Recent Policy Updates

RPH 4.7 - Summary of Changes

1. Sequestration of Royalties and Income. The previous version of the policy required sequestration of any royalty or equity revenue received by Stanford when Stanford is conducting human research on the same technology that was licensed to an external commercial entity. The updated policy allows for other management approaches tailored to the particular interests and risks of a given situation instead of an across-the-board sequestration of funds approach.
2. Prohibition on Stanford Investments. The previous version of the policy prohibited investment in a commercial entity if Stanford is conducting human subjects research on a product of that company. The updated policy manages SMC investments through a "firewall" policy adopted by SMC to maintain separation of investment decision making. The policy also allows investment by the President’s Venture Fund or School investment funds with appropriate management as opposed to a prohibition on investment.
3. Significant and Sensitive Human Health Data. The previous version of the policy was applicable only when Stanford is conducting human subjects research related to an institutional interest. The updated policy includes the exchange of significant and sensitive human health data with entities where Stanford or an institutional leader has a significant financial interest.
4. Process for Identifying Institutional Leader Conflicts. The previous version of the policy required Center Directors, Department Chairs, Division Heads, Deans and VP level leaders to self-identify when they have an outside interest in an entity related to human subjects research being conducted at Stanford and report this to VPDoR. The updated policy creates a new process where potential Institutional Leader conflicts will be identified using data already available in Stanford systems, reducing the administrative burden on the Institutional Leader.
5. Authority and Appeals. The previous version of the policy identified VPDoR as the official who recommends a management approach for ICOIs with the Provost serving as the deciding authority. The updated policy adopts an approach where the ICOI Committee will make recommendations to the VPDoR who is the deciding authority and introduces an appeal process for Institutional Leaders with the Provost identified as the final arbiter of a proposed management strategy.
6. Reorganization and Language Clean-Up. The previous version of the policy included a significant amount of process language as opposed to policy requirements. This revision separates procedural aspects out from the key policy requirements as a separate document. In addition, policy sections were reorganized and edited for clarity.

After review by Committee on Research; changes approved by VPDOR, President&Provost for updates to composition of ICOIC (section 5.D.)

Approved by leadership of Office of Technology Licensing. Added to Section 3.A 3 2) that clinical trial research ends at Stanford, and or when the license is terminated, or the product which was the subject of the clinical trial is no longer being developed by a licensee/sublicensee.

In developing this policy and related procedures, the University has taken into account the issues identified and discussed in "Protecting Patients, Preserving Integrity, Advancing Health: Accelerating Implementation of COI Policies in Human Subjects Research," published in 2008 by the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU).

Establishes principles and procedures designed to ensure that research involving human subjects at Stanford University is conducted without untoward influence resulting from either the University's financial investments or holdings or the personal financial interests or holdings of key institutional leaders.