Review for Tobacco Industry Sponsors

Regents Policy 2309 directs Chancellors to establish a policy requiring a scientific review for all research or research activities supported by Tobacco Industry Sponsors.  At UCI, this requirement is implemented as Policy 483-40:  UCI Implementation of Regents Policy 2309:  Policy Requiring Special Review/Approval Procedures Prior to University Submission of Research Proposals to Tobacco Industry Funders.

Review and Approval Requirements

While the Chancellor is responsible for appointing committee members, the Vice Chancellor for Research (if designated by the Chancellor) may form the committee and appoint its members.  UCI does not have a standing committee; therefore, it is important that a Principal Investigators (PI) contact the Office of Research to seek guidance and request a review as early in the proposal development process as possible.  It may not be possible to complete the review and approval process if a PI makes such a request less than 30 days prior to a sponsor’s proposal submission deadline.

In accordance with Regents Policy 2309, the scientific review committee must be composed of at least three faculty members with expertise in the science relevant to the proposed research or research activity.  The committee is responsible for producing a written report, including:

  • An assessment of whether the proposed study uses sound methodology and whether it is designed to allow the researcher to reach objective and scientifically valid conclusions.
  • A recommendation as to whether the proposal should be approved for submission, and/or whether any changes should be made to the proposal prior to submission.
  • The rationale for the committee’s recommendation.

In addition, if required by applicable UCI policy, the Conflict of Interest Oversight Committee (COIOC) will review financial disclosures made by the Principal Investigator and research personnel involved in the proposed research or research activity.  The COIOC will advise the Vice Chancellor for Research regarding recommendations for addressing and mitigating or eliminating real or perceived conflicts of interest.

The Vice Chancellor for Research will receive the committee’s report and consider the COIOC’s recommendation.  The Vice Chancellor will provide the Chancellor with the scientific review committee’s report and brief the Chancellor about any COIOC recommendations.  The Vice Chancellor will also advise the Chancellor regarding risk, potential consequences, and the potential benefits associated with approving the research.

The Chancellor will determine whether to approve the research proposal/research funding.  In making this determination, the Chancellor will consider the written review of the scientific peer review committee, the recommendation of the COIOC, and any advice provided by the Vice Chancellor for Research.

The Office of Research will convey the Chancellor’s determination to the PI, the President, and The Regents.

The full text of Policy 483-40 and other important guidance is available on the Office of Research Policy Library.