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Explanation

Research involving human subjects requires additional oversight because of the potential to compromise the health or safety of human subjects.

Example of potential conflict situation
The University owns the patent on a device being tested in a clinical trial and preliminary results indicate that the device may be unsafe. University senior administrators could be influenced by the institution's financial interest to allow additional subjects to be enrolled.

Processes for Potential Conflict Identification and Management

1. Identify the potential institutional conflict of interest
   • Licensing and other technology transfer arrangements

     Potential conflicts are identified by a question on the human subjects research application form. The question asks the applicant to indicate whether the proposed study evaluates a University invention.

     In addition, twice a year, the Office of Technology Commercialization (OTC) generates a list of companies that pay royalties of $100,000 or more per year and units and principal investigators that receive the revenue. OTC forwards this report to the Regulatory Affairs Officer.

     Annually, OTC generates a list of companies in which the University has an equity interest and which units and principal investigators benefit from this revenue. They forward this list to the Regulatory Affairs Officer.

     The Regulatory Affairs Officer compares that list against a database of research sponsors in those units. If the company is on both lists, the Regulatory Affairs Officer will gather information about the project. If the project involves human subjects, the Regulatory Affairs Officer will automatically forward the matter to the Institutional Conflict Review Committee to develop a management plan.

   • University officials

     The Proposal Routing Form (PRF) is the form researchers use to route a research proposal to the department head, dean, and research administration office (SPA) for review and signatures. When the department head and dean are asked to sign the PRF, they will also be asked to check a box indicating whether they have a potential significant financial conflict with the sponsor. If this box is checked in the affirmative, the PRF will be routed to the Regulatory Affairs Officer for further investigation. The Regulatory Affairs Officer will then check to see if the project involves human subjects. If so, it will be sent to the Institutional Conflict Review Committee for review and management.

   • Gifts

     Each quarter, the Regulatory Affairs Officer receives a list of donors giving $50,000 or more. The Regulatory Affairs Officer compares that list against a database of research sponsors. If a particular sponsor has made a donation to any college or department that conducts research with human subjects paid for by that sponsor, the Regulatory Affairs Officer will gather further information.

   • Other Reporting

     Potential conflicts are also identified by employees or other individuals who are concerned about possible conflicts of interest and report the situation to University officials.

2. Gather information regarding the potential conflict

   The Regulatory Affairs Officer and the Executive Committee of the Institutional Conflict Review Committee will gather information regarding these projects. If the project involves evaluating a technology that the University has a financial interest in, this information will include reasons for allowing the project (e.g., it cannot be conducted elsewhere or it would be of greater risk to subjects if it were conducted elsewhere). They will forward the information to the full Institutional Conflict Review Committee.

3. Develop a management plan

   The Institutional Conflict Review Committee will develop a management plan for the potential conflict, coordinating with the Institutional Review Board.

4. Determine whether the potential conflict management plan must be approved by the Regents

   The Regulatory Affairs Officer and the Executive Committee of the Institutional Conflict Review Committee will evaluate whether the potential conflict management plan fits the criteria for Regents' approval (it presents an unusually significant financial impact, it involves the president, it raises serious policy issues or has a significant public impact on the University's mission or reputation, or it needs their review under the Reservation and Delegation of Authority policy). If so, the President or delegate will bring the plan to the Regents for review and action. If not, the Regulatory Affairs Officer will summarize the management plan in an annual report to the Regents.

5. Implement the management plan

   Once the Institutional Conflict Review Committee or Regents approve the management plan, the appropriate University official will implement it.

6. Oversight

   The Institutional Conflict Review Committee verifies post-approval compliance with the management plan and addresses any issues that arise.