5: Independence of the University's IRBs
To insure the consistent and unbiased application of the requirements for human research protection, IRBs must have the authority to make human research determinations and must be allowed to function independently of the organization in making these determinations.
- The IRBs function independently of, but in coordination with, other institutional regulatory committees. Approval by other institutional bodies cannot substitute for IRB approval.
- IRB disapprovals may not be superseded by other institutional authorities although studies which receive IRB approval may be deemed inappropriate for conduct at the University by other institutional authorities.
Reporting and Management of Attempts to Limit IRB Independence
The University VPRI is given the authority to address inappropriate attempts to limit IRB independence or to influence the IRB process, IRB members, or RIO staff. This authority extends to research conducted by University affiliates.
- The RIO Director, QA/QI Officer, and staff; IRB chairs and members; and other individuals involved in human subjects research may inform the VPRI of attempts to limit IRB independence or influence the IRB process.
- Investigators who believe that the IRB has been unduly influenced, may make a confidential report to the VPRI for investigation.
- The VPRI will respond immediately to all such allegations.
- The VPRI may intervene immediately if warranted to halt attempts at inappropriate influence.
- Based on the nature of the allegation, the VPRI may assign an appropriate person to investigate and make recommendations for resolution or corrective action.
Individuals involved in the regulatory compliance of human subjects research conducted at the VASNHCS or other University Affiliate sites will make the same report to site officials whenever undue influence involves VASNHCS or affiliate researchers or staff. When necessary, the University VPRI will conduct a thorough investigation in coordination with VASNHCS and affiliate site officials to determine the corrective action necessary to prevent additional occurrences.