What Is IRB And How It Works

An Institutional Review Board or IRB is a committee that monitors and protects the rights and welfare of human subjects in research under the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) regulations. According to HHS, the definition of a Human Subject is as,

“Human subject – A living individual about whom an investigator (whether professional or student) conducting research obtains, uses, studies, analyzes or generates identifiable private information or biospecimens” (45 CFR 46.102(e)).

What Does An IRB Do?

The IRB evaluates whether the research activities meet regulatory requirements and ethical standards before and throughout the research for the protection and welfare of research participants.

Except for some research that has very low risk, an important role of the IRB is to verify that potential participants have sufficient information which they need to decide to volunteer for the study. Either they can understand the study, including information about the risk, and are free to choose whether to participate in the research. Much of this is done through the informed consent process.

What is An Informed Consent?

This is when researchers provide important and relevant information to potential volunteers so that they can decide whether to join the study. Each participant is given an information sheet that describes very clearly who is conducting the research, what are its motives, what type of questions can be asked, and if any type of adverse or unanticipated event can occur during the research. If a participant agrees to the informed consent then the research is good to go.

In the case of a very low-risk study, an IRB may not require informed consent. However in this situation, an IRB still reviews the research to make sure the participants are protected in the absence of informed consent.

Protection of Personally Identifiable Information

An IRB also makes sure that the research is not unnecessarily risky and checks that other benefits of the participants are in place i.e. whether their privacy and confidentiality are protected. This is done by keeping personally identifiable information of research participants under restricted access and storing them in a safe place.

The U.S. Office of Management and Budget (OMB) defines Personally Identifiable Information (PII) as “Any information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other information that is linked or linkable to a specific individual.”

Who Is On An IRB?

Because of the gravity of this responsibility, the selection of individuals to serve on the IRB should be done with care and special attention to their expertise and perspectives. The laws mandate that each IRB has at least five members with diverse backgrounds.

Each IRB must include at the minimum one scientist, one non-scientist, and one member who is not otherwise affiliated with the institution. An administrator who meets the membership requirements may also serve as a member.

In addition to the other categories of members, if an IRB regularly reviews research involving a population vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged people, considerations must be given to including their representatives as an IRB member.

Which Research Requires an IRB Review?

Not all studies require an IRB review. Only the research involving human subjects is constrained to get approved before conducting it. Moreover, the common rule does not require an IRB review of the study. If the samples upon which the researcher has to work are coming from anonymous sources then it also doesn’t require an IRB review. Additionally, a study that might not fall under any federal regulations is also not restricted to get an IRB review.

Where Can You Find An IRB Review?

An institution can have its own IRB for reviewing the research proposals of its scholars. Moreover, you can also use commercial IRBs or IRBs of another institution to get your research approved. If a research proposal is being reviewed by multiple IRBs then getting it approved by anyone of the IRBs permits you to conduct that research.

Termination of IRB Approval

According to the Electronic Code of Federal Regulation,

“An IRB shall have authority to suspend or terminate approval of research that is not being conducted per the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head”(§46.113).

So, be careful about all the IRB restrictions while conducting your research otherwise it can cause trouble or even suspension of your approval.

We hope that this blog has greatly helped you to understand an IRB review. Do let us know in the comment section below about your thoughts and experiences with your Ph.D. and what other topics you would like us to discuss.

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