COI COMMITTEE’S HUMAN SUBJECT RESEARCH WORKING COI POLICY

Individuals are generally prohibited from serving as principal investigators of a human subject research study if they have a significant financial interest (SFI) that may be affected, or perceived to be affected, by the outcome of the research study. Any exception to this policy must be approved by the authorized institutional official for human subject research, the vice chancellor for research conduct and compliance.

Individuals with an SFI that may be affected, or perceived to be affected, by the outcome of a human subject research study may be permitted to serve as a co-investigator with the implementation of the Standard Conflict of Interest Management Plan for Human Subject Research. If the Institutional Review Board (IRB) and/or the investigator with the SFI wishes to request an exception to the standard plan (e.g., to add/remove elements to/from the plan), such request should be communicated to the director of the COI Office. The request will then be forwarded to a subcommittee of the Conflict of Interest Committee for deliberation. The results of these deliberations will be reported to the IRB and the investigator with the SFI within two weeks of receiving the request.

In the unlikely event that the IRB is not in agreement with the proposed COI management plan, and an agreement cannot be reached following the above procedures, the decision to grant approval of the protocol remains with the IRB.

The COI Committee will inform the IRB of any known violations of this policy; the IRB, in cooperation with the investigator’s department chair and dean, is responsible for invoking any sanctions that it determines should be applied for such violations.

1 Consistent with University policies and applicable laws, an SFI includes an interest owned by the individual, the individual’s spouse, dependent children or other members of his/her household and means anything of monetary value, including, but not limited to, current or contingent salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, bonds); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

The term SFI includes:

  1. an equity interest in the entity that either sponsors this research or owns the technology being evaluated that when aggregated for the individual, individual’s spouse, dependent children and other members of the household exceeds 5% ownership interest or a current value of $10,000, as determined through reference to public prices or other reasonable measures of fair market value;
  2. salary, royalty or other payments from the entity that either sponsors this research or owns the technology being evaluated that when aggregated for the individual, individual’s spouse, dependent children and other members of the household is expected to exceed $10,000 per year;
  3. an agreement with the University or an external entity that would entitle sharing current or future commercial proceeds related to the technology being evaluated (e.g., royalties through a license agreement); and
  4. a financial relationship with a start-up company (which is being monitored by the Entrepreneurial Oversight Committee) that has an option or license to utilize the technology being evaluated. An SFI exists under these circumstances regardless of the individual’s ownership percentage in and/or remuneration received from the start-up company.

The term SFI does not include:

  1. salary from the University of Pittsburgh, UPMC, or VA;
  2. income from seminars, lectures, or teaching engagements sponsored by governmental or nonprofit entities; and
  3. income from service on advisory committees or review panels for governmental or nonprofit entities.