NUMBER / DATE / APPROVED BY / PAGE
HRP-082 / 08/01/15 / IRB Office / 1 of 2
1PURPOSE
1.1This procedure establishes the process to add a new IRB member.
1.2The process begins when the Institutional Officialor designee has appointed a new IRB member to an IRB. (This may be a new IRB member, or the addition of a previous member to another IRB.)
1.3The process ends when the IRB registration is updated with OHRP and the new member has completed training.
2REVISIONS FROM PREVIOUS VERSION
2.1None
3POLICY
3.1IRB rosters are maintained using the “DATABASE: IRB Roster (HRP-601).”
4RESPONSIBILITIES
4.1IRB staff members carry out these procedures.
4.2The Institutional Official or designee appoints IRB members, alternate members, IRB chairs, and if used, other officers (e.g., vice chairs.).
5PROCEDURE
5.1Determine from the Institutional Officialor designee whether the individual will be a regular IRB member, alternate IRB member, or IRB chair.
5.2Have the individual complete the “FORM: IRB Member Information (HRP-202).”
5.3For Veterans Administration (VA) representatives, communicate with the Veterans Administration (VA) Medical Center Director in writing to obtain confirmation of the appointment.
5.45.3Obtain a copy of the individual’s résumé or curriculum vita.
5.55.4Add the individual to the “DATABASE: IRB Roster (HRP-601).”
5.65.5Prepare a “TEMPLATE LETTER: IRB Member Appointment (HRP-560)” for the individual.
5.75.6Provide to the Institutional Officialor designee for review and approval:
5.7.15.6.1FORM: IRB Member Information (HRP-202).
5.7.25.6.2Résumé or curriculum vita.
5.7.35.6.3Completed “TEMPLATE LETTER: IRB Member Appointment (HRP-560)”
5.85.7Once the appointment letter is signed:
5.8.15.7.1Send the signed “TEMPLATE LETTER: IRB Member Appointment (HRP-560)” to the individual.
5.8.25.7.2If the individual requires training, schedule the individual for training.
5.8.35.7.3Update the registration of all affected IRBs.[1]
5.95.8File:
5.9.15.8.1DATABASE: IRB Roster (HRP-601)
5.9.25.8.2TEMPLATE LETTER: IRB Member Thank You (HRP-561)
5.105.9Notify the IRB Director or Assistant IRB Director when the individual has completed training.
5.10.15.9.1Assign individual the “Committee Member” role in the system.
5.10.25.9.2If the individual is designated to conduct non-committee reviews, update the “Update Eligible Designated Reviewers” activity.
6MATERIALS
6.1DATABASE: IRB Roster (HRP-601)
6.2FORM: IRB Member Information (HRP-202)
6.3TEMPLATE LETTER: IRB Member Appointment (HRP-560)
6.4TEMPLATE LETTER: IRB Member Thank You (HRP-561)
7REFERENCES
7.145 CFR §46.107, 45 CFR §46.103(b)(3), 45 CFR §46.115(a)(5).
7.221 CFR §56.107, 21 CFR §56.115(a)(5).
[1] See Use Web site: