ELEMENT II.1.A.

ELEMENT II.1.A.: The IRB or EC membership permits appropriate representation at the meeting for the types of research under review, and this is reflected on the IRB or EC roster. The IRB or EC has one or more unaffiliated members; one or more members who represent the general perspective of participants; one or more members who do not have scientific expertise; one or more members who have scientific or scholarly expertise; and, when the IRB or EC regularly reviews research that involves vulnerable participants, one or more members who are knowledgeable about or experienced in working with such participants.

Laws, regulations, codes, and guidance usually define the requirements of the IRB or EC membership roster. The information in this roster should be used to provide for effective review of research and management of the IRB or EC. For example, if the IRB or EC directs protocols to primary reviewers with scientific or scholarly expertise (professional competence), the information in the IRB or EC roster should be sufficient to implement this function. The IRB or EC roster should include at least one member who represents the perspective of research participants, such as a former or current research participant or a research participant advocate.

At least one individual whose primary interest is scientific, and at least one individual whose primary interest is non-scientific and at least one non-affiliated member should attend meetings. IRB or EC minutes should demonstrate that IRB or EC meetings were convened with members appropriately representing regulatory or legal requirements and the general perspective of participants.

When the IRB or EC reviews research that involves categories of participants vulnerable to coercion or undue influence, if there is not at least one person who is knowledgeable about or experienced in working with such participants present at the meeting, the IRB or EC should defer review until such expertise can be obtained through membership or consultation.

Regulatory and guidance references

DHHS: 45 CFR 46.103(b)(3), 45 CFR 46.108(b), OHRP Step-by-Step Instructions on Registering an Institutional Review Board (IRB) or Independent EC (IEC)
FDA: 21 CFR 56.108(c), 21 CFR 56.115(a)(5), FDA Information Sheets: Frequently Asked Questions: IRB Membership, FDA Information Sheets: Frequently Asked Questions: IRB Procedures
ICH-GCP: 3.2.1, 3.2.3, 3.2.4
VA: 38 CFR 16.103(b)(3), 38 CFR 16.108(b), VHA Handbook 1058.01, VHA Handbook 1200.05,7, 12
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Review of Research involving Prisoners and the Role of the Prisoner Representative
AAHRPP Tip Sheet: The IRB or EC Member Roster

Required written materials

Essential requirements:
1. IRB or EC rosters include:
  1. Names.
  2. Earned degrees.
  3. Representative capacities.
  4. Scientific/nonscientific status.
  5. Affiliation status (whether the IRB or EC member or an immediate family member of the IRB or EC member is affiliated with the organization).
  6. Indications of experience sufficient to describe each IRB or EC member’s chief anticipated contributions.
  7. Employment or other relationship between each IRB or EC member and the organization.
  8. Alternate members.
  9. The primary members or class of primary members for whom each alternate member can substitute.
2. According to IRB or EC rosters:
  1. Each IRB or EC has at least five members with varying backgrounds to promote complete and adequate review of research commonly conducted by the organization.
  2. No IRB or EC has members who are all males or all females.
  3. No IRB or EC has members who represent a single profession.
  4. Each IRB or EC has at least one member whose primary concerns are in scientific areas.
  5. Each IRB or EC has at least one member whose primary concerns are in nonscientific areas.
  6. Each IRB or EC has at least one member who is not otherwise affiliated with the organization and who is not part of the immediate family of a person who is affiliated with the organization.
  7. Each IRB or EC has at least one member who represents the perspective of research participants.
When following VA requirements:
1. VA representation on external IRBs, such as academic IRBs, is optional and at the discretion of the organizational official and the external IRB.
  1. IRBs serving VA should consider including a veteran or veteran's representative.
2. VA facility research office staff including, but not limited to, the ACOS/R&D, the AO for R&D, and IRB administrative staff may not serve as members of the IRB. They may serve as ex officio attendees.
3. Research Compliance Officers (RCOs) may act as consultants to the IRB, but may not serve as members of the IRB. RCOs may attend IRB meetings when requested by the IRB or as specified by the IRB’s SOPs. RCOs must be aware of and manage any potential, actual, apparent, or perceived conflicts of interest that arise because of their role.
4. Facility Directors, their administrative staff, COS, other facility senior administrators such as Associate or Assistant Directors or Chief Nurse, and NPC Administrative Staff may observe IRB meetings, but may not serve as members of the IRB.

Common types of materials that may be used to meet the element

IRB or EC roster

Outcomes

The IRB or EC roster contains all the required categories and information.

Proceed To: ELEMENT II.1.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.1.A.