PURPOSE This procedure establishes the process to remove a member of an IRB. This procedure begins when the [Organizational Official] has decided to remove an IRB member. This procedure ends when the member has been removed and the IRB’s registration has been updated. POLICY The [Organizational Official] is responsible for deciding whether to remove an IRB member. RESPONSIBILITY A designee of the [Organizational Official] carries out these procedures. PROCEDURE Update the IRB roster. Use IRB Composition (HRP-430)” to evaluate whether the IRB is “WORKSHEET: appropriately constituted. Revise the membership as needed. Notify the IRB member. If the IRB member will no longer as an IRB member prepare and send a thank you letter signed by the [Organizational Official]. If the removed member was a chair, update the IRB’s registration at within 90 days REFERENCES 21 CFR §56.106 and §56.107 45 CFR §46.107 and 45 CFR §46 Subpart E
PURPOSE This procedure establishes the process to remove a member of an IRB. This procedure begins when the [Organizational Official] has decided to remove an IRB member. This procedure ends when the member has been removed and the IRB’s registration has been updated. POLICY The [Organizational Official] is responsible for deciding whether to remove an IRB member. RESPONSIBILITY A designee of the [Organizational Official] carries out these procedures. PROCEDURE Update the IRB roster. Use “WORKSHEET: IRB Composition (HRP-430)” to evaluate whether the IRB is appropriately constituted. Revise the membership as needed. Notify the IRB member. If the IRB member will no longer as an IRB member prepare and send a thank you letter signed by the [Organizational Official]. If the removed member was a chair, update the IRB’s registration at within 90 days REFERENCES 21 CFR §56.106 and §56.107 45 CFR §46.107 and 45 CFR §46 Subpart E
HRP-133%20SOP%20-%20IRB%20Member%20Removal_0.docx