Institutional Conflict of Interest in Research Involving Human Subjects

• Recognizes the principle that individual scholars at Stanford are free to select the subject matter of their research and to seek support for their work, consistent with the principles enunciated in RPH 1.1, Principles Concerning Research. 

• Sets forth principles and a process to address circumstances in which an institutional conflict of interest, if it is not managed appropriately or eliminated, has the potential to adversely impact a faculty member's research or the University. (Individual – as opposed to institutional – conflicts of interest and commitment are covered separately in RPH 4.1, Policy on Conflict of Interest and Conflict of Commitment.)  

• Seeks to balance the ability of eligible individuals to participate in research conducted at Stanford with the need for appropriate protections to ensure the integrity of human subjects research. 

2. Definitions 

• “Human Subjects Research” is defined as any research that requires review and approval by an Institutional Review Board (IRB) or is deemed exempt from IRB review, as outlined in Stanford policy. In addition, it includes select activities that involve the exchange of sensitive or significant human health data, as further defined in guidance documents. 

• "Institutional Leaders" are individuals who have direct authority over faculty, staff, or trainees engaged in human subjects research. The authority may be over appointments, salaries, promotions, or allocation of institutional resources, such as assignment of graduate students, postdoctoral scholars, funding, or space. The most common job titles held by Institutional Leaders are identified in section 4 below. 

3. Institutional Conflicts of Interest Arising from the Financial Holdings or Investments of Stanford University

A. Licensing Activities 

When Stanford University licenses technology or other intellectual property to an outside entity, it may be eligible to receive royalties, milestone payments, or other compensation for the use of that intellectual property. It may also receive equity or other financial interests as compensation or as part of a co-investment in the company by the University. An ICOI is created if an investigator at Stanford subsequently undertakes human subjects research on a drug, device, biologic, or other item, or subsequently uses human health data, in circumstances in which Stanford has the potential for financial gain through future royalties, milestone payments or equity appreciation.​ ​ 

When the Office of Technology Licensing identifies such a situation, the matter will be referred to the Chief Conflicts Officer (CCO) or designee for review of potential ICOI and, if a conflict exists, the CCO will initiate a process to manage or eliminate it in accordance with the procedures described in RPH-PR 4.7, Procedure on Institutional Conflict of Interest in Research Involving Human Subjects.  

B. University Investments 

i. Merged Pool 

The Merged Pool (“MP”), overseen by Stanford Management Company (“SMC”), is the primary investment vehicle for the University’s endowment. The MP is almost entirely invested through third-party fund managers who operate independently of the University in selecting individual investments. Third-party fund managers have no influence or oversight over University research, and University leaders outside of SMC and its board have no knowledge of the specific investments held by these managers. Investments made on behalf of the MP by third-party fund managers or other investment advisors will not be considered to create an ICOI for purposes of this policy. 

SMC itself makes relatively few direct investments in endowment funds. SMC has adopted a ​​“​​firewal​​l​” policy to ensure such direct investments are selected independently and without knowledge of or connection to human subjects research being conducted at the University.  

ii. School and Department Funds 

Several schools and departments of the University have funds that are invested in private venture-backed companies. These funds currently include the School of Engineering Venture Fund, the Law School Venture Fund, the DAPER Investment Fund, and the Business School Trust.  Each of these funds has a volunteer advisory board comprised of venture capitalists and other experts who recommend individual equity investments. Each investment by a fund is approved by the fund’s fiduciary, who is the school or department leader or their designee. SMC’s School and Department Funds Group provides middle and back-office support to the funds, but SMC does not make investment decisions for them or provide investment advice to them.  

Most investments by the school and department funds are quite small and financially immaterial to the University. On some occasions, multiple school and department funds will invest in the same company. For purposes of this policy, investments of school and department funds with a total cost basis of less than $150,000 in any individual company will not be considered material enough to have the potential to create an ICOI, and therefore will not be subject to this policy, whereas investments of $150,000 or more will be subject to this policy.  

When a school or department fund’s cumulative investment in a company exceeds this threshold, and that company provides products or services that could be evaluated in human subjects research (e.g., therapeutics, medical devices, biologics, diagnostics or healthcare services), the investment will be reviewed by the CCO in the Office of the Vice Provost and Dean of Research (VPDOR) for potential ICOI in accordance with RPH-PR 4.7.

The financial threshold of $150,000 will be reviewed at least triennially by the VPDOR or the VPDOR’s designee; if this review determines the threshold should change, this policy will be updated accordingly. 

• Payments for consulting, board service, or other services and any other financial relationship that involves payments by the company to the Institutional Leader. 

B. Identification and Prior Approval Requirements of Potential ICOI by Chairs, Division Chiefs, and Institute and Center Directors  

Institutional Leaders are required to obtain prior approval for outside professional activities, including consulting, company equity holdings, and service on a board of directors for a company. RPH 4.1 sets forth these requirements and defines “outside professional activities.”

Prior approval requests are managed in accordance with school procedures. Reviews are conducted by the school-designated COI reviewer, in consultation with the CCO, to determine whether Stanford is conducting human subjects research associated with the outside entity or whether there are known sensitive or significant human data exchange agreements with the entity.

Conflicts identified through these procedures will be considered  significant if they involve any of the following: 

• Regardless of the value of the interest, any financial interest in a non-publicly traded company (e.g., in a start-up company). 

• Current or pending ownership interests (including shares, partnership stake, or derivative interests such as stock options) in a public company with a value of $25,000 or more. 

• Income of $25,000 or more, including consulting, honoraria, licensing or royalty income, or employment of an immediate family member. 

Any ICOI related to an Institutional Leader that is found to be significant by applying these criteria must be reviewed by the CCO prior to the conduct of human subjects research at Stanford. If the human subjects research is already underway at Stanford, the review must precede an Institutional Leader accepting or conducting outside activities identified above. The identification of a significant conflict may trigger the need for review by the Institutional Conflict of Interest Committee (“ICOIC”), a body described in  RPH​-PR​ 4.7, Procedure on Institutional Conflicts of Interest in Human Subjects Research.  

C. Identification, disclosure, and approval requirements of potential ICOI of the President, Provost, Vice Provost and Dean of Research, School Deans and Senior Associate Deans for Research (or equivalent)  

The President, Provost, VPDOR, school deans, and Senior Associate Deans for Research (or equivalent) do not have direct knowledge of all of the human subjects research being proposed or conducted at Stanford, nor knowledge of how such research may intersect with their own outside activities and interests. Therefore, given this lack of direct knowledge, the required disclosure process under RPH 4.1, Policy on Conflict of Interest and Conflict of Commitment is relied upon for Institutional Leaders to report their financial interests.  The CCO then reviews those disclosures to determine whether any interests are significant and related to human subjects research at Stanford using the following criteria: 

• Any financial interest in a non-publicly traded company (e.g., in a 'start up' company) that is more than 0.5% of the ownership interest in the company or valued at $50,000 or more.  

• Current or pending ownership interests (including shares, partnership stake, or derivative interests such as stock options) in a public company valued at $50,000 or more.  

• Annual income of $50,000 or more, including consulting, honoraria, licensing or royalty income, or employment of an immediate family member. 

Senior Associate Deans for Research (or equivalent) must disclose to their School Dean. The School Deans and the Vice Provost and Dean of Research must disclose to the Provost. The Provost must  disclose to the President, and the President must disclose to the Chair of the Board of Trustees. These disclosures are provided to the Human and Animal Research Compliance Office by the person responsible for receiving the individual's annual COI disclosure.  

If any human subjects research at Stanford involving one of these disclosed companies is proposed during the ensuing year, the Human and Animal Research Compliance Office notifies both the affected Institutional Leader and the CCO.  If, at any time during the year, an Institutional Leader becomes aware of actual or proposed human subjects research involving a company, or the use in human subjects research of the product of a company in which they have a significant financial interest, they must advise the Human and Animal Research Compliance Office and the CCO of the possible ICOI. Any questions of whether a significant conflict triggers ICOI Committee review under the policy are assessed by the CCO before the CCO convenes the ICOIC. 

Potential ICOIs involving Institutional Leaders are reviewed by the CCO and , where appropriate, by the ICOIC, in accordance with applicable procedures. See, RPH 4.7, Procedure on Institutional Conflicts of Interest in Human Subjects Research. 

5. The Institutional Conflict of Interest Committee  

The Institutional Conflict of Interest Committee (ICOIC) provides oversight and expertise in relation to institutional conflicts of interest in research. The Committee reviews potential conflicts referred to it, determines whether they are significant, and recommends management, reduction, or elimination strategies. These recommendations are provided to the Vice Provost and Dean of Research (VPDOR), who has final authority for approving the course of action. 

The ICOIC establishes criteria for determining which matters may be addressed administratively by the CCO and which require full committee review. Members are appointed by the Provost to ensure independence, relevant expertise, and faculty representation from multiple Schools. The ICOIC may include members who are unaffiliated with the University. Committee members must recuse themselves from matters in which they have a personal conflict of interest. 

The ICOIC operates under procedures established by the Office of the Vice Provost and Dean of Research (VPDOR). See, RPH​-PR​ 4.7, Procedure on Institutional Conflicts of Interest in Human Subjects Research.