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Institutional Review Board (IRB) or Ethics Review Committee (ERC)


Last Updated: 3/8/2024

What Are IRB and ERC?

Institutional Review Board (IRB) is a committee that reviews, approves, and monitors clinical trials. The primary goal of the IRB is to protect the rights and safety of human subjects who participate in clinical trials.

Ethics Review Committee (ERC) is the term used for the IRB in countries outside the United States. In your clinical research career, working with the IRB and ERC will be a part of your duties when conducting clinical trials at sites.

The FDA defines an IRB as:

(g) Institutional Review Board (IRB) means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act.

FDA 21 CFR 56.102

Institution vs. Centralized IRB

An IRB can be a part of an institution or centralized. IRBs that are affiliated to an institution often serve only that institution. Centralized IRBs (also known as independent IRBs) do not have affiliation to any institution. Centralized IRBs can review, approve, and monitor any clinical trials that are within the geographical area under their regulatory allowance. One of the largest centralized IRBs is Western Institutional Review Board (WIRB) (Puyallup, WA, USA).

Composition

The FDA requires that the IRB:

  • Have 5 or more members with different
  1. Backgrounds, experience, and expertise.
  2. Diversity (race, gender, cultural backgrounds, community attitudes).
  • The members must include persons knowledgeable in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
  1. For example, if the IRB reviews clinical trial that involves a vulnerable population (e.g children, prisoners, pregnant women, etc.), the IRB should have members who have working knowledge about the subject group.
  • Efforts should be made to ensure that the members include:
  1. Both men and women (as long as selection is not based on gender alone).
  2. At least one member who has scientific expertise to evaluate the clinical trial.
  3. At least one member who is non-scientific.
  4. At least one member who is not affiliated with the institution and is not part of the immediate family of a person affiliated with the institution.
  • Member who has conflict of interest may provide information but may not make decision (member cannot vote on his/her own clinical trial).
  • Advices from expert can be used in decision making, but expert advisor may not vote with the IRB.
21 CFR 56.107

IRB Functions & Operations

The FDA requires that the IRB:

  • Follow written procedures in all review, approval, and oversight of clinical trial.
  • Review clinical trial at regular meetings with majority of the members attending, including at least one non-scientific member.
21 CFR 56.108

One exception to the above procedure is when the clinical trial under review may be qualified for expedited review procedures (21 CFR 56.110) where FDA allows each IRB to use a procedure that does not required majority review.

Ethics Review Committee (ERC)

Ethics review committee (ERC) is governed under the institutional requirement and the law of the country where the ERC is located. Despite the difference in law and practice between regions and countries, each ERC should base it’s practice following the work by the World Medical Association Declaration of Helsinki as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects.

Author

Post author

Ernie Sakchalathorn

Polachai Ernie Sakchalathorn is the founder of ClinicalResearchAssociateCRA.com and has been in clinical research since 2007. While he is no longer affiliated with the website or benefits financially from site operations, he still remains a professional in the clinical research space and currently serves as a Clinical Affairs Manager at a medical device company.

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