a translational research perspective

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What is translational research?

Cornell’s College of Human Ecology is pursuing a translational research model to better link social and behavioral science research to extension and outreach, creating a more seamless link between science and service. But the question arises: What is “translational research?”

Evidence-Based Living sat down with Wethington to talk about the growing field of translational research.

To start off, what exactly is translational research?

Many definitions have been given for translational research, but the definition I like best is that it is a systematic effort to convert basic research knowledge into practical applications to enhance human health and well being. 

Translational research was designed for the medical world.  It emerged in response to concern over the long time lag between scientific discoveries and changes in treatments, practices, and health policies that incorporate the new discoveries.

What is applied research, and how does it differ?

Translational research is broader than the traditional term “applied research.”  Applied research is any research that may possibly be useful for enhancing health or well-being. It does not necessarily have to have any effort connected with it to take the research to a practical level. 

For example, an applied research study might analyze longitudinal data that tracks participants’ health and social relationships.  The researchers would report their findings in an academic journal.

But in translational research, the same study would include some “action steps.”  The researchers would partner with a community and ask for ideas about how their findings might apply there.  Together, they would come up with an intervention plan that would also include scientific evaluation of its effectiveness. 

Why are social science researchers slower to adopt these models compared to the medical community?

I think the answer to this question is that researchers have followed where the money has been allocated. The opportunities for social and behavioral scientists have not been established as rapidly.

More recently, three major government institutions have been funding projects that emphasize public health outreach using translational research – the Centers for Disease Control, the National Institutes of Health and the National Institute on Aging.  All three have been establishing translational research centers across the country, primarily focused on underserved communities and health disparities.

Thus, social scientists are only now being encouraged to take part.  More recently economic stimulus funds dispersed the National Institute of Health funded a number of translational research projects headed by social scientists, including three funded at Cornell.  I predict that soon there will be social scientists engaged in translational research across the country, not just at funded centers.

What are the benefits of moving toward translational research?

For researchers, there is benefit to being affiliated with a center that provides seed funding for projects, methodological assistance, advice on developing proposals and experience in getting community input into research projects.

For universities, translational research centers provide a tactical advantage for attracting more funding.  Translational research centers also provide a way for universities to meet public service goals in their strategic plans.

For communities, translational research provides opportunities to make a difference in their own communities.  As part of one of the Cornell centers, we engaged public service agency directors in events where they could contribute to our research agenda.  With a stake in the research, communities feel that they are making a valued and important contribution.  We heard over and over from the community members that this was a real source of pride and accomplishment for them.

How can extension programs participate?

One way local extension programs can participate in translational research is to take part in community stakeholder groups that meet with researchers who are designing intervention and prevention research programs.  Typically, a wide variety of stakeholders need to be engaged.  County Cooperative Extension offices have many collaborative relationships in their counties and can work with researchers to make contacts.

Typically, local extension professionals do not have time to engage in research themselves.  Yet they have valuable experience that can be shared.  This makes Cooperative Extension an ideal contributor for implementing programs.

Nice reading! Thank you

A remarkable extraordinary read, ideally other huge schools can take an interest in something like this.

Quite the great read, hopefully other large schools are able to participate in something like this.

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• Open access
• Published: 30 September 2014

Translational ethics: an analytical framework of translational movements between theory and practice and a sketch of a comprehensive approach

• Kristine Bærøe 1  

BMC Medical Ethics volume  15 , Article number:  71 ( 2014 ) Cite this article

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Translational research in medicine requires researchers to identify the steps to transfer basic scientific discoveries from laboratory benches to bedside decision-making, and eventually into clinical practice. On a parallel track, philosophical work in ethics has not been obliged to identify the steps to translate theoretical conclusions into adequate practice. The medical ethicist A. Cribb suggested some years ago that it is now time to debate ‘the business of translational’ in medical ethics. Despite the very interesting and useful perspective on the field of medical ethics launched by Cribb, the debate is still missing. In this paper, I take up Cribb’s invitation and discuss further analytic distinctions needed to base an ethics aiming to translate between theory and practice.

The analytic distinctions needed to base an ethics aiming to translate between theory and practice are identified as ‘movements of translation’. I explore briefly what would constitute success and limitations to these intended translational movements by addressing the challenges of the epistemological gap between philosophical and practical ethics. The categories of translational movements I suggest can serve as a starting point for a systematic, collective self-inspection and discussion of the merits and limitations of the various academic and practical activities that bioethicists are engaged in. I further propose that translational ethics could be considered as a new discipline of ethical work constructively structured around compositions of translational movements.

Breaking the idea of translational ethics into distinct translational movements provide us with a nuanced set of conditions to explore and discuss the justification and limitations of various efforts carried out in the field of bioethics. In this sense, the proposed framework could be a useful vehicle for augmented collective, self-reflexivity among both philosophers and practitioners who are ‘doing bioethics’. Also, carefully designed, overall approaches combining justified, self-reflexive philosophical and practical efforts according to the suggested distinctions could be expected to realise – or at least improve a facilitation of – translation of ethics across the theory-practice gap.

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Translational research in medicine requires researchers to identify the steps to transfer basic scientific discoveries from laboratory benches to bedside decision-making, and eventually into clinical practice. On a parallel track, philosophical work in ethics has not been obliged to identify the steps to translate theoretical conclusions into adequate practice. Some years ago, the medical ethicist A. Cribb suggested that it is now time to debate ‘the business of translational’ in medical ethics [ 1 ]. Although Cribb himself was not convinced that it would be ‘… useful to echo the wider call for translational medical research that moves from bench to bedside with a call for translational medical ethics that moves from argument to action’ , he argued for the usefulness of discussing translation to clarify the limitations and opportunities of the theoretical and practical achievements within the field of medical ethics.

In this paper, I take up Cribb’s invitation to debate the potential academic and practical achievements in the multi- and interdisciplinary field of medical ethics through the lens of translation. While welcoming this initiative as a golden opportunity for coordinated, collective scrutiny, debate and justification of the work carried out within this field, I argue that crucial analytical steps are called for to facilitate a self-reflective debate.

Firstly, it is necessary to differentiate between approaches that can be labelled as ‘translational ethics’ but are based on fundamentally different conditions. The theory-practice gap can refer to the particular gap between basic medical research and clinical implementation of effective interventions, i.e. the gap being bridged by translational medical research. Translational medical research requires researchers to identify the steps needed (1) to transfer basic scientific discoveries into useful health improving interventions , as well as (2) to ensure the adequate implementation of best clinical practice and healthcare decision-making [ 2 ]. The ethics related to bridging this particular gap between theory and practice in medicine encompasses all ethical issues encountered in translation from theoretical assumptions to developed medical interventions, i.e. ‘from bench to bedside’. Further distinctions can be made within this version of translational ethics by considering the involvement of different stakeholders and their responsibilities in the research, implementation and evaluation process.

This version of translational ethics can be understood as the ethics of translational medical research . This particular version of translational ethics will, for example, concern the use of animals for experimental or therapeutic purposes, requirements on patient consent at different phases of clinical trials, and the role of the pharmaceutical industry in directing innovative research. In the literature, there are many examples of this kind of ethical work (see e.g. [ 3 – 5 ]). Cribb, on the other hand, focuses on translational ethics in relation to the internal gap between theory and practice within the field of ethics itself . In the rest of the paper I reserve the label ‘translational ethics’ for intentional attempts to cross this particular gap within ethics. It is worth noting that this latter interpretation of translational ethics also encompasses basic concerns of ethics addressing the thematic particularities of translational medical research.

Secondly, it is necessary to identify and distinguish the various translational movements that can be carried out in ethics. These translational movements are not likely to bring about the complete translation of theoretical ethics into practice by themselves. However, as I will argue, these distinct translational movements can be combined into a coordinated process of ethical work structured according to distinct, successive phases (as in translational medical research) which translate theoretically justified, normative arguments into practice. In this respect, I endorse a more optimistic view than Cribb does on the possibility of translating between theory and practice in ethics.

Several presuppositions for this conceptually mapping of translational movements should be clarified from the start. I will assume that philosophical approaches are broadly understood as any normative-theoretical approaches to ethics independently of what discipline it emerges from. I will assume that such approaches differ fundamentally from practical approaches, in that the former have the mere aim of seeking ‘truthfulness’ in terms of rational justification, coherence, logical reasoning (consistency) and conceptual clarity, while the latter do not [ 6 ]. The truth-seeking aim of practical approaches is to find feasible, justifiable and practical solutions to the confronted ethical issues and act accordingly. In addition, practical approaches are directly connected to personal moral responsibility for one’s own actions, while theoretical approaches are not (although it might be argued that they should be considered indirectly responsible for consequences of what they recommend).

Further, I assume that since philosophical and practical approaches are carried out within fundamentally different conditions for reaching conclusions it gives us reasons to consider philosophical and practical conclusions as representing different categories of knowledge. Consequently, we should be aware of the distinction between the translations of knowledge that take place within one of the knowledge areas and translation that cuts across these two different areas. The specific structures of translation (or at least ‘structures of transference’) of knowledge from one context to another within an area of knowledge make for an interesting discussion in their own right, like the use of hypothetic, construed examples to justify theories and casuistic in real world, practical reasoning. Here, however, ‘translation’ involves the aim of bridging epistemologically distinct areas involving different kinds of training and competence.

Moreover, I also assume that the general structures describing the nature of translation in medical ethics also describe the general structures of translation in ‘doing ethics’ in general and bioethics in particular. Bioethics covers ethics related to any living entities, including the environment, and to related decision-making carried out at any level, i.e. clinical as well as political. Thus, the field of bioethics encompasses medical ethics, but also opens up a broader scope of ethical issues and stakeholders beyond medical ethics. I will refer to the general conceptions of translational ethics and translational bioethics to keep the scope of relevant issues as broadly defined as possible.

Finally, I do not claim that translational ethics would require a straightforward, top-down application of normative theory on clinical work, nor do I presume that the philosophers (broadly understood as theorists working on normative matters) have all the pertinent premises for a justified practice. Rather, I assume that the key to translational ethics can be found within complex structures of interplay between the two very different approaches of gaining theoretical and practical ethical knowledge, respectively. In this paper, I unpack this complexity by providing a topology of different translational movements in bioethics. This topology invites greater reflexivity among philosophers and practitioners working within the field of bioethics. Thus, it can also support better and more nuanced justifications of chosen translational approaches to bioethical issues on a case-to-case basis.

In the following section, I identify different approaches that promote translation by systematically reflecting on how the movement of translation can take place across different modes of ‘doing ethics’.

Bridging the philosophical reflection-practice gap: In what direction? What kind of intervention? Whose responsibility?

There are two general directions in which to try and bridge the philosophical reflection-practice gap: from philosophical reflection to practice, or from practice to philosophical reflection. In the former, the object for translation is bioethical research carried out in academic institutions as theoretically justified reasoning and conclusions. In the latter, the object for translation is bioethics as it is carried out as practical reasoning and conclusions about what to do within the field of medicine or other bio-related activities (e.g. environmental interventions). Translation thus involves the transference of elements of knowledge production from one area to the other.

I will further analyse the movement of translation with respect to (a) the direction in which the translation occurs (from philosophical reflection to practice, or vice versa), (b) the nature of the intervention (i.e. academic work, political/moral engagement/involvement or implementation/adherence to particular methodological strategies for shaping practice) and (c) the locus of responsibility. I shall point out several categories of approaches that qualify as translational movements in bioethics, structured around these three distinguishable factors. I will first consider different versions of academic bioethics aiming for translation across the philosophical reflection-practice gap, before considering practical, bioethical approaches seeking to bring about translation across this gap.

Translational philosophical bioethics

In this section, I will first discuss academic work that supports translation from philosophical reflections to practice, followed by academic work that initiates the translation of practical knowledge into philosophical reflection. In general, the responsibility for carrying out translational, philosophical bioethics must be on those being trained in philosophical theory and reasoning . This does not, as we will see, exclude competent, empirical research on on-going practice from playing a key role in this kind of translational work.

Translational philosophical bioethics research by researchers

The translation from theory to practice occurs when philosophical, bioethical research affects how bioethical practice is shaped. Cribb uses the term translation metaphorically to investigate whether translation applies as well in ethics as it does in biomedical research. He succinctly points out that theoretical, rigorous thinking cannot be turned into practical conclusions in a real-world context without losing its initial, distinct characteristics [ 1 ]. If we were to take translation at face value as an application of theoretical, normative conclusions in practice we would have to expect equal outcome in the conclusions reached by philosophical reasoning on the one side and practical reasoning on the matter on the other. This represents too strong and substantial a claim on what translation amounts to in an ethical setting since it presumes that either theoretical thinking will have to collapse into practical reasoning or practical reasoning will have to mirror theoretical reasoning in order for any translation to take place. Thus, we might have to reject the idea that any talk about bridging between theory and practice in ethics in terms of translation can be useful. Or, alternatively, we can make a normative definition of ‘translation’ that makes it meaningful to use the concept to capture the exchange that can be carried out across the theory-practice gap in ethics. My suggestion is to go for the latter alternative. I propose that ‘translation’ from philosophical normative reflection to practice refers to what is produced by philosophical work when it facilitates practical conclusions on the terms of practice itself that can be theoretically justified . This means that theoretical approaches do not need to presume the validity of one particular normative theory to settle practical issues, like for instance a specific utilitarian approach. Examples of translational, theoretical work would not have to include theoretically justified, substantial conclusions, such as the moral acceptability of enhancement interventions or genetic screening. The point here is that translation between the knowledge areas should avoid the presumption that theoretical approaches based on the characteristics of theoretical reasoning stands in any authoritative position to dictate the rightness of the practical conclusions arrived at on the conditions of a practice. Relevant examples on apt translational theory are instead methodological approaches to ethical education and deliberation that are developed with the aim of supporting and shaping political, professional or private practical conclusions while accepting pluralism with respect to the normative points of view of the stakeholders involved. Concrete examples of this kind of work are the non-conclusive framework of the four principles of biomedical ethics, the structured ‘Moral Case Deliberation’ approach and the framework ‘Accountability for Reasonableness’ developed to sustain fair limit setting in healthcare [ 7 – 9 ]. Carefully designed teaching approaches in health ethics are also relevant examples of this kind of work (see e.g. [ 10 , 11 ]).

Taking these considerations into account, purely normative, theoretical research on ideal premises (i.e. simplified, limited premises that basically allow for discussion and justification of principles, not real world actions) cannot be characterised as being translational in its own right. In order to enable the success of this particular kind of translational movement, the philosophical work must address, as adequately as possible, the relevant challenges of the real world of practice . This means that the researcher must aim to base his or her normative approach as closely as possible on non-ideal features of human psychology and socio-empirical conditions. He or she must design the approach to counteract identified barriers to ideal decision-making, such as particular empirical features structuring the context (e.g. resource scarcity, geographic and demographic challenges), biased distribution of opportunities among individuals (e.g. to voice concern, deliberate, process information, reach a conclusion and act on it), and pragmatic barriers that undermine feasibility (e.g. organisation of information flow in institutions). In this respect, practice in terms of empirical psychological, social studies and pragmatic, organizational structures must inform philosophical reflection and justification of the underlying structures of normativity on a case-by-case basis. It is important to note that although drawing upon empiric information, these approaches do not lapse into ordinary practical reasoning. The aim is to facilitate normatively justifiable practical decision-making among stakeholders under certain constraints, not to arrive at practical conclusions about what to do as a policy or in particular contexts. If researchers engage in this latter activity and take a normative stand on what to do, they act as politicians or stakeholders. Their moral right to do so should be questioned as legitimate on a case-by-case basis.

The responsibility for identifying relevant premises, and for producing and coordinating academic work on ethics that adequately , and in a non-arbitrary manner, facilitates the translation of philosophically justified knowledge into practice, rests with theoretical researchers. The reason for this is that practitioners, per definition, do not approach ethical issues primary as philosophical issues.

Translation of philosophical work into bioethical practice by practitioners

The translation from philosophy to practice can also be carried out with the support of practitioners. It can be considered an ethical responsibility of people working within the field of medicine to seek well-justified solutions to the ethical dilemmas encountered in their practice. By seeking to identify and clarify such dilemmas and discuss solutions in light of theoretical perspectives, they may support the translation of philosophical theory into practice on philosophical premises. However, a lack of training in theory and philosophical reasoning may veil the recognition of an ethical dilemma in the first place. It may disturb focused deliberation and lead to invalid conclusions. In this respect, practitioners with a double competence in both practical and philosophical training (without requiring formal education) might be crucial for the success of this translational movement. Although the initiative of this form of translation rests on the practitioners, theoretically trained bioethicists can help to prepare easily understood presentations of normative theory to facilitate its success.

Translational meta-bioethics analysis

In addition to the translational philosophical bioethics research described above, another kind of translational philosophical work may focus on analytical discussions of the different conditions for translational bioethics. The approach presented in this paper is an example of this translational movement. This meta-theoretical perspective aims to have an indirect impact on real-world bioethical practice by suggesting distinctions and conditions to facilitate discussions on how to properly carry out translational bioethics. Again, the responsibility for adopting this meta-perspective must be on theoretical bioethics researchers given the theoretical nature of this investigation.

Translational practice of bioethics

Bioethical practice encompasses all kinds of contextualised reasoning and practical conclusions, including policy-making, which shape the ethical formation of real-life, medical and environmental decisions and interventions. I will begin by accounting for practical activity that supports the translation from theory into practice, before I describe the practice that supports the translation from practice into theory. By locating the responsibilities of different actors involved in medical ethics, I will further distinguish the movements of translation in ethics.

Researchers’ translation of philosophical work into bioethical practice

Philosophers or theoretical researchers may take on the ethical task of shaping the field of practice themselves, according to principles and theories they find theoretically convincing. When researchers are involved in real-world, ethical decision-making on practical terms , the translation from philosophical reflections to practice can be realised in several ways. By ‘going political’ , they can lobby for the implementation of theoretically justified, bioethical policies. Philosophers such as Peter Singer and Thomas Pogge toil to translate abstract principles and theory into feasible policies, and advocate for these on practical, political terms [ 12 , 13 ]. Brock has convincingly reported on the need to distort philosophical normative reasoning on the premises of non-philosophical argumentation in order to avoid unfortunate misunderstandings in practical policy-making [ 14 ]. In this respect, theoretically trained scholars may realise a translational movement by facilitating acceptance for a theoretically justifiable point of view. However, theoretical bioethicists who actively influence substantial policy-making with their own normative viewpoints should take precautions to avoid undue impact. Scholars have the responsibility of clarifying that one is then acting as a citizen and is merely representing the political opinion of one citizen – he or she is not due exclusive political authority as an expert on political questions.

At the same time, philosophers may indeed have a legitimate authoritative role to play as theoretically trained academics when teaching, as well as in political or ethical committee work. This applies when they are introducing and mentoring theoretically justified analytical approaches on practical terms, while aiming to structure processes of moral or political deliberation to promote understanding and to help others reach practical conclusions. In this way, they can bring about a version of translational movement through instructive guidance.

Researchers’ translation of practice into philosophical research

Researchers can also support translation from practice to philosophical reflection by engaging in practice themselves. This occurs when a researcher assumes the role of an action researcher and gets involved in ethical deliberation processes. Here they can support practitioners or other stakeholders in identifying and articulating ethical issues at stake and learn to speak ‘the same language’ as practitioners, i.e. express concerns and lines of reasoning in the way they do. An analysis of this knowledge-producing process can bring new ethical themes to the desk for philosophical reflection. The deliberative process may also reveal new data to the participating researcher that supports new meta-theories on the underlying structures of ethical perception and reasoning. This translation from practice to theory can then, in turn, be used in the translation from theory to practice in the translational, philosophical work described above.

Researchers can also support the translation from practice to philosophical reflection by ensuring that the philosophical issue they are discussing is not merely a theoretical construct but an accurate reflection of the issue as it presents itself to real-world stakeholders in non-idealised, practical terms. The stakeholders’ perceptions – as well as the discovery of previously unrecognised perspectives – may lead the researcher to reformulate the issue or even articulate previously overlooked dilemmas [ 15 ]. The researcher may test out the presentation of an issue before subjecting it to rigorous scrutiny, for example by arranging focus group interviews with stakeholders. In this way, philosophical research includes the translation of practice into the process of articulating the objective for normative, philosophical scrutiny. There is no guarantee that stakeholders’ perspectives are always relevant – they might, for example, be more focused on how to overcome minor practical challenges than the challenges involved in broader issues like organising a fair healthcare system. Nevertheless, the experiences and perspectives of real-world stakeholders should be recognised as potentially valuable sources to render philosophical research relevant.

Practitioners’ translation of practice into philosophical research

Practitioners can also realise the translation from practice to philosophical reflection. They can use channels to draw attention to pressing ethical issues that they experience in their work, e.g. by contacting media, or by approaching philosophical researchers directly. In this way, practical experiences can find their way onto the research agenda for theoretical scrutiny (and potentially back again to shape practice, if the prescribed strategies are implemented in the form of new policies). It is worth noting that there might be practical and cultural barriers (e.g. a lack of time or social resources and informal codes of loyalty) to seeking external guidance on ethical challenges experienced within the field of practice. In addition, involving a third party such as the media – who might be more interested in fronting spectacular cases than structural, everyday ethical challenges with no clearly identified wrongdoers – may skew the attention on concerns generated by this form of translational movement.

Conditions for translational ethics

I have now identified distinct, translational structures within the field of bioethics. The list is not necessarily exhaustive, and I have merely hinted at what would constitute success and the limitations of the presented versions. I strongly believe that it should be considered a collective responsibility of the research community in bioethics to explore and debate the conditions for these different approaches as they promote a normatively justifiable, real world, bioethical practice. Debating the justified role that a bioethicist should play in various settings is a core task of a self-reflecting ethics research community. This task could benefit from more systematically organised attention. The same goes for the role of representatives of other disciplines within this field. Bioethics journals should strongly encourage and facilitate this type of self-reflecting work.

As mentioned earlier, the different translational movements should be considered to facilitate, rather than to actually realise, translation between theory and practice. For translation to be completed, it seems useful to adopt similar analytical phases that describe translational medical research: identification of the ethical challenge, development of a normatively justified approach, testing of the feasibility of the proposed approach in a real-world setting, implementation of the adjusted result, evaluation of the resulting practice, and if not successfully implemented (i.e. the ethical challenge still remains), the challenge of re-designing an adequate decision-making process or educational or mentoring effort is sent back for further scrutiny. The translational movements described earlier can be used in these various phases of bringing about translation; sets of self-reflexive, justified substantive conditions for translational movements can be coordinated for realising normatively valid translational ethics. The justified combination of distinct translational movements is likely to vary according to the kind of practice subject to ethical change (e.g. policy-making processes may call for other combinations of translational movements as compared to clinical challenges). The planning and designing of well-justified processes of translational ethics will thus be a crucial element of translational ethics itself. Translational ethics can now be described as an intended and purposive construction of theoretically justified, translational movements. ‘Translation’ in this sense is not taken at face value as theoretical reasoning being adopted by practice. Rather, the overall translational movement taking place between the epistemological different areas of theory and practice by this suggested overall strategy is better understood as a facilitation of well justified practices carefully respecting both theoretical and practical premises. Considered in this way, it occurs as a new academic discipline rather than, negatively defined, a compromise between theory and practice.

In this paper, I have explored the conditions for translational ethics by identifying different categories of translational movements that address the theory-practice gap. As an analytical framework, the proposed overview of substantive versions of translational movements can serve as a starting point for a systematic discussion, and a self-reflective inspection of the knowledge-producing conditions of the multifaceted field of bioethics. As part of a coordinated approach, they can serve as building blocks in the overall process of constituting a new ethical discipline – translational ethics that cross the theory-practice gap within ethics.

Author information

Kristine Bærøe is employed in a 50/50 position as an Associate Professor and a postdoc at the Department of Department of Global Public Health and Primary Care, University of Bergen. Her background is in philosophy. Her post doc project “Translational ethics: Bridging the theory-practice gap in medical ethics by translational approaches to core issues in medical research, clinical care, and public health” addresses the fundamental challenges of bridging the gap between theoretical and practical bioethics in a constructive manner.

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Acknowledgement

I am indebted to Doris Schroeder for invaluable comments and discussions on the conceptualisation of translational ethics. I owe her the examples of politically engaged philosophers. I am also grateful to James Wilson for pointing out the translational structure of philosophers ensuring the practical relevance of topics for philosophical scrutiny, and to the reviewers of this journal, Richard Ashcroft and Lucy Frith, for their thoughtful and useful comments on a previous manuscript.

The paper emerges from a post doc project funded by the University of Bergen.

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Department of Global Public Health and Primary Care, University of Bergen, Kalfarveien 31, Postboks, 7804, NO-5020, Bergen, Norway

Kristine Bærøe

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Correspondence to Kristine Bærøe .

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Bærøe, K. Translational ethics: an analytical framework of translational movements between theory and practice and a sketch of a comprehensive approach. BMC Med Ethics 15 , 71 (2014). https://doi.org/10.1186/1472-6939-15-71

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DOI : https://doi.org/10.1186/1472-6939-15-71

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• PMCID: PMC6408273
• DOI: 10.1176/appi.ajp.2018.17121311

Epidemiologic studies, including prospective birth cohort investigations, have implicated maternal immune activation in the etiology of neuropsychiatric disorders. Maternal infectious pathogens and inflammation are plausible risk factors for these outcomes and have been associated with schizophrenia, autism spectrum disorder, and bipolar disorder. Concurrent with epidemiologic research are animal models of prenatal immune activation, which have documented behavioral, neurochemical, neuroanatomic, and neurophysiologic disruptions that mirror phenotypes observed in these neuropsychiatric disorders. Epidemiologic studies of maternal immune activation offer the advantage of directly evaluating human populations but are limited in their ability to uncover pathogenic mechanisms. Animal models, on the other hand, are limited in their generalizability to psychiatric disorders but have made significant strides toward discovering causal relationships and biological pathways between maternal immune activation and neuropsychiatric phenotypes. Incorporating these risk factors in reverse translational animal models of maternal immune activation has yielded a wealth of data supporting the predictive potential of epidemiologic studies. To further enhance the translatability between epidemiology and basic science, the authors propose a complementary approach that includes deconstructing neuropsychiatric outcomes of maternal immune activation into key pathophysiologically defined phenotypes that are identifiable in humans and animals and that evaluate the interspecies concordance regarding interactions between maternal immune activation and genetic and epigenetic factors, including processes involving intergenerational disease transmission. [AJP AT 175: Remembering Our Past As We Envision Our Future October 1857: The Pathology of Insanity J.C. Bucknill: "In the brain the state of inflammation itself either very quickly ceases or very soon causes death; but when it does cease it leaves behind it consequences which are frequently the causes of insanity, and the conditions of cerebral atrophy." (Am J Psychiatry 1857; 14:172-193 )].

Keywords: Animal Models; Epidemiology; Maternal Immune Activation; Neuropsychiatric Outcomes; Translation.

Publication types

• Research Support, N.I.H., Extramural
• Research Support, Non-U.S. Gov't
• Autistic Disorder / immunology
• Bipolar Disorder / immunology
• Neurodevelopmental Disorders / immunology*
• Pregnancy Complications / epidemiology
• Pregnancy Complications / immunology*
• Pregnancy Complications, Infectious / epidemiology
• Pregnancy Complications, Infectious / immunology
• Schizophrenia / immunology
• Translational Research, Biomedical

Grants and funding

• R01 ES019004/ES/NIEHS NIH HHS/United States
• R01 ES028125/ES/NIEHS NIH HHS/United States

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• Published: 28 October 2002

The challenge of translational research—a perspective from the NINDS

• Robert Finkelstein 1 ,
• Thomas Miller 2 &
• Robert Baughman 3  

Nature Neuroscience volume  5 ,  pages 1029–1030 ( 2002 ) Cite this article

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There has been a remarkable sea change in biomedical research. Recent advances in basic science are providing hope that treatments will be developed for many disorders that are currently intractable. This is particularly true in the realm of neurological disease, where neuroscientists are increasingly in a position to translate discoveries about disease mechanisms into clinical interventions. It is critical that the organizations that fund biomedical research seize the opportunity to facilitate this process. The challenge for the National Institutes of Health (NIH) is twofold. First, we must continue to support the basic, investigator-initiated studies that brought us to this point. Because only a small fraction of promising therapeutic leads are ultimately applicable to the clinic, basic researchers must continue to provide a foundation for new strategies. Second, we must develop creative new funding mechanisms that not only facilitate, but actively accelerate therapy development. The doubling of the NIH budget, which will be completed in 2003, should allow us to achieve both goals.

To promote the development of new treatments, the National Institute of Neurological Disorders and Stroke (NINDS) recently announced a comprehensive Translational Research Program. At the heart of this program is a collection of new funding mechanisms specifically tailored to the process of translational research. The program is aimed at investigators seeking to apply their research findings to the treatment of neurological disease (for examples of relevant disorders, see the NINDS website at http://www.ninds.nih.gov ). Here, we describe the thinking that led to the development of this initiative.

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Challenges and Drivers of Translational Research

Jun 3, 2021

15 min read

Translational research is aimed at deploying knowledge collected from trials and clinical observations to improve clinical benefits and enhance product attributes. 

Translational research is also referred to interchangeably as translational medical or translation science. This research also works on effective optimum migration of knowledge from one system to another or from one level of discovery to another level of discovery. This covers the full translation of animal to human data, and backward for bringing new solutions for different diseases, identifying current and future unmet needs and possible solutions to overcome these.

A final goal of translational medicine is to help patients with the more rapid development of new diagnostics, medicinal products, and new medical knowledge for treating diseases, giving access to care for people at reasonable costs. Insights on where a novel therapy might have the highest impact on diseases and what research needs to be done before clinical testing

It is a circular concept encompassing so-called bench-to-bedside-to-community factors, which aim to increase the efficiency by which new therapeutic strategies developed through basic research are tested clinically, and bedside-to-bench factors, which provide feedback about the applications of new treatments and how they can be improved. It also facilitates the depiction of disease processes and the generation of connected novel hypotheses based on direct human observation.

Some of the examples could be patient and physician-reported outcomes, community knowledge, and incorporating the clinical observations and questions into scientific hypotheses in the laboratory.

Translation research takes place at every level of the product value chain, and it involves multiple stakeholders

Translational research is evidence-based research, or disease-targeted research is a collaboration between clinics, research hospitals, governments, academic institutes, and small to large scale industries where different diseases (infectious, acquired, or genetic) are identified, and discoveries are tested in cell culture, animal models, and clinical trials to determine the relevance of novel discoveries in the biological sciences for human health and longevity.

Different stakeholders in the healthcare value chain such as patients, healthcare providers, and practitioners use the term for the need to accelerate the incorporation of benefits of research into clinical medicine and to close the gap between “what we know” and “what we practice.”

A final goal of translational medicine is to help patients with the more rapid development of new diagnostics, medicinal products, and new medical knowledge for treating diseases, giving access to care for people at reasonable costs.

The most current translation model in the literature is the 4 T’s model:

• T1: Basic scientific discovery (basic knowledge) to potential clinical application (theoretical knowledge) to
• T2: Evidence-based guidelines (efficacy knowledge) to
• T3: Clinical care or intervention (applied knowledge) to
• T4: The health of a community or population (public health knowledge)

Due to the introduction of translational research, the knowledge generates since the inception of the concept is far more than actual implementation in clinical practice. Hence translational research is needed to fill this gap. In history, medicine took more than 15 years to reach the patient since its discovery. Most of the portion of this time was consumed by clinical trials and the correction of erroneous methods.

Translational research creates a developmental playground where scientists can design experimental approaches while maintaining the view of the implications their work may have in the discovery of new therapies. Translational research creates a defined path that allows researchers from different disciplines to walk together in harmony, transcending the barriers left behind by medicine’s historical legacy.

The search for new drugs is at a historic moment of crisis considering the pressures across society as well as scientific limitations. Despite enormous technological advances, the new drug development process is becoming unsustainable. The technological explosion has not been accompanied by reinforcement of quality in experimental designs which are radically different from the traditional models, especially in the discovery phases. The high level of failure at a clinical trial in Phase II swallows up economic resources generates exhaustion among researchers and clinicians and more seriously for patients.

Valleys of Death:  Between basic scientific research and clinical research is what’s known as translational research often referred to as “the Valley of Death,” where promising discoveries meet their demise. To cross the “Valley of Death, several key requirements must be in place to move these discoveries into new treatments, diagnostics, and preventions.

Drivers and Challenges

There are several unmet needs at different levels of the value chain such as clinical, commercial, R&D, regulatory, and social levels. The industry is trying to find solutions to these unmet needs and which are resulting in the drivers. Traditionally translational research is considered as an important bridge joining basic research to clinical research. Following are a few specific drivers.

Ensure the success of R&D, increase R&D productivity and shorten the R&D lifecycle – On the one hand, the product prices have eroded due to social pressure and competition, and on the other hand, R&D expenses have increased over the years. The drop in R&D productivity has pushed the industry to improve the success rate of R&D programs, improve R&D productivity by optimally utilizing existing knowledge, collaboration with other industry players, and taking novel approaches.

Repurposing and life Cycle Management  – Efforts to resolve medical unmet needs through the existing and proven science/material/methods

Increasing life expectancy and evolving disease pattern-  Aging population and rapidly growing life expectancy in most world populations have resulted in an increased prevalence of the chronic disease. Also, the changing disease pattern, emerging new diseases, and re-emerging infectious diseases have pushed the industry to bring new solutions to address clinical needs.

Promise and expectations of growth in healthcare-  The continued rise in prevalence have resulted in the projected growth of health care spending. Despite the pricing pressure, treatments are getting costly due to the prolonged use of medicines and hospital stays.

While the Translation research is getting traction across the industrial corridors, there are still large and small level challenges that need to be undertaken before applying at the institutional level. The questions could the know-how of the translational process, detailed risk-benefit analysis, and strategic intent bearing in mind the consequentialist approach. A few of the challenges faced during the Translational research could be-

• Lack of coordination and connectivity between research and clinical teams
• Available funds for projects and ideas at critical stages in the research process
• Lack of novel ideas to design clinical trials
• Cross therapy area applicability of MoAs and targets, and repurposing
• Culture of translation and shared goals of fundamental research for humanities
• Availability of data related to success rates and real-time examples of implementation
• Financial conflicts of interest
• Ethical issues with respect to resource allocation basis the nature of the research, chances of success, and impact

Additionally, some of the challenges are Interdisciplinary training, Translational research as a recognized discipline, Evolution from departments to interdisciplinary research centers, and widely shared resources across the structural setup of organizations and eco-systems.

Overcoming the Challenges

Across the developed countries, almost all major public group health institutions and drug companies have addressed the issue of translational medicine in one way. In collaboration with the academics and research community, the NIH launched the Clinical and Translational Science Awards (CTSA) Consortium in 2006 with the plan of linking approximately 60 institutions to energize the discipline of clinical and translational sciences. The primary goal of the CTSA Programs is to assist institutions to forge an integrative academic home for Clinical and Translational Science. American universities addressed the challenge by establishing centers for translational medicine, e.g. at Duke or Pennsylvania University.

In Europe, the National Translational Cancer Research Network was set up by the British government to facilitate and enhance translational research in the United Kingdom. Depending on the structure and focus, institutional structures range from independent departments of translational or discovery medicine to completely dependent department which works cross-functionally with drug discovery/development teams without central facilities.

From the funding point, the US being the largest healthcare market, it had invested the most (NIH has announced to spend a total of up to 10 billion USD) and are at the forefront of translational institutionalization, while Europe lagging behind at very different distances knowing the geographical challenges.

In general, the US had been at the forefront where innovation to commercialization process could be speeded up through adequate re-modeling of institutional structures and translational medicine has a lot to do with expertise accrued during commercialization processes

When following a structured approach the translatability potential of a given drug, device, or diagnostic test project is assessed by multiple variables such as Lab results, associated markers and ligands, disease models, wet-med results, genetic and omics data, and other dimensions.

However, to develop a strategy for identifying the gaps in the existing process such as the environment of competing projects for a Go-No go decision or a program such as a biomarker development, it is imperative to develop a long-range approach that impacts stakeholders across the value chain such commercials, funding authorities, regulatory agencies, academia. The potential novel approaches could be new mechanisms to rate funding application with regards to translation potential, reasonable balances of associates risks, high potential exploitation, expert opinions to drive evaluation processes, and connecting investments with translational evidence-based analysis. While academic institutes should consider completely or partially re-shape research approached as a route to out-licensing success.

With this increased focus on the ability to influence traditional research and commercialization paradigm, there are hopes for promotion of multi- and inter-disciplinary clinical and translational research and new knowledge and techniques which would become more readily available to patient care.

Illustrative Examples and Conclusion

While Translational Research is still evolving, there are some specific examples and the way it has helped to shape discoveries made in basic research, into clinical treatments:

• Professor Fölling’s research in partnership with the Egeland family began the long journey to discover what we know about phenylketonuria (PKU) today. PKU is a metabolic disorder that can lead to intellectual disability, seizures, and other serious medical problems. This amazing story, which took place before the concept of translational medicine was even known, led doctors, biochemists and geneticists to discover more congenital metabolic diseases, which can also cause neurological damage.
• Children with Marfan syndrome were treated by Harry Dietz and his colleagues at Johns Hopkins University. This resulted in findings that medicine already approved in the United States as a treatment for high blood pressure can also prevent the aortic aneurisms found in mice with Marfan syndrome. This syndrome affects the body’s connective tissue and the complications are normally defects of the heart valves and aorta, which often lead to early death. The medicine has now been tested as a therapy in a group of children with this syndrome and was found to inhibit the development of the potentially deadly abnormalities in the aorta.
• In patients with early-stage prostate tumors, Anant Madabhushi and colleagues at Rutgers University used sophisticated image processing algorithms to analyze the texture of medical images made with high-resolution magnetic resonance imaging (MRI), to detect and locate tumors at an early stage. This led to a more sensitive and reliable technique for clinical application than other existing approaches.
• James Tunnell’s group at the University of Texas in the USA developed gold nanoparticles that can be targeted at cancer cells, allowing detection by fluorescence spectroscopy even when the tumors are quite small. These same particles can then be activated with strong light to potentially destroy the tumor. This approach combines optical imaging, spectroscopy, and nanotechnology for early cancer diagnosis and treatment.
• To delay the onset of blindness, many patients with glaucoma must administer eye drops multiple times during the day, a demanding routine that can prevent effective control of the disease. The work of Erin Lavik at Case Western Reserve University led to an improvement in the way that glaucoma patients receive their medication, and to more consistent levels of the medicine being applied, and thus to better outcomes for the patient. Prof. Lavik developed microspheres containing a glaucoma medicine, which can be injected into one spot in the eye, where the microspheres secrete controlled amounts of the medicine for over a month.

Strategic and cross-functional collaborations between academic institutions and bio-industries have been gaining momentum over the last decade due to the mutually beneficial and synergistic values each party brings to the table. Some of the examples are 

The broader goals of Translation Research are not limited to a specific topic or condition but the impact that it should have on overall populations and society at large. For example, if a state implements a policy to reduce the psychological disease burden in kids, it will not only promote the research related to it but also, various other stakeholders such as movies, advertisements, or children related touchpoints where any examples of violence, drug use or other such activities might be taking place. Translational medicine seeks to coordinate the use of new knowledge in clinical practice and to incorporate clinical observations and questions into scientific hypotheses.

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Open Access

Peer-reviewed

Research Article

Optimising Translational Research Opportunities: A Systematic Review and Narrative Synthesis of Basic and Clinician Scientists' Perspectives of Factors Which Enable or Hinder Translational Research

* E-mail: [email protected]

Affiliations Division of Health and Social Care Research, Faculty of Life Science and Medicine, King’s College London, London, United Kingdom, National Institute for Health Research (NIHR) Comprehensive Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, United Kingdom

Affiliation Centre for Implementation Science, Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, United Kingdom

Affiliations Department of Research Oncology, King’s College London and Guy’s Hospital, London, United Kingdom, Department of Clinical Immunology and Allergy, King’s College Hospital, London, United Kingdom

• Nina Fudge, 
• Euan Sadler, 
• Helen R. Fisher, 
• John Maher, 
• Charles D. A. Wolfe, 
• Christopher McKevitt

• Published: August 4, 2016
• https://doi.org/10.1371/journal.pone.0160475
• Reader Comments

Introduction

Translational research is central to international health policy, research and funding initiatives. Despite increasing use of the term, the translation of basic science discoveries into clinical practice is not straightforward. This systematic search and narrative synthesis aimed to examine factors enabling or hindering translational research from the perspective of basic and clinician scientists, a key stakeholder group in translational research, and to draw policy-relevant implications for organisations seeking to optimise translational research opportunities.

Methods and Results

We searched SCOPUS and Web of Science from inception until April 2015 for papers reporting scientists’ views of the factors they perceive as enabling or hindering the conduct of translational research. We screened 8,295 papers from electronic database searches and 20 papers from hand searches and citation tracking, identifying 26 studies of qualitative, quantitative or mixed method designs. We used a narrative synthesis approach and identified the following themes: 1) differing concepts of translational research 2) research processes as a barrier to translational research; 3) perceived cultural divide between research and clinical care; 4) interdisciplinary collaboration as enabling translation research, but dependent on the quality of prior and current social relationships; 5) translational research as entrepreneurial science. Across all five themes, factors enabling or hindering translational research were largely shaped by wider social, organisational, and structural factors.

To optimise translational research, policy could consider refining translational research models to better reflect scientists’ experiences, fostering greater collaboration and buy in from all types of scientists. Organisations could foster cultural change, ensuring that organisational practices and systems keep pace with the change in knowledge production brought about by the translational research agenda.

Citation: Fudge N, Sadler E, Fisher HR, Maher J, Wolfe CDA, McKevitt C (2016) Optimising Translational Research Opportunities: A Systematic Review and Narrative Synthesis of Basic and Clinician Scientists' Perspectives of Factors Which Enable or Hinder Translational Research. PLoS ONE 11(8): e0160475. https://doi.org/10.1371/journal.pone.0160475

Editor: Dan Weary, University of British Columbia, CANADA

Received: December 28, 2015; Accepted: July 20, 2016; Published: August 4, 2016

Copyright: © 2016 Fudge et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: Data used in this systematic review are available from the journal sources or from author depository if the journal does not operate an open access policy.

Funding: This article presents independent research funded by the National Institute for Health Research (NIHR) Comprehensive Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London (award number 652300), www.nihr.ac.uk/about/biomedical-research-centres.htm ; and the NIHR Collaboration for Leadership in Applied Health Research and Care South London at King's College London NHS Foundation Trust (award number NIHR CLAHRC-2013-10022), Prof Charles DA Wolfe, http://www.nihr.ac.uk/about/collaborations-for-leadership-in-applied-health-research-and-care.htm . The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

The term translational research has been in use for over 30 years, but has really come into focus in the health field in the last ten years and is now central to international health policy, research and funding initiatives [ 1 ]. Translational research has been characterised as harnessing the use of discoveries from basic science to develop new diagnostic tests, therapies and prevention devices (sometimes referred to as T1 type translation), as well as the implementation of research findings into practice to improve care for patients (T2 type translation) [ 2 ]. The need for translational research is based on the premise that much research in the life sciences has failed to advance human health, and it offers itself up as a solution to tackle intractable health problems [ 3 ].

Although accorded much prominence internationally, the translation of basic science findings into clinical practice is not straightforward. A substantial number of editorials, opinion pieces and policy documents make reference to barriers to translational research. These barriers include: a lack of a ‘culture of translation’ within institutions [ 4 , 5 ]; inadequate infrastructure, including a lack of facilities to conduct clinical research [ 2 , 5 ]; and an inadequately trained workforce and difficulties retaining those who do possess the necessary skills [ 4 , 6 , 7 ]. Collaboration is proposed as a key requirement for translational research with suggestions that it is inhibited by the compartmentalisation of departments within universities and hospitals, a cultural divide between scientists and clinicians, and a university system that rewards individual achievement rather than joint working practices [ 4 – 6 , 8 ]. At the policy level, a number of initiatives have been established with the aim to reduce perceived bottle necks in translational research in order to accelerate the translation of scientific knowledge into effective health measures with health benefits for patients and wealth benefits for the nation [ 9 – 12 ]. For example, in the US, Clinical and Translational Science Awards (CTSA) fund the development of innovative solutions to improve the efficiency, quality and impact of the translational research processes. In England, the creation of biomedical research centres brings together those working in a hospital setting with those in a university setting. However, less is known about the challenges and enablers of translational research from the perspective of those largely held responsible for conducting translational research: basic and clinician scientists. A growing body of empirical research has begun to address this gap.

To date, translational research has been positioned as bridging two seemingly disparate worlds: basic science and clinical medicine, with the former assumed to inform and feed into the latter. However, a number of commentators have challenged this view, affirming the huge diversity of activities within translational research, and pointing out that, although often framed as a singular ‘bench to bedside’ concept, translational research actually consists of multiple forms and processes which vary by discipline, institution and country [ 3 , 13 – 15 ]. This also underscores the importance of studies informed by the social sciences which until recently have paid only limited attention to translational research [ 13 ]. Scholars have begun to theorise how translational research is defined, what the organisation of health research into translational research models can tell us about biomedicine today, and how institutional practices shape visions for translational research [ 3 , 16 ]. These authors point to a number of factors shaping translational research, including the increased bureaucratisation of the university, the influence of an audit culture on structuring research, and the increased capitalisation of the life sciences.

The review team consisted of social scientists and clinician scientists, affiliated to a translational research organisation, charged with understanding methods to improve translational research processes. We argue that synthesising the growing body of empirical research on the views of basic and clinician scientists can shed light on how to optimise current policy agendas of translational research, but also provides empirical evidence to address broader questions about translational research as a concept. The aim of our investigation is first, to systematically review and synthesise studies examining factors enabling or hindering translational research from the perspective of basic and clinician scientists; and second, to use these findings to inform policy at the institutional level to better realise the potential for translational research.

Synthesis approach

We conducted a narrative synthesis of available papers that examined scientists’ perspectives of the factors which enable or hinder translational research. Narrative synthesis is an established method providing a rigorous framework for systematically reviewing and synthesising emerging conceptual themes from studies, which can be of qualitative, quantitative or mixed designs [ 17 ]. The approach aims to produce a textual, narrative understanding of findings from included studies conducted in different settings and contexts. It is suited to a field of enquiry where little is known, and aims to synthesise findings from studies in order to generate new knowledge, and critique existing concepts. This approach was considered particularly useful to examine themes related to factors perceived to inhibit or enable translational research from the perspective of scientists.

Selection criteria

We included primary research studies published in peer reviewed English language journals that used qualitative, quantitative or mixed methods to examine factors which hinder or enable translational research, from the perspective of clinician and basic scientists. We excluded editorial sources as these are essentially opinion or commentary from one individual. Our intention was to review the growing empirical research in this field which not only reports views of scientists but subjects them to conceptually and contextually based critical analysis. For the purposes of this review, our definition of translational research focused on research at the interface of laboratory and clinical research, although authors and their research participants did not have to explicitly use the term ‘translational research’. Studies were excluded if they: defined translational research as the implementation of research findings into practice as this area is conceptually different from T1 type translational research [ 2 ] and has been the focus of numerous reviews and meta-reviews to date [ 18 – 22 ]; did not discuss factors enabling or hindering translational research; only considered patients’ perspectives of translational research; or solely explored difficulties with recruiting participants to trials, as this topic has been the focus of several reviews already [ 23 , 24 ].

Search strategy.

The search strategy utilised a range of systematic and serendipitous methods to identify relevant studies [ 25 ]. First, we searched two electronic database platforms–SCOPUS and Web of Knowledge–from inception until April 2015. These were searched in the title, abstract and keywords using key terms for translational research combined with thesaurus and free text terms for the subject areas of health and medicine (see Table 1 ). The titles and abstracts of returned articles were scrutinised and full text articles obtained for papers likely to meet the inclusion criteria. Each potentially relevant article was retrieved and read in full by two authors to determine whether it met the inclusion criteria. After identifying relevant papers through database searching, the reference lists of retrieved articles were searched for other studies which might meet the inclusion criteria. We searched personal biographies of experts in the field. Finally, we undertook citation tracking in Google Scholar of all included papers, to identify any additional studies. Fig 1 illustrates the flow of studies through the stages according to PRISMA [ 26 ].

• PPT PowerPoint slide
• PNG larger image
• TIFF original image

https://doi.org/10.1371/journal.pone.0160475.g001

https://doi.org/10.1371/journal.pone.0160475.t001

Quality appraisal.

Two authors (NF, ES) independently appraised the quality of each study using a five-point checklist comparing quality scores given to each paper to reach a consensus [ 27 ]. This checklist assesses the methodological quality of studies and can be applied to empirical papers regardless of study design. Quality appraisal involved scoring each paper out of five according to how well the following criteria were met:

• Are the aims and objectives of the research clearly stated?
• Is the research design clearly specified and appropriate for the aims and objectives of the research?
• Do the researchers provide a clear account of the process by which their findings were produced?
• Do the researchers display enough data to support their interpretations and conclusions?
• Is the method of analysis appropriate and adequately explicated?

Papers scoring four or five were considered to be of high quality. Papers scoring 1 to 3 only partially met the five criteria and were judged to be of low quality. Given the lack of consensus surrounding the use of quality appraisal in qualitative research, with suggestions that appraisal scores can be more reflective of the written report rather than the actual study and that there is a risk of discounting important studies for the sake of ‘surface mistakes’ [ 28 , 29 ], we did not exclude studies with low quality scores. Instead we used this quality appraisal to assess the robustness of the synthesis.

Data extraction and method of synthesis

Following the guidance developed by Popay et al., we first used tabulation and thematic analysis to systematically extract and synthesise data from included studies [ 17 ]. NF and ES constructed tables, adding relevant information from each included paper under the following column headings: country, field of translational research, methods, definition and model of translational research, theoretical approach and main findings. Once tabulation was complete NF and ES used thematic analysis, guided by the principles of the constant comparative method [ 30 ], to inductively look for similarities and differences across the studies, grouping these patterns and relationships into conceptual themes. We used the ‘one sheet of paper method’ to visually map out themes and subthemes [ 31 ]. Themes and subthemes identified through the synthesis were then reviewed by the remaining authors in order to check for consistency in the data brought together under a theme.

Our search generated a total of 9427 articles, of which 1132 duplicates were removed. The papers were then screened based on title and abstract, with 8236 papers excluded for not meeting the inclusion criteria. Studies were mainly excluded because they did not focus on T1 type translational research or because they discussed translational research from an editorial or opinion piece perspective rather than being based on empirical research. Full text articles of 59 studies were retrieved and read in full. Thirty-nine papers were excluded primarily because they were not empirical studies, with other reasons for exclusion listed in Fig 1 . Six additional papers were identified through: hand searching reference lists of included studies (n = 2), personal biographies of experts in the field (n = 1), and citation tracking of included studies (n = 3) (see Fig 1 ).

Overview of included studies

The 26 papers included in the synthesis focused on studies investigating enablers and barriers to translational research from the perspectives of basic and clinician scientists undertaking translational research across nine countries (see Table 2 for a summary of the included papers). The majority of papers reported on translational research from the USA (n = 10), with papers also from Canada (n = 4), UK (n = 4), Australia (n = 1) and China (n = 3). In addition, four papers compared translational research across a number of countries: Austria, Finland and Germany; Germany and USA; UK and USA; UK and Germany. The dominance of western countries covered by studies included in our review is perhaps not surprising given our inclusion requirement that papers were published in the English language and the importance of translational research in the Anglo-American biomedical audit and funding cultures [ 3 ]. The earliest paper was published in 1998 and the most recent in 2014, with the majority (n = 21) being published in the six years between 2009 and 2014. This is indicative of the increased interest in translational research and policy concerns with improving the process of translating biomedical knowledge and innovation into clinical benefit [ 13 , 14 ]. The majority of papers (n = 17) were concerned with translational research undertaken in university or hospital settings or as part of institutions which combined university and clinical facilities, such as academic health science centres, translational research organisations or research networks. The papers used a range of quantitative and qualitative methods to investigate scientists’ views of translational research, with six using a survey and eight using semi-structured interviews. Other methodological approaches were case studies (n = 6), ethnographic (n = 4) and documentary analysis (n = 2). Of the 20 papers which adopted a qualitative approach to data collection and analysis, 14 studies explicitly incorporated a theoretical approach through which to collect, analyse and interpret the data. Incorporating a theoretical perspective enhances the quality of qualitative research; allowing understanding and contextualisation of translational research as a dynamic, negotiated, and situated entity or construct. Authors of these 14 studies either situated their approach in a sub-field of a social science discipline or specifically indicated their theoretical perspective. The following theories and concepts were drawn on: symbolic interactionism (n = 1), argumentative policy analysis (n = 1), Bourdieu’s logic of practice (n = 1), Gieyrn’s boundary work and the concept of therapeutic misconception (n = 1), Wittgenstein’s rules for the interpretation of a rule (n = 1), the sociology of professions (n = 1), the sociology of expectations (n = 2), entrepreneurial science (n = 2), and theoretical concepts on innovation (n = 4). Two studies using quantitative survey methods also located their data within theoretical frameworks related to the concept of team science and theoretical concepts from the management field.

https://doi.org/10.1371/journal.pone.0160475.t002

We identified five main conceptual themes representing factors which enabled or hindered the practice of translational research. The thematic categories and how they interrelate are discussed in detail in the sections below and are visually summarised in Fig 2 . Within each thematic category illustrative supporting quotations are provided.

https://doi.org/10.1371/journal.pone.0160475.g002

Theme 1: Concepts of translational research.

Only one study in our sample explicitly looked at how scientists defined and understood the concept of translational research [ 44 ]. Morgan et al. conducted interviews with basic and clinician scientists in 2008 at a time when the ‘ requirements of translational research were only beginning to emerge ’ [ 44 , p.948]. Both types of scientists reported awareness of the concept and its current policy emphasis, describing it as the ‘ mantra of the moment ’, but were unclear as to its meaning, and were able to give only a minimal definition such as ‘ to try to move stuff from the lab to the clinic ’ [ 44 , p.948]. The other included studies, particularly those which utilised survey methods for data collection, did not report explicitly asking respondents to define translational research.

The type of translational research model adopted by an organisation or institution was perceived by scientists in a number of studies in our sample to influence the practice of translational research, with a linear model seen as an impediment to successful practice [ 33 , 34 , 40 , 45 , 53 ]. Institutional representation of translational research as a ‘pipeline’, and a process which requires acceleration, was articulated by basic and clinician scientists as problematic for a number of reasons: that science was seen as being reduced to solving problems and producing cures rather than discovering new knowledge [ 45 , 53 ]; a lack of recognition that good science takes time [ 40 , 45 , 53 ]; and rapid selling of biomedical innovations to the public due to pressures to translate findings quickly for patient benefit without thinking through the implications of these developments or making better use of existing policies and interventions [ 34 , 40 , 45 , 53 ]. For example, scientists working in the field of addiction research acknowledged that: ‘ translation takes time , that bodies of knowledge are built slowly over many years , and that basic science has value even in the absence of swift translation ’ [ 45 , p.4].

These views contrast with institutional and policy interpretations of translational research which assume a linear model, impeded by ‘blocks’ that act as barriers to translating laboratory discoveries into improvements in human health [for example see 7 ]. The methods adopted by researchers in our sample allowed scientists to present a more subtle and nuanced view of the problems attributed to translational research and how they should be addressed [ 40 , 51 ]. For example, basic and clinician scientists interviewed in one US study described challenges of translational research as ‘dilemmas’ as opposed to the oversimplified notion of ‘barriers’ and ‘blocks’ typically perceived by external agencies, including policy makers and research funders [ 40 ]. The preferred term ‘dilemmas’ indicates that there are sometimes very valid and important reasons why things do not unfold according to the expectations that policy makers and research funders may have.

Viewing translational research as a circular or iterative process, was seen to facilitate translational research practices by encouraging reciprocal interactions between the lab and the clinic. This was thought to promote a collaborative research environment, which in turn attracted basic and clinician scientists who wanted to collaborate (this is elaborated upon further in the theme ‘interdisciplinary collaboration’) [ 34 , 41 , 52 , 57 ]. A case study of eight translational research organisations (TRO) in China elaborates on this point. In this study, TROs were established primarily by biomedical organisations. This limited the potential for TROs to address intractable problems because key disciplines required for successful translation, such as public health, health policy, social sciences, community engagement, had not been included [ 57 ].

Theme 2: Research processes.

Research processes were perceived by basic and clinician scientists across a number of studies to enable or hinder translational research practices. Research processes included: regulatory and ethics processes [ 32 , 33 , 38 , 49 , 52 , 54 , 56 ]; patient recruitment to research [ 32 , 35 , 38 , 52 ]; and informatics and information technology [ 38 – 40 , 46 , 47 ].

Several studies identified complex regulatory processes, such as ethics and research governance, as barriers to translational research, in effect slowing it down [ 32 , 38 , 49 , 52 , 54 , 56 ]. Two surveys of senior researchers working in US medical schools and academic health science centres, found that 38% and 54% of those surveyed identified complex regulatory requirements as particularly challenging for translational research, thus limiting the success of biomedical innovation being translated into benefits for patients [ 32 , 54 ]. Four qualitative studies, from the field of stem cell research, explain why regulatory processes are particularly challenging for translational research [ 33 , 49 , 52 , 56 ]. The rudimentary nature of stem cell research, yet to determine whether stem cell therapy should be defined as a drug or medical technology, complicated regulation in two studies in our sample [ 33 , 49 ]. Scientists in both these studies reported that this led to confusion over which authority should oversee regulation–a human tissue authority or a food and drug authority. Scientific and technological developments and their accompanying ‘ imagined futures ’ therefore created uncertainty on the part of both scientists and regulators as both parties sought to develop and refine interpretations of rules and regulations, as this extract from a field note illustrates:

[ The representative from the regulator] noted that the views upon this were different across the EU [European Union] . He reiterated that it’s hard to know until people make medicinal products what the regulations and guidance should be . But the [regulators] are asked to give guidelines anyway even though this is not known , and he said ‘it’s circular , it goes around and around and around’ [ 49 , p.351].

In another Chinese study, also investigating stem cell research, regulation was complicated by numerous, overlapping regulatory jurisdictions inadvertently promoting inconsistency and minimal conformity with the law, resulting in scientists feeling powerless to change the system [ 56 ]. Ethical and social implications of scientific breakthroughs were perceived to add an additional layer of complexity to translational research. Scientists working on stem cells as a potential therapy for leukaemia [ 33 ] and diabetes [ 52 ] reported making a deliberate effort to follow strict regulatory processes to ensure acceptance and legitimacy of their research [ 33 ]. They argued that public attention to the ethical and social implications of stem cell research breakthroughs would limit the move from bench to bedside:

That then requires a wholesale change of ethical thought as to whether you can put some genetically modified cell back into a human , and that’s going to take years and years of legislation [ 52 , p. 2061]

Basic and clinician scientists articulated mixed views about the role of patient recruitment and collection of patient samples and the implications this has for translational research [ 32 , 35 , 38 , 52 ]. In one US study of medical school research leaders, 37% of respondents identified recruitment of research subjects as challenging. When asked whether formal institutional processes and adaptations to counter these challenges had been initiated, 34% identified processes to aid recruitment of research participants, with more than half (54%) reporting that this innovation had a moderate to large effect on the amount of clinical research conducted [ 32 ].

Inherent within translational research is the assumption that animal studies will lead to human studies. However, scientists from two studies in our sample [ 33 , 52 ] commented on a tension between the ‘ relevance of ‘human studies” and the ‘ rigour of ‘animal experiments” [ 52 , p.2061]. In one study, based in the UK, basic scientists reported that experiments on animals, due to their availability, were seen as preferable and more likely to lead to outputs in the form of publications. In comparison, experiments on donated human cells were considered to carry a greater risk in terms of output due to difficulties obtaining samples from patients and their families:

To plan a proper research programme you need regular access to the tissue and you are never going to get that with [human] donor material , particularly if the primary objectives are research , because the relatives just don’t see it as important to give permission for all this to be used for research . Quite rightly I think , they don’t feel it’s going to somebody else’s benefit and research is going to be a lower priority . [ 52 , p.2061]

In the other study, based in China, drugs that had proved effective in animal studies were not effective in human clinical trials because patients’ health conditions were far more complicated than the animal models suggested, requiring scientists to constantly adjust their clinical trial protocols [ 33 ].

Solutions proposed to address the problems of recruitment to clinical trials and promote interactions between clinical researchers and potential recruits included community outreach and engagement projects and community advisory boards [ 38 ]. Results from one Canadian study suggested that state funded systems of care, such as Canadian Academic Health Science Systems, facilitated translational research due to the availability of a population of patients readily accessible to the researcher [ 35 ]. Scientists argued that it is the publicly funded system of care that has made access to patients and their data possible, contrasting this system with that of their neighbours in the United States, whereby the fragmented, privatised systems of care limits the potential for such a valuable resource:

[The population] is very special and to not take advantage of it would be a huge loss because we can do things here that other people can’t do . [ 35 , p.721]

Basic and clinician scientists in five studies identified a lack of infrastructure to develop skills in translational research as a further organisational barrier. These included acquiring research skills and access to equipment and effective information technology systems. [ 38 – 40 , 46 , 47 ]. Effectiveness of clinical and translational science, particularly with regards to accessing information technology systems, was perceived by a number of these scientists to be determined by organisational and leadership factors [ 46 , 47 ]. For example, a translational research grant awarded to a medical centre was praised by scientists for enabling the widespread provision of infrastructure such as bioinformatics, which was previously unavailable to individual scientists [ 40 ].

Theme 3: Research versus clinical care.

Basic and clinician scientists in four studies identified a perceived cultural divide between basic and clinical science as a key barrier to conducting translational research [ 44 , 52 , 54 , 55 ]. In one of these studies, clinician scientists engaged in early stage clinical trials of stem cells understood that such a divide was due to differing scientific worldviews, language and needs among scientists. For example, one clinician scientist said:

[It’s] still very apparent that we do face , this massive void that exists between scientists and clinicians , that for most of the part , certainly in our area , seems to exist , with no great understanding of the needs of both . [ 55 , p.504]

For other scientists, it was no great surprise that basic and clinician scientists were divided given they were educated within different faculties, with differing foundations, management approaches, and hierarchical systems but were then expected to come together to undertake translational research [ 52 , 57 ]. In contrast, a UK study which interviewed basic and clinician scientists working in cancer genetics found no clear division between clinical practice and research [ 36 ]. While, in theory, research and clinical care may be seen as highly differentiated, in practice, as results from this study bear out, the situation may be more complex. The boundary between clinical care and research was characterised as ambiguous, fluid and flexible. This was attributed to the exploratory nature of medical practice sharing similar motivations and procedures to that of clinical research, with both seeking to further knowledge. The fluidity of the relationship was considered to benefit patients (who through research participation gained access to DNA tests not available within clinical services), as well as clinical staff, improving their clinical skills through engagement with research processes [ 36 ].

Organisational and structural factors were perceived by clinician scientists in several studies to influence the apparent separation between research and clinical care, which consequently acted as a barrier to translational research [ 32 , 39 , 40 , 42 , 51 , 55 ]. These included: a lack of training in relevant research skills and training being too time intensive [ 32 , 42 ]; a lack of time to undertake research among clinician scientists due to demanding clinical roles [ 32 , 40 , 55 ]; and the pressure of combining clinical service and research roles [ 32 , 40 ]. For clinicians working in a community setting, a perceived lower value attributed to research compared to clinical care, with its associated lack of recognition, status and career progression, deterred their participation in research [ 39 ]. Clinician scientists reported that having to compete with full-time, non-clinical researchers, perceived as having more time and being better embedded in infrastructures to secure research funding, was a barrier to conducting translational research [ 42 , 51 ]. This led to the perception among clinician scientists that research was not always considered to be an economically viable activity due to a lack of remuneration for clinical staff’s time and effort to conduct research [ 39 ]. The value of conducting translational research for clinician scientists was strongly linked to perceived patient benefit of the research; research considered likely to have low patient benefit was viewed as disruptive to clinical care [ 36 , 39 ].

In a more positive light, clinician scientists interpreted their role as enabling translational research because they played a key role in bridging the perceived cultural divide between basic and clinical science [ 33 , 39 , 41 , 44 , 52 ], or by acting as ‘ agents of change ’ due to the strength and breadth of their knowledge [ 55 , p. 503]. Clinician scientists viewed themselves as ‘ boundary-spanners ’ or ‘ important bridges ’ between the laboratory and clinic, acting as mediators and translators in collaboration with ‘ pure ’ clinicians and scientists, whom they relied upon to provide the in-depth clinical and scientific knowledge required for successful translational research [ 41 , p. 542]. In a UK study one clinical-scientist clearly articulated the benefits of adding laboratory work to clinical responsibilities as part of a dual role:

Mechanistic studies are what I do . To do the clinical work [without the lab work] you wouldn’t have learned anything about how it worked and that seemed a bit of a shame to me…you might as well do the study properly . [ 44 , p.950].

Intellectual differences between basic and clinician scientists in terms of what was considered to constitute ‘legitimate science’ shaped both positive and negative views of translational research among scientists [ 44 , 52 , 54 ]. Basic scientists articulated a greater emphasis on scientific discovery rather than translation research [ 44 , 54 ], whereas clinician scientists placed more focus on patient-related outcomes to enable translational research [ 52 ]. For example, in a US survey of research investigators at a Medical School the most common reason given by basic scientists for not pursuing translational research was because it was not considered central to their research agenda; respondents with PhD degrees were significantly less likely to report they were conducting translational research compared to those with MD or MD/PhD degrees [ 54 ].

Basic scientists in five studies tended to hold negative views about translational research as a form of legitimate science [ 44 , 45 , 51 , 54 , 55 ]. They articulated the view that translational research was not central to their research agenda [ 45 , 54 ], and perceived clinician scientists as having greater authority to conduct clinical trials to enable translational research practices [ 55 ]. Basic scientists perceived reward and career progression as more difficult to achieve in the field of translational research and shared significant concerns about how translational research as a form of science was viewed by their peers and promotion committees [ 44 , 54 ]. They questioned how they would be able to retain standing in the field if they were publishing in translational research journals, instead of their key disciplinary journals, the former not ‘ sufficiently valued by their peers to form ‘authentic’ knowledge’ [ 44 , p.949]. The downsides of engaging in translational research for non-clinician scientists’ career progression were further emphasised by the tendency for translational research policy to focus on the needs of clinician scientists rather than providing new career structures for basic scientists to work within the requirements of translational research [ 44 , 51 ]. For example, a basic scientist reported how exasperating she found it that so much attention was paid to ‘ clinician scientists when other professional trajectories might also lead to the establishment of a class of translational investigators’ [ 51 , p.8]. In comparison, most clinician scientists interviewed were more positive about the translational research drive. Translational research was viewed as aligning closer to their own research interests in answering particular health-related questions.

Theme 4: Interdisciplinary collaboration.

Interdisciplinary collaboration between basic and clinician scientists, but also with other professional groups, was perceived by scientists to facilitate translational research practices [ 37 , 38 , 40 , 48 , 52 , 56 , 57 ], by providing opportunities for knowledge exchange [ 37 , 52 ], offering distinct forms of expertise [ 48 , 56 ], and creating a working environment which encouraged communication and co-operation between different scientists [ 38 ]. Collaboration was seen as being best achieved through multi-disciplinary teams, working throughout the entire research process [ 40 , 52 ], or through ‘team science’–a field of inquiry to understand and enhance processes which facilitate or inhibit collaboration of researchers across different fields and organisations [ 37 , 48 ]. For example, one basic scientist working in human embryonic stem cell research in the UK said:

This is a good place to be because you have got people who make hES cells and this group is a recognised area or centre for expertise in beta cell biology . If you put the two together then you progress quite quickly [ 52 , p.2058].

In contrast, scientists working on stem cell research in China in another study reported that the typical research team structure consisting of ‘ one professor and many students’ , with few, if any, middle ranking researchers was a hindrance to research efficiency and productivity:

In China, everybody is a professor; everybody works on their own project; there is no connection between groups. Everybody is their own team-leader. Thus it’s hard to make progress [ 56 , p. 197] .

Perceived facilitators of collaborative working in a translational research network included geographical proximity of different professionals to enable sharing of values and knowledge exchange [ 34 , 43 , 52 ], cohesive bioinformatics and clinical-informatics teams [ 46 ] and the appropriate institutional and structural arrangements to accommodate the range of professional expertise required to meet research objectives [ 56 ]. Conversely a lack of collaboration between industry and clinical science [ 50 ] and poor coordination between translational research and biomedical informatics teams [ 46 ] inhibited interdisciplinary collaboration.

The nature of relationships within interdisciplinary collaboration teams was perceived among scientists as another factor shaping collaborative working, which could either enable or hinder translational research. Specifically, translational research was considered to be facilitated by past working relationship practices [ 43 ], prior experience of collaboration among scientists across departments [ 48 ], and teams with key members who could act as knowledge brokers [ 43 ]. Institutions which portrayed themselves as places of collaboration were considered to enable translational research as this collaborative attitude would in turn attract other scientists who believed in collaborative ways of working as an integral part of conducting research [ 52 ].

In contrast, scientists identified a number of characteristics that hindered effective collaborative working relationships and practices. Such factors reflected previous professional groupings that encouraged silo-working (where departments or groups do not want to share information or knowledge beyond their group) rather than collaboration in a translational research network [ 43 , 56 , 57 ], and poor leadership or weak mentorship skills of leaders of teams [ 40 , 57 ]. Other perceived barriers pointed to a lack of experience among scientists collaborating across different departments to form effective teams [ 48 ], as well as institutional arrangements which not only inhibit collaboration between research groups within the same institution but also make collaboration between institutions harder [ 56 ]. Finally, traditional relationships between academia and industry, with universities as providers of basic research knowledge and industry as translating this knowledge into applications and profits, were viewed by scientists to discourage collaborative working and therefore hinder translational research practices [ 34 , 52 ].

Theme 5: Entrepreneurial science.

From a policy perspective, translational research endeavours to improve the health of the nation through the development of effective drugs and treatments, while simultaneously increasing wealth by generating income from a nation’s research capabilities. Translational research therefore comes with health and wealth-based performance measures for those working within translational research environments. A number of papers included in our synthesis suggest that scientists’ research practices are being shaped by this policy agenda [ 33 – 35 , 41 , 44 , 51 , 53 , 57 ]. They reported a perceived shift in attitudes among scientists and organisations to become ‘entrepreneurial’, thereby facilitating translational research [ 33 – 35 , 53 ]. Scientists who considered that both the intellectual and commercial benefits of their research would facilitate translational research, and those with perceived entrepreneurial skills, saw themselves at an advantage to secure funding for translational research.

In addition to the concept of the ‘entrepreneurial scientist’, the concept of the ‘entrepreneurial hospital’ was proposed as a resource for enabling translational research [ 35 ]. Scientists in this study considered accessible patient populations, attending publicly funded hospital-university collaborations for their care, as a resource to attract partnerships with industry:

So the drug company comes in for example to develop a drug with us on a phase I study . If we were to extract information at the molecular level for individual patients both of their DNA as well as changes to their tumour , we would get a very good understanding as to who’s responding to that treatment . We would then be able to advise the drug company as to where we see the best outcomes in terms of patient populations that respond well . This , presumably would be passed on when it comes to developing their Phase II and Phase III studies and actually improve the likelihood of success [ 35 , p.721].

Accessible patient populations as a resource had value in terms of rationalising medicine and saving money as well as meeting the commercial aims of translational research. The challenge, as one scientist commented, was ensuring that the mandates of the company and the hospital are both met:

no matter how they pose the issue of what their mandate is, the company is there to safeguard shareholder value, right? And that usually means sales, how much money have you made? [Our organisation] requires access to those companies’ drugs in many cases to take care of our shareholders, right? But if you look at it as shareholder, what our shareholders are interested in is not making money but being treated appropriately [ 35 , p.722].

Results from several papers suggest the need for a broader view of translational research whereby not-for-profit institutions have an entrepreneurial role to play [ 34 , 35 , 41 , 57 ]. One study identified the need for organisations such as universities to develop the technology to enable translational research opportunities, particularly when industry had lost interest due to patent problems [ 41 ].

In two studies, scientists identified the lack of knowledge and interest concerning commercialising research as a barrier to translational research [ 34 , 44 ]. In a UK study, basic scientists highlighted organisational and structural barriers as limiting their ability to exploit the commercial potential of their research. These were: a lack of awareness of how to patent scientific discoveries or even that this is a necessary step in translational research; and academic funding systems which employ scientists on closed contracts, with institutional measures of performance (and implications for renewal of contracts) based on publication record rather than patents. For example, one basic scientist observed:

my instinct is I’m wasting my grant time doing that sort of work , I’m rewarded for publications not patents [ 44 , p.949].

However, respondents in a US study highlighted the value of technology transfer offices within a university for taking on industrial collaborations in situations where scientists were less interested in the commercial exploitation of their discoveries [ 34 ].

This article reports a systematic review and narrative synthesis of factors that enable or inhibit translational research, from a growing body of empirical studies investigating translational research from the perspective of basic and clinician scientists. To the best of our knowledge this is the only systematic review to have synthesised these factors from the point of view of scientists, a key stakeholder group in translational research. We identified 26 empirical papers from which we synthesised five themes from the perspectives of scientists conducting translational research. These point to areas where policy and practice need development to enhance policy ambitions for translational research to accelerate scientific discoveries into clinical applications with benefits for patients.

The first theme, concepts of translational research , identifies a disconnect between linear models of translational research, often adopted at the policy or organisational level, and scientists’ own experience of conducting translational research. Scientists reported that a linear model inhibited key attributes required for successful translation of biomedical innovation, such as interdisciplinary collaboration. Our findings are supported by theoretical work from social scientists who have begun to challenge assumptions underpinning contemporary translational research policy initiatives: the dominant, linear model of translational research does not reflect the reality of how research translation happens in practice [ 3 , 13 , 16 ]. Second, research processes at organisational and system levels influenced scientists’ ability to conduct translational research, with complex and lengthy ethical and regulatory research governance processes, difficulties with patient recruitment, and poor access to bioinformatics identified as key barriers limiting translation. Research settings with readily accessible patient populations, for example as part of publicly funded university-hospital collaborations, facilitated patient recruitment for trials and encouraged partnerships with industry, hence enabling translational research. Third, the theme research versus clinical care highlighted a cultural divide between science and medicine. Clinician scientists were perceived to bridge this cultural divide, to enable translational research due to their breadth of knowledge, awareness of clinical need and flexible working practices, access to patients for research and ability to run research trials. However, the policy focus on clinician scientists as sole champions for translational research with their perceived ability to bridge the gap between science and medicine was alienating for non-clinician scientists. Fourth, interdisciplinary collaboration was thought to enable translational research practices, but depended on the quality of prior and current social relationships. Finally, the theme entrepreneurial science indicated that policy drives focusing on health and wealth had encouraged entrepreneurial activity amongst scientists and organisations such as hospitals, although a key challenge was to increase basic scientists’ awareness of the commercial impact of their discoveries.

Social, organisational and structural factors were identified as key contexts across all five themes both enabling and hindering translational research practices. A number of papers in our sample suggest that organisational practices and systems have not kept up with the pace of change in knowledge production brought about by the translational research agenda [ 42 , 44 , 51 ]. For example, the way academic organisations reward work based on individual output from publications and research grants does not match expectations of translational research, which require team working and simultaneously seek to enhance benefits for patients through development of therapies, and to increase the wealth of organisations and nations.

The need to accelerate research as a means to ensure that the endpoints of translational research are met is a view largely articulated in policy, which views the health and medical sciences as an opportunity to increase a nation’s health and wealth. However, basic and clinician scientists in the studies we synthesised did not entirely share this view and warned of unintended consequences resulting from an overly strong focus on translational research and its associated endpoints. They emphasised the need for a broader view of translational research which acknowledges that progress and achievements in science and biomedical innovation may require a longer time frame and that science’s role is concerned with knowledge production and discovery as well as solving problems and producing cures [ 34 , 40 , 45 , 53 ].

Strengths and limitations

A strength of our review is that we used systematic and rigorous methods for searching and synthesising the existing literature on scientists’ perspectives on factors enabling and hindering translation research practices across diverse clinical fields. This included using a number of sources to search the literature and two researchers to select and appraise the literature, and extract and synthesise the data. However, a number of methodological issues could have affected the validity of our findings. The findings of the study are limited by the diversity of terms that are used to describe translational research which may have resulted in a small number of studies being overlooked. Our search strategy focused on English language papers in peer reviewed journals. There are a number of published books concerned with translational research from scientists’ perspectives which were not included due to the design of our search strategy [ 58 ]. The omission of this literature, and literature in languages other than in English, may have potentially produced bias or excluded further insights into factors enabling and hindering translational research. We did not exclude studies on the basis of quality. The quality of included studies was mainly high. Seven of the 26 included studies were rated as lower quality (scoring 3 or below). A sensitivity analysis to assess the robustness of our findings, suggests that removing the seven lower quality studies does not alter the thematic categories we derived from the synthesis.

Implications for Policy and Practice

Some of the barriers we have identified in our review have been reported in opinion pieces, (for example inadequate infrastructure, the need for a research culture that facilitates collaboration [ 2 , 5 ]). This study investigated translational research practices across health domains, scientific disciplines, and countries, and included the perspectives of wide range of scientists. Our findings substantiate and add to known concerns, highlighting that new strategies are required to maximise the potential for translational research to deliver benefits to patients. The findings of our review point to a number of policy implications for those seeking to better realise the potential for translational research.

First, our findings question the usefulness of the pipeline, linear model of translational research. This does not reflect how scientists conducting translational research describe what they do. We call for policy and institutions promoting translational research to refine their conceptual models of translational research to one that is more reflective of scientists’ experiences of translational research, fostering greater buy in from all types of scientists. Our review provides evidence that scientists’ consider collaboration as a key ingredient for successful translational research and that viewing translational research as a circular or iterative process encourages collaboration. Therefore a refined model of translational research may foster greater reciprocal interaction between the laboratory and the clinic, in turn attracting further collaborations.

Second, the challenge of undertaking translational research requires change at organisational and institutional levels. This will necessitate streamlining regulatory and governance processes and facilitating access to infrastructures such as bioinformatics, in order to reduce delays to translational research. The conflicting needs of academic and hospital institutions, whose primary goals are respectively to foster academic achievement and to provide healthcare solutions, will need to be resolved. Stronger leadership and integrated institutions are required with single managerial, governance and administrative structures that afford appropriate weight to these conflicting needs in order to prioritise translational research.

Third, the end points of translational research are frequently discussed as contributing to a nation’s health and wealth, although it is not always clear from policy statements which component is being prioritised and, as stated earlier, whether these aspirations have been met through the push for translational research. A broader policy focus on translational research would facilitate the contribution to biomedical innovation from public sector institutions as well as industry to drive translational research, particularly in situations when industry cannot participate due to problems with patents or when public sector institutions can establish the market before it is viable for the commercial sector to enter. In line with other literature on the potential for translational research, findings from our synthesis suggest that translational research provides opportunities for realigning relations between citizens, patients, healthcare providers, pharmaceutical companies and biomedical researchers [ 16 ].

Supporting Information

S1 prisma checklist. preferred reporting items for systematic reviews and meta-analyses checklist..

https://doi.org/10.1371/journal.pone.0160475.s001

Author Contributions

• Conceptualization: NF HRF CM.
• Formal analysis: NF ES HRF CM JM CDAW.
• Funding acquisition: CDAW.
• Investigation: NF HRF ES CM.
• Project administration: NF.
• Supervision: CM.
• Validation: NF ES CM.
• Visualization: NF.
• Writing - original draft: NF ES.
• Writing - review & editing: NF ES CM HRF JM CDAW.
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Qualitative Methodology in Translational Health Research: Current Practices and Future Directions

Kritika rana.

1 Translational Health Research Institute, Western Sydney University, Campbelltown, NSW 2560, Australia

2 Philanthropy Nepal (Paropakari Nepal) Research Collaboration, Auburn, NSW 2144, Australia; [email protected]

Prakash Poudel

3 Office of Research and Education, Canberra Health Services, ACT Government, Garran, ACT 2606, Australia; [email protected]

Ritesh Chimoriya

4 School of Medicine, Western Sydney University, Campbelltown, NSW 2560, Australia

5 Concord Institute of Academic Surgery, Concord Repatriation General Hospital, Concord, NSW 2139, Australia

Associated Data

Not applicable.

Translational health research is an interdisciplinary field aimed at bridging the gap between basic science studies, preventative studies, and clinical practice to improve health-related outcomes. Qualitative research methods provide a unique perspective on the emotional, social, cultural, and contextual factors that influence health and healthcare and thus are recognized as valuable tools for translational health research. This approach can be embedded within a mixed method design which complements the quantitative findings. This methodological paper aims to provide a comprehensive review of the fundamental concepts and methodologies used in qualitative research, emphasizing their utilization and significance in translational health research. Several approaches to qualitative research methodology are discussed in this review, including ethnography, phenomenology, grounded theory, case study, and action research. Theoretical frameworks such as the social-ecological model, intersectionality, and participatory action research are also examined to provide a structure for understanding and interpreting complex health issues. This methodological paper also reviews commonly used sampling techniques such as purposive, snowball, convenience, theoretical, and maximum variation sampling, along with data collection methods such as in-depth interviews, focus groups, observation, document analysis, and participatory methods. Moreover, data analysis techniques such as thematic analysis, grounded theory, content analysis, narrative analysis, and reflexive analysis, are discussed in the context of translational health. Overall, this review highlights the challenges and opportunities of using qualitative methods in current practice, while also discussing future directions and providing valuable guidance and insights to researchers interested in conducting qualitative research in translational health.

1. Introduction

Translational health research is a complex and interdisciplinary field that aims to bridge the gap between preclinical studies and clinical practice, with the goal of improving health-related outcomes [ 1 ]. Qualitative research methods have become increasingly recognized as valuable tools for translational health research, as they offer a unique perspective on the social, cultural, and contextual factors that influence health and healthcare [ 2 , 3 ]. As opposed to quantitative methods which rely on numerical data, qualitative methods involve the collection and analysis of non-numerical qualitative data, such as interviews, observations, and documents. This approach allows researchers to explore the experiences and perspectives of patients, healthcare providers, and other stakeholders, and to generate new insights into the complex and dynamic processes that shape health and healthcare [ 4 , 5 ].

Qualitative studies in healthcare translation play a crucial role in enhancing patient care by unraveling the intricate world of emotions [ 6 ]. The understanding of the role of emotions in healthcare is in an early state; thus, qualitative research can be utilized in exploring strategies for mitigating safety risks and shifting cultural norms in medicine [ 7 ]. Similarly, this can be used in understanding the complex emotional dynamics of patients’ and caregivers’ relationship with healthcare professionals, and how this impacts the management of illness and overall disease trajectory [ 8 ]. This further empowers healthcare providers to offer culturally sensitive, empathetic, and patient-centered care which ultimately improves patient experiences and outcomes [ 6 , 9 ]. Similarly, qualitative research is also a valuable tool that can be used in healthcare education, particularly in incorporating emotional intelligence in healthcare education [ 7 ]. For instance, recent qualitative research underscores the value of employing emotionally intelligent behaviors in healthcare settings to effectively manage stress and foster better professional relationships among healthcare students and staff [ 10 ].

In recent times, the significance of qualitative design has become increasingly apparent, particularly in understanding the intersectionality and aid in the digital transformation within the healthcare sector [ 11 , 12 ]. Since qualitative research has been extensively used in informing the development of quantitative instruments, this design also enhances the understanding of results from quantitative analysis [ 13 ]. Qualitative research has been increasingly used in translation health research to better understand user’s expectations and enhance inclusive engagement, thereby developing the translation or implementation process [ 13 , 14 , 15 , 16 ]. Similarly, qualitative studies may complement quantitative studies and can be seamlessly included within a larger study design. This methodological paper provides a comprehensive review of the fundamental concepts and methodologies used in qualitative research, emphasizing their significance in translational health research. As a summary of the application of these concepts, Figure 1 illustrates a comprehensive framework for conducting qualitative research in translational health. Furthermore, this review explores how the qualitative method has been used to address study objectives and research questions in the field of translational health research, and highlights some of the strengths, limitations, challenges, and opportunities associated with using qualitative research methods in translation health research.

Conducting qualitative research in translational health.

2. Approaches to Qualitative Research Methodology

Qualitative research methodology in translational health research encompasses a diverse range of techniques that aim to explore and understand the subjective experiences, meanings, and social contexts surrounding health phenomena [ 17 ]. These methods provide in-depth insights into individuals’ perspectives, behaviors, and beliefs, which allows to uncover complex and nuanced aspects of health [ 18 , 19 ]. Qualitative research uses several approaches and some of the common approaches used in translational health research are provided in Table 1 .

Qualitative research approaches commonly used in translational health research.

3. Theoretical Frameworks for Qualitative Methodology in Translational Health Research

Theoretical frameworks provide a map for qualitative exploration by describing concepts and relationships within a phenomenon [ 38 ]. These frameworks can be built inductively or based on the existing theories and literature and can help direct attention to the phenomenon of interest [ 39 ]. The utilization of theoretical frameworks can be valuable in qualitative methodology for translational health research, as it provides a structured framework for understanding and interpreting the intricate nature of health issues.

3.1. Social-Ecological Model

The social-ecological model is a theoretical framework used to understand the complex interplay between individual, interpersonal, institutional, community, and societal factors that shape human behavior and health outcomes [ 40 ]. This model recognizes that individuals are not solely responsible for their health and well-being, and a range of environmental and societal factors play a fundamental role in influencing health outcomes. At the individual level, factors such as genetics, knowledge, attitudes, beliefs, and behaviors influence health outcomes. The interpersonal level encompasses social relationships and social networks that individuals form a part of, including families, friends, and colleagues [ 41 , 42 ]. The institutional level focuses on organizations, policies, and social institutions that shape behavior and influence health outcomes. The community level includes factors associated with the physical and social environment, including access to resources and community norms and values. Finally, the societal level integrates broader social, cultural, economic, and political factors that influence health outcomes, including policies, laws, and cultural norms [ 41 , 42 ]. The social-ecological model emphasizes the interconnectedness of these multiple levels and the importance of addressing health issues through a multi-level approach by considering the broader context in which individuals live, work, and interact [ 43 ]. For instance, interventions aimed at reducing the rates of obesity may need to target individual-level factors such as knowledge and behaviors, as well as community-level factors such as access to healthy food options and physical activity opportunities, and societal-level factors such as food industry marketing practices and government policies on nutrition.

3.2. Intersectionality

Intersectionality is a valuable theoretical framework for understanding the complex and intersecting social identities that shape individuals’ experiences of health and healthcare [ 44 , 45 ]. In health research, intersectionality can help to identify the unique challenges faced by marginalized individuals and communities and can inform interventions and policies that address these challenges [ 45 , 46 , 47 ]. For instance, a health researcher may use an intersectional lens to explore how the intersection of race, gender, and socioeconomic status impacts individuals’ access to healthcare. The researcher may conduct interviews with individuals from different racial and socioeconomic backgrounds, asking them about their experiences with healthcare providers and their ability to access medical care. By examining the ways in which multiple identities intersect to shape individuals’ experiences, the researcher can gain a deeper understanding of the unique barriers and challenges faced by marginalized communities. Moreover, intersectionality can help health researchers to identify areas of privilege and power within the healthcare system [ 46 ]. For example, a health researcher may examine the ways in which gender and sexuality intersect to create unique challenges for LGBTQ+ individuals seeking healthcare. By identifying areas of privilege and power within the healthcare system, the researcher can develop interventions and policies that promote equity and justice.

3.3. Participatory Action Research

Participatory action research is a theoretical framework that emphasizes collaboration between researchers and community members. This approach seeks to empower individuals and community members to identify and address health issues that affect them, rather than imposing solutions from the outside [ 48 ]. It involves a cyclical process of reflection, planning, action, and evaluation, where researchers work in partnership with community members by involving them as active participants in all stages of the research [ 48 ]. This collaborative approach allows for the development of more culturally responsive and relevant interventions and policies, as community members can provide valuable insights into the unique challenges and needs of their communities [ 49 ]. Participatory action research in health research focuses on addressing health disparities, promoting community ownership and action, as well as fostering sustainable solutions to health challenges. For instance, in a project focused on mental health services in a marginalized community, researchers and community members may collaborate to identify barriers and co-design interventions. This inclusive approach may lead to tailored and sustainable improvements, such as the development of community-based support programs and policy advocacy to address the mental health needs specific to the community.

4. Sampling Techniques in Qualitative Methodology for Translational Health Research

Qualitative research sampling refers to the process of selecting individuals or cases to be included in the research sample. Qualitative research uses a non-probability sample, as the selected sample does not reflect a list of all possible elements in a full population and make inferences of the findings, but is guided by the principle of seeking information-rich cases or individuals who can contribute diverse perspectives and experiences, allowing for a comprehensive exploration of the phenomenon under investigation [ 50 ]. As summarized in Table 2 , there are several sampling techniques that are commonly used in qualitative methodology for translational health research. There are strengths of each sampling technique, and it is crucial to carefully select the most appropriate technique based on the research question, population of interest, and available resources [ 51 ].

Summary of sampling techniques commonly used in qualitative translational health research.

* The enumerated strengths are not exhaustive and may vary depending on the specific context in which the sampling technique is used.

5. Data Collection Methods in Qualitative Methodology for Translational Health Research

Data collection plays a crucial role in qualitative methodology as it has a direct impact on the accuracy and dependability of research outcomes, and the quality of data collected can determine the validity of study findings [ 57 ]. Qualitative methodology in translational health research encompasses various data collection methods to gather rich and nuanced information, which can also be used in combination to gain a comprehensive understanding of the phenomena under investigation.

5.1. In-Depth Interviews

In-depth interviews are one of the most used data collection methods in qualitative methodology for translational health research. This method involves conducting individual interviews with participants to gather detailed and rich data on their experiences, beliefs, and perspectives related to the research question [ 58 ]. While in-depth interviews allow researchers to explore complex and sensitive topics, the interviews require extensive planning and training to ensure that the interviewer establishes rapport and creates a safe and supportive environment for the participant [ 59 , 60 ]. In-depth interviews in health research allow researchers to gather rich and detailed data on participants’ experiences and perspectives, which can provide valuable insights into the social and cultural factors that shape health outcomes. Moreover, in-depth interviews can be particularly useful for exploring sensitive topics, such as stigmatized health conditions or experiences of discrimination in healthcare [ 60 ]. In-depth interviews in health research generally follow a semi-structured or unstructured format, which allows for flexibility and exploration of unexpected themes or topics [ 58 , 59 ]. The interviewer may begin with a set of open-ended questions and follow up on the responses to explore further. To ensure ethical and respectful treatment of participants, in-depth interviews should be conducted in a private and confidential setting, with informed consent obtained prior to the interview [ 58 , 61 , 62 ].

5.2. Focus Groups

Focus groups are also one of the commonly used data collection methods in qualitative methodology for translational health research. In this data collection method, group interviews are conducted with participants who share similar characteristics or experiences related to the research question [ 63 , 64 ]. A focus group involves a moderator who facilitates a discussion among a small group of participants, with the goal of exploring a range of opinions, experiences, and attitudes related to the health issue or topic of interest [ 64 , 65 ]. Focus groups can be particularly useful for exploring topics that may be difficult to discuss in one-on-one interviews, as the group dynamic can create a more comfortable and supportive environment for participants to share their experiences and perspectives [ 63 ]. Focus groups also allow participants to discuss and explain to each other the questions/topics discussed. Furthermore, focus groups can be especially valuable for marginalized or stigmatized populations who may feel more comfortable discussing sensitive health topics in a group setting [ 65 ]. While focus groups allow researchers to capture diverse perspectives and generate rich and interactive data, this method may also introduce group dynamics and biases that can affect the quality of the data [ 63 , 65 ].

5.3. Observation

Observation is a data collection method that involves observing and documenting participants’ behavior, interactions, and environments related to the research question. Observation can be conducted in natural settings or structured environments, such as clinics or hospitals [ 66 ]. Observation allows researchers to gather data on participants’ behavior and experiences in real-life situations and understand the context, which will eventually be helpful in planning subsequent interviews. However, it is essential for the observer to have extensive training to ensure that the observer remains neutral and non-intrusive [ 67 ]. Participant observation can be very helpful for translational health research as this would enable access to many people and a wide range of information [ 68 ].

5.4. Participatory Methods

Participatory methods refer to a set of data collection methods that actively involve individuals or communities as active participants in the research process, such as co-design, co-production, and co-research. Therefore, this is a useful tool in translation health research as participants have the opportunity to engage in the design and development of a new treatment/care and they could facilitate the translation process efficiently. Participatory methods allow participants to actively shape the research question, methods, and findings and can lead to more relevant and impactful research [ 69 ]. However, participatory methods may be resource-intensive, and require careful consideration of power dynamics, ethics, as well as sustainability [ 69 ].

6. Data Analysis Techniques in Qualitative Methodology for Translational Health Research

6.1. thematic analysis.

Thematic analysis is a widely used data analysis technique in qualitative phenomenology design for translational health research. It involves identifying and analyzing common patterns, themes, and categories in the data to generate insights and develop a coherent and comprehensive account of the research question [ 70 ]. Thematic analysis is more focused on the deductive approach but can be used in inductive approaches. In deductive approaches, researchers begin with pre-existing themes or categories that have been derived from previous research or theory and subsequently apply them to the data. In contrast, in inductive approaches, researchers allow the themes or categories to emerge from the data itself, without imposing any pre-existing framework [ 71 ]. The process of thematic analysis usually involves several steps. The first step is to become familiar with the data by reading and re-reading it several times. The next step is to code the data, which involves identifying and labeling segments of data that relate to the same idea or concept. Codes can be descriptive, such as labeling a segment of data as “patient experience”, or conceptual, such as labeling a segment of data as “loss of autonomy”. Once the data has been coded, the next step is to identify and analyze patterns, themes, and categories that emerge from the data [ 72 ]. Themes can be derived from similarities or differences in the codes, or from concepts that are repeated across the data [ 70 , 72 ]. The final step is to develop a coherent and comprehensive account of the research question by organizing the themes and categories into a meaningful framework. Thematic analysis allows researchers to capture the complexity and diversity of the data and generate rich insights that can inform policy, practice, and research [ 72 ]. It is a flexible and adaptable technique that can be applied to a wide range of research questions and populations, making it a frequently used data analysis technique in qualitative methodology for translational health research [ 62 , 70 , 72 ]. The key approach and outcome of the analysis are shown in Table 3 .

Data analysis framework.

6.2. Grounded Theory

Grounded theory is another data analysis technique often used in qualitative methodology for translational health research. This technique involves developing a theory or framework based on the data collected through a process of constant comparison and iteration [ 28 ]. Grounded theory allows researchers to generate new and innovative insights and theories that are grounded in the data, and can lead to the development of new practices, policies, and interventions [ 28 ].

6.3. Reflexive Analysis

Reflexive analysis is a data analysis technique where researchers reflect on their role and positionality in the research process, allowing researchers to critically evaluate their biases and assumptions and generate insights into how they may have impacted the data collected and analyzed [ 73 ].

7. Leveraging Computer-Assisted Qualitative Data Analysis Software (CAQDAS) for Systematic Qualitative Insights

The analysis of qualitative data represents a complex process and the multi-faceted nature of qualitative data, often comprising rich narratives, interviews, observations, or textual content, and thus demands a systemic approach to generate meaningful insights. To enhance the comprehensibility and rigor of qualitative research, it is recommended to incorporate thorough and systematic analysis mechanisms into each chosen research strategy [ 74 ]. One valuable addition would be the utilization of computer programs and software tools specifically designed to aid in the analysis process. These programs provide researchers a systematic and efficient means to code vast datasets, identify patterns, and derive meaningful interpretations [ 74 , 75 ]. By integrating these digital tools into qualitative research strategies, researchers not only streamline the analytical process but also increase the transparency and replicability of their work. This orientation can serve as a roadmap, enabling interested individuals to explore these analysis strategies in more depth through specialized texts or resources. There are numerous Computer-assisted Qualitative Data Analysis Software (CAQDAS) such as NVivo (QSR International, Burlington, MA, USA), Atlas.ti (Scientific Software Development GmbH, Berlin, Germany), Dedoose (SocioCultural Research Consultants/UCLA, Los Angeles, CA, USA), and QDA Miner (Provalis Research, Montreal, QC, Canada) [ 74 ]. NVivo, which offers a variety of packages including NVivo Starter, NVivo Pro, and NVivo Plus, is widely used in qualitative health translational research [ 75 ]. Recently, Quirkos (Quirkos, Edinburgh, Scotland, UK) has also been widely used which is facilitated by its graphic interface to understand qualitative data [ 76 , 77 ].

8. Ethical Considerations in Qualitative Methodology for Translational Health Research

Ethical considerations in qualitative methodology are crucial to ensure that research is conducted responsibly, respecting the rights and well-being of the participants. Consideration of ethical challenges is particularly important while conducting qualitative research in the field of translational health due to the potential vulnerabilities and sensitive nature of health-related topics [ 78 ].

8.1. Informed Consent

Informed consent is a fundamental ethical principle in research, which requires that participants provide voluntary, informed, and ongoing consent to participate in a study [ 79 , 80 ]. In qualitative research, obtaining informed consent involves providing participants with information about the study, including its purpose, procedures, potential risks and benefits, and their rights as participants. Participants should be given the opportunity to ask questions and to withdraw from the study at any time. It is important to ensure that participants have the capacity to give informed consent and that they fully understand the implications of their participation.

8.2. Confidentiality and Anonymity

Confidentiality and anonymity are crucial ethical considerations in qualitative research [ 81 ]. Participants should be assured that their personal information and identities will be kept confidential and that their anonymity will be protected. Researchers must ensure that participant data is kept secure and only accessible to authorized personnel. Moreover, researchers must ensure that the data is stored in a secure location and that any identifying information is removed or disguised in the analysis and dissemination of findings [ 81 ].

8.3. Power Dynamics

Power dynamics exist in all research relationships, and it is important for researchers to be aware of and sensitive to these dynamics [ 80 ]. Researchers must ensure that participants feel comfortable and empowered to share their experiences and perspectives. This may involve creating a safe and supportive research environment, using language and terminology that is culturally and linguistically appropriate, and acknowledging and respecting the diversity of experiences and perspectives among participants.

8.4. Beneficence and Non-Maleficence

The principles of beneficence and non-maleficence require that researchers strive to maximize benefits and minimize harm to participants [ 80 ]. In qualitative research, this may involve ensuring that participants are not subjected to emotional distress or psychological harm, providing appropriate support and resources for participants who may require assistance, and ensuring that the research findings are used to inform the development of culturally responsive and effective interventions and policies that promote health equity.

8.5. Rigor and Trustworthiness of the Research

Rigor is a critical aspect of qualitative inquiry, aiming to establish the credibility, transferability, dependability, and confirmability of the findings [ 82 ]. A range of methodological strategies can be employed to ensure the rigor and trustworthiness of the research [ 82 , 83 ]. One key measure would be conducting interviews with a researcher who has undergone specialized training in qualitative research methods, ensuring a high level of proficiency and sensitivity to the nuances of qualitative inquiry [ 82 ]. Similarly, debriefing sessions may be helpful to review the completeness of the gathered data and to identify potential areas for further exploration, and these sessions may continue until data saturation is achieved [ 84 ]. It is also essential to reach a consensus on coding through collaborative efforts within the research team. The results presented may be fortified by the inclusion of direct quotes from participants, providing a robust foundation for the findings [ 83 ]. Moreover, the study design and reporting of results may also be guided by established guidelines, such as the Consolidated Criteria for Reporting Qualitative Studies (COREQ), to ensure comprehensive and transparent reporting of qualitative research [ 85 ].

The key components of the qualitative analysis in practice are shown in Figure 2 .

Visual summary of key components of qualitative data collection and analysis in practice in translational health.

9. Challenges and Limitations of Qualitative Methodology in Translational Health Research

Qualitative research can provide rich and detailed insights into the complex social and cultural factors that influence health outcomes and can inform the development of more effective and culturally responsive interventions and policies [ 2 , 59 ]. However, qualitative methodology also presents several challenges and limitations that must be considered and addressed to ensure the rigor and validity of the qualitative research [ 83 ].

9.1. Subjectivity and Bias

One of the primary challenges of qualitative research is the potential for subjectivity and bias in data collection, analysis, and interpretation [ 86 ]. Qualitative research relies heavily on the perspectives and experiences of participants and researchers, which can be influenced by a variety of factors, including personal biases, cultural norms and values, and power dynamics [ 87 ]. Researchers must be aware of their own biases and take steps to minimize their influence on the research, such as using multiple data sources and methods, engaging in reflexive practice, and using triangulation to verify the study findings.

9.2. Sample Size and Generalisability

Another challenge of qualitative research is the relatively small sample sizes that are often used, which can limit the generalizability of the research findings. Qualitative research generally seeks to explore in-depth experiences and perspectives of a specific group or population, rather than seeking to make generalizations to larger populations [ 88 ]. However, this can be a challenge in translational health research, where policymakers and healthcare providers may need information that is generalizable to larger populations in order to make informed decisions [ 89 ].

9.3. Validity and Reliability

Qualitative research involves a complex and iterative process of data collection, analysis, and interpretation, which can be influenced by a variety of factors [ 88 ]. Therefore, ensuring the validity and reliability of qualitative research can also be a major challenge. Researchers must take steps to ensure that their findings are valid and reliable, such as using rigorous data collection and analysis methods, engaging in reflexivity and triangulation, and seeking feedback from participants and other stakeholders [ 90 ].

9.4. Ethical Considerations

The consideration of varied ethical concerns involved in qualitative research in the field of translational health is also a challenge. Qualitative research in translational health involves working closely with participants and engaging in sensitive and potentially emotional topics [ 88 ]. Therefore, researchers must ensure that the qualitative research is respectful and culturally appropriate, with strategies in place to minimize the potential for harm or distress to participants [ 80 , 91 ]. Ethical considerations may involve ensuring that participants have provided informed consent, along with maintaining confidentiality and anonymity, and providing appropriate support and resources for participants who may require assistance.

9.5. Time and Resource Constraints

Qualitative research can be time-consuming and resource-intensive, which can present challenges for researchers in the field of translational health [ 92 , 93 ]. Qualitative research generally involves a lengthy process of data collection, analysis, and interpretation, which can be further complicated by the need to collaborate with diverse populations and stakeholders [ 93 ]. Researchers must ensure that they have adequate time, resources, and support to conduct their research effectively and to address any challenges or limitations that may arise during the study duration.

10. Future Directions and Implications of Qualitative Methodology in Translational Health Research

Future directions for qualitative research in the field of translational health include promoting health equity, understanding emotions in healthcare, using participatory research approaches, leveraging digital technology, and incorporating mixed methods approaches [ 94 , 95 , 96 ]. Evidence suggests that emotions play an integral role in healthcare; however, the area is least explored in terms of how it influences clinical practice [ 7 , 96 ]. Qualitative methodology can be employed to provide insights into the underlying emotions, the social determinants of health, and health disparities. Hence, qualitative research facilitates identifying the underlying causes of health inequities, such as systemic racism or social exclusion, and can help inform interventions to address these issues. In addition, by centering the experiences and perspectives of marginalized communities, qualitative research can help ensure that interventions are culturally sensitive and appropriate [ 97 , 98 , 99 ]. Participatory research is a collaborative approach that involves engaging community members in all stages of the research process [ 48 ] and is an important part of the translation health research. This approach can help ensure that research questions are relevant to the community and that interventions are designed in partnership with community members. Participatory research can also help address power imbalances in the research process and can increase community engagement and ownership of the research findings [ 48 , 49 ]. The comparison of traditional manual and digital data collection and coding in qualitative research has not been extensively investigated [ 100 ]. This choice may be contingent on factors such as project scale, available funds, and time, as well as the researcher’s inclination and proficiency in the chosen method. However, digital technology offers new opportunities for qualitative research, such as online focus groups or social media analysis [ 94 , 101 ]. These methods can increase access to hard-to-reach populations and can provide new insights into online communities and social networks [ 94 ]. However, researchers must be aware of potential biases and ethical considerations associated with online research [ 101 ]. Mixed methods research combines both qualitative and quantitative approaches in a single study. This approach can provide a more comprehensive understanding of complex issues and can allow for triangulation of data [ 102 ]. However, mixed methods research requires careful integration of both approaches and may be resource-intensive. Despite the potential benefits of qualitative methodology in translational health research, there are also several challenges that must be addressed. A major challenge is the lack of standardization in qualitative research, which can make it difficult to compare and synthesize findings [ 103 ]. There is also a risk of researcher bias in qualitative research, which can impact the validity and reliability of findings. The nuanced perspectives generated from the qualitative research can inform the development of policies and practices that are more responsive and tailored to diverse populations [ 104 ]. By incorporating these insights, health systems can strive for greater inclusivity and effectiveness in delivering quality healthcare.

11. Conclusions

Qualitative research methodology in translational health research provides a valuable lens to explore the social and cultural factors that shape health and healthcare, thus informing the development of interventions and policies that better address the health needs of marginalized communities. However, researchers must carefully consider the limitations and challenges associated with qualitative research and take steps to address these through rigorous research design and methodology. By embracing participatory approaches and leveraging digital technology, qualitative research in the field of translational health can play a critical role in advancing health equity and ensuring that interventions are culturally responsive and effective for diverse populations. To truly enhance translational health research and practice, we must invest in further studies, prioritize education, and advocate for policy changes that fortify the rigor and impact of qualitative methodologies in shaping a more inclusive and effective healthcare landscape.

Acknowledgments

We would like to acknowledge all the members of Philanthropy Nepal (Paropakari Nepal) Research Collaboration for their support.

Funding Statement

This review received no external funding. In-kind support has been provided by the Philanthropy Nepal (Paropakari Nepal) Research Collaboration.

Author Contributions

All authors were involved in the conceptualization and design of the study. R.C. and K.R. conducted the literature search. K.R. drafted the manuscript. R.C. and P.P. critically revised the manuscript. R.C. supervised the review project. All authors have read and agreed to the published version of the manuscript.

Institutional Review Board Statement

Informed consent statement, data availability statement, conflicts of interest.

The authors declare no conflict of interest.

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