ELEMENT II.1.B.

ELEMENT II.1.B.: The IRB or EC has qualified leadership (e.g., chair and vice chair) and qualified members and staff. Membership and composition of the IRB or EC are periodically reviewed and adjusted as appropriate.

IRB or EC chairs, members, and staff involved in review should have the knowledge, skills, and abilities necessary to carry out the function of the IRB or EC. The membership of the IRB or EC must be qualified through the experience and expertise, or the use of consultants (See Element II.1.E.) to review the research. Which individuals have this expertise is unimportant, provided the expertise is available and applied.

Policies and procedures should define the requirements to be an IRB or EC chair, member, staff, and describe the periodic evaluation of their performance. Policies and procedures should describe the periodic review and adjustment of the membership and composition of the IRB or EC.

See AAHRPP Tip Sheet 7

Regulatory and guidance references

DHHS: 445 CFR 46.107, 45 CFR 46.304, OHRP Guidance on Written Institutional Review Board (IRB) Procedures
FDA: 21 CFR 56.107, FDA Information Sheets: Non-Local IRB Review, IRB Membership
ICH-GCP: 3.2.1, 3.3.1
VA: 38 CFR 16.107, VHA Handbook 1200.05, 12
AAHRPP Tip Sheet: Evaluation of IRB Chairs, Vice-Chairs, IRB Members, and IRB Staff

Required written materials

Essential requirements:
1. Policies and procedures describe the membership and composition of the IRB or EC, including:
  1. The appointment of:
    1. IRB or EC members.
    2. IRB or EC chairs and vice-chairs when appropriate.
    3. Alternate members.
  2. The function of alternate members.
  3. The periodic assessment and feedback provided to:
    1. IRB or EC members.
    2. IRB or EC chairs, and vice-chairs when appropriate.
    3. IRB or EC staff.
When following VA requirements:
1. Policies and procedures indicate the facility director is responsible for appointing the IRB chair (or co-chairs, or chair and vice chair), and IRB voting members in writing.
2. IRB members are appointed for a period of up to three years. They may be re-appointed to a new terms of up to three years without a break in service at the end of each term. There is not a maximum number of terms for IRB members as long as the composition of the IRB meets all requirements.
3. The IRB chair (or co-chairs, or chair and vice chair) are appointed for a term of up to three years, and may be re-appointed indefinitely.
4. There may be one IRB chair, co-chairs, or a chair and a vice chair.
5. The IRB chair, co-chairs, and vice-chairs are voting members of the IRB.
6. The IRB chair at the VA facility must be a paid VA employee.

Outcomes

The IRB or EC is sufficiently qualified through the experience, expertise (professional competence), and diversity of its members to protect the rights and welfare of research participants.
IRB or EC chairs, members, and staff are knowledgeable.
The composition of the IRB or EC is periodically evaluated and, when necessary, adjusted so that the membership and composition of the IRB or EC meet legal or regulatory and organizational requirements.
IRB chairs, vice-chairs and members are periodically evaluated and provided feedback.

Proceed To: ELEMENT II.1.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.1.B.