.” William Penn, American writer, (1644–1718).

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1 What Are Ethics, Medical Ethics, and Bioethics?

2 What Is the History of Medical Ethics?

Hippocrates is considered to be the father of medicine (as well as medical ethics) and enunciated what is now known as the Hippocratic oath around the fifth century BC, which most graduating doctors are required to take even today. In China, Confucius, the great philosopher, enunciated the concepts of ethics [ 1 ]. In 1947, after the Second World War a landmark court in Nuremberg, Germany which was investigating the atrocities of Hitler and the Nazis enunciated the Nuremberg Code which has now served as the foundation of modern-day ethics. This was followed in 1949, by the Geneva Declaration and subsequently, in 1964, there was a Declaration of Helsinki that modified the ethical code. 1n 1996, the International Conference on Harmonization of Technique Requirement and Good Clinical Practice Guidelines were published (ICH GCP) [ 2 ] involving 13 core principles which all investigators follow today.

In India, the history of medical ethics goes back to the Indus Valley civilization. Ayurveda is an ancient science and two of its manuscripts the ‘Charak Samhita’ and ‘Shushrut Samhita’ provide guidelines on ethical practice. More recently, in 2017, the Indian Council of Medical Research enunciated a set of guidelines on medical ethics which we will discuss later.

3 What Are the General Principles of an Ethical Clinical Trial?

These are based upon protecting the patients’ rights, safety and ensuring his or her willingness to participate. The notorious Tuskegee study on Negro (African-American) males who had syphilis and were left untreated to observe the natural course of the disease was a landmark where no medical ethical principles were followed. It was supposed to last for 6 months but continued for 40 years (1932–1972) [ 3 ]. Although the drug penicillin, which could have cured them, was discovered in 1947, the trial patients were not given it or even informed about its existence. They were just given food, free treatment, and a burial [ 3 ]. Other studies which were unethical were done by the Nazis during the Second World Ward and in some of these they observed the physiological effects of immersing prisoners in ice-cold water. The Nuremberg code was a direct result of such gruesome experiments.

4 What Are the Principles of Medical Ethics?

The four principles are Autonomy, Beneficence, nonmaleficence, and Justice (Fig. 13.1 ).

Autonomy means patients should have a choice on whether they want to participate in a study [ 4 ]. They also have the right to information on the purpose of the clinical trial the right to withdraw midway, and also the right to know about the details of the drug used in the clinical trial. After stopping the trial, the patient has the right to be on an approved standard of care.

Beneficence is derived from the Latin word meaning ‘good deed’. It is to perform an act of ‘charity, mercy, and kindness’ with the strong implication of doing good to others including doing what is one’s moral duty [ 5 ].

Nonmaleficence means ‘to do no harm’. Thus, the trial should benefit the participant rather than harm them. The principle of nonmaleficence supports the following rules—do not kill, do not cause pain or suffering, do not incapacitate, and do not cause offence [ 6 ].

Justice. The fruits of the research should be for all sections of society and benefit the rich and poor equally. Each patient should be treated on his or her merit and need [ 6 ].

Basic principles of Ethics

5 What Are the Duties of Ethics Committees?

Research is an important method of advancing medical knowledge but, at the same time, those who do research should not violate human rights. Every institution which does research should have an ethics committee which is a heterogeneous group of individuals whose aims are to monitor all research projects involving humans so that they are being done in the right way and on the right patients. They ensure patient safety and have the right to accept, modify, reject and stop any trial [ 7 ]. They should also look at the risk-to-benefit ratio to the participants and to their safety. Their specific duties are to:

Review the scientific soundness of the trial.

Accept or reject the proposed trial.

Ensure the safety of the patient.

Ensure the well-being of all the participants.

Ensure travel reimbursements for the participants.

Debar any group or individual which does not follow ethical principles.

6 What Is an Institutional Review Board (IRB)?

Sometimes an Ethics Committee is called an IRB which consists of members who ensure human safety during trials. There should be at least 5 members, according to good clinical practice, 7 according to the schedule Y of the Act, and 8–12 according to the Indian Council of Medical Research (ICMR) [ 8 ]. The members should be from different fields, one from civil society, one lawyer, one social worker, one basic medical scientist, one clinician, and one philosopher. It should have a Chairperson who is usually from outside and a Secretary from within the institution in which the project is proposed to take place. It must also include a woman. The quorum should be complete while addressing any issue. The IRB requires registration from the Central Drugs Standard Control Organization (CDSCO) and its registration requires renewal after every 3 years [ 9 ]. All records related to trials should be kept with the IRB for at least 3 years after their completion.

7 Which Documents Are Required to be Submitted to the Ethics Committee for Approval?

The list includes the following:

Protocol of the trial.

Any amendments related to the trial.

Consent form given to the subjects.

Investigators’ details.

Curricula vitae of the investigators.

The Clinical Trial Agreement (CTA).

Insurance papers that are site specific.

Regulatory approval letter from the Drugs Controller (DCGI).

Any advertisements related to the trial.

Proof of travel reimbursements to the participants.

Data collection form.

Besides these, the committee may ask for any other paper which is related to the trial.

8 What Happens in Case an Adverse Effect Occurs in a Clinical Trial?

All investigators are required to send regular recruitment-related updates, trial-related protocol deviation, report side effects, and serious adverse effects. In case a patient has any adverse effects, the primary investigator/sponsor should inform the ethics committee and treat the patient. The trial should be accompanied by insurance which covers any hospitalization or death. In case of death or serious adverse effect, the patient or his family needs to be awarded compensation based on a specified formula (Table 13.1 ) [ 10 ].

A serious adverse effect is defined by the Central Drugs Standard Control Organization as: [ 8 ]

Hospitalization of the participant in case the study was being conducted as an out-patient.

Prolongation of hospitalization in case the study was being conducted on an in-patient.

Persistent or significant disability or incapacity.

A congenital anomaly or birth defect.

Life-threatening condition.

The Drugs Controller General of India has issued a directive mentioning that any trial injury or death should be compensated by the sponsor. A compensation formula has already been proposed by the Independent Expert Committee for clinical trial-related death (Table 13.1 ).

9 What Is Medical Research Misconduct?

The Primary Investigator is the principal person who leads the research team. He or she needs to act in a way that is not influenced by his sponsors, pharmaceutical companies, or his peers. Research misconduct includes the following:

Construction/making-up of data intentionally.

Recording/reporting of fabricated data.

Manipulating the research content.

Omitting/suppressing data or results in the analysis.

Overlooking scientific data without statistical justification.

Plagiarism—‘stealing of ideas’ or using other authors’ language for publication.

10 Is Consent Important in Doing Research?

Written Informed Consent is a very important document that is required to be signed before starting or enrolling a patient. It means that the patient is willing to participate in the study. This document is signed by the patient who is explained about the risks, benefits, and side effects of the drug being tested. This is applicable for all adults of more than or equal to 18 years of age. If a child is involved in the study and has not attained legal age this is called ‘assent’. This information can be given to the patient verbally or in the form of a written document or both. Figure 13.2 explains the need for three important aspects for taking consent [ 10 ].

Purpose of informed consent

Informed consent form must include the following:

A declaration stating that it is research.

Explaining the purpose of the study in simple language and how it will be done.

Information about the probable duration of the involvement and the number of times the subject will be called for data collection.

What benefits might accrue to the patient /subjects or to the community with the results expected from the research.

Any predictable risks, distress, or awkwardness to the subject from participation in the trial.

The level at which the privacy of the records will be maintained.

Imbursement/reimbursement for subjects and accompanying relatives depending on the type of study.

Free treatment and/or reimbursement of the subject for research-related injury and/or harm.

Liberty of the subject to participate and/or withdraw from the trial at any time without consequence.

Trial-related information of the Principal Investigator and other members of the team and of the Chairperson and Secretary of the IRB.

In addition, the following information may also be required depending on the type of study:

Any different drugs/measures which may be beneficial to the participant.

If there is a likelihood that the trial could lead to any defamation of the subject.

Indemnification coverage if any, for research-related to serious adverse effects (SAE).

Time for which the sample will be stored and used for secondary purposes.

If the biological tissue will be shared with other researchers.

Potential strategies to enhance the informed consent process.

11 What Are the Ways to Enhance the Informed Consent Process?

The various ways to enhance informed consent have been listed in Table 13.2 . The process of consent should be voluntary, comprehensive, and informative. Additional audio-visual aids and printed sheets can help in decision-making [ 11 ].

12 Conclusions

Ethics is an important aspect of the medical profession.

The principles of ethics are autonomy, beneficence, nonmaleficence, and justice.

Consent is an act of voluntary agreement between the patient and doctor.

Consent is in simple language which the participant can understand. It gives details of treatment, possible side effects, and benefits to the patient.

Compensation is given if there are adverse events in a clinical trial.

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Department of Surgical Gastroenterology and Liver Transplantation, Sir Ganga Ram Hospital, New Delhi, India

Samiran Nundy

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Institute for Global Health and Development, The Aga Khan University, South Central Asia, East Africa and United Kingdom, Karachi, Pakistan

Zulfiqar A. Bhutta

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Nundy, S., Kakar, A., Bhutta, Z.A. (2022). Ethics in Research. In: How to Practice Academic Medicine and Publish from Developing Countries?. Springer, Singapore. https://doi.org/10.1007/978-981-16-5248-6_13

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• Fostering relational autonomy in end-of-life care: a procedural approach and three-dimensional decision-making model
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• http://orcid.org/0009-0000-7846-7784 Kar-Fai Foo 1 ,
• http://orcid.org/0000-0002-5992-2144 Ya-Ping Lin 1 , 2 ,
• http://orcid.org/0000-0001-5810-8776 Cheng-Pei Lin 3 , 4 ,
• http://orcid.org/0000-0001-7234-4484 Yu-Chun Chen 5
• 1 Institute of Public Health , National Yang Ming Chiao Tung University , Taipei , Taiwan
• 2 Department of Medical Humanities and Education , School of Medicine, National Yang Ming Chiao Tung University , Taipei , Taiwan
• 3 Institute of Community Health Care, College of Nursing , National Yang Ming Chiao Tung University , Taipei , Taiwan
• 4 Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation , King's College London , London , UK
• 5 Department of Nursing , National Taiwan University Hospital , Taipei , Taiwan
• Correspondence to Dr Ya-Ping Lin, Department of Medical Humanities and Education, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan; arete{at}nycu.edu.tw

Respect for patient autonomy is paramount in resolving ethical tensions in end-of-life care. The concept of relational autonomy has contributed to this debate; however, scholars often use this concept in a fragmented manner. This leads to partial answers on ascertaining patients’ true wishes, meaningfully engaging patients’ significant others, balancing interests among patients and significant others, and determining clinicians’ obligations to change patients’ unconventional convictions to enhance patient autonomy. A satisfactory solution based on relational autonomy must incorporate patients’ competence (apart from decisional capacity), authenticity (their true desires or beliefs) and the involvement level of their significant others. To that end, we argue that John Christman’s procedural approach to relational autonomy provides critical insights, such as the diachronic or socio-historical personhood, sustained critical reflection and his recent explication of the nature of asymmetrical relationships and helpful interlocutors. This study reviews Christman’s account, proposes minor modifications and advocates for an integrated three-dimensional model for medical decision-making. Clarifying the relationship among the three elements promotes an ethical framework with a coherent understanding of relational autonomy. This model not only provides a descriptive and normative framework for end-of-life care practice but also reconsiders the nature of the clinician–patient relationship and its normative implications. We further present a case study to illustrate the merits of our proposed model. Altogether, our proposal will help navigate complex medical decision-making, foster trust and negotiate shared values between patients and their significant others, particularly in end-of-life care.

• Relational Autonomy
• Decision Making
• Terminal Care
• Professional-Patient Relations

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Introduction

In end-of-life care, intricate decisions on whether to undergo invasive interventions or withhold or withdraw life-sustaining treatment involve not only great uncertainty but also tension between the patient’s self-determination and the interest of third parties. Respect for autonomy is widely asserted as a key arbiter, operationalised through assessing patients’ decision-making capacities and fulfilling their treatment preferences. 1 However, this principle’s role as an ideal ethical panacea is increasingly being challenged, particularly from the perspective of relational autonomy (RA).

Originally proposed in political and social philosophy, RA criticises the mainstream individualistic interpretation of autonomy for its omission of social connectedness as the quintessence of human existence and external forces on one’s autonomy. 2–4 RA has been increasingly adopted to resolve end-of-life issues, 5–9 and its proponents recognise that the clinician–patient relationship has important ramifications in fostering patient autonomy. 10 Three ethical recommendations are commonly highlighted for clinicians: (1) merely securing patients’ informed consent is insufficient to respect their autonomy; (2) consulting or involving patients’ significant others in the decision-making process is desirable and; (3) one must sensitively deal with relevant historical, religious, cultural and social contexts that influence patient autonomy.

Despite these laudable recommendations, clinicians struggle with knotty dilemmas: how to ascertain the true beliefs of their patients, how to meaningfully engage with various parties, 11 and the potential disagreements among them. 12 13 Further, given a patient who firmly endorses a rather unconventional cultural stance or personal conviction, should a dissenting clinician attempt to proactively change the patient’s perspective? 14

Scholars generally endorse competence and authenticity as two essential conditions of autonomy, subject to specification by each theory. 15 As a specific theory of autonomy, RA purports that individuals must possess some necessary competence apart from ordinary decision-making capacities and act according to their true desires or authentic selves. 3 Some scholars propose an interdependent decision-making model that justifies different modes of involving others , depending on the patient’s capacity or competence. 11 However, this model fails to incorporate the patient’s authenticity and thus does not completely align with RA. Contrary to some early critics, 16 17 authenticity has gained considerable traction in bioethical discourse. 18–21 Incorporating the authenticity condition of autonomy may produce a thorough, coherent RA solution to the above-mentioned dilemmas. To the best of our knowledge, only one study 8 has attempted to balance all three essential elements (ie, patients’ competence, authenticity, and the involvement level of others) by using Mackenzie’s multidimensional theory of RA, 22 however, without contemplating any potential alterations to the nature of the clinician–patient relationship.

In this study, we refer to a largely undervalued resource as a better theoretical construct: John Christman’s theory of RA. Christman’s theory of RA has recently received considerable attention from bioethicists in terms of ethical issues involving deep brain stimulation, 23 psychiatric disorders, 24 cognitive enhancement, 25 genetic counselling, 26 biobanking, 27 advanced directives for dementia patients, 28 29 shared decision-making (SDM) 30 and organ donation. 31 Nevertheless, these studies often use Christman’s theory in fractions, primarily based on his famous explication of the authenticity condition of autonomy. This may be because of the publication lag between Christman’s contributions and his sequential minor revisions, making it difficult for bioethicists to track his account. Nevertheless, his recent view of the nature of asymmetrical relationships holds great potential for reconciling ethical conflicts in end-of-life care, lending a critical lens to reflect on clinicians’ roles in actual clinical encounters.

We believe Christman’s theory could contribute to two veins. First, with two minor modifications to his theory, we propose a three-dimensional decision-making model that fully agrees with RA. This integrated model provides a descriptive and normative basis for end-of-life care. Second, this theory could explain the nature of the clinician–patient relationship by emphasising that clinicians should respect and foster patient autonomy. In this context, this study uses an illustrative case to demonstrate how clinicians can facilitate meaningful interactions with various parties to enhance patient autonomy during clinical encounters.

Revisiting John Christman’s account

Some understanding regarding the categorisation of RA is necessary here. There are two types of relational autonomists: proceduralists and substantivists. Proceduralists commit to ‘content-neutrality’ and do not provide a normative standard to determine the ‘rightness’ of the agent’s choice, while substantivists place certain normative constraints on the contents of agents’ preferences. 3 In this study, we commit to justifying an ethical solution in a procedural sense by pacing Christman’s stance. This section first lays out Christman’s original position and then proposes modifications that lead to a distinctive ethical approach to end-of-life care decision-making.

Christman’s diachronic or socio-historical conception of self maintains that everyone has a unique trajectory of growth, consciously or not, explicitly or implicitly accepting or rejecting numerous social norms across their lifespan. Although individuals might encounter countless ambivalences about their true beliefs or possible tensions between beliefs, or they could never elucidate the formation of certain beliefs, Christman encourages us to embrace such a human reality: an individual who can always clearly identify their beliefs with wholehearted endorsement is virtually non-existent. 32–34 Hence, this theory rejects the Frankfurtian and Dworkinian hierarchical model of desire (ie, identification and endorsement). Moreover, it contrasts with the time-slice or ahistorical conception of self, which devoids individuals from their intimate experiences, viewing their living history as irrelevant to selfhood. 34–36

Perceiving selfhood in a diachronic way thus affirms that one’s authentic beliefs cannot settle on the functioning of faculties at a given time but hinges on subjective approval of personal history. The same traits can be reflected over time and under different circumstances to produce a coherent autobiography or an appropriate narrative. Christman calls this reflective process ‘ sustained critical reflection ’ (SCR), which ensures that certain traits can endure through an ever-growing personal history, better reflecting one’s true self 34 (p152) . Christman is not proposing ‘any actual reflection take place on the characteristic in question; nor does it demand that wholesale self-evaluation from a disembodied standpoint take place,’ instead, he claims that occasional, tokenistic ‘ hypothetical and piecemeal ’ reflection ‘in light of the history of the factor’s development to take place, [one] would not feel deeply alienated from the characteristic in question’ 34 (p145, emphasis added in italics) .

Accompanied by the SCR, Christman used a non-alienation test to determine whether certain traits were counted as authentic. Being alienated involves not only one’s cognitive judgement but also one’s salient emotional arousal, strong disapproval and intense resistance towards certain traits. Christman viewed subjective non-alienation as a good basis for instantiating one’s ‘ diachronic practical identity’ 34 (p151) . Borrowing Christine Korsgaard’s theory of practical identity, Christman asserts that a well-consolidated, non-alienated practical identity not only provides motivation for agents to act authentically but also elicits their ‘ reflexive self-affirmation ’ upon their identity, promoting their self-regarding attitudes (ie, self-trust and self-confidence) 37 (p222) . Acknowledging that individuals are hardly detached from their social roles, Christman expands SCR to include publicly available categories, allowing one to examine whether a description of certain social roles (ie, mother, teacher) could reflexively pass the non-alienation test, apart from solely focusing on the private category of personal desire or motivation 37 (p219-220) .

To reckon as a competent agent, Christman maintains that one only needs minimal social, bodily, affective and cognitive competence to engage in SCR; the lack of self-regarding attitudes is not necessarily a prior precluding factor 34 (p182) . However, the reflective process might also need to be free from constraining factors, such as ‘in an uncontrollable rage, or while on heavy doses of hallucinogenic drugs, or having been denied minimal education and exposure to alternatives’ 34 (p147) . Since this depiction does not impose sophisticated or complex requirements, it is firmly in accord with Christman’s commitment to broadest inclusivity in political and social circles; it reaffirms his long-standing stance as a proponent of anti-perfectionism by rejecting to preclude people’s political and social participation only based on specific moral standards external to their convictions. 38

More recently, Christman has acknowledged that third parties or interlocutors could aid in forming practical identities by proposing a joint deliberation model that presses a more relational approach to RA. 37 39 40 Christman has revised his theory to consider ‘asymmetrical relationships,’ reconciling potential paternalist charges on RA. While paternalism might be difficult to eliminate in this context, the advantaged actor might decide whether the best advice or intervention is to restore the vulnerable person’s sense of autonomy depending on the latter’s evolving practical identity 39 (p379) . In some cases, Christman suggests the advantaged, such as social workers, not only ought to assess the vulnerable’s autonomy—a requirement to respect their autonomy—but also bear an obligation to value their autonomy and facilitate their sense of autonomy 39 (p373, p379) . Further, Christman also underlines that the advantaged must avoid performing anti-social attitudes towards the vulnerable, which could posit a detrimental effect on the latter’s autonomy 39 (p381) . To maintain the proceduralist ‘content-neutrality’ commitment, Christman suggests that, while the vulnerable might feel alienated from their previous autobiographies or entirely change their perspective after accepting advice or intervention, they need to provide at least a ‘ process-independent reason ,’ indicating that the change of mind has nothing to do with the intervention itself, to avoid potential undue influence from the powerful actor. 40

An integrated decision-making model of RA

Terminally ill patients often encounter deep uncanniness; they experience profound life-transformative events, such as unfamiliarity with their currently ill bodies, first-time experience living in wards, inexperienced communication with medical teams and duelling with family members’ loaded emotions. This uncanniness not only frustrates them but ultimately undermines their RA. Focusing solely on one’s decisional capacity or treatment preferences at the decision-making point cannot effectively discharge the ethical duty of respecting patient autonomy.

To that end, operationalising Christman’s RA theory, this section integrates an individual’s competence, authenticity and involvement level of significant others into a unified, three-dimensional framework. Our proposal raises the need to reinvigorate the need to maintain good clinician–patient communication and is not intended to promote a direct, hands-on to resolving ethical dilemmas. As noted by Entwisle et al , ‘[r]elational account will not generate simple action lists for clinicians that guarantee protection for patients’ autonomy’ 10 (p744) ; clinicians must attend to the context-specific nature of each encounter and patients’ characteristics. We elaborate on the relationships among the key elements and discuss a minor modification to Christman’s original account: relaxing the competence condition to allow a broader spectrum of patients to engage in SCR.

Competence and authenticity

A comprehensive theory of RA must define a clear relationship between competence and authenticity. According to Christman’s theory of RA, stake detachment between a patient’s current episodes and past historical narratives undoubtedly interrupts socio-historical selfhood. To better capture the traits that truly reflect a patient’s autobiography after experiencing drastic events, clinicians can first invite the patient to engage in SCR and use the non-alienation test. An appropriately constructed autobiography could, in turn, serve as an essential reference for medical decision-making and determining the treatments that align with a patient’s authentic wishes. In addition, clinicians can help patients rethink their expectations of their multiple social roles, enhancing reflexive self-affirmation.

Regarding the competence condition, patients’ fluctuating conditions and possible acute situations may seem too demanding to engage in SCR. As stated above, Christman maintains that only minimal social, bodily, affective and cognitive competence are required to engage in SCR. Patients with mental capacity or consciousness impairment (eg, dementia, brain injury, frailty or delirium due to deteriorating illness), temporary emotional distress (eg, anxiety or depression), psychiatric disorders (eg, schizophrenia or bipolar disorder) and learning disabilities (eg, people who are illiterate or have little or no speech) might have increased disadvantaged of being precluded the chance to express their preferences or wishes. 41

Christman’s competence requirement reminds clinicians to resist the temptation to forgo engagement with patients unwarrantedly based solely on their disease category. A person with one of the health conditions stated above does not necessarily lack the capacity to make a specific decision and engage in SCR, unless evidence proves that this is not possible by any means. 42 One may lack the capacity to make some decisions (eg, to decide on complex financial issues) but can still make other decisions (eg, to decide what items to buy at the local shop). Hence, not only clinicians ought to engage with their patients substantially and creatively, but future research must also be encouraged to develop feasible communicative tools and techniques for clinicians to meaningfully engage with patients with special needs. Granted, when individuals are concerned, patients in a persistent vegetative state, irreversible coma and certain severe psychiatric and learning disability conditions might be deemed unsuitable to engage in SCR. Clinicians and significant others may determine these patients’ authentic wishes, which will be addressed in the following discussion.

However, we contend that a subpart of Christman’s competence requirement—one must be free from the constraining factors—must be relaxed to maintain his ambit and include a broader range of individuals in healthcare settings. Particularly, Christman’s original position precludes people ‘having been denied minimal education and exposure to alternatives’ from engaging in SCR. This condition must be dropped in the end-of-life realm, as it might deny their opportunity for critical reflection and result in the unilateral exclusion of certain groups or people, impeding Christman’s anti-perfectionist stance. By recognising that some patients might be too deprived to form their authentic wishes, clinicians and the interdisciplinary treatment team must always allocate sufficient time to continuously engage with and consult patients to understand their perspectives to the greatest extent. Moreover, clinicians could invite significant others’ input to construct possible contours of patients’ autobiographies. However, if clinicians’ prudence deems patients susceptible to familial malfunctioning or interpersonal dominance, they should consider limiting the perpetrators from speaking on patients’ behalf. Given the best efforts to draw possible historical profiles of patients, and they are comfortable with, or at least not opposed to this narrative, we contend that it is sufficient to locate patients’ non-alienation. We believe this does not oppose Christman’s SCR requirement that the patient has engaged in ‘hypothetical and piecemeal’ reflection, and overdoing patients might not be beneficial to building trust towards clinicians. Additionally, appealing to substituted judgement standards straight away might further strip patients of autonomy.

In figure 1 , the two extremes of the continuum reflect the probability of performing autonomous decision-making: ‘likely autonomous decision’ and ‘unlikely autonomous decision’. The former implies that an individual can engage in SCR and is not alienated from their basic organising values and commitment in light of historical processes. The latter implies that an individual cannot engage in SCR and that their decision cannot be explained by their socio-historical understanding. Between these extremes, a plausible autonomous decision could coincide with changes in an individual’s critical reflection ability, and it must be assessed whether this decision aligns with or deviates from the individual’s fundamental life-long values and goals.

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Competence and authenticity. *C= basic organizing values & commitments of an individual.

Competence and involvement level of significant others

Largent et al have elaborated on the relationship between an individual’s capacity and the involvement level of significant others in medical decision-making. 11 Their interdependence model proposes a continuum between ‘total independence,’ where patients with full capacity can decide for themselves, and ‘total dependence’, where patients without capacity would need a surrogate to speak on their behalf. Between these extremes, the individual’s capacity level and various combinations of significant others involved in the decision-making process exemplify the interdependent nature of the decision-making continuum (eg, in the form of supported decision-making and permission plus partial involvement).

We adapted Largent et al ’s model and applied Christman’s conceptual understanding of ‘competence’ to propose a revised model as seen in figure 2 . Building on the proposed changes in Christman’s condition of competence, this model values one’s ability to perform SCR as well as the involvement of others during the decision-making process. Patients without a bare minimum of competence cannot decide for themselves (lower-left corner of figure 2 ) and should be considered rare in real clinical settings. Moreover, even if patients possess full competence, they could voluntarily delegate their decision-making authority to others (lower-right corner of figure 2 ).

Competence and involvement level of significant others.

Apart from patients’ significant others and surrogates, healthcare providers can use their expertise to partially alleviate barriers for patients to enable them to exercise competence, such as by restoring appropriate cognitive or physical functions and reducing physical and/or psychotic distress. As illuminated by Christman, clinicians ordinarily in a superior position could use communicative skills to improve patients’ self-regarding attitudes and avoid anti-social attitudes towards them. Certain communicative and social conceptions, such as cultural competency, 43 structural competency, 44 and epistemic justice, 45 must be imbued into clinical conversations. Tackling clinicians’ unconscious, implicit biases towards certain patient traits 46 47 and raising awareness about disempowering daily language could better equip clinicians to empower their patients. 48 Without such prior readiness, clinicians might not detect anything extraordinary in their patients and be unable to resolve ethical dilemmas sensitively by considering each patient’s uniqueness.

Moreover, when medicine cannot restore a patient’s competence (eg, permanently incapacitated), clinicians could determine which decision-making standards should be applied in collaboration with patients’ significant others or surrogates. We agree with Scheunemann et al that if the surrogates hold sufficient information to make decisions that accord with the patients’ authenticity, this standard should prevail over the best interest standard. 19 Hence, clinicians need to robustly and sensitively engage with surrogates, especially those experiencing psychological distress and grief.

Authenticity and involvement level of significant others

According to Christman’s theory of RA, once individuals’ decisions are not alienated from their life values and commitment after exploring their historical experience and self-identity, certain competence conditions are satisfied. We further echo Christman’s characterisation of helpful interlocutors, showing that clinicians, and not physicians alone, play an equally paramount role as significant others in coconstructing a patient’s autobiography. 11 19

In our approach, desirableness includes patients’ significant others in decision-making; however, we elucidate what clinicians might contribute. Some proponents of SDM have highlighted its nature as an ‘existential journey,’ viewing patients from a whole-person perspective rather than mere patients. 49 50 As Gulbrandsen et al highlighted, patients’ dependency on medicine and health professionals could invariably be seen as putting trust in this asymmetrical relationship. Taking a relational view of patients’ selfhood, while good cure strives to accommodate patients’ physical or bodily related vulnerabilities, good patient-centred care would need to take their delicate relationalities and social needs onboard, particularly their inevitably interrupted sense of selfhood. As a ‘curator’, the clinician needs to tailor appropriate strategies for conducting SDM for each patient, adjusting the content of the daily clinician–patient conversation, and working jointly with the patient to rebuild their new sense of selfhood and existential meaning for consecutive life 49( p1508) .

Moreover, numerous practical techniques, such as the ‘life review’ approach and lifeline interview, have also been developed to guide clinicians in working with patients and constructing treatment preferences based on their socio-historical backgrounds. 51 52 These trends have coincided with Christman’s ethos. As mentioned above, clinicians must be equipped with certain communicative skills and mindsets to better engage with patients and their significant others. Recently, a group of clinician scholars have shown the feasibility of the ‘lifeline interview’ method for advanced lung cancer patients. 52 In this study, these Japanese patients are asked to draw a consecutive line on a formatted graphic to describe the magnitude of the ups and downs of certain life events. This process is accompanied by a semistructured interview guide conducted by the research team to better elicit the reason why patients put a certain magnitude towards each life event and record whom the patient would want to engage in the SDM or advanced care planning process. The authors claim their work is feasible mainly to help patients ‘to rediscover their values and strengths’ even in a country that usually sees talk of death as taboo 52( pE142) .

Clarification and implications

We have proposed a three-axis model of RA in end-of-life decision-making, enabling more contextual medical decision-making practices. Therefore, we have shown that integrating the three elements (competence, authenticity, and involvement level of significant others) for end-of-life care decision-making is theoretically possible within the ambit of RA and largely explains the core insight of current end-of-life care practices.

We do not prescribe any concrete marker(s) to indicate potential signals of the patient’s alienation or what milestone(s) should be achieved in the clinical encounters. Although we encourage the development of practical tools and educational curricula, we urge clinicians to exert their practical wisdom to unearth delicate details in each conversation session and act responsively. Busy clinicians might be relying on the prescribed marker(s), thus creating a perverse incentive for them to disregard potential signals from their patients and undermining their ethical sensitivity in the long run.

This study’s model has two implications. First, it might appear that the SCR and non-alienation test are not different from other mechanical procedures, such as decision-making capacity assessment. By contrast, while the latter might be executed without robust bidirectional engagement between clinicians and patients, the former urges clinicians to exemplify their professional competence by diligently working with various parties to co-construct an autobiography that best fits the patient’s authenticity. Hence, a proceduralist does not necessarily adopt a non-interfering formalistic stance but is open to meaningful humane interaction and healthcare within the ambit of the RA. Second, this model urges clinicians to play an active role in constructing patients’ autobiographies, underlining an interdisciplinary approach to end-of-life care. Although physicians and nurses bear the primary responsibility for the care plan, the involvement of pain management, bereavement, holistic care and spiritual care share differential weights depending on the situation.

The clinician–patient relationship and relevant obligations

To better characterise the obligations borne by clinicians and patients, we must rethink the asymmetrical clinician–patient relationship. We agree with Entwisle et al that clinicians have a general duty to support patient autonomy but maintain that it is supererogatory to restore patients’ self-regarding attitudes in every instance. 10 Although one needs to possess some social skills to develop and exercise autonomy, it is distinct to state that clinicians must instil or foster these skills in patients. A proceduralist only needs to adopt an ‘interpretive model’ of the clinician–patient relationship to ‘reconstruct the patient’s goal and aspirations, commitments and character’ 53( p2222) .

Building on the classic procedural-substantive RA debate, the substantivist might worry that patients’ elicited beliefs might be influenced by ‘adaptive preferences’, hence undermining their capabilities for developing and exercising RA. 3 When Mackenzie presents a female patient whose practical identity ‘is governed by the norms of traditional femininity’, she decries the procedural account of RA even operationalises with the non-alienation test. The patient might be so oppressed that she could not feel alienated from her belief 14( p518, 521) . She further charges clinicians an obligation to proactively shift patients’ adaptive preferences to enable them to discover alternatives 14( p528) .

Against this backdrop, we err on Christman’s assertion that even if one is genuinely influenced by adaptive preference, it does not automatically preclude them from exercising RA on a particular decision, including medical decision-making. 34 37 It seems inappropriate to value patients’ global autonomy 1 , and this overarching goal may overextend the mission of medicine, especially in the end-of-life realm. Recently, prominent subtantivists also admit that ‘[h]ealthcare professionals cannot be expected to secure the global autonomy of healthcare recipients’ 4( p80) . As shown above, clinicians should work jointly with their patients and significant others to produce a coherent autobiography. Patients’ dependence on clinicians is best explained as they put an equivocal trust in their power, clinicians not only to relieve their physical illness but also seeking to build a new sense of selfhood for them. 49 If we are correct that the procedural approach of RA is best to adopt an interpretive model of the clinician–patient relationship, attempting to proactively change patients’ unconventional convictions would obscure the opportunity to uncover their true beliefs and hence violate their autonomy, not to mention that patient would lose trust to their clinicians momentarily if clinicians persistently challenge their basic life commitments.

Additionally, even leaving aside whether there is a universal understanding of ‘adaptive preference’, it is unwise to label all unconventional beliefs under this category. As Quill Kukla (writing as Rebecca Kukla) shows, given that clinicians use their authority positively to enable patients to ‘critical engagement with their own healthcare practices’, it is justified to ascribe patients who fully delegate their decisional authority to clinicians as autonomous 54( p40) . Some might argue that such patients could be motivated to lower their cognitive dissonance during decision-making or to please their clinicians. However, this objection does not present a unique problem given that the conclusion is reached through robust conversations with clinicians and that their competence and authenticity do reflect that.

Under this clinician–patient relationship model, we largely agree with Lewis, contending that these parties are engaging in a bidirectional, mutual-recognition relationship and each must be answerable to the other, enabling the co-production of medical decision-making 30( p125-126) . For clinicians, proceduralists confirm numerous established obligations (eg, privacy and confidentiality) and impose additional obligations. Although clinicians are permissible to incorporate third parties’ opinions or convictions in decision-making, they cannot coerce or manipulate patients’ decision-making by arbitrarily limiting the scope of information flow and treatment options. Furthermore, clinicians are obliged to assess whether patients’ wills and choices contradict medical norms, even when patients exercise proper competence and authenticity.

Patients, in turn, are obligated to provide ‘appropriate reasons’ for their choices, inform those who will be influenced by the decision (ie, clinicians, family members, and significant others), and consider the latter’s views in their deliberations 30( p130) . Then, combining Christman’s theory, must patients provide ‘process-independent reason’ when changing their minds? Notwithstanding this legitimate coercive concern, we believe this should not be the case. In contrast to Christman’s example as a social worker, the end-of-life dialogue might be the only channel for patients to engage in reflection, perhaps the only one in their lifetime. As medicine might not be intended to promote patients’ global autonomy, requiring patients to provide a process-independent reason could overburden patients facing life-threatening conditions. It may necessitate disclosing excessive personal information to justify a changing stance, disproportionately bleaching their privacy. Additionally, the worry of ‘adaptive preference’ must not divert attention to hold the medical enterprise to a higher bar and take serious care of each patient by constructing their unique autobiographies.

A reiterative reflective framework is essential for procedural accounts of RA that are not prescribed positively. This framework can become integral to clinical practice, particularly in the context of end-of-life care. In the remainder of this paper, we use an illustrative case study to demonstrate how our three-dimensional RA model contributes to real-life end-of-life care decision-making.

A case study

Consider the following scenario: 2

Shu-Fen is a 63-year-old woman who has terminal bone cancer. She is being cared for by her daughter, a single mother with two young children. Shu-Fen has decided to refuse all life-sustaining treatments to reduce physical suffering and avoid becoming a burden on her daughter and society. The healthcare team concludes that she possesses full decision-making capacity.

Recently, Shu-Fen underwent a below-the-knee amputation and is having to come to terms with the prospect of permanent disability. Her illness left her feeling guilty towards her daughter and questioning her own self-worth. Shu-Fen expressed her wish to the healthcare team to cease any further treatment and let nature take its course if the cancer spreads to other parts of her body.

However, at times, when Shu-Fen experiences pain from cancer, she longs for the healthcare team to save her or at least allow her to spend more time with her daughter and grandchildren after talking and being with them.

Seeking to understand the daughter’s perspective, the healthcare team discusses with her. They observe that Shu-Fen is a self-abnegating woman who always puts family needs before her own and is used to sacrificing herself for others. Her daughter explains that her mother has experienced hardship since childhood and is not used to being dependent on others. However, she has willingly taken on the responsibility of caring for her mother and pleads with the healthcare team to do everything possible to save her.

Recognising the importance of understanding Shu-Fen’s desires and ensuring that she makes informed decisions, the healthcare team approaches her to explore her thoughts. However, she declines to express her views directly, indicating her preference to leave the decision-making authority to her daughter. Privately, though, she frequently hints that she believes her life has been fulfilling enough and does not want to burden others further.

The healthcare team finds itself in a difficult situation, as it has been unable to make substantial progress in direct communication with Shu-Fen. They are left with no choice but to discuss with her daughter, which raises concerns about whether this approach fully respects and honours Shu-Fen’s autonomy and wishes.

Shu-Fen’s case exemplifies a common scenario in clinical settings, especially in Asian contexts. This case demonstrates various complexities: (1) Shu-Fen has expressed seemingly conflicting feelings, expectations and preferences regarding her illness and death; (2) Shu-Fen and her daughter disagree; (3) Shu-Fen delegates decision-making authority to her daughter but occasionally expresses her preferences, making it challenging for others to follow. Some patients may be hesitant or reluctant to make decisions for themselves, lack a sense of autonomy, or be unfamiliar with their rights in healthcare decisions. They may not even consider themselves to have the authority to make decisions. In such cases, healthcare teams often communicate with patients’ family members and act on their decisions. While this approach may be well intentioned and ease the decision-making process, it can result in disregarding the patient’s agency and autonomy in healthcare.

First, patients often have oscillating preferences rather than clear-cut or consistent. As noted by Ohnsorge et al , the coexistence of opposing wishes can be authentic, multilayered experiences and moral understandings at the end of life. 55 Recognising that patients’ seemingly contradictory thoughts and requests can be part of the process of meaning-making and negotiating normative claims on a personal level and through interactions with others, healthcare professionals can adopt a more nuanced approach 55( p630) . Through the lens of a diachronic socio-historical account of selfhood, the patient’s self is an ongoing, transforming process. By engaging in open and empathetic discussions with Shu-Fen, the healthcare team can evaluate the extent of her competence in reflecting on her fundamental values, desires, and beliefs, as well as her expectations of her social roles as a mother and grandmother. It is vital to facilitate a decision that is not alienated from her diachronic practical identity. In the terminal phase, patients approach death with each passing moment. Self-understanding may be more important than consistent decision-making. Exploring the patient’s authentic self and collaboratively composing an autobiography and narrative that embraces evolving perspectives may be the proper way to honour RA in end-of-life care.

Furthermore, the development of RA transcends mere individual contemplation–a procedure of internal critical reflection–and transforms into an intersubjective, interactional accomplishment that unfolds within the fabric of communicative practices. In particular, one’s narrative may become more explicit through joint reflection and support from others. As argued in the previous section, healthcare teams, instead of being detached from the whole process, are obligated to provide support, such as offering medical information, alleviating symptoms, and enhancing patient confidence and self-esteem, to reduce the barriers to patients’ reflection and decision-making and to take an active part in the co-construction of patients’ autobiographies. In this case, we propose that clinicians should not limit their role to merely assessing Shu-Fen’s decisional capacity and freedom of choice; instead, they should try to engage both Shu-Fen and her daughter in a meaningful dialogue to exercise Shu-Fen’s RA. When clinicians actively support patients in exploring and reflecting on their authentic wishes, it builds trust and strengthens the healing relationship. 56

Our proposed model also considers the broader socio-cultural and healthcare contexts and the interpersonal and social dynamics within which one is situated. Therefore, when supporting the decision-making process of terminally ill patients, it is essential to be mindful of how their past experiences and social and structural backgrounds interact and how these relationships can shape their identities and, in turn, either enhance or hinder their autonomy. In Shu-Fen’s case, her upbringing and social norms shape her perspective. As a woman and mother, she may have become habituated to self-sacrifice, prioritising the well-being of her family over her own. Nevertheless, pulled in different directions by her intersecting relationships with her daughter and the clinicians, she remains uncertain about her true preferences.

Closer examination revealed that Shu-Fen’s perspective evolved as she interacted with her family. Initially, Shu-Fen perceived herself as a burden and thought that the best way to benefit her daughter was to die earlier. In this case, the healthcare team should regard Shu-Fen’s refusal of treatment as an opportunity to create an open space for meaningful dialogue. This would allow the patient to express her reasons for refusal and negotiate treatment choices that may deviate from standard medical advice. Additionally, it provides an occasion to communicate with her daughter and clarify her understanding, considering what these relations mean to her identity and, hence, her decisions. Through these open and supportive dialogues and interactions, the family members can foster mutual understanding and realise that the daughter also depends on Shu-Fen, values her company and desires her to live longer, revealing the interdependence of their relationship. These relationships facilitated Shu-Fen in developing a stronger sense of self-worth and self-trust, improved her articulation skills, fostered self-reflection over time and enabled better integration of her practical identity and social values during the decision-making process.

How should we approach the role of Shu-Fen’s daughter? Engaging significant family members in communication and decision-making is crucial when patients prefer family-led care. This involvement should neither be perceived as hindering or impeding the patient’s autonomy nor should it suggest substituting for the patient’s decision. By integrating these three interrelated dimensions into the decision-making process for end-of-life care, the healthcare team seeks to foster Shu-Fen’s competence and authenticity in a ‘cooperative deliberation’ process with others. 40 Respecting Shu-Fen’s RA in a procedural sense does not compromise her choices in clinical practice. It is important to note that we should avoid endorsing East/West cultural stereotypes and perpetuating the false dichotomy between Eastern and Western principles of autonomy. 57 58

This study enriched the application of RA in end-of-life care medical decision-making. Our primary contribution lies in modifying John Christman’s theory, illuminating the nuanced interplay between competence, authenticity, and relational dynamics. We proposed relaxing Christman’s competence condition of autonomy to include the broadest range of patients engaged in SCR. Additionally, we suggested that terminal patients should not be obligated to provide ‘process-independent reason’ when changing their treatment preferences.

Adopting a procedural approach to RA is justified in end-of-life care where strong substantive conditions are inappropriate for terminal patients who should not be compelled to undergo significant changes in beliefs and values unless overt manipulation or oppression is evident. The case of Shu-Fen exemplifies how factors such as illness and oppressive socialisation can affect decision-making, prompting a shift in focus from liberating patients from external influences to promoting their competence and authenticity in autonomous decision-making.

Moreover, our integrated three-dimensional decision-making model for RA refines Christman’s socio-historical account and offers descriptive and normative insights into end-of-life care. This model emphasises the dynamic and evolving nature of the authentic self and recognises the fundamental roots of autonomy in intersubjective and dialogical processes, thus providing a more contextual framework for medical decision-making. In the ongoing pursuit of advancing RA in end-of-life care, future studies should build on our model and provide concrete suggestions for enhancing clinicians’ competencies through professional development.

Importantly, advocating for a procedural approach to RA does not imply an endorsement of a ‘thin’ or ‘minimalist’ conception of autonomy. In the terminal phase, patients undergoing a stressful ordeal due to life-threatening illnesses make decisions concerning and depending on clinicians and other professionals. Our theory of RA contributes a meaningful explication to the nature of the clinician–patient relationship, emphasising the ethical responsibility of healthcare teams in responding to patients’ needs and expectations and fostering their autonomy. It provides a practical framework for navigating complex decision-making scenarios, fostering trust and negotiating shared values between patients and their families. By embracing a relational perspective and considering the dynamic nature of authenticity, we hope to pave the way for healthcare professionals to engage in meaningful and supportive interactions with patients. This approach ensures that autonomy is respected and actively fostered throughout the challenging journey of end-of-life care.

Ethics statements

Patient consent for publication.

Not applicable.

Acknowledgments

We thank Wenmay Rei, KLC, HWC, YYL for their thoughtful comments on the initial version of the manuscript. We are also grateful to two anonymous reviewers for their careful reading and insightful comments.

• Beauchamp TL ,
• Childress JF
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K-FF and Y-PL are joint first authors.

Twitter @YaPingLIN84

Contributors KFF and YPL contributed equally to this work. All listed authors contributed to the conceptualisation of the manuscript. CPL and YCC critically reviewed and revised the manuscript. All listed authors approve the final manuscript and accept accountability for all aspects of the work. No AI technology has been used throughout the drafting and revision of the manuscript. YPL is the guarantor of the study.

Funding This study was funded by Ministry of Science and Technology, Taiwan (MOST 111-2314-B-A49 -012 -MY3).

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

↵ While ‘local autonomy’ refers to one’s exercise of autonomy on a particular decision, proponents of ‘global autonomy’ go further to claim broader oppressive social structure hinders one’s genuine autonomy. 3

↵ This case is inspired by the clinical experience of the authors CPL and YCC with cancer patient care.

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COVID-19 Pandemic's Enduring Imprint on Colorectal Cancer Surgery

Researchers unveil the hidden consequences of the pandemic on colorectal cancer, revealing that surgical cases dramatically declined in 2020 and patients had more advanced-stage disease.

March 25, 2024

Key Takeaways 

• In a retrospective analysis of 105,517 patients with colorectal cancer, researchers found that colorectal cancer surgical cases fell by 17.3% during the first year of the pandemic. 
• Patients who underwent surgery for colorectal cancer in 2020 displayed more advanced stages of cancer compared to those treated in 2019. 
• The authors attribute these findings to multiple factors, including delays in screening, fear of COVID-19 exposure that may have prevented some people from seeking care, and disparities in cancer care that were likely exacerbated during the pandemic. 

CHICAGO: While the COVID-19 pandemic is no longer considered a public health emergency, pandemic-related stressors continue to impact cancer care across the board. New research published this week in the Journal of the American College of Surgeons ( JACS ) describes how surgery for colorectal cancer — the third most commonly diagnosed cancer — was considerably disrupted during the pandemic.  

In a large-scale retrospective analysis of 105,517 colorectal cancer cases, researchers noted a 17.3% overall decline in colorectal cancer surgeries in 2020 compared to 2019. There was also a notable shift toward more advanced disease in the same period, with researchers finding that patients who underwent surgery in 2020 were more likely to have advanced stages of colorectal cancer, which is harder to treat and cure. 

“With this study, we found that approximately 10,000 fewer patients did not have surgery for colorectal cancer in 2020 compared to 2019. That’s a profound decrease,” said David W. Larson, MD, MBA, FACS, FASCRS, senior author of the study and a professor of surgery in the division of colon and rectal surgery at Mayo Clinic in Rochester, MN. “Colorectal cancer is a serious illness, and timely surgery is critical for improving patient outcomes.” 

Under normal circumstances, Dr. Larson added that researchers would expect stable, if not increasing, growth of colorectal cancer surgeries from year to year. Though rates of colorectal cancer have remained stable in people 50-64, the disease is increasingly diagnosed in younger adults and is now a leading cause of cancer deaths in people younger than 50.1,2 

Study Details 

Using the National Cancer Database (NCDB), the team reviewed cases of all adult patients who underwent operations for colon and rectal cancer from January 1, 2019, through December 31, 2020, in hospital systems that contribute to the NCDB. The NCDB, an oncology research database jointly operated by the American College of Surgeons and the American Cancer Society, captures approximately 74% of all newly diagnosed cancer cases.  

Patients who had surgery were divided into two groups: pre-COVID, which included patients operated on in 2019; and the COVID group, which included patients operated on in 2020. The researchers further analyzed the data by type of surgery, age, sex, race, ethnicity, income, insurance status, and other variables.  

Other Key Study Findings 

• Operations for rectal cancer decreased by 21% and 16% for colon cancer, corresponding to an overall 17.3% decrease in colorectal cancer operations during the first year of the pandemic.   
• Patients in the COVID group had a significantly lower rate of early-stage cancer (35.5% vs. 38.2%) and a significantly higher rate of advanced tumors (19.2% vs. 15.7%), which are associated with increased mortality risk.  
• Black patients, patients on Medicaid, and those who lacked insurance were affected by more advanced colon and rectal cancer stages, and low-income patients had worse colon cancer stages. 
• However, researchers did not find any significant delays in time to treatment once a patient was diagnosed with colorectal cancer. 

The researchers attribute these findings to multiple factors, including an overall reduced number of colorectal cancer screenings in 2020, delays in colonoscopies, and widespread avoidance of medical care due to the fear of contracting COVID-19. Additionally, the pandemic may have exacerbated known disparities in cancer care that frequently impact vulnerable patient populations, including Black patients and patients without insurance. A silver lining, Dr. Larson added, was noting the resilience of hospital systems that continued treating patients with colorectal cancer despite the constraints of the pandemic. 

Pandemic’s Enduring Imprint 

In discussing the implications of their findings, the authors wrote in their paper: “The COVID-19 pandemic has left a significant and enduring imprint on colorectal cancer surgery, intensifying the challenges faced by patients and health care systems. Comprehensive studies are imperative to comprehend the long-term consequences of delayed screenings, diagnoses, and treatments, as health care planning for the future must consider the unintended repercussions of pandemic-related disruptions.” 

One limitation of the study is that it only describes the first nine months of the pandemic and its initial consequences. Dr. Larson noted that it will also be important to study optimal approaches for treating patients with advanced disease in future research. “We need to prioritize colorectal cancer care as a nation and work to address barriers to care,” Dr. Larson said. “There’s no question that early diagnosis of colorectal cancer remains critical.” 

Study co-authors are Davide Ferrari, MD; Tommaso Violante, MD; Courtney N. Day, MS; Nicholas P. McKenna, MD, MS; Kellie L. Mathis, MD, MS; and Eric J. Dozois, MD. 

Citation : Ferrari D, Violante T, Day C. Unveiling the Hidden Consequences: The Initial Impact of COVID-19 on Colorectal Cancer Surgeries. Journal of the American College of Surgeons, 2024. DOI: 10.1097/XCS.0000000000001042  

Conflicts of interest : The authors declare no conflict of interest. 

Funding : This research did not receive external funding. 

This study is published as an  article in press  on the JACS website.  

1 Cotler J, Chan K, Zhu X. Colorectal cancer statistics, National Cancer Database, 2024. 

2 American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society, Inc. 2022. 

About the American College of Surgeons

The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has approximately 90,000 members and is the largest organization of surgeons in the world. "FACS" designates that a surgeon is a Fellow of the American College of Surgeons.

• Sheila Lai | 312-202-5403
• Dan Hamilton | 312-202-5328
• Email: [email protected]

This paper is in the following e-collection/theme issue:

Published on 26.3.2024 in Vol 26 (2024)

Designing and Implementation of a Digitalized Intersectoral Discharge Management System and Its Effect on Readmissions: Mixed Methods Approach

Authors of this article:

Original Paper

• Christoph Strumann 1 , PhD   ; 
• Lisa Pfau 1 , MD   ; 
• Laila Wahle 2 , MBA   ; 
• Raphael Schreiber 1 , MD   ; 
• Jost Steinhäuser 1 , Prof Dr Med, MD  

1 Institute of Family Medicine, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany

2 Lacanja GmbH Health Innovation Port, Hamburg, Germany

Corresponding Author:

Christoph Strumann, PhD

Institute of Family Medicine

University Medical Centre Schleswig-Holstein, Campus Lübeck

Ratzeburger Allee 160

Lübeck, 23538

Phone: 49 451 3101 8005

Email: [email protected]

Background: Digital transformation offers new opportunities to improve the exchange of information between different health care providers, including inpatient, outpatient and care facilities. As information is especially at risk of being lost when a patient is discharged from a hospital, digital transformation offers great opportunities to improve intersectoral discharge management. However, most strategies for improvement have focused on structures within the hospital.

Objective: This study aims to evaluate the implementation of a digitalized discharge management system, the project “Optimizing instersectoral discharge management” (SEKMA, derived from the German Sektorübergreifende Optimierung des Entlassmanagements), and its impact on the readmission rate.

Methods: A mixed methods design was used to evaluate the implementation of a digitalized discharge management system and its impact on the readmission rate. After the implementation, the congruence between the planned (logic model) and the actual intervention was evaluated using a fidelity analysis. Finally, bivariate and multivariate analyses were used to evaluate the effectiveness of the implementation on the readmission rate. For this purpose, a difference-in-difference approach was adopted based on routine data of hospital admissions between April 2019 and August 2019 and between April 2022 and August 2022. The department of vascular surgery served as the intervention group, in which the optimized discharge management was implemented in April 2022. The departments of internal medicine and cardiology formed the control group.

Results: Overall, 26 interviews were conducted, and we explored 21 determinants, which can be categorized into 3 groups: “optimization potential,” “barriers,” and “enablers.” On the basis of these results, 19 strategies were developed to address the determinants, including a lack of networking among health care providers, digital information transmission, and user-unfriendliness. On the basis of these strategies, which were prioritized by 11 hospital physicians, a logic model was formulated. Of the 19 strategies, 7 (37%; eg, electronic discharge letter, providing mobile devices to the hospital’s social service, and generating individual medication plans in the format of the national medication plan) have been implemented in SEKMA. A survey on the fidelity of the application of the implemented strategies showed that 3 of these strategies were not yet widely applied. No significant effect of SEKMA on readmissions was observed in the routine data of 14,854 hospital admissions ( P =.20).

Conclusions: This study demonstrates the potential of optimizing intersectoral collaboration for patient care. Although a significant effect of SEKMA on readmissions has not yet been observed, creating a digital ecosystem that connects different health care providers seems to be a promising approach to ensure secure and fast networking of the sectors. The described intersectoral optimization of discharge management provides a structured template for the implementation of a similar local digital care networking infrastructure in other care regions in Germany and other countries with a similarly fragmented health care system.

Introduction

Digital patient process systems offer several advantages over analog systems. On the one hand, this can lead to more systematic, targeted use of resources, and on the other hand, easier communication and transmission of data can enable better coordination of the various cooperating partners [ 1 ]. Patient records are becoming increasingly digitalized, with some countries being prototypes in this area, such as Latvia, Denmark, and Spain [ 2 ].

In Germany, there have been several governmental attempts to shape different elements of health care digitalization. A recent example is the Hospital Future Act (Krankenhauszukunftsgesetz) from 2020. It was designed to support digitalization in hospitals by promoting the technical equipment of hospitals through state-funded investments. The investments are expected to improve process organization, documentation, and communication (internal, sectoral, and intersectoral) [ 3 ]. The results suggest that the Hospital Future Act, together with the COVID-19 pandemic, led to an increase in the digital maturity of hospitals and, thus, reduced the digitalization backlog [ 4 ]. Another approach to promote health care digitalization is the introduction of an electronic health record (EHR) within a secure telematics infrastructure. The EHR should not only simplify rapid communication within and across different health care institutions but also enable further eHealth applications, for example, electronic prescriptions [ 5 ]. However, the introduction of EHRs as well as other reforms promoting health care digitalization have been accompanied with strong resistance underpinned by arguments of data protection and security as well as by technical problems. Especially in the outpatient sector, the latter has resulted in a perceived disproportionate administrative effort without adequate financial compensation for the care providers such as private practices [ 6 ]. As a result, Germany lags behind other industrialized countries in the digitalization of the health care system [ 7 , 8 ].

An EHR could make treatment pathways more transparent and improve communication between different health care providers, including inpatient, outpatient and care facilities [ 9 ]. The exchange of information is particularly susceptible if a patient is discharged from hospital. With regard to the strongly pronounced sectoral separation in Germany [ 10 , 11 ], information loss is particularly high between inpatient and outpatient care. Moreover, owing to the accelerated tendency toward shortening the length of stay of patients in the inpatient sector as a result of the introduction of the diagnosis-related group–based reimbursement system [ 12 ], hospitals no longer provide care and treatment until full recovery [ 13 ]. Instead, parts of the treatment and recovery process are moved to the posthospital setting [ 14 ]. Similar developments have been observed after introducing the diagnosis-related group–based reimbursement system in other countries, for example, the United States [ 15 - 17 ]. Shortened length of stay and ineffectively designed transitions are associated with adverse events, higher risks of readmission, and higher costs [ 18 - 21 ]. Up to 1 (18%) in 5 patients are readmitted to the hospital within 30 days of discharge [ 22 , 23 ]. Individualized discharge management can reduce the number of readmissions of older patients with a health problem [ 24 ], leading to potential cost savings for the health care system [ 25 ]. To date, many strategies to improve discharge management have focused on structures within the hospital. However, to ensure a holistic and continuous treatment, the cooperation between different health care providers from the inpatient and outpatient sectors as well as care facilities should also be considered.

As there is still no EHR accessible to all caregivers in Germany, experience with digitalized health information systems has been gathered only in model projects, which are intended to provide insights into possible barriers and enablers for a successful implementation [ 5 , 26 - 30 ].

This study aims to explore the determinants of a digitalized discharge management system, to implement such a system within 1 area, and to evaluate its impact on the readmission rate.

The evaluation was done within the project “Optimizing intersectoral discharge management” (SEKMA, derived from the German Sektorübergreifende Optimierung des Entlassmanagements).

Study Design

A mixed methods design was chosen to evaluate SEKMA. Owing to the complexity of the intervention, the evaluation was based on the framework of developing tailored interventions [ 31 ]. This approach allows a detailed description and analysis of the components of the intervention that contributed to its effectiveness or ineffectiveness. For this purpose, this framework distinguishes between a development and an application phase. In the first step, barriers and enabling factors for a successful implementation of a digitalized discharge management system such as SEKMA were explored using qualitative research methods, that is, interviews. Second, strategies were developed for addressing these determinants. Third, these strategies were prioritized using a (quantitative) questionnaire, and a logic model was formulated to describe the logical linkages among the resources and activities needed to achieve the results. After the implementation (application phase), the congruence between the planned intervention (logic model) and the implemented intervention was evaluated. In this step, the fidelity of the use of the different strategies in the routine was examined [ 32 ]. Finally, the effectiveness of the implementation on the readmission rate (outcome) was evaluated based on routine data of hospital admissions.

The digitalized discharge management system was implemented at a medium-sized hospital (approximately 350 beds) in the northern German federal state Schleswig-Holstein in the Metropolitan area of Hamburg, the second-largest city in Germany. Before the intervention, the internal and external exchange of information was typically performed by phone, fax, and email. As the network between the various caregivers was rather weak, communication occurred only on request, tying up resources and causing delays in the transfer of information.

SEKMA aimed to develop and implement a digitalized, intersectoral discharge management system that considers the patient’s entire treatment pathway, from hospital admission to possible admission to a care facility, and the follow-up treatment by general practitioners (GPs). All information relevant to ongoing (postinpatient) treatment and care should be available quickly and easily to all care providers involved. This includes providers from the inpatient and outpatient sectors as well as care facilities. For this purpose, an ecosystem of hospital and postinpatient care facilities has been implemented within a digital infrastructure based on a standardized and harmonized IT system for data exchange [ 33 ]. The workflow of the digitalized, intersectoral discharge management can be described as follows:

• The hospital coordinates and organizes follow-up care in a timely manner based on the patient’s agreement with the hospital’s discharge management.
• A discharge plan for medication, follow-up care, and rehabilitation is created and all professionals in the hospital are involved. This includes admission staff, medical service, nursing service, social service, and the patient information system.
• In cooperation with the nursing staff and social service, the patient is informed and advised about care options and structures that correspond to their illness. The contents are prepared digitally.
• The patient is discharged from the hospital and transitions to outpatient, rehabilitative, or nursing care. All documents necessary for discharge and further treatment are available digitally and can be transmitted directly to the relevant sectors.
• If a patient contacts a primary care physician for outpatient follow-up treatment, the patient’s digital discharge documentation is already in the system of the private practice.
• In case of a query or deterioration of health status, the primary care physician can contact the hospital and previously treating physicians directly.
• If there is a readmission, the hospital can digitally access documentation on posttreatment care and procedures, as well as the medical history, at any time and continue treatment directly. The same applies to nursing and rehabilitation facilities.

The information transfer across the distinct health care provider is organized via KIM (Kommunikation im Medizinwesen) embedded in the telematics infrastructure. All organizations involved in the project have a KIM connection. Using KIM, participants can transmit documents in a secure and encrypted manner [ 34 ]. Overall, all communication processes have been digitalized compared with before the intervention. Since April 2022, optimized discharge management has been implemented in the department of vascular surgery.

Individual Interviews

Enabling factors and barriers leading toward successful digital discharge management were identified through individual interviews with physicians, medical assistants, social workers and nurses at the hospital, GPs, and staff from nursing homes and care services. This was performed using the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines for qualitative studies ( Multimedia Appendix 1 provides details of the COREQ guidelines [ 35 ]). Originally, a combination of interviews and focus groups was planned. Owing to the COVID-19 pandemic, focus groups had to be abandoned.

The hospital, along with collaborating partners such as physician networks and nursing homes, conducted participant recruitment for interviews through face-to-face interactions, telephone calls, and emails. Previously developed partially standardized interview guidelines were used and pilot tested ( Multimedia Appendix 2 ). The interviews were conducted by telephone by a medical student (LP) between April 30, 2020, and October 9, 2020, at the workplace of the interviewees. A theoretical saturation effect in the statements made during the interviews resulted in the final number of interviewees.

The individual interviews were conducted in a protected setting and subsequently pseudonymized, thus providing the opportunity to explore the personal opinions of the interviewees beyond any possible social group pressures. The interviews were recorded using a digital dictaphone and were transcribed orthographically. The material was subsequently analyzed using structured content analysis according to Mayring [ 36 ]. The development of the categories was initially based on the questions (deductive) listed in the partially standardized interview guideline ( Multimedia Appendix 2 ). In addition, categories were extracted from the text (inductive). Five persons were involved in the development of the category scheme (LP: medical student [female researcher], JS: GP and experienced health service researcher including qualitative research [male researcher], CS: health economist with some experience in qualitative research [male researcher], a legal project advisor [female researcher], and a physiotherapist [female researcher]; all of them except LP were employed at the Institute of Family Medicine at the University of Lübeck at the time of the analysis). After individual coding, a coding scheme was discussed in a consensus meeting. The final coding scheme was applied to the interview material.

Development and Evaluation of Strategies

On the basis of the described processes for treating the patients, the optimization potential, and the determinants from the evaluated individual interviews as well as the workshop with clinicians and physicians in private practice, strategies for the implementation of optimized discharge management were developed. These strategies were developed in such a way that they addressed the determinants identified and were, thus, conducive to a successful implementation.

During a project meeting on February 3, 2022, employees of the Institute of Family Medicine at the University of Lübeck and the chief and senior physicians of the involved hospital discussed these results. Subsequently, the hospital’s chief or senior physicians were invited to evaluate each identified strategy according to its relevance and feasibility using a 6-point Likert scale (very high, rather high, high, rather low, low, and very low) to avoid the central tendency bias.

The resulting list of the ranked strategies formed the logic model. This model was finally compared with the list of strategies implemented in the project.

Routine Data Analysis

The focus of the evaluation of the optimized discharge management was the reduction of (unnecessary) readmissions. With the help of the evaluation of the routine admission data of the involved hospital, the effect of optimized discharge management on rehospitalization was analyzed.

Routine Data and Study Design

The hospital extracted routine data from its internal patient information system. The extracted data were provided by the hospital in an anonymized form. For each inpatient case, the data consisted of information on the date of admission and discharge, the reason for admission and discharge, diagnoses and conducted medical procedures, demographic information of the patients, and the department or departments where the patients had been treated.

Within the framework of a longitudinal study design, a pre- and postcomparison was performed. The intervention group was the department of vascular surgery, in which the optimized discharge management was implemented since April 2022. A case was assigned to the intervention group if the patient was admitted to or discharged from the department of vascular surgery. The outbreak of COVID-19 during the sample period might have affected the readmissions of the entire hospital. To minimize the risk of bias owing to the pandemic on the intervention effect, in addition to the pre-post comparison of the department of vascular surgery, a control group comparison was applied to enrich the empirical strategy. To ensure that the patients in the intervention group were as similar as possible to those in the control group, the departments of internal medicine (medical clinic) and cardiology formed the control group.

Statistical Analysis

The effect of the implementation was estimated using the difference-in-difference (DiD) approach. The sample covers the period from 2019 to August 2022. To counteract the possible COVID-19 pandemic bias, patients admitted between January 2020 and March 2022 were not considered in the analysis. To avoid any seasonal influences on the results, we restricted the preintervention period such that it covered exactly the period after the implementation, that is, from April to August. Therefore, the baseline period (T 0 ) consisted of April 1, 2019, to August 31, 2019, whereas the intervention period (T 1 ) started from April 1, 2022.

In addition to the bivariate analysis, a multivariate logistic regression model was applied. By including control variables, differences between patients from the intervention and control group were minimized. In the first step, risk factors for rehospitalization were determined by estimating separate bivariate logistic regression models. The identified risk factors served as control variables in the multivariate DiD regression analysis. A P value <.05 was considered statistically significant. Statistical analyses were performed with Stata (version 15; StataCorp LLC).

Ethical Considerations

The study was approved by the ethics committee of the University of Lübeck before recruitment commenced on December 11, 2019 (approval number 19-387). This study was conducted in accordance with the Declaration of Helsinki.

All participants provided verbal and written informed consent for their participation in the interviews and surveys. The participants were informed that they could withdraw their consent at any time. No identifiable information was recorded to ensure the confidentiality of the participants. No compensation was paid for participation.

For the analysis of routine hospital data, only anonymized data were transferred to the evaluating institution. Owing to the anonymization of the data, no additional informed consent was required to perform the routine data analysis in accordance with German law, ethical standards, and the Declaration of Helsinki. No data requiring informed consent will be presented in the routine data analysis. The ethics committee of the University of Lübeck waived the requirement for informed consent owing to the retrospective nature of this study.

A total of 26 interviews were conducted. These consisted of 14 employees of the hospital (3 doctors, 4 nurses, 4 social workers, and 3 administrative staff), 9 employees from nursing homes or mobile nursing services, and 3 GPs. The average age of the participants was 42.4 (SD 8.9; range 25-65) years, and the proportion of female participants was 54% (14/26). The average interview duration was 33 minutes and 11 seconds. An overview of the characteristics of the interview participants is provided in Table S1 in Multimedia Appendix 3 .

A total of 21 determinants were explored with various subcategories for the introduction of successful digitalized discharge management. These could be divided into 3 categories: “optimization potential,” “barriers,” and “enablers.” The aspects mentioned for optimizing the discharge process covered all areas from admission to follow-up and included inter- and intrasectoral transmission of information ( Textbox 1 ).

Category and subcategories

• Preliminary discharge letter before discharge
• Final discharge letter at the time of discharge
• Digital transmission (mail, chat, and video call)
• Platform for information exchange
• Standardized information
• Increased readiness to communicate
• Information exchange at admission
• Consent to discharge management
• Awareness of the existence of discharge management in the hospital
• Timely completion of the discharge process
• Continuous preparation for (unplanned) discharge
• Improvement of patient communication
• Faster approvals by health insurances
• Discharge in the morning of the working day
• Material transfer, issuing of prescriptions and incapacity certificate
• Nursing services accompany discharge from hospital
• Increase in the availability of patient transport
• Visits to general practitioner after discharge
• More aftercare places
• Training on discharge
• Digital checklist
• Standardized processes
• Clarified responsibilities
• Knowledge of the performance and processes at other facilities
• Evaluation of criticism or review
• Supervision
• Ethics committee

In the German health care system, the discharge letter is at the center of information transmission between the inpatient and outpatient sectors. Participants saw a need for improvement in the early, or at least timely, delivery of this letter. In the best case, information would already be transmitted during the hospital stay to the follow-up service providers such as private practices or care facilities:

To have all the information and data, everything before the patient arrives here. That would be the absolute dream. [...] You can just admit the person better[...] if you just have preliminary information. [P03]

Digital transmission of data was also perceived as beneficial; the participants could imagine using conventional media such as email or video calls as well as via a platform provided specifically for this purpose:

If you could even find some other common platform where information can be exchanged. [P01]

Furthermore, the potential for optimization was seen in the standardization of the information. The information to be communicated should be transmitted through a central entity, and at the same time, selected contacts who can be reached on demand and who can provide information about the patients would be beneficial:

Yes, standard, standard, standard. So, that you try to agree on what information I need and then it has to appear—in a structured form, so in principle already like my patient information. [P10]

Some participants also noted that, in principle, a greater willingness to communicate between the individual players would improve the transmission of information.

Participants noted that for a seamless discharge, information about the patient should already be available at the time of admission to the hospital:

Discharge or discharge planning and a good discharge process starts at admission. [...] The important thing is not to think about discharge on the day of discharge, but already on admission. [P25]

Improved patient communication was also considered important by interviewees:

And that is certainly a wish that I would have that the patients in the hospital are also informed about what they actually have, what has happened and what the next steps are. [P01]

An optimal discharge should ideally take place in the morning on a working day, and the handing over of medication and required materials should be regulated. This is considered to be the case by nursing homes and outpatient care services as well as by hospital staff:

From 9 or 10 a.m onwards, the number of patients in the emergency room increases and drops again from 8 p.m onwards. And during this peak time, there are few beds available in the hospital. Afterwards, however, when we are closed, the hospital finally loses cases and at night we have more free capacity again. And that is a mismatch between demand and capacity which can be improved. [P20]

Textbox 2 shows the barriers and enabling factors for intersectoral collaboration in the context of optimizing discharge management. In addition to the technical aspects and subjective reasons, there were concerns about data protection and fear that a change in the discharge process would require more time:

Time pressure is always an issue, both in the hospital and in outpatient care. We just often don’t have the time for some processes that we would all consider useful. [P01]

• Data transmission security
• Legal uncertainties
• Leaving known structures and processes
• Lack of electronic data processing experience
• Higher time consumption
• Lack of personnel
• Limitation of one’s own competence
• Unclear communication processes
• No perceived benefit
• Low appreciation for discharge management
• No priority of discharge management
• No consequences for noncompliance
• User-unfriendly system
• Electronic data processing errors
• Interface problems
• Outdated technical equipment
• Lack of education or communication
• Lack of networking among health care providers
• Clear responsibilities, instructions, contact persons, or responsibilities
• Surveillance
• Introduction or training of new processes
• No overload and enough time
• Regular exchange for networking
• Time saving
• Workload reduction
• Improved exchange of information
• Feedback loops
• Priority in the management
• Communicating the advantages
• Involvement of employees

In contrast, a possible reduction in workload owing to digitalized processes was seen as conducive:

Digitalization must not be an end in itself, in my opinion, but it must really mean an advantage for the processes, increase safety, increase communication, but it must not be a question of just because it is digital, that it is better in every case and is then associated with the fact that medical or nursing working time is lost or additionally created. [P23]

For the changeover to be successful, the communication of the advantages associated with optimized discharge management was emphasized above all as part of change management.

On the basis of the surveyed processes, the optimization potential, and the determinants from the evaluated individual interviews as well as the workshop with clinicians and physicians in private practice, 19 strategies for the implementation of optimized discharge management were developed. To rank these strategies, chief physicians of the hospital were invited to rate their relevance and feasibility.

A total of 11 physicians participated in the survey to evaluate the strategies ( Table 1 ). The strategies of always sending the discharge letter to the GP, equipping the hospital’s social service with mobile devices (eg, laptops and tablets), generating individual medication plans in the format of the national medication plan, and exclusively using the federal medication plan received the highest ratings. In contrast, the introduction of a chat function used exclusively by physicians for direct exchange between hospital and office-based physicians received the lowest rating.

a Mean over participants (6=very high, 5=rather high, 4=high, 3=rather low, 2=low, and 1=very low).

b GP: general practitioner.

c Not part of the intervention but planned for the future by the hospital.

On the basis of these ratings, the hospital staff discussed which of these strategies were already being implemented or planned for implementation in the near future. Of the 19 strategies, 6 (31%) were assessed as already implemented, 7 (37%) were assessed as planned, and 6 (31%) were assessed as not feasible to implement in the project. The 7 strategies rated highest in the development of the logic model (planned implementation) have been implemented or will be implemented in the near future as part of SEKMA.

To summarize, by April 2022, at the department of vascular surgery, (1) discharge letters were continuously updated digitally, (2) they were always sent, (3) they were sent electronically to the GP (via the infrastructure of KIM), (4) the hospital social service was equipped with mobile devices, (5) individual medication plans were in the format of the national medication plan, (6) the discharge management consent process at admission was standardized, and (7) a hotline for direct communication between hospital physicians and primary care physicians was implemented. The information transfer via the discharge letter was oriented by the standard of medical information objects (MIOs) eArztbrief. The development of this standard was initiated in 2022 by the National Association of Statutory Health Insurance Physicians and the German Hospital Association. It defines a standard for the electronic hospital discharge letter within the EHR ensuring the transition of relevant information from inpatient to subsequent care in a structured and secure manner [ 37 ]. The MIO eArztbrief was not yet ready during the project; however, the current status of the MIO was incorporated into the letter as much as possible.

Fidelity Analysis

After the implementation of the optimized discharge management into the routine in the department of vascular surgery as well as at the external partners in April 2022, the stakeholders participating in the project were asked in a fidelity analysis in September 2022 to what extent the identified strategies were implemented in practice. The survey showed that many of these strategies were not yet widely applied.

A total of 14 individuals responded to the survey (Table S2 in Multimedia Appendix 2 ). Of the 14 individuals, 11 (79%) were employed at the hospital and 1 (7%) each at an outpatient nursing service, nursing home, and private practice. Employees from social services and medical assistants did not participate in this survey. Of those surveyed, >30% (4/13) stated that they were satisfied with the implementation of the change in discharge management.

There are differences in the fidelity of use among the strategies implemented (Table S3 in Multimedia Appendix 3 ). Although sending or receiving an electronic discharge letter was always or sometimes used in their routine by only a quarter of respondents, approximately 85% (11/13) of the respondents indicated that medication plans from the hospital were always in the format of the federal medication plan at discharge.

Readmissions

In total, 12,407 patients were admitted to the hospital as inpatients during the study period (from April 2019 to August 2019 and from April 2022 to August 2022), corresponding to 14,854 cases treated. The internal medicine department (medical clinic) treated most of the cases (4175/14,854, 28.11%). Cases treated in the interventional group (vascular surgery) accounted for 5.11% (759/14,854) of all inpatient cases. Overall, 8.73% (994/11,386) of the patients were readmitted after 30 days. In terms of treated cases, the readmission rate was 9.07% (1222/13,477). The rates increased to 17.1% (1542/9016) for patients and 18.85% (1975/10,478) for cases when considering a longer time horizon for the readmission (90 days). Readmission rates were generally higher in the intervention group (80/705, 11.3%) at 30 days and 28.8% (161/560 at 90 days) than in the hospital as a whole and the control group. Table S4 in Multimedia Appendix 3 provides the number of admitted patients and cases treated as well as the readmissions after 30, 60, and 90 days for the total hospital cases and the departments involved.

Risk Factors

Risk factors for readmission were identified to take the differences between patients from different departments into account for the evaluation of the project’s implementation effect.

Older patients, as well as cases with a length of stay of >6 days, had a significantly higher risk of readmission. Similarly, discharge time influenced the readmission risk: patients discharged during the night (9 PM to 5 AM) had a higher risk of readmission. Similarly, there were significant differences in readmissions between cases with different ICD-10 ( International Statistical Classification of Diseases , Tenth Revision ) chapters of principal and secondary diagnoses (Table S5 in Multimedia Appendix 3 ).

Intervention Effect

Table 2 shows the implementation effects on the readmission rate after 30, 60, and 90 days (DiD) of the bivariate analysis. In the intervention group, the 30-day readmission rate increased by 2.33 percentage points from 10.4% (45/431) to 12.8% (35/274) after SEKMA was implemented. For the 60- and 90-day readmission rate, the increase was even higher (60 days: 2.25 and 90 days: 3.94). These increases have been smaller in the control group. Therefore, a reduction effect of the intervention on the readmission rate (ie, a negative DiD estimate) cannot be observed. Concentrating the analysis on patients aged ≥65 years revealed similar results (Table S6 in Multimedia Appendix 3 ). As a robustness check, the preintervention period was extended to include admissions between 2011 and 2019. These results confirm the previous findings.

a Only admissions between April 2019 and August 2019 and between April 2022 and August 2022 were considered.

b DiD: difference-in-difference, Δ: Difference between the readmission rates of the intervention and the control group at T 0 and T 1 , respectively.

c Intervention period (T 1 ): from April 1, 2022.

d N/A: not applicable.

e Baseline period (T 0 ): April 1, 2019, to August 31, 2019.

The results of the multivariate logistic regression model ( Table 3 ) confirm the results of the bivariate analysis that there were higher readmission rates in the intervention group and that there was no significant effect of the optimized discharge management on readmissions in the available data. This result was also confirmed for patients aged >65 years (Table S7 in Multimedia Appendix 3 ). Furthermore, the insignificance of the effect of the implementation of SEKMA on readmission rates was also confirmed in a pre-post comparison estimated by a multivariate logistic regression based on vascular surgery cases only (Table S8 in Multimedia Appendix 3 ). Finally, the estimated effects remained very similar if the preintervention period began in 2011 and ended at the end of 2019.

b In addition to the variables listed here, the International Statistical Classification of Diseases, Tenth Revision chapters of the principal and secondary diagnoses were also included as control variables.

d DiD: difference-in-difference.

This study aims to explore the barriers and enablers of a digitalized discharge management system, to implement such a system using a logic model developed from these determinants, and to evaluate its impact on the readmission rate.

Determinants and Implementation Strategies

The importance of the transmission of information for improved discharge management is also highlighted in the high rating of the strategies regarding the discharge letter, that is, developing an electronic discharge letter, continuously entering information into the letter, and always sending it to the GP. The discharge letter is the standard communication tool between inpatient and ambulatory care and found to be a source for deficits in information transfer [ 38 ]. In particular, delay and incompleteness of medication-related information endanger patients’ safety [ 39 , 40 ], leading to an increased risk of hospital readmission [ 41 ]. As shown for a sample of 20 Dutch hospitals, discharge letters vary in quality depending on patient and admission characteristics [ 42 ]. A standardized discharge letter can reduce transcription time and improve medical communication between physicians [ 43 ]. In addition, GPs prefer that discharge letters be written in a clear, concise, and understandable manner [ 44 ]. An electronic discharge letter generated from a computer-based document not only avoids transcription errors and lacks standardization but also ensures timely delivery [ 45 ]. In Germany, the discharge letter played a central role in approaches to creating a standard for intersectoral information exchange. For example, the VHitG (derived from the German “Verband der Hersteller von IT-Lösungen im Gesundheitswesen”) initiative “Intersectoral Communication” developed an implementation to facilitate the exchange of discharge letters between sectors, which is integrated into the existing IT system [ 46 ]. Another example is the recent approach by the National Association of Statutory Health Insurance Physicians and the German Hospital Association to create a standard for the electronic hospital discharge letter within the EHR [ 37 ].

To improve the standardization of the transmitted medication information, the use of the format of the nationwide medication plan was considered an important strategy in this study. In Germany, several projects have shown that physicians, pharmacists, and patients realize the benefits and accept the nationwide medication plan [ 47 - 49 ]. It can serve for the health care providers as a promising tool to improve the interdisciplinary and multiprofessional collaboration, especially as a digital solution that can realize its full potential [ 50 ]. Similar results have been reported in other countries [ 51 , 52 ]. In this study, participants suggested transferring medication-related information electronically and always in the format of the national medication plan. In the participating hospital, this strategy has been implemented during the project. For older patients in particular, shared medication records have the potential to reduce hospital readmissions [ 51 ].

Concerns about technical and temporal integrability were identified as an important barrier to the implementation of optimized discharge management. This includes an expected higher time consumption for the introduction of digitalized processes, a general fear of contact (owing to leaving known structures and a lack of electronic data processing experience), and further technical aspects (as a user-unfriendly system, electronic data processing errors, and interface problems). Similar barriers were identified in related eHealth projects [ 53 - 57 ]. Although the digitalization of processes was expected, in general, to be associated with time advantages, many of those involved associate the introduction with additional work effort. To overcome these concerns, successful implementation requires streamlining, simplifying, and redesigning the existing health care practices as a first step [ 58 ]. The strategy of introducing a physician-only hotline and a chat function for direct communication between the hospital and GPs could be seen as a simplification of communication instead of relying solely on the legally required discharge letter.

Effect on Readmissions

A possible explanation for the low level of fidelity as well as the insignificant effect of SEKMA on readmissions could be the relatively short application period of half a year (from April 2022 to September 2022). Complex implementations such as those elaborated in SEKMA may require a longer time before they are applied in daily routines. Another reason for the insignificant effect on readmissions could be the rather good baseline level of the outcome in national comparison. Although other studies in Germany showed readmission rates, for example, of 18.1% (30 days) to 35.4% (90 days) for older patients (aged >65 years) [ 22 ], these rates were substantially lower for the patients in this study, that is, 11.8% (30 days) to 23.6% (90 days).

Limitations

Our study had several limitations. First, the restrictions that existed owing to the COVID-19 pandemic might have affected the effectiveness of the implementation. All stakeholders involved in SEKMA faced a high workload owing to the pandemic as well as the requirements and measures resulting from the pandemic. However, the study results show that even under the special circumstances of the pandemic, it was possible to develop and implement an intersectoral optimization of discharge management. The infrastructure for the intersectoral care of patients created by the project has great potential to increase the quality of care, even if this could not yet be demonstrated with regard to readmissions. Future research should analyze the routine hospital data over the next 5 years.

Although the study included all relevant health care providers and considered the entire patient care pathway, the number of respondents from some professions may be rather small. For example, only 3 GPs were interviewed. However, the theoretical saturation effect in the statements made during the interviews suggests that this number is sufficient to identify the optimization potential as well as determinants.

Conclusions

Creating a digital ecosystem that connects different health care providers seems to be a promising approach to ensure secure and fast networking of the sectors and to promote rapid information exchange between the sectors. The described intersectoral optimization of discharge management provides a structured template for the implementation of a similar local digital care networking infrastructure in other care regions in Germany and other countries with a similarly fragmented health care system.

Acknowledgments

This study was financially supported by the Ministry of Justice and Health (Ministerium für Justiz und Gesundheit), Schleswig-Holstein. This study was conducted independently.

Data Availability

The data sets generated during and analyzed during this study are not publicly available due to the votum of the Ethics Committee of the University of Lübeck.

Authors' Contributions

CS contributed to conceptualization, formal analysis, investigation, methodology, and validation; prepared the original draft; and reviewed and edited the manuscript. LP participated in methodology, conducted and analyzed the interviews, and reviewed and edited the draft. LW participated in conceptualizing the digital discharge system and reviewed and edited the draft. RS was involved in conceptualization and reviewing and editing the draft. JS contributed to conceptualization, investigation, methodology, and validation and reviewed and edited the draft. All authors have read and approved the final manuscript.

Conflicts of Interest

LW was a hospital manager with a focus on digitalization at the hospital under study during the time of the project, Sektorübergreifende Optimierung des Entlassmanagements (SEKMA). LW is the founder of the company Lacanja GmbH Health Innovation Port, Hamburg, Germany, and is a member of several committees, including the expert group of the Gematik IOP (Interop) Council. All other authors declare no other conflicts of interest.

COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist.

Interview guide.

Supplemental tables with results of supplemental analyses.

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Abbreviations

Edited by T Leung; submitted 09.03.23; peer-reviewed by P Nohl-Deryk, S Meister; comments to author 21.04.23; revised version received 13.06.23; accepted 31.01.24; published 26.03.24.

©Christoph Strumann, Lisa Pfau, Laila Wahle, Raphael Schreiber, Jost Steinhäuser. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 26.03.2024.

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• Indian J Orthop
• v.51(1); Jan-Feb 2017

Ethics of medical research and publication

Ish kumar dhammi.

Department of Orthopaedics, UCMS and Guru Teg Bahadur Hospital, New Delhi, India

Rehan Ul Haq

The Indian Journal of Orthopaedics (IJO), an official journal of the Indian Orthopaedic Association (IOA) is one of the very few journals from the country (across all specialties) which is indexed with Science Citation Index (SCI) - expanded and therefore has to maintain a high publication standards. The journal strives to publish as many articles from the IOA members as possible. However, it has been observed that in spite of the huge amount of good quality clinical work being done in the country, the number of manuscripts from Indian authors is few. Moreover, many a times, in spite of the quality of the content being very good, publication has to be declined because of poor presentation or design. In order to help authors to improve the quality of their manuscripts and understand the review process better, the editorial team has decided to come out with a series of editorials. The previous two editorials in this series, one on indexing and other on plagiarism, 1 , 2 were well received by the readers. This editorial focuses on the ethics of medical publication.

The moment a research is conceived, especially if it involves human participants, ethical issues come into play. The World Medical Association (WMA) developed a set of ethical principles regarding human experimentation for the medical community called the Declaration of Helsinki (DoH). 3 It is widely regarded as the key document on human research ethics. This document contains 32 points. According to this document, “the primary purpose of medical research is to improve prophylactic, diagnostic, and therapeutic procedures and the understanding of the etiology and pathogenesis of disease.” 3 It further states that “even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility, and quality.” 3 Most research involves a team effort, and some junior members of the team who may be playing a substantial or lead role may not be aware of the ethical issues involved in human research though all researchers are equally abide by ethical principles. It is the duty of the senior researchers to discuss everyone involved in the project, make them aware about the ethical issues that need to be addressed.

Authors must know that irrespective of where or how a research is done, patients confidentiality, right to anonymity, and privacy is of paramount importance. 3 During the whole course of the conduct of the research till its final submission for possible publication, the authors must ensure that any information which reveals patient identity such as name and hospital number is avoided. A common mistake that should be avoided is submitting clinical photographs which reveal the patient identity. IJO, like many other journals, wants that only the images of affected areas must be provided to preserve patient anonymity. The patients’ face must be completely removed rather than just the eyes being blurred. If it is necessary to show patient's face then proper consent from patient is taken.

Authors must also understand that patients consent, given for medical management or surgery by the caregiver, should not be assumed to be blanket consent. A separate informed consent must always be taken if the researchers plan to use patient data for research purposes. Moreover, approval from an Institutional Review Board, Ethics Committee, Departmental Board of Study, or an equivalent authority of competence is mandatory for any human research. 3 A statement about the same in the material and method section must be made. Omission of the same may be a ground for technical or outright rejection of the manuscript. Sometimes, the editorial team may want to see a copy of the approval, and authors must keep it handy. It is also the morale duty of the researchers to ensure that the patients are not harmed. If at any time during the study, the authors feel that the patients interests are being harmed they must stop the study.

During the conduct of the study, fabrication (presenting unsubstantiated facts or data) and falsification (changing or selecting certain data to achieve desired results) should be strictly avoided. 4 If there is any missing datum, which usually is the case in most studies, no effort must be made to hide it. It should be reported with appropriate reason. It is also a good idea to involve a statistician early in your study so that design of the study and statistical tools can be fine-tuned. Doing an underpowered study and then misusing statistics to defend your results is also a type of ethical misconduct.

Based on the type of research, one is conducting, there are a number of broad consensus statements such as Consolidated Standards of Reporting Trials (CONSORT statement) for randomized controlled trials; Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA statement) and Strengthening the Reporting of OBservational studies in Epidemiology (STROBE statement) for observational studies, which researchers must use as templates not only to increase their chances of publication but also avoiding any ethical misconduct. 5 , 6 , 7 The Enhancing the QUAlity and Transparency of health Research (EQUATOR network) (website: http://www.equator-network.org ) is a very good network which provides a comprehensive collection of reporting guidelines that can be used based on the design of the study. It is a good idea that all research team members make themselves familiar with these statements at the time of start of the study so that they have a clear plan in their mind. All clinical trials done in India should be registered with the Clinical Trials Registry of India (CTRI) (website: http://ctri.nic.in ) set up by the Indian Council of Medical Research, and authors should provide the CTRI number along with the manuscript.

Once the study is complete and ready for submission, the first ethical issue that comes up is on authorship: Who should be listed as authors and in what order? The International Committee of Medical Journal Editors consensus statement is a useful guide and must always be followed. 8 Only those researchers who are involved in the conception and design, acquisition of data or analysis and interpretation of data, and drafting the article or revising it critically, must be listed as authors. 8 General supervision of the research group is not sufficient for authorship. 8 As a rule and good practice, the order of authorship should be based on the relative contribution of each author. Both honorary and ghost (not naming an author who has made a significant contribution) authorship should not be done. 9 , 10 Names of other researchers who have helped but who do not qualify to be authors may be declared in the acknowledgment section.

Plagiarism of any form, intentional or unintentional, must be strictly avoided. 2 If any of the authors has a doubt that some part of the manuscript may be plagiarized, they must run it through a plagiarism detecting software ( www.ithentical.com , www.turnitin.com , www.plagiarism.org , etc.) to avoid embarrassment later. 11 The authors must also ensure that they do not submit their manuscript to more than one journal at any given time. This is extremely important from the copyright point of view and may sometimes lead to serious consequences, to the extent of the article be retracted and disciplinary proceedings being initiated against the authors according to the Committee on Publication Ethics guidelines (website; http://publicationethics.org ). Junior researchers in their enthusiasm to get their work published may want to retort to this method, but the senior members must actively discourage them from doing it.

All authors must explicitly disclose all their personal or institutional conflicts of interest and source of funding for the research being submitted for possible publication. 12 This not only helps the editors but also the readers to interpret the results of the study more judiciously. Authors must always ensure that the conclusions they present should always be based on the results from their study and should not be influenced by the monetary or other benefits they may have gained as a result of conducting the study.

Most reputed journals including the IJO have a robust system of peer review. Peer review ensures that only the highest quality research is published, and errors and oversights corrected. 13 Following the review process, most authors would be asked to do a major or minor revision of their work. As an ethical rule authors must take the reviewers comments positively and must answer the concerns raised systematically and within the stipulated time frame. This helps the journal to meet their submission to decision time guidelines. Sometimes, queries might be raised by the editorial team even after a manuscript has been accepted and authors must again respond to them quickly. Once a manuscript is published, queries may be raised by the readers formally in the form of letter to editors of informal communication. Again it is the authors’ moral duty to respond to these questions. All records and data pertaining to the study must be maintained for a sufficient period of time so that they can be produced anytime for scrutiny if desired by readers, other researchers, agencies, or editorial teams.

The animals in experimental studies are used for research. They should be used if strict ethical ‘animal use guidelines’ are followed. They are used if there is clear benefit, with animal experiments to the environment, animals or humans. The optimal standards of animal health and care should be followed. 15 The “best practice in research involving animals will embody the principles of the 3Rs (replacement, reduction and refinement) and a paper must also demonstrate that the study has adhered to these. Further details of theses principles can be found on the National Centre for the Replacement, Refinement and Reduction of Animals in Research website ( http://www.nc3rs.org.uk/the-3rs ). 16 Animals should not be used if there are alternative approaches available.

The WMA Declaration of Geneva binds the physician with the words, “the health of my patient will be my first consideration.” 14 Further, the DoH states that “In medical research on human participants, considerations related to the well-being of the human participant should take precedence over the interests of science and society.” 3 If all members of a research team follow these words in letter and spirit, a number of ethical issues which crop up during the conduct and publication of medical research, especially involving human participants, would be taken care of automatically.

To summarize both authors and publishers have ethical obligations. “Reports of experimentation not in accordance with principles laid down by ‘Declaration of Helsinki’, should not be accepted for publication. 13

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