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. For a VA using an academic affiliate’s IRB or other local VA facility’s IRB, policies and procedures indicate:
  1. The IRB includes at least two VA employees who hold a minimum of 1/8ths VA-compensated appointments to serve as voting members to each IRB of record, except the VA Central IRB or the central IRB of another federal agency (e.g., National Cancer Institute Central IRB). VA facilities with fewer than ten active protocols are only required to appoint one voting member and one alternate member. Members appointed to affiliate IRBs may be scientific or non-scientific members.
  2. Alternate members must have qualifications similar to the member they replace. Alternate members may not serve for a class of members (for example a physician may not serve for all physician regular members, but must be designated to serve for a specific physician member). The individual the alternate is serving for must be referenced specifically by name.
  3. At least one VA voting member of the IRB must be in attendance when VA research is discussed at a convened meeting.
  4. IRBs serving VA should consider including a veteran or veteran's representative.
  5. Physicians, dentists, nurses, pharmacists, social workers, other clinicians, statisticians, and allied health professionals are considered scientists.
  6. Veterans whose only relationship with the VA facility is receiving care at a VA facility or receiving benefits from the Veterans Benefits Administration are not considered to be affiliated for the purpose of being an IRB member. Individuals who perform occasional volunteer activities without compensation (WOC) are not considered affiliated. However, those who hold a WOC appointment for volunteer activities other than IRB service are considered to be affiliated. Individuals who have retired from the VA and who are receiving VA retirement benefits are considered affiliated.
  7. The facility director, administrative staff, chief of staff, other senior administrators such as associate or assistant directors, or chief nurse, may observe meetings but not serve as voting or non-voting members of the facility’s IRB. Research office staff including, but not limited to, the associate chief of staff for research and development, the administrative officer for research and development, and IRB administrative staff, may not serve as voting members of the IRB.
  8. The facility director appoints the privacy officer and information security officer as non-voting members or consultants of the IRB or research and development committee.
  9. The research compliance officer may serve as a non-voting consultant, as needed, to the VA facility’s IRB. The research compliance officer may not serve as a voting or non-voting member of the IRB. The research compliance officer may attend meetings of the IRB when requested by the IRB or as specified by local procedure. These requirements are also relevant for an affiliate 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.