What are the requirements for Institutional Review Board (IRB) or Independent Ethics Committee (IEC) membership?
The requirements for Institutional Review Board (IRB) or Independent Ethics Committee (IEC) membership are addressed in the Department of Health and Human Services (HHS) regulations at 45 CFR 46.107 [Note: 45 CFR 46.304 requires a specialized IRB composition when research involving prisoners is being reviewed, including the presence of a prisoner representative]. An IRB/IEC must: i) have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution; ii) make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women; iii) include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas; iv) include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution;
Related Questions
- How will I know when my Institutional Review Board (IRB) or Independent Ethics Committee (IEC) registration has been processed?
- What if my institution does not have an internal Institutional Review Board (IRB) or Independent Ethics Committee (IEC)?
- What are the requirements for Institutional Review Board (IRB) or Independent Ethics Committee (IEC) membership?
