A. Policy Background and Applicability

On September 20, 2007, The Regents of the University of California approved RE-89, a resolution that requires special review, approval and reporting procedures related to University submission of research proposals seeking funding from tobacco industry sponsors. RE-89 defines “tobacco industry” as “entities whose principal business is the manufacture and sale of tobacco products, and agencies that are substantially controlled by or acting on behalf of such entities.” UC Irvine’s Office of Research (working with the UCOP Office of Research) can provide guidance, as needed in interpreting or applying this definition.

UC Office of the President subsequently determined that, given the intent of RE-89, these review/approval procedures should be extended to all tobacco-funded University activities that can reasonably be construed as research (e.g., including testing or services that may be provided under a research services agreement), regardless of whether they were initiated by an investigator submitting a proposal and regardless of the funding mechanism (i.e., whether the university activity is funded via grant, contract, gift, research services agreement or other mechanism).

The special review and approval requirements apply only to tobacco industry sponsors of research, with proposals submitted after September 2007 (new proposals and/or competitive renewals of current grants), and include funds received by UC Irvine via grant, contract, gift, research services agreement or other mechanism. Such funding arrangements and sponsorships must undergo internal review and be approved by the Chancellor.

These Guidelines apply to all funds received after June 15, 2008, from a sponsor that may be considered to be part of the tobacco industry and to extramural sponsored project proposals submitted to such a sponsor after September 2007.

B. Recommendations for Researchers

University researchers are strongly urged to:

1. Consider carefully whether to accept research funding from the tobacco industry (and whether their research might be better served by seeking funding from alternate sources).
2. Exercise the utmost care in assuring that their research (including research carried out with tobacco industry funding) adheres to the highest scientific and ethical standards. This includes being particularly vigilant about not allowing any funder to direct or control the outcome of the research or the dissemination of its results.

C. Review and Approval Requirements

Researchers intending to seek funding from a sponsor that may be considered to be part of the tobacco industry should contact the Office of the Vice Chancellor for Research for guidance regarding the process for review and approval, and should do so well in advance of any submission deadline.

As required by RE-89, the review and approval process for receipt of tobacco industry research funding and for submissions of proposals for such research funding will include the following:

1. Review of all such proposals by a scientific peer review committee designated by the Chancellor for that purpose. The Vice Chancellor for Research may provide recommendations to the Chancellor regarding the membership of this review committee.
   1. The scientific review committee will be composed of at least three faculty members with expertise in areas of science relevant to the proposal being submitted, and they will advise the Chancellor regarding whether the proposed study uses sound methodology and whether it appears designed to allow the researcher to reach objective and scientifically valid conclusions.
   2. For each proposal it reviews, the scientific review committee will produce a written report including 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, along with the rationale for the committee’s recommendation.
2. Chancellorial approval prior to submission of any proposal to seek funding from the tobacco industry or to accept funding from the tobacco industry via grant, contract, gift, research services agreement or other mechanism. In deciding whether to approve submission of a proposal, the Chancellor will take into account the written review of the scientific peer review committee and any advice issued by UC Irvine’s Conflict of Interest Oversight Committee, in cases where, under existing policy requirements, the researcher has disclosed a financial interest in the research sponsor. The Vice Chancellor for Research may advise the Chancellor regarding the peer review committee’s recommendations and the potential for conflict of interest.
3. Issuance of a written Chancellorial determination approving or disapproving receipt of funding from a tobacco industry sponsor or submission of a proposal to seek funding from a tobacco industry sponsor – including a rationale of the determination – with a copy to be provided to the researcher, the Vice Chancellor for Research, the President, and The Regents.
4. An annual report from the President of the University to The Regents summarizing the number of proposals submitted to a scientific review committee under RE-89, the number approved, and the number funded, along with a description or abstract of each proposal, as well as an accounting of funds received via grant, contract, gift, research services agreement or other mechanism from a tobacco industry sponsor.