Updated WPPs Posted
The IRB’s Written Policies and Procedures (WPPs) have been updated online at https://research.vcu.edu/human_research/guidance.htm.
Investigators are reminded to use the single PDF document that contains all of the VCU IRB’s WPPs. This single file is meant to serve as a resource to the VCU research community while each policy is individually updated on the VCU IRB WPP website.
Summary of Changes:
All WPPs were reformatted with minor administrative changes for ease of reading and navigation. Readers are advised to use the document table of contents or bookmarks to navigate within the document.
Important content changes were made (effective 6/15/2019) in the following WPPs/sections:
- IV-2 IRB Member Responsibilities and Conflicts of Interest
- Clarification in section 2.7 about determining conflicts of interest when appointing new IRB members
- V-2 IRB Members and Staff Education and Training
- Language regarding “expected training” was changed throughout to “required training”
- VII-2 Activities of the Full Board
- Revisions to section 2.5 about requirements for quorum
- New section 2.8 about subcommittees of the IRB
- VIII-7 Review of Grant Applications
- Clarifications to the policy statement about when congruency review (certification) will be done for studies under the 2018 Common Rule.
- IX-1 Principal Investigator Eligibility and Statement of Responsibilities,
- Edits to section 2.2, bullets 5 and 11 about the PI’s responsibilities to ensure research staff are qualified and trained to perform assigned study procedures and to maintain appropriate oversight of the study
- XI-1 Informed Consent Process, Elements, Waiver of Element(s), and Alteration
- Note added to section 2.3.2 about VCU’s interpretation of the requirement of 45 CFR 46.116(f)(3)
- Clarification added in section 2.4 about obtaining consent for all study procedures including asking participants to refrain from certain activities or to take certain actions prior to the first study visit (e.g. fasting)
- XIII-1 Pregnant Women, Human Fetuses, and Neonates (Special Protections)
- Regulatory references in sections 2 and 2.1 removed
- XIV-1 Prisoners as Research Participants (Special Protections)
- Clarification in section 2.6 about when a prisoner representative must participate in reviews
- Clarification in section 2.6 about applicability of the Epidemiological Research Waiver to registry/repository studies