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This lesson will explain the purpose and membership requirements of Institutional Review Boards, or IRBs. This lesson focuses on the Revised Common Rule (or 2018 Requirements) that became effective in 2018.
This lesson contains three parts:
You will answer quiz questions throughout each part to test your knowledge. A correct response is required to advance in the lesson.
After completing this lesson, you will be able to:
Institutional Review Boards, or IRBs, review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants.
Some people may also call IRBs Independent Review Boards or refer to them as Ethics Review Committees.
IRB reviews help to ensure that research participants are protected from research-related risks and treated ethically, a necessary prerequisite for maintaining the public’s trust in the research enterprise and allowing science to advance for the common good.
What are some important reasons for having IRBs?
a) The law requires it for all researchb) They provide independent review of research to help ensure that research is ethical and research participants are protected
c) They monitor research data collection d) All of the above Click to Answer!What are some reasonable objectives for IRB review? (Select all that apply)
a) Minimizing risks to human subjects b) Ensures financial benefits to participants c) Ensures public trust in research is upheld d) Ensures improvements to the Common Rule Click to Answer! 
The Common Rule requires at least five members with varying backgrounds on the IRB, so that research is reviewed from a collection of different perspectives.
At a minimum, members must include someone who provides the perspective of a scientist, someone who provides the perspective of a nonscientist, and someone who is not affiliated with the research institution.
The IRB, as a group, must be sufficiently qualified through the experience, expertise, and diversity of its members to be able to review the research activities commonly conducted by the institution. Relevant considerations may include training and education, race, gender, cultural background, and sensitivity to community attitudes. Institutions may wish to put effort into having a roster of IRB members that is diverse, inclusive, and representative of the communities with whom they conduct research.
Watch this video to learn about the specific membership requirements for IRBs.
Under the Common Rule, what is the minimum number of members required for an IRB?
e) It depends Click to Answer!The Common Rule requires that an IRB must have which of the following types of members? (Select all that apply)
a) IRB administrator b) Scientist c) Institutional official d) Nonscientist e) Representative of a minority group Click to Answer!Only people with a graduate degree can serve as an IRB member. True or false?
Click to Answer!
Research institutions with sizeable human research portfolios often have a human research protection program (HRPP) office, part of whose job is to coordinate the administrative work needed to support their research studies, including IRB review.
IRB administrators working in HRPPs support the work of the IRBs. They may also serve as IRB members if they meet the requirements for membership. In addition, administrators provide a valuable resource for researchers involved in human subjects research because of their familiarity with relevant regulations and knowledge of institutional policies. Experienced IRB administrators often provide researchers with meaningful advice on how to better protect research participants in their studies.
Many institutions conducting human subjects research adopt the Common Rule’s provisions to protect research participants regardless of whether the research comes under the jurisdiction of the Common Rule. Institutions may do this by developing policies that are consistent with the Common Rule provisions. Some institutions may even choose to go beyond the Common Rule requirements by including institutional policies that provide more protections for research participants.
It is important that researchers familiarize themselves with the Common Rule and their institution’s policies and seek assistance from their institutions’ HRPP or IRB office.
Effective HRPPs or IRB offices establish efficient communication mechanisms with their investigators to promote a strong sense of collaboration toward the common goals of promoting ethical research and protecting research participants.
For additional information, please review the following resources:
What are some of the characteristics of an effective HRPP or IRB office?
a) Has experienced IRB administrative staff b) Has written institutional policies for research oversight c) Provides relevant education and advice on human research protections to investigators d) Communicates effectively with investigators e) All of the above Click to Answer!When would an investigator want to reach out to their institution’s HRPP office?
a) When they have questions about applicable regulations, laws, and institutional policies b) When preparing a protocol for submission to the IRB for review c) When determining whether a research project is non-exempt human subjects research d) All of the above e) None of the above Click to Answer!
In order to further facilitate nonexempt research and increase the efficiency of IRB review of cooperative research, or research involving more than one institution, there has been a move toward relying on single IRBs to review and approve research. Since January 20, 2020, certain cooperative research that comes under the Common Rule must rely on a single IRB for approval of the portion of the research conducted in the U.S.
U.S. researchers collaborating on a non-exempt human subjects research project should understand how the Common Rule single IRB requirement works. They should know which collaborating institutions need to rely on the single IRB, which IRB will be the single IRB of record, and how to ensure seamless communications amongst all the parties involved.
You can review the following resources to learn more:
Single IRBs are becoming less common in the field of research. True or false?
