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Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim

Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories, for example, still use RUO products in diagnostic procedures, sometimes even with the knowledge of the manufacturers. This can have consequences – not just for manufacturers and operators, but for patients as well.

In this article, you will learn:

• What the “Research Use Only” label (RUO) means
• What the requirements for RUO products are
• How to avoid legal problems
• What alternatives there are to RUO products

1. “Research Use Only” – what does it mean?

Labeling products for “research use only” has far-reaching consequences. It means the products are barely subject to any regulatory controls under the IVDR. As a result, for a lot of manufacturers and operators, they are desirable alternatives to more costly and time-intensive conformity-assessed in-vitro diagnostic medical devices (CE-IVDs) that must comply with the applicable legal requirements.

a) Institutions affected

The following institutions, in particular, use RUO products:

• Medical laboratories can use RUO products, but this makes them the manufacturer with all the consequences this entails. You can find more information on “lab developed tests” in our article “ The E U Regulates Medical Laboratories. Are Laboratory Developed Tests Still Allowed? ”
• If medical laboratories use RUO products for purposes other than research then, in the worst case, this makes them liable for damages as well as criminally liable.
• Therefore, medical laboratories should inform themselves about the parameters for RUO products and possible alternatives .
• Manufacturers Manufacturers use RUO products as components for their IVDs. They should, therefore, make sure that they know all the requirements in detail before labeling a product as “RUO”.

b) Definition

There is no uniform definition of “research use only” products. In general, they can be understood to be what the name implies, i.e., products to be used for analysis that are intended to be used for scientific research purposes only.

They primarily differ from medical devices in that they cannot be used for medical purposes.

However, the understanding of “research use only” is different in Europe and the USA.

Definition in Europe

In Europe, the MEDDEV 2.14/2 guidance document (IVD Guidance: Research Use Only products – A guide for manufacturers and notified bodies) provides clues as to the definition of RUOs. This guidance was written within the framework of the now obsolete Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) and, in the absence of an up-to-date replacement, it can still be considered the state of the art.

MEDDEV 2.14/2 states:

“for a product to be categorized as an RUO product it must have no intended medical purpose or objective."

Source: MEDDEV 2.14/2 rev.1

This means that an RUO product must not have even a rudimentary medical purpose.

However, in the case of tests developed in-house by a laboratory (LDTs), this restriction does not apply provided that the products are not sold to other companies. The guidance gives the following specific examples of LDTs that may be designated “research use only” under this requirement:

• PCR enzymes
• Gel component agars

The IVDR also addresses RUO products.

“device for performance study’ means a device intended by the manufacturer to be used in a performance study.

A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study; ”

Source: IVDR Art. 2(45)

Thus, the IVDR, like MEDDEV 2.14/1 (IVD Medical Device Borderline and Classification issues), draws a distinction between RUO products and “devices for performance studies.”

Again, the key aspect of the definition is the RUO product’s lack of medical purpose.

To be classed an RUO product, it is vital that the product does not serve a medical purpose. Even a suspected medical purpose is enough for a device to be no longer considered an RUO product.

(See MEDDEV 2.14/1 section 1.1 4.)

Definition in the USA

In 2013, the FDA published a guidance document on RUOs entitled “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.”

This guidance defines RUO products as follows:

“ An RUO product is an IVD product that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812” [NB: Part 812 concerns the provision of devices for performance evaluation purposes as a preliminary step to IVDs]

Source: FDA guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only”

Some examples of products that the FDA believes fall into this research phase of development are:

• Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured
• Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods
• Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.

Therefore, according to the FDA, a clearly visible RUO label must be affixed specifically to products that are in a research phase.

c) What are the consequences of using the “Research Use Only” label?

Normally, IVDs are subject to regulatory requirements (for example, according to the IVDR or FDA) based on their risk class.

However, RUO products do not fall within the definition of “in vitro diagnostic medical devices” given by the IVDR or the relevant FDA regulations . This means that these regulations do not apply to RUO products.

Definition: In vitro diagnostic medical devices (IVDs) in the EU

“‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

(a) concerning a physiological or pathological process or state;

(b) concerning congenital physical or mental impairments;

(c) concerning the predisposition to a medical condition or a disease;

(d) to determine the safety and compatibility with potential recipients;

(e) to predict treatment response or reactions;

(f) to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices;”

Source: Article 2 IVDR

Definition: In vitro diagnostic medical devices (IVDs) in the USA

“In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.”

Source: 21 CFR 809.3

Therefore, the requirements of the IVDR do not apply to RUO products. In the USA, they are exempt from cGMP and the FDA's quality regulations.

Depending on the product, they may still have to comply with requirements that are not specifically intended for IVDs (such as the REACH regulation for chemicals or the Machinery Directive ).

Since RUO products are thus subject to considerably fewer controls than IVDs, it is necessary to severely restrict their use.

Therefore, in particular they may not be used to:

• Make diagnoses
• Conduct performance studies

2. Use and misuse of “Research Use Only” labels

A) what should ruo products be used for.

As the name “research use only” indicates, products with RUO labeling are intended for research purposes only. RUO products are particularly attractive for the research sector due to the simplified process and lower hurdles for placing them on the market.

MEDDEV. 2.14/2 rev.1 provides a precise list of areas where RUO products may potentially be used:

• Basic research
• Pharmaceutical research
• Better identification and quantification of individual chemical substances or ligands in biological specimens
• In house manufacturing of so called “home brew kits” for research purposes

And of areas where the use of RUOs is expressly not permitted:

• Use of raw materials which are labeled “for “research use only” but which are incorporated into a finished product
• So called “research use” products being tested against a comparator IVD product that bears the CE mark
• Products for market studies/ feasibility studies

b) What RUO products are often used for

However, the low hurdles are also the reason why RUO products are often used for purposes they are not intended for. This poses significant dangers for manufacturers, operators and patients.

Sale of RUO products to medical laboratories

RUO products are sold by manufacturers to medical laboratories. Although doctors sometimes also conduct research, this is not really the main purpose of a medical laboratory. Therefore, when discussing sales with doctors, it should always be assumed that there is a medical reason behind the use of the product.

This means that anyone who knowingly sells RUO products to medical laboratories is potentially under suspicion of using the pretext “for research use only” to ignore an intended medical purpose and thus avoid responsibility for a medical device.

There are certainly laboratory products that clearly have no specific medical purpose, e.g.:

• Nutrient media
• Reaction vessels
• Washing solutions

These products are best labeled as “general laboratory supplies” rather than “RUO”.

Avoid reference to any specific diagnostic procedures in your advertising materials for products that clearly do not have a medical purpose. You should always stay on the technical or purely analytical level.

The issue with analyte specific reagents

Whether an RUO product contains analyte specific reagents, e.g., primary antibodies, FISH probes, PCR primers and probes, and sequencing panels, can be critical. In some cases, a medical purpose can be inferred just from the description of the product's performance.

This would be the case if a manufacturer of a RUO-labeled kit for the detection of viral genes specifies a number of copies per ml of blood that the kit can detect.

ASR in the USA

The FDA abbreviates the term “analyte specific reagents” to “ASR” and defines it as follows:

“Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.”

Source: 21CFR864.4020 a)

In other words, US law says that, by definition, ASRs have a diagnostic purpose.

Exception: The sale of ASRs to IVD manufacturers as components for manufacturing kits or to non-clinical laboratories for research and development without compliance with regulatory requirements is permitted.

ASR in the EU EU law does not contain this exception. Nor does the term “analyte specific reagent” does appear in any of the applicable EU regulations. Therefore, such products may have a general laboratory purpose in the EU, depending on the justification. This means they do not fall under the IVDR if the manufacturer defines the intended purpose accordingly.   However, if the manufacturer assigns a medical or diagnostic purpose to these products, the regulatory hurdles will very high once the IVDR comes into full effect (currently scheduled for May 26, 2022).

This means that the crucial factor is whether manufacturers have clearly defined the intended purpose and whether communication with customers (e.g., in advertising materials) is in line with this purpose.

Further information

You can find out more about the intended purpose of medical devices here: Intended purpose and intended use

Use of RUO products in medical laboratories

It is not just manufacturers for whom the sale of RUOs to medical laboratories represents a problem. The laboratories themselves may also not be acting in line with their status as operators and may, as a result, be liable under certain circumstances.

• Medical laboratories are free to develop in-house tests themselves. In such cases, RUO products are often used in diagnostic procedures. Even under the IVDD, MEDDEV 2.14/2 was critical of this. However, with the new In Vitro Diagnostic Medical Device Regulation (IVDR) , the EU is explicitly placing more restrictions on the routine use of such lab developed tests . Read more in our article The EU Is Regulating Medical Laboratories. Are Laboratory Developed Tests Still Allowed? .
• Due to the low regulatory hurdles, purchasing RUO products is very affordable. As a result, medical laboratories prefer them over expensive CE-IVD devices if they can achieve the same level of performance. Nevertheless, the use of RUO products for purposes other than research, even in cases where they provide similar results, is not permitted.

3. Consequences of incorrect classification

Lack of controls can have a negative effect on quality. As a result, the relevant bodies (e.g., authorities during inspections) take a closer look at whether a product is actually intended for “research use only”.

Manufacturers should also be aware that simply sticking an RUO label on a product does not on its own mean that the product no longer has to comply with requirements for IVDs that would otherwise apply.

In its guidance document on RUO , the FDA writes that only the actual intended use qualifies a product as RUO – or doesn’t. The FDA also uses marketing materials or other general factors as evidence of the intended purpose.

"Because these products are exempt from most regulatory controls, it is important that they are not distributed for clinical diagnostic uses. Mere placement of an RUO or IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval, or other requirements. FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed. ”

Manufacturers and operators who misuse the RUO label could face severe penalties, as such behavior can cause serious harm to patients or even the general public.

a) Consequences for manufacturers and operators

Improperly selling IVDs with an RUO label or using RUO products for purposes other than research is not a trivial offense.

Manufacturers who demonstrably hide or aim to hide a diagnostic purpose behind the RUO label should expect legal consequences in Germany. The same applies for operators who misuse RUO products. There is the possibility of a fine or even prison sentences. In addition, there is potential liability for harm suffered by patients.

b) Consequences in the USA

There are also severe penalties in the USA. If an RUO label is deemed to have been incorrectly used for a product, the product would be considered misbranded under sections 502(a) and 502(o) of 21 US Code, 352(a), 352(o) [A1] and would be considered adulterated under section 501(f) of 21 US Code 351(f).

c) Consequences for patients

However, the consequences can be even worse for patients. After all, the regulatory requirements for IVDs aren’t just plucked out of thin air to annoy manufacturers and operators. The regulations are intended to protect patients against incorrect results and subsequent wrong decisions. False-negative results can lull patients into a false sense of security and an existing disease may worsen undetected. One example would be the metastasis of an undetected cancer due to a test not performing as intended.

Some incorrect diagnoses could even be so severe that they can cause the death of a lot of people: an undetected viral infection can cost many lives in the early stages of an epidemic or pandemic, as the coronavirus pandemic sadly demonstrated.

4. Alternatives to “research use only” products

To avoid legal problems and risks for third parties, manufacturers and users should use alternatives to RUO products in borderline cases.

These alternatives don’t always have to be CE-IVDs. Depending on the specific situation, the following alternatives can be considered based on the intended purpose:

a) Products for general laboratory use

According to the MEDDEV 2.14/1 (IVD Medical Device Borderline and Classification Issues) guidance, it is a product's characteristics that determine whether it can be classified as a product for general laboratory use or not.

• If, based on its characteristics, a product is not specifically intended to be used for in vitro diagnostic examinations, it is not an IVD.
• Manufacturers cannot label products for general laboratory use as IVDs.

RUO products used for a better identification and quantification of individual chemical substances or ligands in biological specimens

Source: MEDDEV 2.14/2

Such products must have a general use. However, use as an IVD does not have to be ruled out, provided the product is not made specifically for a particular test. According to MEDDEV 2.14/2, even the aforementioned analyte specific reagents (ASRs) without a medical purpose fall into this category.

There are several advantages to using products for general laboratory use instead of RUO products:

• The product does not fall under the IVD Directive or the IVDR, which saves you a lot of time and money.
• Laboratories that use these products for in-house procedures are not in danger of being accused of using RUO products in routine diagnostic procedures.

However, the disadvantage is that the medical laboratory is responsible for ensuring that the examination conforms with the IVDR. This can make the product less interesting because the regulatory requirements entail a lot of work.

b) Lab developed tests with class A CE-IVDs Manufacturers may sell general laboratory reagents, which can be authorized as IVDs under the IVDR, to medical laboratories.

In combination with the ASRs developed in-house, laboratories can validate and use these products as lab developed tests (LDTs).

Read our article on lab developed tests to find out what laboratories should be aware of.

c) “For performance evaluation only” as a preliminary stage for certified IVDs

The IVDR defines " device for performance studies ” as follows:

“‘Device for performance study’ means a device intended by the manufacturer to be used in a performance study.”

Source: IVDR 2017/746/EU

These devices must already be safe, as far as possible, and meet the relevant general safety and performance requirements.

5. Ways to protect yourself

Manufacturers, operators and patients can take the following steps to avoid legal and other negative consequences when using RUO products:

a) Manufacturers

In the case of manufacturers, it is particularly important that they narrowly define the intended purpose of their product.

Analyte specific reagents should only be labeled as RUO products for specific non-medical purposes.

Example: SARS-CoV-2 and its mutations: a test kit that uses specific primers and probes to distinguish the variants B.1.1.7 (alpha variant) and B.1.351 (beta variant) from the initial variant following a positive result may be an RUO product if it is only intended to be used to determine the prevalence of the variant in the population. A specific intended purpose in this case would be: “Intended solely for epidemiological research for the purpose of surveying the prevalence of SARS-CoV-2 variants in the general population.” If a medical laboratory subsequently, based on new findings, used this test to provide the best possible treatment for infection by a specific variant, this would be an off-label use. The laboratory would then be responsible for the test's conformity.

Provided the manufacturer did not advertise the product with this clinical benefit, it would be adequately protected.

b) Operators

Operators should record exactly what they use IVDs and RUO products for.

Medical laboratories are operators of medical devices and IVDs and, therefore, are responsible for only using medical devices according to their intended purpose and in accordance with the generally accepted rules of the technology. This is stipulated in Section 4 of the German Medizinprodukte-Betreiberverordnung (MPBetreibV (German)). To be on the safe side, laboratories should keep a record of which medical devices and IVDs are in operation and routine use. This record should include a reference to the applicable test procedure and the intended purpose of the IVD.

This record can also be used to identify investigational procedures for which there are no adequate CE-IVDs available on the market. The lack of alternatives would justify the use of RUOs (as lab developed tests) in validated processes it has developed in-house, provided that the laboratory checks and can demonstrate that the general safety and performance requirements and the additional requirements of Article 5(5) of the IVDR are met.

Read more about the requirements for LDTs in our article on the topic .

c) Patients

Patients lack the knowledge to recognize what is and isn’t an RUO on their own. They are often given little to no information about the test they are undergoing. So, patients should follow this basic rule: ask your doctor or pharmacist!

• Patients can ask for the complete test report from the laboratory so that they can get a second opinion in case of doubt. The report should also indicate which specific test was performed.
• Patients should inform themselves about how “well” or “poorly” a test works, as well as the benefit-risk ratio.
• In the future, patients and doctors will also be able to get information about medical devices from EUDAMED and use this information to decide whether or not the test was performed with certified and thus legally compliant IVDs.

6. Conclusion

In the opinion of the EU Commission and the FDA, products “for research use only" have no place in diagnostics. To be used for diagnostic purposes, products have to go through the necessary controls. But these controls do not apply to RUO products.

Anyone who ignores this prohibition and uses or sells RUO products for purposes other than pure research is playing with fire. Manufacturers and operators run the risk of legal trouble and could even endanger patients’ health. Therefore, RUO products should only be used for research purposes. For other uses, manufacturers and operators should use the alternatives mentioned.

Our tip is: if you, as a manufacturer or medical laboratory, find that an RUO product is particularly well-suited for in vitro diagnostics, consider whether further development and conformity assessment to make it an IVD is worthwhile. We will be happy to help you work out which of the three alternatives to RUOs mentioned above is the best alternative to your product as part of our IVD authorization strategy consultation. If necessary, we can also help you ensure your product development conforms with the regulations.

Dr. Diana Gabriel

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An Introduction to Research Use Only (RUO)

In this blog, we recap our eBook, “An Introduction to Research Use Only (RUO)” – Click HERE to download the entire publication.

Learn how it differs from adjacent labels, the FDA and EU guidance, its appropriate use, and the consequences of mislabeling products RUO.

Introduction

In the complex world of medical device development, regulation, and distribution, finding the appropriate label to put on a device may not be simple. When is one label appropriate over another? Does a device need to go through additional testing, verification, or validation? And what are the consequences of using the wrong label? In this eBook, we’ll cover the differences between Research Use Only (RUO) and a medical device – although, it’s generally a very clear distinction.

Using the right language and label is critical to complying with best practices. This is why Regulatory Affairs works with the regulatory bodies to ensure that the limitations of the product are properly documented. In a rush to get products to market, it may be tempting to use a Research Use Only (RUO) label to avoid additional regulatory processes while still empowering other researchers and developers. However, there are risks to using the RUO label inappropriately that can have serious consequences for developers, users, and patients. In fact, mislabeling a product is illegal, and punishable. You can see an example warning letter the FDA sent to Carolina Liquid Chemistries Corp after finding intentional mislabeling in 2019 here.

This introduction will provide an overview of the Research Use Only label, how it differs from similar, adjacent labels, its appropriate use, and the consequences of mislabeling products RUO.

What is Research Use Only (RUO)?

The label Research Use Only (RUO) is generally used to indicate products that are intended for scientific research only. They cannot be used for diagnostic or medical purposes. However, there is no standard definition of “research use only,” and the label has slightly different meanings in the European Union and the United States. With the IVDR regulations, RUO products that are being used in the LDT space are going to be revisited and potentially reclassified as a medical device. With this new classification, teams will likely need to follow design controls, best practices, and industry standards.

What is the FDA guidance on Research Use Only products?

Under the FDA’s guidance issued in 2013 , a product labeled Research Use Only is an In Vitro Diagnostic (IVD) product “that is in the laboratory research phase of development and is being shipped or delivered for an investigation that is not subject to part 812.” The agency includes in this category:

• “Tests that are in development to identify test kit methodology, necessary components, and analytes to be measured.
• “Instrumentation, software, or other electrical/mechanical components under development to determine correct settings, subcomponents, subassemblies, basic operational characteristics, and possible use methods.
• “Reagents under development to determine production methods, purification levels, packaging needs, shelf life, storage conditions, etc.”

The European guidance document MEDDEV 2.14/2 states that a product categorized as an RUO product “must have no intended medical purpose or objective.” The guidance does exempt some tests developed for in-house use as long as the products are not sold to other companies. Some examples of items that can be classified as “research use only” under this exemption include PCR enzymes, gel component agars, and primers.

RELATED: FDA released new draft guidance of premarket submissions for medical devices – are you ready?

What is the difference between ruo and ivd.

An IVD is an “In Vitro Diagnostic Medical Device,” and the general term applies to any device or product that either alone or with other products is intended to be used for diagnostic, monitoring, or compatibility purposes. There are four different regulatory levels for IVDs:

• Research Use Only (RUO)
• General Laboratory Use (GLU)
• For Performance Studies Only (PSO)
• In Vitro Diagnostic Medical Device (IVD)

The simplest explanation for these different levels is that each increasing level requires more testing and oversight. Research Use Only products are at the lowest level of regulation, and In Vitro Diagnostic Medical Devices are at the highest level. Occasionally in the US, products will be labeled as “RUO IVD,” which means an in vitro device that is intended for research use only.

Products labeled with the “CE-IVD” label indicate that they have progressed through the applicable regulatory process and standards (such as IVDD or IVDR). These products are approved for diagnostic use and must include the IVD symbol to be used for medical purposes.

In the EU, as of May 2022, IVDs must comply with Regulation (EU) 2017/746 (IVDR) . The IVDR defines IVDs as follows:

“‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:

(a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures.”

All IVDs that comply with the IVDR must carry the CE Mark if marketed in the EU.

Research Use Only products are not subject to regulatory requirements in either the US or the EU, but because they don’t meet the same compliance standards as IVDs, they must be clearly labeled as RUO products and cannot be used for medical purposes.

A known exception is the lab developed test (LDT) pathway for clinical purposes.

What are the requirements for an RUO product?

In the US, RUO products are basically unregulated and do not need to meet any specific requirements to carry the RUO label. The FDA does not specify any restrictions or limitations on RUO products, provided they are clearly labeled “For Research Use Only. Not for use in diagnostic procedures.” For this reason, RUO products can be an excellent solution for laboratories that need research materials for testing and research purposes. Because products with the RUO label do not require extensive testing, verification, and validation, they tend to be more cost-effective for research purposes.

The EU rules are similar. Because RUO products do not have clinical applications, they are not considered medical devices, and there are no requirements for RUO products defined by either the IVDD or the IVDR. These products should not be marked with the IVD mark, and they should be clearly labeled as “Research Use Only.”

RELATED: See how Jama Software ® helped Össur improve the mobility of millions by replacing process rigidity with speed and agility.

Are there alternatives to ruo labels.

Given the significant differences between labeling a product as RUO and labeling a product as IVD, manufacturers and users can’t be too careful when it comes to assigning labels or using products for specific purposes. If there is a risk to using products labeled as RUO, manufacturers and users should opt for products that have attained a higher compliance level. For example, for a doctor’s office or home use, IVD is the right path. For clinical purposes or hospital labs, RUO could be used as LDT as long as they are CAP/CLIA certified, such was the case with COVID-19 testing kits when the pandemic first hit.

For products that meet a higher degree of compliance, it is possible to assign General Laboratory Use (GLU), Performance Studies Only (PSO), or even In Vitro Diagnostic Medical Device (IVD) labels. However, depending on the intended use for the Research Use Only products, pursuing these additional levels of compliance may or may not make sense.

What is CLIA certification?

CLIA stands for Clinical Laboratory Improvement Amendments. The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the United States through CLIA.

What is a CAP accreditation?

CAP stands for The College of American Pathologists (CAP) . The purpose of CAP laboratory accreditation is to ensure laboratories provide precise test results for accurate patient diagnoses, meet CLIA and CAP requirements, and demonstrate compliance with professionally and scientifically sound and approved laboratory operating standards.

What are RUO products used for?

As the name implies, RUO projects should be used for research purposes only. They may be used for basic research, pharmaceutical research, or in-house manufacturing of “home brew kits” for research purposes and potentially for clinical applications via the LDT pathway. RUO products are specifically not to be used to make diagnoses, conduct performance studies, or as a substitute or comparator for a CE-IVD device. They may also not be used for market or feasibility studies. Raw ingredients labeled as RUO products may not be incorporated into a finished IVD product.

Learn more about the advantages and disadvantages of the RUO label (and more) by downloading the entire eBook HERE .

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What is Research? – Purpose of Research

• By DiscoverPhDs
• September 10, 2020

The purpose of research is to enhance society by advancing knowledge through the development of scientific theories, concepts and ideas. A research purpose is met through forming hypotheses, collecting data, analysing results, forming conclusions, implementing findings into real-life applications and forming new research questions.

What is Research

Simply put, research is the process of discovering new knowledge. This knowledge can be either the development of new concepts or the advancement of existing knowledge and theories, leading to a new understanding that was not previously known.

As a more formal definition of research, the following has been extracted from the Code of Federal Regulations :

While research can be carried out by anyone and in any field, most research is usually done to broaden knowledge in the physical, biological, and social worlds. This can range from learning why certain materials behave the way they do, to asking why certain people are more resilient than others when faced with the same challenges.

The use of ‘systematic investigation’ in the formal definition represents how research is normally conducted – a hypothesis is formed, appropriate research methods are designed, data is collected and analysed, and research results are summarised into one or more ‘research conclusions’. These research conclusions are then shared with the rest of the scientific community to add to the existing knowledge and serve as evidence to form additional questions that can be investigated. It is this cyclical process that enables scientific research to make continuous progress over the years; the true purpose of research.

What is the Purpose of Research

From weather forecasts to the discovery of antibiotics, researchers are constantly trying to find new ways to understand the world and how things work – with the ultimate goal of improving our lives.

The purpose of research is therefore to find out what is known, what is not and what we can develop further. In this way, scientists can develop new theories, ideas and products that shape our society and our everyday lives.

Although research can take many forms, there are three main purposes of research:

• Exploratory: Exploratory research is the first research to be conducted around a problem that has not yet been clearly defined. Exploration research therefore aims to gain a better understanding of the exact nature of the problem and not to provide a conclusive answer to the problem itself. This enables us to conduct more in-depth research later on.
• Descriptive: Descriptive research expands knowledge of a research problem or phenomenon by describing it according to its characteristics and population. Descriptive research focuses on the ‘how’ and ‘what’, but not on the ‘why’.
• Explanatory: Explanatory research, also referred to as casual research, is conducted to determine how variables interact, i.e. to identify cause-and-effect relationships. Explanatory research deals with the ‘why’ of research questions and is therefore often based on experiments.

Characteristics of Research

There are 8 core characteristics that all research projects should have. These are:

• Empirical  – based on proven scientific methods derived from real-life observations and experiments.
• Logical  – follows sequential procedures based on valid principles.
• Cyclic  – research begins with a question and ends with a question, i.e. research should lead to a new line of questioning.
• Controlled  – vigorous measures put into place to keep all variables constant, except those under investigation.
• Hypothesis-based  – the research design generates data that sufficiently meets the research objectives and can prove or disprove the hypothesis. It makes the research study repeatable and gives credibility to the results.
• Analytical  – data is generated, recorded and analysed using proven techniques to ensure high accuracy and repeatability while minimising potential errors and anomalies.
• Objective  – sound judgement is used by the researcher to ensure that the research findings are valid.
• Statistical treatment  – statistical treatment is used to transform the available data into something more meaningful from which knowledge can be gained.

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Types of Research

Research can be divided into two main types: basic research (also known as pure research) and applied research.

Basic Research

Basic research, also known as pure research, is an original investigation into the reasons behind a process, phenomenon or particular event. It focuses on generating knowledge around existing basic principles.

Basic research is generally considered ‘non-commercial research’ because it does not focus on solving practical problems, and has no immediate benefit or ways it can be applied.

While basic research may not have direct applications, it usually provides new insights that can later be used in applied research.

Applied Research

Applied research investigates well-known theories and principles in order to enhance knowledge around a practical aim. Because of this, applied research focuses on solving real-life problems by deriving knowledge which has an immediate application.

Methods of Research

Research methods for data collection fall into one of two categories: inductive methods or deductive methods.

Inductive research methods focus on the analysis of an observation and are usually associated with qualitative research. Deductive research methods focus on the verification of an observation and are typically associated with quantitative research.

Qualitative Research

Qualitative research is a method that enables non-numerical data collection through open-ended methods such as interviews, case studies and focus groups .

It enables researchers to collect data on personal experiences, feelings or behaviours, as well as the reasons behind them. Because of this, qualitative research is often used in fields such as social science, psychology and philosophy and other areas where it is useful to know the connection between what has occurred and why it has occurred.

Quantitative Research

Quantitative research is a method that collects and analyses numerical data through statistical analysis.

It allows us to quantify variables, uncover relationships, and make generalisations across a larger population. As a result, quantitative research is often used in the natural and physical sciences such as engineering, biology, chemistry, physics, computer science, finance, and medical research, etc.

What does Research Involve?

Research often follows a systematic approach known as a Scientific Method, which is carried out using an hourglass model.

A research project first starts with a problem statement, or rather, the research purpose for engaging in the study. This can take the form of the ‘ scope of the study ’ or ‘ aims and objectives ’ of your research topic.

Subsequently, a literature review is carried out and a hypothesis is formed. The researcher then creates a research methodology and collects the data.

The data is then analysed using various statistical methods and the null hypothesis is either accepted or rejected.

In both cases, the study and its conclusion are officially written up as a report or research paper, and the researcher may also recommend lines of further questioning. The report or research paper is then shared with the wider research community, and the cycle begins all over again.

Although these steps outline the overall research process, keep in mind that research projects are highly dynamic and are therefore considered an iterative process with continued refinements and not a series of fixed stages.

A well written figure legend will explain exactly what a figure means without having to refer to the main text. Our guide explains how to write one.

Scientific misconduct can be described as a deviation from the accepted standards of scientific research, study and publication ethics.

Multistage sampling is a more complex form of cluster sampling for obtaining sample populations. Learn their pros and cons and how to undertake them.

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Find out the differences between a Literature Review and an Annotated Bibliography, whey they should be used and how to write them.

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Nidhi is a PhD student at Virginia Tech, focused on developing an engineered platform to study the breast tumor microenvironment, for diagnostic and prognostic purposes.

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Article Contents

2 nonstandard abbreviations:.

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“Research Use Only” Reagents: Is There an Imperative for Increased FDA Oversight?

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Timothy J O'Leary, “Research Use Only” Reagents: Is There an Imperative for Increased FDA Oversight?, Clinical Chemistry , Volume 57, Issue 12, 1 December 2011, Pages 1681–1683, https://doi.org/10.1373/clinchem.2011.174268

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On June 1, 2011, the US Food and Drug Administration (FDA) 2 Office of In Vitro Diagnostic Device Evaluation and Safety issued draft guidance for industry and FDA staff intended to provide guidance regarding the FDA's thinking about in vitro diagnostic device (IVD) products labeled for “Research Use Only” (RUO) or “Investigational Use Only” (IUO) ( 1 ). Reagents may be marketed under either of these labels without FDA premarket review and are partially or totally exempt from compliance with the Quality Systems Regulation (21 CFR 820). Therefore, an IVD manufacturer might it very tempting to avoid the trouble and expense of a 510(k) or premarket-approval submission by labeling a product as RUO or IUO, despite knowing full well that the product is likely being used as an IVD under conditions in which there is no research protocol and no oversight by an institutional review board.

There is no doubt that the FDA's intent is to improve patient safety. Compliance with the Quality Systems Regulation provides assurance that an IVD meets manufacturing specifications and that lot-to-lot variations are minimized and well understood. FDA clearance provides further assurance that the performance characteristics of laboratory tests are sufficiently well understood as to enable their intelligent use. Furthermore, the use by clinical laboratories of FDA-cleared IVD products likely reduces interlaboratory variation in testing and increases the ease with which results can be “ported” from one healthcare facility to another, potentially reducing healthcare costs that arise from duplicate testing. Nevertheless, the laboratory community is right to be concerned about the guidance document statement that manufacturers should not sell RUO or IUO reagents “to laboratories that they know use the product for clinical diagnostics use.” This statement could have unintended consequences that adversely affect patient care. In particular, the molecular diagnostics community has expressed concern that such reagents as PCR primers and sequencing reagents and equipment could become unavailable and that this outcome could affect many aspects of medical care, including newborn screening, HLA testing, and human papilloma virus genotyping, among others.

When considering approaches by which the FDA and the laboratory community can improve patient care and safety, it is important to consider the overall medical and regulatory environment in which laboratory tests that currently use RUO and IOU IVDs are conducted. In the remainder of this Opinion, I consider potential deficits in laboratory testing that currently do not rely on FDA-cleared IVDs and discuss principles that the FDA and other agencies may wish to consider when determining whether a regulatory solution is the most appropriate way to address the perceived deficits in laboratory testing.

The design and implementation of regulations entail substantial costs on the part of both regulator and regulated, both of which must ultimately be borne by the public. Therefore, regulators should take a measured approach when deciding to implement a regulatory solution to a perceived problem. In my opinion, such decisions should be based on a careful and narrow definition of the public health problem to be addressed, a scientifically valid and quantitative assessment of the magnitude of this problem, and strong evidence that the overall cost of implementing the regulatory approach (including both the cost to the regulator and the cost to the regulated entities) is cost-effective. The regulatory reasoning and the cost–benefit analysis should be published together to facilitate public scrutiny and comment. Implementation of this approach would unquestionably be associated, at least initially, with an adverse financial impact on regulatory agencies, because the assessment of regulatory impact would undoubtedly be more costly than is currently the case. The overall cost to the public seems likely to be offset, at least in part, by avoidance and/or rescission of ineffective and costly regulatory interventions. The recent FDA guidance document does not implement such an approach, so I consider some of the issues that the agency may have attempted to address.

Several potential problems are associated with the use of RUO and IUO reagents in clinical laboratory testing: ( a ) the creation of an uneven playing field for manufacturers; ( b ) the perception that manufacturers or laboratories are defying FDA regulatory authority; and ( c ) the reporting of inaccurate, misleading, or inconsistent results, either within a laboratory or among several laboratories. There is no question that the cost avoidance produced by ignoring regulatory requirements creates an economic environment that gives unfair advantage to commercial manufacturers, compared with institutions that play by the FDA interpretation of the law. Both the clinical investigations and the paperwork requirements associated with FDA submissions are costly. These costs may come at the expense of profit or at the expense of healthcare organizations and insurers (including the federal government).

Inaccurate or misleading results can occur when a clinical laboratory result does not mean what a clinician believes that it means. That situation could arise, for example, if an RUO or IUO reagent is not what the vendor says it is or performs in a manner that both is inconsistent with what the vendor states and is unexpected by the clinical laboratory. It is thus incumbent on laboratories to conduct their quality-assurance activities in a manner that ensures that reported results mean exactly what they purport to mean, whether or not a laboratory test has been cleared by the FDA. Under the framework proposed above, increased regulatory effort by the FDA might be appropriate if evidence of harm exists, although CLIA also provides a framework for achieving this objective.

Although the FDA has not officially elucidated the reason for issuing the guidance document, there have been a number of reports of inaccurate testing with laboratory-developed tests. Perhaps the most prominent is prescribing Herceptin® based on the results of immunohistochemical tests for HER2 (human epidermal growth factor receptor 2) overexpression. 3 Some of these results have depended on the use of uncalibrated laboratory-developed tests; indeed, some authors have postulated that as much as 20% of immunohistochemical HER2 testing used for selecting patients for Herceptin therapy has not been correlated, either directly or indirectly, with response to the drug ( 2 ). If true, that finding demonstrates a clear failure of the CLIA framework alone to adequately protect public health, and it seems likely that the burden of regulatory compliance, if narrowly directed to this issue, is proportionate to the problem. Inaccurate or misleading results have also been associated with direct-to-consumer genetic testing ( 3 ), which is widespread. The magnitude of the harm associated with such testing is uncertain but may be considerable, and oversight under the CLIA mechanism has failed to address the issue.

The potential reach of the FDA guidance document is broader than necessary to deal with HER2 assessment and direct-to-consumer testing. There are substantial numbers of important laboratory-developed tests for which only RUO and IUO reagents are currently available. The FDA guidance document (which, I should note, is nonbinding) could lead to withdrawal of these tests from clinical practice. In my opinion, FDA officials should work to minimize the likelihood of such an occurrence. In addition, there is a risk that innovative new tests for which only RUO and IUO reagents are available will not be deployed in a timely way, further compromising patient well-being. There is clearly a role in medical practice for laboratory-developed and -validated tests that will, of necessity, use reagents that have not passed FDA muster. The failure of CLIA oversight mechanisms is not a reason for the FDA to act unilaterally. Enforcement of both the Food Drug and Cosmetics Act and the Public Health Service Act [which created the CLIA 88 (CLIA amendments of 1988) framework] falls to the Department of Health and Human Services. It is thus appropriate for the FDA and the Centers for Medicare and Medicaid Services to work cooperatively, not only with each other but also with industry and laboratory communities, to develop a robust framework for reducing inaccurate and unreliable laboratory testing while maintaining access to high-quality laboratory testing and minimizing its economic burden.

US Food and Drug Administration

in vitro diagnostic device

Research Use Only

Investigational Use Only

human epidermal growth factor receptor 2

CLIA amendments of 1988.

HER2 is used in this Opinion to refer to the protein encoded by the gene with HUGO-approved gene symbol ERBB2 [v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog (avian)], as HER2 is the name commonly used in practice.

Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article .

Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the Disclosures of Potential Conflict of Interest form. Potential conflicts of interest:

Employment or Leadership: T.J. O'Leary, Association for Molecular Pathology and Journal of Molecular Diagnostics .

Consultant or Advisory Role: None declared.

Stock Ownership: None declared.

Honoraria: None declared.

Research Funding: None declared.

Expert Testimony: None declared.

Disclaimer: The views or opinions expressed in this paper are those of the author and are not to be construed as official or as representing the views of the Department of Veterans Affairs or any other entity of the United States government.

U.S. Food and Drug Administration . Draft guidance for industry and FDA staff-commercially distributed in vitro diagnostic products labeled for research use only or investigational use only: frequently asked questions . http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253307.htm (Accessed October 2011) .

Carlson B . HER2 tests: How do we choose? Biotechnol Healthc 2008 ; 5 : 23 – 7 .

Google Scholar

U.S. Government Accountability Office . Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices . http://www.gao.gov/new.items/d10847t.pdf (Accessed October 2011) .

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Research Uses and Disclosures

217-may a covered entity accept documentation of an irb waiver of authorization.

Yes. The HIPAA Privacy Rule explicitly permits a covered entity to reasonably rely on a researcher’s documentation of an Institutional Review Board (IRB) or Privacy Board waiver of authorization pursuant to 45 CFR 164.512(i) that the information requested is the minimum necessary for the research purpose. See 45 CFR 164.514(d)(3)(iii).

302-Will HIPAA hinder medical research

We do not believe that the Privacy Rule will hinder medical research. Indeed, patients and health plan members should be more willing to authorize disclosures of their information for research and to participate in research when they know their information is protected.

303-Are some criteria so subjective that IRB and privacy boards may makeinconsistent determinations

Under the HIPAA Privacy Rule, IRBs and Privacy Boards need to use their judgment as to whether the waiver criteria have been satisfied.

304-Does HIPAA prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing information

No. The Privacy Rule does not address conditions for enrollment in a research study. Therefore, the Privacy Rule in no way prohibits researchers from conditioning enrollment in a research study on the execution of an authorization for the use of pre-existing health information.

305-Does HIPAA permit creating a database for research purposes through an IRB or Privacy Board waiver

Yes. A covered entity may use or disclose protected health information without individuals’ authorizations for the creation of a research database, provided the covered entity obtains documentation that an IRB or Privacy Board has determined that the specified waiver criteria were satisfied.

306-Can researchers access existing databanks or repositories created prior to the compliance date without permission

Under the HIPAA Privacy Rule, covered entities may use or disclose protected health information from existing databases or repositories for research purposes either with individual authorization as required at 45 CFR 164.508, or with a waiver of individual authorization as permitted at 45 CFR 164.512(i).

307-How does the Rule help IRBs handle the additional responsibilities imposed by the HIPAA Privacy Rule

Recognizing that some institutions may not have IRBs, or that some IRBs may not have the expertise needed to review research that requires consideration of risks to privacy, the Privacy Rule permits the covered entity to accept documentation of waiver of authorization from an alternative body called a Privacy Board–which could have fewer members, and members with different expertise than IRBs.

308-By establishing new waiver criteria and authorization requirements, hasn't HIPAA modified the Common Rule

No. Where both the Privacy Rule and the Common Rule apply, both regulations must be followed. The Privacy Rule regulates only the content and conditions of the documentation that covered entities must obtain before using or disclosing protected health information for research purposes.

309-Is documentation of IRB and Privacy Board approval required by the HIPAA

No. The HIPAA Privacy Rule requires documentation of waiver approval by either an IRB or a Privacy Board, not both.

310-Does HIPAA require a covered entity to create an IRB or Privacy Board before using or disclosing protected health information for research

The IRB or Privacy Board could be created by the covered entity or the recipient researcher, or it could be an independent board.

311-What does HIPAA say about a research participant's right of access to research records or results

With few exceptions, the Privacy Rule gives patients the right to inspect and obtain a copy of health information about themselves that is maintained by a covered entity or its business associate in a “designated record set.”

313-Do HIPAA's requirements for authorization and the Common Rule's requirements for informed consent differ?

Yes. Under the Privacy Rule, a patient’s authorization is for the use and disclosure of protected health information for research purposes. In contrast, an individual’s informed consent, as required by the Common Rule and the Food and Drug Administration’s (FDA) human subjects regulations, is a consent to participate in the research study as a whole, not simply a consent for the research use or disclosure of protected health information.

314-When is a researcher considered to be a covered health care provider under HIPAA

A researcher is a covered health care provider if he or she furnishes health care services to individuals, including the subjects of research, and transmits any health information in electronic form in connection with a transaction covered by the Transactions Rule.

315-When can a covered determine whether a research component of the entity is part of their covered functions

A covered entity that qualifies as a hybrid entity, meaning that the entity is a single legal entity that performs both covered and non-covered functions, may choose whether it wants to be a hybrid entity. If such a covered entity decides not to be a hybrid entity then it, and all of its components, are subject to the Privacy Rule in its entirety. Therefore, if a researcher is an employee or workforce member of a covered entity that has decided not to be a hybrid entity, the researcher is part of the covered entity and is, therefore, subject to the Privacy Rule.

316-If a research subject revokes authorization to disclose information can a researcher continue using the information already obtained

Covered entities may continue to use and disclose protected health information that was obtained prior to the time the individual revoked his or her authorization, as necessary to maintain the integrity of the research study.

317-Can the preparatory research provision of the HIPAA Privacy Rule be used to recruit individuals into a research study

The preparatory research provision permits covered entities to use or disclose protected health information for purposes preparatory to research, such as to aid study recruitment. However, the provision at 45 CFR 164.512(i)(1)(ii) does not permit the researcher to remove protected health information from the covered entity’s site.

318-Does HIPAA require documentation of IRB approval of an alteration or waiver of individual authorization

No. Documentation of IRB or Privacy Board approval of an alteration or waiver of individual authorization is only needed before a covered entity may use or disclose protected health information under 45 CFR 164.512(i)(1)(i).

319-If consent was obtained before the compliance date but the IRB modifies the document is authorization required

If informed consent or reconsent (ie., asked to sign a revised consent or another informed consent) is obtained from research subjects after the compliance date, the covered entity must obtain individual authorization as required at 45 CFR 164.508 for the use or disclosure of protected health information once the consent obtained before the compliance date is no longer valid for the research.

320-Can covered entities continue to disclose adverse event reports that contain information

Yes. The Office for Human Research Protections is a public health authority under the HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected health information to report adverse events to the Office for Human Research Protections either with patient authorization as provided at 45 CFR 164.508, or without patient authorization for public health activities as permitted at 45 CFR 164.512(b).

321-Can covered entities continue to disclose information to the HHS Office for Human Research Protections

Yes. The Office for Human Research Protections is a health oversight agency under the HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected health information to the Office for Human Research Protections for such compliance investigations either with patient authorization as provided at 45 CFR 164.508, or without patient authorization for health oversight activities as permitted at 45 CFR 164.512(d).

Airport Passenger-Related Processing Rates Guidebook (2009)

Chapter: chapter 3 - defining the research: purpose, focus, and potential uses.

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

14 Chapter 3 identifies roles, relationships, and responsibilities of stakeholders. It examines principal steps involved in planning an airport passenger-rate data collection effort. It begins with the ques- tion of whether the potential benefits of the proposed effort outweigh the anticipated cost; describes different types of research (i.e., exploratory, descriptive, inferential); summarizes the questions each type addresses; and notes the ends to which the data might be used. 3.1 Roles and Responsibilities When an airport data collection event is first mentioned, it invariably raises numerous ques- tions: Who is asking for the data? How will it be used? What’s the budget? What’s the schedule? What kind of resources can be made available? Without answers to these fundamental questions, the success of your research is in jeopardy. This section will help the researcher establish the role of key stakeholders and their interrelationships within the team. Many entities can sponsor a data collection study, including airports, airlines, manufacturers, and various agencies. Likewise, there are many ways of managing and staffing the event and pro- moting involvement with stakeholders. There are therefore myriad ways of organizing a study. Exhibit 3-1 is an example of how a study could be arranged with the airport as the sponsor. 3.1.1 Client/Sponsor For airports, oversight is guided by a board, commission, or an authority consisting of appointed or elected officials. While these agencies typically provide oversight to airport man- agement and approve long-term plans and large capital expenditures, usually it is the airport director or manager who makes day-to-day decisions. Depending on the size of the airport, there may be several departments, each having its own manager. In such cases, passenger terminal-related studies would typically fall within the purview of the planning and/or engineering department and would be managed by its director. Regardless of the affiliation of the project sponsor(s), it is essential that the following ques- tions be answered clearly and unambiguously as they pertain to the sponsor at the beginning of any project: • Who has primary responsibility for defining the questions the study is intended to address? • What preference does this person or group have regarding ongoing involvement with the project? – What information would they like to receive, in what format, and with what frequency? – Who should be the principal point-of-contact (POC) on the client’s side for questions that might emerge related to the study’s focus, direction, etc.? C H A P T E R 3 Defining the Research: Purpose, Focus, and Potential Uses

Defining the Research: Purpose, Focus, and Potential Uses 15 • Who is the designated project manager, and what information would he or she like to receive, in what format, and with what frequency? • If the person given responsibility for day-to-day issues pertaining to access, authorizations, etc. is different from the project manager, who is that person, and what is the scope of issues he or she is authorized to address? • If problems or obstacles arise in implementing the study, and the project manager is not able or authorized to resolve them, what is the chain of persons through which the issue should be escalated? 3.1.2 Study Team The size of the study team will depend on the team’s depth and organization, and the size, duration, and complexity of the study itself. For a typical medium- to large-scale study, the roles listed in the following sections are the most typical. Multiple roles might be assumed by a single person or distributed across multiple persons. Titles vary as well, but the functions are largely universal. Project Manager The project manager is typically a mid-level to senior person who has the long-term, day-to- day relationship with his or her client counterpart. The need for the passenger-related process- ing rate study may initially originate from discussions between the project manager and those within the airport or airline. Survey Manager The survey manager is usually a mid-level staff person. His/her role on the project would be to oversee the day-to-day management of the data processing rate study, including leading the development of the scope, schedule, and budget; developing the team; and assigning roles and responsibilities. The survey manager would have the responsibility of ensuring the survey goals were adequately defined and met. Decision Maker Survey Manager Admin. Support Staffing Source (e.g., airport personnel, mkt. research firm) Surveyor Surveyor Surveyor Sponsor/Client (Airport) (Large Airport: Dir./Mgr.) Project Manager (Large Airport: Dir. Planning/Eng.) (Small Airport: Apt. Mgr.) Project Manager (Typ. oversees multiple tasks of which survey is but one part) Study Team (Typically, Consultant) Statistical Technical Expert Survey Assistant Data Analyst IT Analyst Other Stakeholders • Airlines • Agencies • Concessionaires Exhibit 3-1. Typical sponsor and study team roles (assuming an airport is the sponsor).

16 Airport Passenger-Related Processing Rates Guidebook Research and Statistical Expert A person(s) with expertise in research methodology and quantitative/statistical analysis should be consulted to develop, or provide comments and recommendations about, the overall methodology, the sampling plan, and so forth. Most of this person’s input would occur at the project’s initiation. A distinction is sometimes drawn in the consulting literature among differ- ent approaches to consulting. One such approach, generally referred to as process consultation might be of particular appeal.1 When acting in this role, the consultant not only provides tech- nical expertise related to the specific project, but also works with the client to develop expertise. This arrangement has the goal of, over time, reducing the reliance on the consultant. Survey Assistant The survey assistant has primary responsibility for assisting the survey project manager and secondarily to assist others on the project team throughout the duration of the study. Typically, this staff person will be at a junior level. The degree of assistance this person can provide is based on his/her level of education and current skill sets. Data Analyst The data analyst should not only be well-versed in technical analysis, but should also have a strong familiarity with the airport terminal environment. This person could be a terminal or air- port planner or aviation architect. The analyst is often largely responsible for documenting results, and responsibilities might extend to presenting findings to the client. Administrative Support Data collection efforts are inherently complex and, as such, often require a significant level of coordination and administration. The staff person serving this function would be responsible for such things as making travel plans, scheduling visits to the airport’s security office, buying supplies, shipping and receiving materials, scheduling meetings, preparing invoices and con- tracts, and editing/proofing the report. Data Collection Staff For small studies (e.g., small airports where only a few functional elements are being observed for a limited time period), airport/airline or consultant staffing may be used. For larger studies, typically examining multiple functional elements of a medium or large airport over a multi-day period, a market-research firm is frequently employed. The data collection staff reports directly to the survey manager. 3.2 Is the Study Needed? While the need for data collection is often justifiable, the benefit of validating the need, and avoiding what might be a costly, and possibly unjustified, effort well exceeds the relatively minor cost of pausing to consider a few basic questions (see Appendix C for more information). Exhibit 3-2 illustrates these questions. 3.3 Research Fundamentals This section summarizes a number of fundamental issues and terms related to the research process. (Additional detail is included in Appendix C.) 1 Schein, E. H. (1999). Process Consultation Revisited: Building the Helping Relationship. NY: Addison Wesley.

Research is a dynamic process with both deductive and inductive dimensions. This differs in some ways from what some present as the “traditional” approach to research, i.e., that theory drives hypothesis testing. Sometimes it does, but sometimes it doesn’t work this way. 3.3.1 Theory, Hypotheses, and Evidence The word “theory” often implies a formal set of laws, propositions, variables, and the like, whose relationships are clearly defined. A related implication is that theory may not be particu- larly germane to the everyday world of work. This view of theory is not incorrect, but neither is it complete. While theory can be abstract and complex in its detail, it does not necessarily have to be abstract, complex, or formal. It can be thought of more broadly and simply as an explanation of “how the world works.” For exam- ple, an organization might develop a mission or a value statement (or both); engrave the words in a medium intended to last millennia; and prominently display the statement in the workplace with the intent of communicating to all its perspective clients on issues pertinent to its view. In Defining the Research: Purpose, Focus, and Potential Uses 17 Question Things to Consider Have relevant data been collected at this airport in the past that might be used rather than collecting new data? Might you be able to get data from another airport similar in key ways to this airport? Are there data available that might help answer the research question? Might access to the data be blocked due to proprietary or security issues? Sometimes the data are perceived to be so sensitive that the “owner” of the data may not give permission to share it. Has the decision already been made, and the data are being collected to legitimize the decision? Is there anything to suggest that the study is an attempt to “prove” something true or false? What role will the results play in the decision being considered? To what extent will the decision makers be persuaded by the results? What will the decision makers accept as credible evidence? Before collecting data, make certain that the research plan will result in data that the sponsors will accept. It is better to learn beforehand, for example, that the proposed sampling plan does not meet the sponsor’s criteria for rigor. What is the cost of the potential investment that the data will help inform? What is the cost of conducting the research? Does the benefit equal or outweigh the cost? Cost should be considered not only in economic terms, but as safety, inconvenience, and so forth. Exhibit 3-2. Considerations to determine need for data collection.

2008, British Airways announced a new venture: OpenSkies. The “theory” OpenSkies used to define its clients is reflected in its advertising as shown in Exhibit 3-3. So, how does this relate to airport processing rate studies? It relates in the following two ways: 1. The published research literature may well contain formal theories relevant to what data to collect and how to collect it. For example, Appendix B includes a bibliography of recent research articles related to passenger and baggage processing in airports. It is intended to illustrate the scope and diversity of research available on a given topic. Before embarking on an investigation, review the literature to see how it might enhance the quality of the planned research. The Internet provides access to numerous sources for such scholarly documents. 2. Informally, the key decisions about how to go about collecting data are grounded in assump- tions about how things work (i.e., one’s own theory). For example, you might choose to col- lect passenger security screening data between 6:00 a.m. and 8:00 a.m. on a Monday because your experience is that this time period reflects peak checkpoint activity. While this “theory” may be correct in some circumstances, it may also be wrong in others. For example, at many vacation-oriented airports, the peak at the checkpoint occurs in the late morning due to check-out times at hotels. Another common view of research is of the stereotypical scientist, objectively testing hypothe- ses (or an “educated guess”) arising from theory. Exhibit 3-4 reflects this general approach to research. This is certainly one way in which research proceeds, but, similar to theory, it is not the only way. Before considering an “evidence first” approach, we wish to mention a variation on the tra- ditional approach displayed in Exhibit 3-4 that has been gaining dominance in recent years. In particular, this is a confidence interval (CI) approach rather than a hypothesis driven approach. In a hypothesis driven approach, the researcher’s primary interest is in testing a population parameter, and uses a sample drawn from the population. When the researcher takes a CI approach, the intent is to calculate an interval within which the population parameter is likely 18 Airport Passenger-Related Processing Rates Guidebook Exhibit 3-3. OpenSkies advertisement. Question key assumptions, even if they seem to be “common sense,” by checking with informants, look- ing at the literature, etc.

to fall. Hypotheses are stated before data collection; CIs are calculated after data are collected.2 In conducting passenger-processing rate research in airport environments, the CI approach is going to be the most appropriate in most instances. A markedly different approach to those described above is shown in Exhibit 3-5. In contrast to beginning with a theory and then collecting evidence to test the theory or estimate a popula- tion parameter within some CI, this approach begins with evidence for which one seeks poten- tial explanations, or “theories” to explain the evidence. This approach is subsumed under the broad heading of Bayesian Law, so named after the 18th Century English clergyman, Thomas Bayes, credited with developing the approach. Depending on where one begins can result in potentially dramatic conclusions (see Exhibit 3-6). This is important because limiting oneself to a particular perspective of how research should be conducted and how data ought to be gathered may impose unnecessary constraints. What is important is that the research is executed systematically and with rigor. The documented ways in which science proceeds are often idealized: portraying what is inherently a very dynamic and nonlinear process as logical and linear. 3.3.2 Research Questions and Purposes A basic issue in research is specifying the question the research will help answer. Penning a specific question also helps in determining what approach might be best used in seeking an Defining the Research: Purpose, Focus, and Potential Uses 19 Theory Drives questions & hypotheses Hypothesis: Installing n kiosks will reduce the average time of passengers waiting in line by 10% over check-in agents. Leading to a conclusion Drives data collection Followed by analysis Exhibit 3-4. Hypothesis driven approach. Evidence leads to speculation about possible explanations Which may or may not drive more data collection & analysis Theory Exhibit 3-5. Bayesian approach. 2 While these approaches are presented here as mutually exclusive, they might be integrated in practice.

answer. One classic text in research methodology5 suggests that a research question should express a relationship between two or more variables, and it should imply an empirical approach, that is, it should lend itself to being measured using data. A variable is, not surprisingly, some- thing that can vary, or assume different values. In the next section, illustrative questions are given, categorized by the purpose of research with which they are best matched. The five research purposes are presented as the following: 1. Explore, 2. Describe, 3. Test, 4. Evaluate, and 5. Predict. The distinctions among these purposes are not absolute, nor are they necessarily exclusive of one another. A research initiative might be directed at answering questions with multiple pur- poses. Indeed, this is but one of many ways of classifying research. In addition, the reader whose practice lies primarily in the arena of modeling and simulation might note their absence from this list. Although modeling and simulation applications require input data, for example, to gen- erate distributions and parameters for use as stochastic varieties in modeling, the techniques used to collect data are largely independent of specific applications (such as simulation and model- ing). Those issues unique to modeling are beyond the scope of this guidebook. Explore (Exploratory Research) Exploratory research is sometimes defined as “what to do when you don’t know what you don’t know.” Its aim is discovery and to develop an understanding of relevant variables and their interactions in a real (field) environment. Exploratory research, as such, is appropriate when the 20 Airport Passenger-Related Processing Rates Guidebook If your intent is to… And take action based on… Use… Example Test a hypothesis regarding a population parameter Whether you reject or fail to reject the null hypothesis Hypothesis testing approach The proportion of coach passengers checking in more than 60 min prior to scheduled departure is 80% H A : p > .80 3 H 0 : p .804 Estimate a population parameter The confidence interval selected CI approach Plus or minus 5%, what is the average time coach passengers check in prior to scheduled departure? Determine the likelihood of an event given some evidence The calculated probability Bayesian approach What is the probability that a passenger’s carry on- luggage will be subject to secondary security screening given that the passenger is boarding an international flight? Exhibit 3-6. Research approaches. 3 This is the research, or Alternative, hypothesis. It reads: The proportion is greater than 80%. 4 This is the null hypothesis. It is what is tested, and reads: The proportion is less than or equal to 80%. 5 Kerlinger F. & Lee, H. (2000). Foundations of Behavioral Research, 4th ed. NY: Harcourt Brace.

problem is not well defined. For example, passenger complaints about signs within a facility might prompt the following exploratory question: • “Where should signage be located to minimize passenger confusion?” As another example, if a new security checkpoint configuration is proposed, it may be too novel to rely on variables used in other studies. The question, therefore, might then be the following: • “How does a given alternative security checkpoint configuration affect capacity?” This type of research is often qualitative rather than quantitative. That is, it employs verbal descriptors of observations, rather than counts of those observations (see Appendix C for more information). Describe (Descriptive Research) Descriptive research, as the name implies, is intended to describe phenomena. While descrip- tive research might involve collecting qualitative data by asking open-ended questions in an interview, it typically employs quantitative methods resulting in reporting frequencies, calculat- ing averages, and the like. The following two questions illustrate the nature of descriptive research. Each implies that the relevant variables have been identified as well as the conditions under which the data should be collected. • “What is the average number of passengers departing on international flights on weekday evenings in July at a given airport?” • “How many men use a given restroom at a particular location at a given time?” Test (Experimental and Quasi-experimental Research and Modeling) Often, the intent of the research is not simply to describe something, but to test the impact of some intervention. In an airport environment, such research might be initiated to evaluate the relative effectiveness of a security screening technology in accurately detecting contraband. It is similar in approach to research conducted to assess the relative effectiveness of an experimental drug in comparison to a control (placebo) or another drug. Variables are often manipulated and controlled. This research lies largely outside the scope of this guidebook and, as such, will not receive much attention. Examples of questions that might be asked in this type of research include the following: • “What is the impact of posting airline personnel near check-in waiting lines on the average passenger waiting time?” In addition to the classic “experiment,” simulation modeling might be used, employing rep- resentative data to help answer questions such as the following: • “What would be the impact on processing time of a new security measure being considered?” • “How many agents are needed to keep passenger waiting time below an average of 10 min?” Evaluate (Evaluative Research) Sometimes, the intent of the research is to assess performance against some standard or stated requirement. Basically, evaluation research is concerned with seeing how well something is work- ing, with an eye toward improving performance, as illustrated by the following two questions: • “Is the performance of a given piece of equipment in the field consistent with manufacturer’s specifications?” • “On average, what proportion of passengers waits in a security checkpoint line longer than the 10-minute maximum threshold specified by an airline?” Defining the Research: Purpose, Focus, and Potential Uses 21

Predict Finally, research might be initiated to attempt to predict or anticipate potential emerging pat- terns before they occur. This is related to environmental scanning, insofar as it represents a delib- erate attempt to monitor potential trends and their impact. For example, in the early 1970s, one might have posed the following question: • “What would be the impact of an increase in the number of women in the workforce on air- port design?” There are numerous documented approaches to answering questions such as these. While well beyond the scope of this guidebook, here is one as illustrative: scenario planning. This method involves convening persons with relevant expertise to identify those areas that might most impact the industry (e.g., regulation, fuel costs, demographic changes), and then to systemati- cally consider what the best, worst, and might likely scenarios might be. The principal value of such an approach is that it facilitates deliberate consideration of future trends, and in so doing, presumably leaves people better prepared. When the goal of the research is to predict, data from multiple sources might be sought. The scenario planning example relies, to an extent, on the judgments of experts. Probabilities can also be drawn from historical data to help identify patterns and trends. Exhibit 3-7 is a summary of the key characteristics of each research type. 3.4 Developing the Research Plan Large research studies, particularly when funding is being requested, often require the researchers to adhere to a specific set of technical requirements. The Research Team is aware that the ad hoc and short timeline of many airport-planning research efforts makes developing a “for- mal” research plan impracticable. Nonetheless, even though you might not have the “luxury” of 22 Airport Passenger-Related Processing Rates Guidebook Research Purpose Characteristics Explore Primary purpose: to better define or understand a situation. Data will help answer the research question. The benefit of conducting the research justifies the cost. Qualitative data are recorded, using observation. Describe Primary purpose: to provide descriptive information about something. Test Primary purpose: to assess the impact of a proposed change in procedure or policy. Evaluate Primary purpose: to assess performance against requirements. Predict Primary purpose: to consider possible future circumstances with the purpose of being better prepared for emerging trends. Exhibit 3-7. Summary of research types.

developing such a plan, there are benefits to considering the issues described in this section, as well as documenting basic information. The following are the three major elements the Research Team believes worth documenting, regardless of the size of the research endeavor.6 1. Goals or aims. 2. Background and significance. 3. Research design and methods. Each is described in the sections that follow. 3.4.1 Goals or Aims Specify the question the research is intended to help answer or the specific purpose of the research. The experience of having to translate an intended purpose into words can help clarify your intent. In addition, a written statement can serve as a way of ensuring that your understand- ing of the purpose of the research is consistent with that of the sponsor and other stakeholders. Two examples follow: Statement of Purpose—Example 1 The purpose of this study is to aid decision makers in determining if extending the dwell time of the airport’s automated guideway transit system (AGTS) vehicles from 30 sec to 35 sec at the Concourse C station might improve overall system capacity by providing more boarding time for passengers. Statement of Purpose—Example 2 The goal of this study is to provide airport management with recent data showing the percent- age of arriving flights whose first checked bag reaches the claim device within the airport’s goal of 15 min. 3.4.2 Background and Significance Document what is already known, and specify how the proposed research initiative will add to this knowledge. Consider a “devil’s advocate” perspective by asking what the consequences of not doing the research might be. 3.4.3 Research Design and Methods In this section, describe how you will go about collecting and analyzing data. Additional infor- mation about these issues, including sampling strategies and sample size, is presented in Chapter 5 and in Appendix C. The research plan does not need be lengthy. It should, however, capture key information that, were it not documented and those familiar with the research were not available, would be diffi- cult to ascertain. Defining the Research: Purpose, Focus, and Potential Uses 23 6 This section is partly based on guidelines published by the Agency for Healthcare Research and Quality, Department of Health and Human Services. http://www.ahrq.gov/fund/esstplan.htm.

TRB’s Airport Cooperative Research Program (ACRP) Report 23: Airport Passenger-Related Processing Rates Guidebook provides guidance on how to collect accurate passenger-related processing data for evaluating facility requirements to promote efficient and cost-effective airport terminal design.

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Definitions

New protocol submissions to COUHES after January 21, 2019 are subject to the Revised Common Rule, also known as the New Rule, and must fulfill the requirements outlined under the New Rule.

Term Definitions

• Authorization for Release of Protected Health Information
• De-identified Data

Engaged in Research

Exempt review, expedited review, financial interest, full committee review, human subject, irb review types, key personnel.

• Limited Data Set

Minimal Risk

Principal investigator.

• Protected Health Information
• Waiver of Authorization

Research is defined as a

“…systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”   [45 CFR 46.102(l)]

Research includes, but is not limited to, observations, formal interviews, responses to questionnaires, and related activities that may be quantified as part of study data. Research does not include interviews used to provide quotes or illustrative statements — as in journalism or related activities.

COUHES does not consider surveys, questionnaires or interviews to be research if (1) they are carried out as part of an administrative responsibility of the investigator AND 2) the use is limited to MIT purposes only.

The following activities do not meet the definition for research and do not require a COUHES submission:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected;
• Public health surveillance activities, including the collection & testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority [with limitations];
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes;
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 

Human subject is defined as

" … a living individual about whom an investigator (whether professional or student) conducting research obtains (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or  (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. ” [45 CFR §46.102(e)(1)]

" Intervention" includes “both physical procedures by which information or biospecimens” (e.g., drawing blood) and “manipulations of the subject or the subject's environment that are performed for research purposes. ” (45 CFR § 46.102(2))

"Interaction" includes communication or interpersonal contact between investigator and subject.

COUHES does not consider research to involve "human subjects" where the research uses only coded private data, specimens or cells: provided that (1) the data, specimens or cells were not collected specifically for the proposed research by an intervention with a living individual, AND (2) the researcher cannot identify the individual(s) from whom the data, specimens or cells were obtained (for example, because the key to decipher the code has been destroyed or an agreement exists prohibiting the release of the key to the investigators).

COUHES also takes jurisdiction over research involving blood, tissue or other specimens derived from human subjects.

In general, an institution is considered engaged in a particular human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. awardee institutions) are considered to be engaged in human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution.

Please see OHRP guidance on Engagement of Institutions in Human Subjects Research

See sample scenarios: Engaged in Research: Scenarios

COUHES reviews all protocols that fall within the definition of human subjects research in the Federal Regualtions that govern the conduct of human subjects research ( 45 CFR 46.102) .

Investigators are required to obtain approval from COUHES prior to the start of any research activites. There are three types of review: Exempt, Expedited, and Full Committee.

Exempt status research is excluded from the requirements of the Regulations and from policies dictacted by the Common Rule. Exempt status research must however, comply with COUHES Policy, as outlined in the   Investigator Responsibilities for Exempt Research .

To qualify for Exempt status, research activities must be:

• Minimal risk
• The only involvement of human subjects will be in one or more of the exempt categories detailed below
• Not involve use of drugs or devices

To qualify for Exempt status, investigators must submit an Exempt Evaluation using  COUHES Connect , and must be granted Exempt status before  initiating their research activities. Research conducted prior to receiving an exempt determination is a violation of MIT policy. Investigators approved for the conduct of Exempt status research are required to comply with the policies as outlined in the  Investigator responsibilities for Exempt Research .

If the Exempt Evaluation process determines that the research activities do not meet the exempt criteria then investigatiors are required to submit a  Comprehensive Review  application.

Categories of Exempt

Note: Research that qualifies for Limited IRB Review (see Category 2.3, Category 3.i.C, Category 7 and 8) as well as Category 4.ii and 4.iv must submit a comprehensive application for full review by COUHES.

Some of the exempt categories do NOT apply to research involving children. All of the exempt categories do NOT apply to research involving prisoners. For more information, see Exemptions (2018 Requirements.

Category 1: Education Research

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.  [§__.104(d)(1)]

Category 2: Surveys, Interviews, Educational Tests, and Public Observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation;
•  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7).  [§__.104(d)(2)]  

Category 3: Benign Behavioral Intervention

• Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
• The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
• For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
• If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.  [§__.104(d)(3)(i)]

Category 4: Analysis of Existing Data or Biospecimen

Secondary research, for which consent is not required, uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

• The identifiable private information or identifiable biospecimens are publicly available;
• Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
• The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.  [§__.104(d)(4)]   

Category 5: Public Benefit or Service Program

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

• Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.  [§__.104(d)(5)]

Category 6: Taste & Food Quality Studies

• If wholesome foods without additives are consumed, or
• If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.  [§__.104(d)(6)]

Category 7: Storage or Maintenance of Identifiable Data\Biospecimens

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).   [§__.104(d)(7)]

Category 8: Use of Identifiable Data\Biospecimens

Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

• Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
• Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
• An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
• The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results. [§__.104(d)(8)]

Studies that involve no more than minimal risk, AND fall under one of the expedited review categories may be eligible for Expedited Review. Researchers are required to submit a Comprehensive Review application to start the review process. For a full list of categories that may be reviewed through Expedited Review, see " Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998) "

By submitting a Comprehensive Review application, your research will be evauated by the COUHES staff to determine if the research is eligible for Expedited Reivew. At the time of submission, researchers are encouraged to include a statement justifying consideration for Expedited Review.

If COUHES determines that the research does NOT qualify for Expedited Review, the application will be considered for full committee review.

Research that qualifies for Expedited Review is reviewed and approved on a rolling basis and is not subject to monthly Full Board meeting dates and deadlines.

If a proposed research study does not qualify for Exempt Status or Expedited Review, as defined above, it will be subject to a Full Committee Review. Researchers are required to submit a Comprehensive Review application to start the review process.  “Full Committee Review” is a review of an application for research involving human subjects that is carried out by COUHES Committee at one of its regular monthly meetings. See this schedule of Deadline dates

“Key personnel” includes co-investigators, associate investigators, student investigators, study coordinators, visiting scientists, consultants, and other individuals involved in the design, conduct or reporting of the research. All personnel are required to complete the human subjects training .

“Minimal risk” (45 CFR § 46.102(i)) means that “ the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater . . . than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations and tests. ”

At MIT three categories of researchers have automatic Principal Investigator (“PI”) status: Faculty, Senior Research Scientists (“SRS”), and Principal Research Scientist (“PRS”). An individual who does not hold any of these three appointments may nonetheless obtain PI status on a specific project, if the individual's Department Head requests and receives permission from the applicable Dean. MIT requires that anyone beyond faculty, SRS, or PRS must provide confirmation of approval from their Dean for PI status with each protocol application to COUHES (i.e., there is no “blanket PI status”).

See  Section 5  of MIT Policies and Procedures.

A financial interest is defined as a monetary conflict of interest that may have the appearance of compromising an individuals’ judgement or integrity in reporting, conducting, supervising or proposing research. Research personnel with financial interests must submit a Disclosure of Financial Interest Supplement for each individual with a financial interest.

A researcher may have a “financial interest” in an:

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Research: Meaning and Purpose

• First Online: 27 October 2022

Cite this chapter

• Kazi Abusaleh 4 &
• Akib Bin Anwar 5  

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The objective of the chapter is to provide the conceptual framework of the research and research process and draw the importance of research in social sciences. Various books and research papers were reviewed to write the chapter. The chapter defines ‘research’ as a deliberate and systematic scientific investigation into a phenomenon to explore, analyse, and predict about the issues or circumstances, and characterizes ‘research’ as a systematic and scientific mode of inquiry, a way to testify the existing knowledge and theories, and a well-designed process to answer questions in a reliable and unbiased way. This chapter, however, categorizes research into eight types under four headings, explains six steps to carry out a research work scientifically, and finally sketches the importance of research in social sciences.

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Abusaleh, K., Anwar, A.B. (2022). Research: Meaning and Purpose. In: Islam, M.R., Khan, N.A., Baikady, R. (eds) Principles of Social Research Methodology. Springer, Singapore. https://doi.org/10.1007/978-981-19-5441-2_2

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Research Writing

Research purpose.

Many of us have experienced research writing projects as a way to “prove” what we already believe.  An essay assignment may ask us to take a position on a matter, and then support that position with evidence found in research.  You will likely encounter projects like this in several classes in college. 

If you enter a research project with a thesis in hand (you already know what you believe!), it’s very tempting to look for and use only those sources that agree with you and to discard or overlook the others. If you’re lucky, you’ll find enough such sources to construct an essay. Ask yourself the following question, though: what have you found out or investigated during your research? Have you discovered new theories, opinions, or aspects of your subject? Did anything surprise you, intrigue you, or make you look further? If you answered “no” to these questions, you did not fulfill the purpose of true research, which is to explore, discover, and investigate.

The purpose of research is not to look for proofs that fit your pre-existing theories, but to learn about the subject of the investigation as much as possible and then form or add to those theories, opinions, and arguments on the basis of this newly found knowledge and understanding.

So, should you begin every research project as a disinterested individual without opinions, ideas, and beliefs? Of course not! There is nothing wrong about having opinions, ideas, and beliefs about your subject before beginning the research process. Good researchers and writers are passionate about their work and want to share their passion with the world. Moreover, pre-existing knowledge can be a powerful research-starter. But what separates a true researcher from someone who simply looks for “proofs” for a pre-fabricated thesis is that a true researcher is willing to question those pre-existing beliefs and to take his or her understanding of the research topic well beyond what was known at the outset. Speaking in terms of the writing process, a good researcher and writer is willing to create new meaning, a new understanding of the subject through research and writing, based on the ideas and beliefs that he or she had entering the research project.

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Purpose of Research – Objectives and Applications

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Purpose of Research

Definition:

The purpose of research is to systematically investigate and gather information on a particular topic or issue, with the aim of answering questions, solving problems, or advancing knowledge.

The purpose of research can vary depending on the field of study, the research question, and the intended audience. In general, research can be used to:

• Generate new knowledge and theories
• Test existing theories or hypotheses
• Identify trends or patterns
• Gather information for decision-making
• Evaluate the effectiveness of programs, policies, or interventions
• Develop new technologies or products
• Identify new opportunities or areas for further study.

Objectives of Research

The objectives of research may vary depending on the field of study and the specific research question being investigated. However, some common objectives of research include:

• To explore and describe a phenomenon: Research can be conducted to describe and understand a phenomenon or situation in greater detail.
• To test a hypothesis or theory : Research can be used to test a specific hypothesis or theory by collecting and analyzing data.
• To identify patterns or trends: Research can be conducted to identify patterns or trends in data, which can provide insights into the behavior of a system or population.
• To evaluate a program or intervention: Research can be used to evaluate the effectiveness of a program or intervention, such as a new drug or educational intervention.
• To develop new knowledge or technology : Research can be conducted to develop new knowledge or technologies that can be applied to solve practical problems.
• To inform policy decisions: Research can provide evidence to inform policy decisions and improve public policy.
• To improve existing knowledge: Research can be conducted to improve existing knowledge and fill gaps in the current understanding of a topic.

Applications of Research

Research has a wide range of applications across various fields and industries. Here are some examples:

• Medicine : Research is critical in developing new treatments and drugs for diseases. Researchers conduct clinical trials to test the safety and efficacy of new medications and therapies. They also study the underlying causes of diseases to find new ways to prevent or treat them.
• Technology : Research is crucial in developing new technologies and improving existing ones. Researchers work to develop new software, hardware, and other technological innovations that can be used in various industries such as healthcare, manufacturing, and telecommunications.
• Education : Research is essential in the field of education to develop new teaching methods and strategies. Researchers conduct studies to determine the effectiveness of various educational approaches and to identify factors that influence student learning.
• Business : Research is critical in helping businesses make informed decisions. Market research can help businesses understand their target audience and identify trends in the market. Research can also help businesses improve their products and services.
• Environmental Science : Research is crucial in the field of environmental science to understand the impact of human activities on the environment. Researchers conduct studies to identify ways to reduce pollution, protect natural resources, and mitigate the effects of climate change.

Goal of Research

The ultimate goal of research is to advance our understanding of the world and to contribute to the development of new theories, ideas, and technologies that can be used to improve our lives. Some more common Goals are follows:

• Explore and discover new knowledge : Research can help uncover new information and insights that were previously unknown.
• Test hypotheses and theories : Research can be used to test and validate theories and hypotheses, allowing researchers to refine and develop their ideas.
• Solve practical problems: Research can be used to identify solutions to real-world problems and to inform policy and decision-making.
• Improve understanding : Research can help improve our understanding of complex phenomena and systems, such as the human body, the natural world, and social systems.
• Develop new technologies and innovations : Research can lead to the development of new technologies, products, and innovations that can improve our lives and society.
• Contribute to the development of academic fields : Research can help advance academic fields by expanding our knowledge and understanding of important topics and areas of inquiry.

Importance of Research

The importance of research lies in its ability to generate new knowledge and insights, to test existing theories and ideas, and to solve practical problems.

Some of the key reasons why research is important are:

• Advancing knowledge: Research is essential for advancing knowledge and understanding in various fields. It enables us to explore and discover new concepts, ideas, and phenomena that can contribute to scientific and technological progress.
• Solving problems : Research can help identify and solve practical problems and challenges in various domains, such as health care, agriculture, engineering, and social policy.
• Innovation : Research is a critical driver of innovation, as it enables the development of new products, services, and technologies that can improve people’s lives and contribute to economic growth.
• Evidence-based decision-making : Research provides evidence and data that can inform decision-making in various fields, such as policy-making, business strategy, and healthcare.
• Personal and professional development : Engaging in research can also contribute to personal and professional development, as it requires critical thinking, problem-solving, and communication skills.

When to use Research

Research should be used in situations where there is a need to gather new information, test existing theories, or solve problems. Some common scenarios where research is often used include:

• Scientific inquiry : Research is essential for advancing scientific knowledge and understanding, and for exploring new concepts, theories, and phenomena.
• Business and market analysis: Research is critical for businesses to gather data and insights about the market, customer preferences, and competition, to inform decision-making and strategy development.
• Social policy and public administration: Research is often used in social policy and public administration to evaluate the effectiveness of programs and policies, and to identify areas where improvements are needed.
• Healthcare: Research is essential in healthcare to develop new treatments, improve existing ones, and to understand the causes and mechanisms of diseases.
• Education : Research is critical in education to evaluate the effectiveness of teaching methods and programs, and to develop new approaches to learning.

About the author

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Your Career Doesn’t Need to Have a Purpose

• Stephen Friedman

Focus on making your work meaningful instead.

Outside of popular anecdotes and social media stories, there is little evidence that a single, defined “purpose” is necessary for a rewarding career. In fact, it can be quite the opposite. It’s surprisingly common to go after what we think is our purpose only to discover that we hate it. Instead, shift your focus from “purpose” to “meaning.” Ask yourself:

• What do I like, prefer, or enjoy doing? Let go of yearning for a career purpose. Dial it back and consider what you liked about any of your previous jobs, school projects or other ways you spend your time. Perhaps you liked helping your peers organize their work or enjoyed researching sources for group projects. Or maybe you liked working on a team than alone. Use that as a starting point. 
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• Would this role provide growth and learning that I can use later? Research shows that what scholars call “ability development” (i.e. getting better at what you do) brings with it greater happiness, satisfaction, and meaning.

As an organizational studies professor at the Schulich School of Business in Toronto, Canada, I get the opportunity to help my students with various aspects of their career development. In the process, I’ve noticed two common threads. First, most of my students are not only eager to enter the world of work, but also to be excellent at what they do. Second, they want their post-graduation job to be loaded with purpose .

• Stephen Friedman is an Adjunct Professor of Organizational Studies and a Senior Faculty of Executive Education, at The Schulich School of Business, York University in Toronto. He teaches and writes about leadership development, organizational behavior, complexity science, career development, human resource management, workplace inclusion, and mental health.

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Cannabis in Tennessee: What push to reclassify marijuana to Schedule III may mean

The Drug Enforcement Agency could move to reclassify marijuana to a lesser severity in what's being reported as the " biggest change in marijuana policy" since the drug was first outlawed.

The proposal, first reported by The Associated Press , would follow a Department of Justice recommendation and lead the DEA to take public comments on a plan to recategorize marijuana, USA TODAY reports .

In this reclassification, marijuana would move from a Schedule I drug which is believed to be highly dangerous, addictive and not for medical use to a Schedule III drug that can be lawfully prescribed as medication. Marijuana has been a Schedule I drug since the Controlled Substances Act was signed in 1970 by President Richard Nixon.

Here is what we know about the reclassification.

What does rescheduling cannabis mean for Tennessee?

While this would be a landmark change, it would not change the state's current cannabis regulations. It would still be a controlled substance even with the new classification. That said, 24 states have legalized marijuana for recreational use and 14 have legalized it for medical use.

In 2022, President Joe Biden directed the Department of Health and Human Services, or the HHS, to conduct a review of how marijuana is scheduled. In the review, the HHS recommended that the drug be rescheduled to a Schedule III .

What to know: Marijuana could soon be reclassified. So just what is a Schedule 3 drug?

Marijuana being classified as a Schedule III drug means it would be classified alongside drugs including ketamine, testosterone, anabolic steroids and Tylenol with codeine, USA TODAY reports . These drugs have "moderate to low potential for physical and psychological dependence," according to the DEA.

The laws regarding Schedule III drugs in Tennessee vary as some drugs are legal with limitations and others are not. Therefore, it is hard to tell if the reclassification of marijuana to a lower schedule would sway Tennessee lawmakers to legalize the drug in any way.

Is marijuana legal in Tennessee?

There is no short answer to the question of whether marijuana is legal in Tennessee for a couple of reasons. Part of the confusion can stem from the various terms − cannabis, marijuana and weed − that might seem interchangeable but are not, at least not as Tennessee defines them.  Hemp  just adds to the confusion.

The defining difference between hemp and marijuana is their psychoactive component: tetrahydrocannabinol, or THC. Hemp has 0.3% or less THC, meaning hemp-derived products don’t contain enough THC to create the “high” traditionally associated with marijuana.

Tennessee has legalized the cultivation of hemp  and defined hemp as cannabis sativa containing less than 0.3% THC. Cannabis sativa containing greater than 0.3% THC, which is defined by Tennessee as marijuana, is still illegal.

While marijuana is not legal, in Tennessee you can buy products containing CBD, or cannabidiol, an active ingredient in cannabis that is derived from the hemp plant but does not cause a high and is not addictive.

Is marijuana a dangerous drug?

Marijuana has been hard to study because of its classification. However, the move to reschedule the drug is largely due to the lower public health risks, federal scientists have said. The rescheduling of marijuana to a Schedule III drug would allow for further studies to be done.

In a leaked HHS document , officials wrote to the DEA in support of rescheduling the drug. Marijuana's risk for addiction is similar to that of tobacco and has relatively mild withdrawal symptoms compared to alcohol. According to the National Institute on Drug Abuse , or NIDA, there are no known deaths from a marijuana overdose.

Despite the less intense symptoms, the drug does affect physical and mental health. According to NIDA, it can cause permanent IQ loss for people who begin using it at a young age. Long-term use has been associated with temporary paranoia and hallucinations. Marijuana can exacerbate symptoms with disorders like schizophrenia.

NIDA found that marijuana smoke has a similar health impacts to tobacco smoke. People who smoke marijuana frequently develop issues with breathing similar to those of tobacco smokers.

Respiratory issues include daily cough, phlegm and a higher risk of lung infections, however, the American Heart Association said it’s unclear if marijuana causes a greater risk of lung cancer. 

Health benefits of marijuana

The cannabis plant has been used for medicinal purposes for centuries, if not millennia. It appears to help with  treating pain , insomnia, anxiety, and glaucoma, among other health conditions. Still, evidence is mixed and more research into its health benefits is needed, researchers at  Johns Hopkins Bloomberg School of Public Health  said in August.

While cannabis is not approved for any medical use by the FDA, several drugs containing cannabinoids, or substances such as THC or CBD, have been approved according to the National Institutes of Health .

USA TODAY and Tennessee Connect reporter Liz Kellar contributed to this report

Money latest: Aldi's market share falls as people head back to traditional supermarkets (except one)

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Aldi's market share has fallen - as people seemingly head back to traditional supermarkets for their shopping.

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"However, this won't entitle the capacitous person to deal with any of the income which comes into that account for the non- capacitous person, such as pensions, or to manage any outgoings in that person's name. 

"If both parties lost capacity, then there would be no access to funds at all."

This feature is not intended as financial advice - the aim is to give an overview of the things you should think about. Submit your dilemma or consumer dispute, leaving your name and where in the country you are, by emailing [email protected] with the subject line "Money blog". Alternatively, WhatsApp us  here .

By James Sillars , business reporter

Another cent has come off oil costs over the past 24 hours - hopefully signalling better news for drivers ahead.

A barrel of Brent crude is currently costing just over $84 and had been trading at $83 in Asian trading.

It had stood above $90 a month ago as the crisis in the Middle East played out.

Evidence of a cooling in tensions between Israel and Iran have assisted the downwards trend.

The FTSE 100 began the day by erasing the losses seen on Wednesday.

A solid set of results for Shell helped the index climb by 0.3% in early deals...

Shell shares were more than 1% higher on the back of better than expected profits.

It revealed further shareholder awards in the form of a dividend and share buyback.

Online gamblers who lose £500 a month or more will face financial vulnerability checks.

Checks will come into force from 30 August.

The figure will reduce to £150 a month from 28 February next year.

The Gambling Commission said this would help identify acutely financially vulnerable online customers, such as those subject to bankruptcy orders or with a history of unpaid debts.

The checks will only use publicly available data and will not  require gambling operators to consider an individual's personal details such as postcode or job title.

As well as light touch checks, the commission said a pilot of enhanced assessments would go ahead, aimed at preventing cases where customers are able to spend large amounts in a short time without any checks, resulting in significant gambling harm.

It's not uncommon to feel uncomfortable with flying - but we'd probably all feel a bit better if we were sitting in first class, wouldn't we? 

The lucky few might be able to pay for themselves, but for the rest of us, frequent flyer experts Flight Hacks have shared their top tips to get a free upgrade (and you can let us know your tips for getting upgrades in the comments box above)...

Stay loyal to one airline

Many airlines have a rewards scheme that offers free upgrades, early check-in and even free flights to loyal customers. 

One research survey found 80% of staff said a customer in the airline's frequent flier scheme would be more likely to receive a free upgrade.

Plus, getting early check-in could place you first in line to secure a seat in the plane's front section.

Travel alone or during quieter times

Let's face it, a single person on an empty flight is much more likely to get an upgrade than a family of six on a booked-out plane. 

Try flying in the middle of the week or at off-peak times to get a quieter plane. 

Dress to impress 

If you're dressed smartly and look like a frequent flier, this can boost your chances of getting an upgrade. 

Business travellers are an airline's favourite type of passenger as they fly regularly and are more likely to spend freely on their company cards - so it could be worth dressing in business attire. 

Don't be afraid to ask

It doesn't hurt just to enquire, as long as you're polite. 

Be flexible

Airlines will frequently overbook flights to compensate for no-shows and ensure the planes are full. 

If there aren't enough seats after everyone checks in, they will often offer incentives to passengers willing to switch to a later flight.

This can mean seat upgrades or cash incentives. 

Take advantage of special occasions

If it's your birthday, honeymoon or a special anniversary, it could be worth casually dropping this into conversation with the check-in staff. 

Be polite when checking in

Perhaps all of these tips should be caveated with the need to remain polite. 

As there is often no strict criteria on how airline staff may choose to give out free upgrades, the number one tip is to be nice. 

Travel expert Immanuel Debeer, from Flight Hacks, says "being respectful and friendly is by far the best way to increase your chances of an upgrade". 

"There are plenty of simple tricks to increase your chances of getting an upgrade, but the most important thing to remember is that airline staff are human."

Every Thursday Savings Champion founder Anna Bowes  gives us an insight into the savings market and how to make the most of your money. Today she's focusing on  ISAs after new rules came in last month. ...

New ISA rules were introduced from 6 April that should make opening and funding ISAs simpler. But what many people may not realise is that ISA providers do not need to implement most of the new rules – and many haven't yet, or may have no intention of doing so.

As a result, savers have been left scratching their heads, unsure if their ISA provider will allow them to make use of the rules or not.

What are the key new rules?

Harmonise ISAs to those over 18:  This is not an optional change. The minimum opening age for adult cash ISAs is now 18, so not good news for those aged 16 and 17 who previously could have funded a junior ISA and an adult cash ISA.

Allowing multiple ISA subscriptions:  People should now be allowed to open and pay into multiple ISAs of the same type in a single tax year. Previously people could only pay into one of each type of ISA every tax year, unless their ISA provider offered what we called "portfolio ISAs". 

A portfolio ISA (other names for this have been used such as "ISA wallet" with Paragon Bank) allows savers to open more than one cash ISA with the same provider in the same tax year - but only a small number of providers offer it, such as Paragon, Aldermore and Charter Savings Bank, Nationwide and Ford Money.

With the new rules, savers assume they can open more than one ISA with either more than one provider or with the same provider. However, our research has shown that while many providers will allow you to open another cash ISA with them if you have already opened and funded an ISA with someone else in the current tax year, this doesn't mean they have adopted the portfolio ISA rule – so you may not be able to open two ISAs with them.

Partial transfers allowed:  Partial transfers of ISA funds for the current tax year should be allowed, rather than being forced to transfer the whole amount of your current tax year ISA. Previously you could only make a partial transfer of old ISAs; you'd have to transfer the current tax year's ISA entirely. 

Once again not many have adopted this rule yet.

The bottom line

So, while in theory these new changes should have made ISAs more flexible, in reality they have added an extra complication for savers and the bottom line is that you need to ask your existing and potential ISA providers about which of the rules they have adopted or are looking to adopt.

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