This SOP outlines additional requirements for ancillary committee and institutional reviews. The WVU OHRP communicates between various offices within WVU’s human research protection program and may rely upon oversight and input by these groups for research that is within WVU IRB purview and research that is within an external IRB’s purview but is occurring at a WVU-owned site.
Ancillary reviews assist the IRB and the institution with matters related to research feasibility, risk, regulatory requirements, and research compliance. Not all studies require ancillary review. If ancillary review is required, documentation of WVU IRB approval (or reliance acknowledgement, for studies under external IRB review) cannot be released until all ancillary reviews are completed.
Some ancillary reviews are automatically routed to appropriate offices and/or groups within WVU’s human research protection program, while others are routed manually by the IRB and/or WVU OHRP staff to obtain the appropriate ancillary review. Although listed below are the most common ancillary reviews assigned to human subject research protocols at WVU, this list is not finite, nor is it all-inclusive. Other ancillary reviews will be utilized on an as-needed basis, and those groups may not be listed within this policy.
The IBC is responsible for ensuring that recombinant DNA activities comply with the NIH guidelines. Projects involving human gene therapy or other DNA-related activities must be reviewed by the IBC, although the review may occur concurrently with IRB review. The IRB and the IBC communicate regarding committee deliberations and required revisions.
If a study requires radiation outside of the amount encountered within standard clinical care settings at WVU, the Radiation Safety Committee must review the study prior to final IRB approval (or reliance acknowledgement, for studies under external IRB review). This committee reviews any research that involves the use of X-rays, radioisotopes, lasers, etc. The committee provides expertise with regards to accepted radiation protection practices and regulations,and provides input on acceptable consent documentation language regarding risks involving radiation exposure in research.
If a study involves an investigational drug, the appropriate administrator within the WVU Investigational Pharmacy is notified and able to review the protocol. The appropriate IDS administrator communicates with the PI and/or the WVU OHRP/IRB if any changes are needed prior to use of an investigational drug for research purposes.
If a study involves access to, use of, or sharing of an individual’s protected health information for the conduct of research (e.g., medical chart reviews), a member of the HIPAA Privacy Board reviews and provides comments regarding the acceptability of HIPAA Authorizations, HIPAA Waivers of Authorization, HIPAA De-identification Forms, Limited Data Sets, etc., used within the course of research. WVU’s HIPAA Privacy Board must ensure the research meets all federal and institutional requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) prior to final IRB approval.
Federal Regulations:
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
AAHRPP:
Standard I-9
