COI COMMITTEE’S WORKING COI POLICY FOR RESEARCH OVERSEEN BY THE HUMAN STEM CELL RESEARCH OVERSIGHT COMMITTEE

Individuals are generally prohibited from serving as principal investigators (PI) of any research that is subject to review by the Human Stem Cell Research Oversight Committee (hSCRO) if they have a significant financial interest¹ (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 research overseen by the hSCRO (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 any research that is subject to review by the hSCRO may be permitted to serve as a co-investigator with the implementation of a plan developed by the COI Committee (COIC) to manage their potential conflict of interest. The plan developed by the COIC will be communicated to the hSCRO, the PI, the investigator with the SFI and his/her department chair and dean. The COIC will consider requests for exceptions received from the hSCRO and/or the investigator with the SFI concerning the management plan developed (e.g., to add/remove elements to/from the plan).

All requests for exceptions to this policy should be communicated to the director of the COI Office. Such requests will then be forwarded to the appropriate party for deliberation. The results of the deliberations will be reported to the hSCRO, the PI, the investigator with the SFI and his/her department chair and dean generally no later than two weeks after the request was made.

The COIC will inform the hSCRO of any known violations of this policy; the hSCRO, 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.

¹Consistent 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 that has an option or license to University of Pittsburgh technology being evaluated in the study. An SFI exists under these circumstances regardless of the individual’s ownership percentage in and/or remuneration received from the start-up company.

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.