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

What are IRB and ERC?

Institutional review board (IRB) is a committee that review, approve, and monitor clinical trial. The primary goal of IRB is to protect the right and safety of human subjects who participate in clinical trial. Ethics review committee (ERC) is the term used for IRB for countries outside the United States. In your clinical research career, working with IRB and ERC will be a part of your work to conduct clinical trial(s) at site(s).

FDA 21 CFR 56.102 defines IRB as: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.102

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.

Institution vs Centralized IRB

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

FDA requires that IRB (21 CFR 56.107): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.107

• 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.

IRB Functions and Operations

FDA requires that IRB (21 CFR 56.108): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.108

• 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.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.110

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 (1964) last updated in 2008 as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2002).

http://www.wma.net/en/20activities/10ethics/10helsinki/

http://www.cioms.ch/publications/layout_guide2002.pdf

Related pages

1. Clinical Trial Site
2. Contract Research Organization (CRO)
3. Regulatory Body
4. Site Management Organization (SMO)
5. Sponsor