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Updated May 31, 2024

The University strives to ensure a culture of compliance with respect to the protection of human participants involved in research. Despite the best efforts of members of the research community, there may be instances where 1) an area of concern is identified related to the conduct of a study, or 2) an individual believes they are being subjected to undue influence. The mechanisms to report instances of undue influence are described in this policy. To ensure the consistent and unbiased application of the requirements for human research protection, the IRB must have the authority to make human research determinations and must be allowed to function independently of the organization in making these determinations.

• The IRB functions 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• IRB disapprovals may not be superseded by other institutional authorities although studies which receive IRB approval may be deemed inappropriate for conduct at the University by other institutional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.
• The IRB may suspend or terminate approval to conduct the research if it is not being conducted in accordance with IRB’s requirements or University policies or that may cause unexpected harm to participants.

Reporting and Management of Attempts to Limit IRB Independence

The University Vice President for Research and Innovation (VPRI) is given the authority to address inappropriate attempts to limit IRB independence or to influence the IRB process, IRB members, or Research Integrity & Security staff. This authority extends to research conducted by University affiliates.

• The Research Integrity & Security Director, Research Compliance Officer, and staff; IRB chairs and members; and other individuals involved in human 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 research conducted at the VA Sierra ÁùºÏ±¦µä Health Care Center (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.