IRB 101: What are they? Why do they exist?

Green Kermit the Frog against dark background. Kermit looks nervous and bites his nails, reflecting how the author feels about IRB.

Last week, I led an IRB 101 workshop for the Visitor Studies Association.  IRB is the acronym for Institutional Review Board.  That short three-letter acronym, IRB, can instill a lot of fear and anxiety in researchers and evaluators for multiple reasons.  For one, IRBs are an oversight organization, so non-compliance can have repercussions.  Additionally, the language used by IRBs is technical and governmental (e.g., non-compliance, human subjects research). Plus, there are so many acronyms (e.g., IRB, HHS, OHRP)!!

I have 15 years of experience using multiple IRBs with many methodologies and audiences.  Yet, I still had a lot of anxiety in leading an IRB 101 workshop. I felt like nervous, nail-biting Kermit the Frog.  I don’t feel like an IRB expert.  My hope in leading the IRB 101 workshop and writing these posts is to help others overcome their nervousness about IRBs.  Let’s start with a shared, foundational understanding of IRB.

What is an IRB?

An Institutional Review Board (IRB) is a formally designated administrative body established to protect the rights and welfare of human research subjects (research participants, in simpler terms).  IRBs do three main things:

  1. Review research and evaluation protocols involving human subjects prior to starting research and evaluation. Prior is a key word.  The review needs to take place before researchers start recruiting any research participants.
  2. Approve, disapprove, or request modifications to research and evaluation protocols. Researchers submit their protocols (and instruments, consent and assent forms, etc.) to an IRB.  The IRB reviews these materials, weighing the risks to research participants against the benefits of doing research and evaluation.  They have the authority to reject or request modifications if they decide the risks to research participants outweigh the benefits.
  3. Monitor research and evaluation activities. Once research begins, IRBs can request to review research activities. This may happen if the IRB has received complaints from research participants. They may also request to review activities if there is potential non-compliance with the approved research protocols (i.e., not following the rules).

Note that IRBs are specifically US entities.  The Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) oversees all IRBs.  This short video from OHRP provides a good overview about IRBs.

Why do IRBs exist?

Historically, researchers have too often mistreated research participants.  An egregious example is the Tuskegee Study of Untreated Syphilis in the Negro Male (1932-1972).  For 40 years, medical researchers studied black men in Alabama. Some had syphilis, and some did not.  The men thought researchers were providing medical treatment. However, researchers were only monitoring them to study untreated syphilis.  At the initiation of the study, treatment for syphilis did not exist.  When treatment became available, researchers withheld it from research participants.

When the public became aware of the study in the 1970s, the US government began to implement policies to protect research participants.  The National Research Act of 1974 established IRBs to oversee research with human subjects.  Then, in 1979, the The Belmont Report was published.  The report identifies three ethical principles for the protection of research subjects: respect for persons, beneficence, and justice.  Providing further guidance to IRBs was the 1991 establishment of the Common Rule.  The Common Rule takes the three principles of The Belmont Report and outlines practices researchers apply to protect research participants.  The Common Rule was revised in 2018, although the revision did not change practices drastically.

The need to protect research participants has not diminished over time.  As society changes, so does our understandings of potential risks to research participants.  For instance, physical effects on research participants were an initial risk concern (e.g., not treating syphilis).  But, the US government now acknowledges that risks to research participants also include psychological, social, economic, and legal risks.  The Protecting Human Research Participants Training identifies the Facebook Social Contagion Study of 2014 as a modern example of the mistreatment of research participants psychologically.  Researchers manipulated a random sample of Facebook users’ news feeds to show either more positive or negative posts.  They were studying the effects of these manipulations on Facebook users’ emotions.

More on IRBs

Hopefully, this post has established the unquestionable need to protect research participants and instills empathy for the process of applying to IRBs. Check back for more IRB 101 posts soon!

Have questions about IRBs? Let us know in the comments!

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