Located Inside: Research Policy Handbook

Summary:

Establishes principles and procedures designed to ensure that research involving human subjects at Stanford University is conducted free from any untoward influence stemming from the University's financial investments, especially investments that are not publicly traded, such as direct equity holdings or rights to equity in start-up companies which might in any way benefit from the results of the research.

In developing this policy, the Office of the Dean of Research has taken into account the issues identified and discussed in "Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research," published in 2002 by the Association of American Medical Colleges (AAMC) and available at http://www.aamc.org/research/coi/start.htm.

Related Research Policy Handbook Documents:

4.1    Faculty Policy on Conflict of Commitment and Interest
4.5    University Investments in Start-Up Companies

Authority:

Developed by the Vice Provost and Dean of Research

Contact Person:

Vice Provost and Dean of Research

This policy charges and empowers the Vice Provost and Dean of Research, through the Office of Technology Licensing, to require divestment of institutional equity holdings that are not publicly traded, where that interest is associated with any Stanford research project(s) involving human subjects, and to decline any research project or line of inquiry that is found to be in violation of the policy.

     DEFINITIONS

For purposes of this policy, "human subjects research" is defined as any research which requires the review of Stanford's Institutional Review Boards (IRBs).

     GENERAL PRINCIPLES

The goal of this policy is to preclude situations in which human subjects research is carried out at Stanford or by Stanford researchers involving organizations in which the University holds ownership equity or rights to equity that is not publicly traded. The fundamental assumption underlying the policy is that such situations present a significant risk to the perceived objectivity of the research. The policy requires that the Office of the Dean of Research be informed of all such situations and provides that, after a review of the facts and circumstances, the Vice Provost and Dean of Research may either arrange the divestment of the University's holdings through the Office of Technology Licensing or, if that cannot be done, refuse to allow the research to proceed.

Another fundamental assumption is that all of Stanford's publicly-traded financial investments including pre-trade organizational equity (such as that acquired indirectly through investments in private venture capital funds) are managed by or through the Stanford Management Company (SMC), and that this arrangement sufficiently insulates University faculty and administrators from presumed biasing effects. Therefore, this policy does not require the Office of the Dean of Research to review proposed human subjects research involving publicly-traded companies or startups in which Stanford's investment is indirect (for example, through a private venture capital fund), provided the University's investments in such organizations are managed by or through SMC.

A final fundamental assumption is that the University's existing policy on Faculty Conflict of Commitment and Interest is adequate to (1) identify any situations in which individual faculty members might realize personal financial gain from the conduct of research at Stanford and (2) mitigate the risks to scientific objectivity and proper treatment of human research subjects which could be created by such situations.

     DISCUSSION AND DETAIL

1. Review by the Office of Technology Licensing (OTL) of all human subjects research protocols proposed by University Principal Investigators:

   At the request of the Office of the Dean of Research, the Stanford Research Compliance Office has established a procedure that requires all new human subjects research protocols submitted for regular or expedited review to the IRBs to indicate

   1. the nature and source(s) of all drugs, devices, or biologics (e.g., vaccine products, gene therapeutics) which will be used in the proposed research and
   2. the source(s) of all funding to be used in supporting the research.

   Per this procedure, the information provided is then reviewed by the Director of OTL to identify situations in which the proposed research involves

   1. the use of drugs, devices, or biologics that make use of Stanford-owned intellectual property or
   2. funding from non-publicly traded organizations in which Stanford owns equity or the right to acquire equity through a licensing agreement.
   
   
   

2. Review by the Office of the Dean of Research of all protocols which might be subject to this policy:

   Per the procedure described above, the Director of OTL flags for further review by the Office of the Dean of Research all proposed new human subjects research proposals involving the use of drugs, devices, or biologics that make use of Stanford-owned intellectual property or are funded in whole or in part by non-publicly traded organizations in which Stanford holds equity or the right to acquire equity through a licensing agreement.

   Based on the facts and circumstances identified in this review, the Vice Provost and Dean of Research will

   1. require OTL to divest that equity on behalf of the University, or
   2. prohibit or require modifications to the proposed human subjects research which would remove any possibility for the University as an institution, or any University department, to benefit as a result of the conduct or outcomes of the proposed research.

   In the event the University's financial interest is in the form of royalties payable as a result of exclusive technology licensing rights, OTL will inform the Vice Provost and Dean of Research, who will determine on a case-by-case basis the significance and management, if appropriate, of the potential institutional conflict of interest.

   
   
   

3. Monitoring compliance:

   The University's Internal Audit Department will periodically review a sample of human subjects research protocols to ensure that all situations in which a potential exists for institutional conflict of interest have been properly identified and all risks to human subjects have been properly mitigated.

   
   
   

4. Responsibilities of the Dean of Research:

   The Vice Provost and Dean of Research is the University officer responsible for interpreting and overseeing implementation of and compliance with this Policy. Questions may be addressed to the Assistant Dean of Research.