Personal financial benefit or economic interest from one’s position that may inappropriately: influence the employee’s judgment compromise the employee’s ability to carry out their responsibilities be a detriment to the integrity of the organization

1980: Bayh-Dole Act passed by Congress – allows universities to patent rights for discoveries made at their institutions Patents are licensed to a commercial entity (industry) and products delivered (sold) to patients 1982: NIH developed SBIR and STTR funding mechanisms to help to assist with the transfer of technology and development of bio-tech companies 1988: MUSC established the Foundation for Research Development to interface with Industry and further technology transfer

Industry Relationships - Academic researchers and their institutions partner in a variety of ways with private industry –Researchers and universities: Own patents Are forming and have equity ownership in biotechnology companies Are consulting with industry for protocol and product development

Jesse Gelsinger June 18, 1981 – September 17, 1999

Patient safety Influence on the integrity of MUSC operations (vendor selection, academic experience of students) Proper use of University property, facilities, equipment or other resources Protecting MUSC’s intellectual property or proprietary information Ensuring public trust –The Physician Payment Sunshine Act will increase transparency, emphasizing the need to evaluate the nature and value of individual relationships

Entrepreneurialism and Industry Partnerships –Contribute to public welfare, economic development in SC and successful application of University research to healthcare needs. –Promote a culture of ethical entrepreneurialism to facilitate innovation and technological advances while maintaining fairness, teamwork, core values and ethical principles.

Examples: –Disclosure to patients and research subjects about relationships –Disclosure to students and trainees about relationships –Disclosure in publications and presentations –Recusal from decision making –Independent or outside periodic reviews

Issue Outside financial interests that may have the potential to harm the academic interests and/or career advancement of the student or fellow Mentor/advisor should disclose any COI related to the project

1.A faculty member has an ownership interest in an outside entity which stands to benefit from the results of the research. The faculty member directs the student or fellow to delay publication until the faculty member can complete the research. 2.A faculty member owns a biotech company, which is sponsoring research at the University and stands to benefit from the results of the research. The student or fellow is pressured to work on the project of interest to the faculty member’s company. 3.A faculty member has a financial interest in a product being evaluated in a research project. A student or fellow generates data from the research project which is not favorable to the product and the faculty member pressures the student not to publish the data.

Drug Inc. approaches Dr. Galloway about doing a study in his lab on a natural compound. Dr. Galloway is well-respected in his field. However, he is struggling to obtain research funding in this economy. Drug Inc. offers to pay 100% of costs associated with this study, and the company rep hints that if the outcome is positive, the company would be willing to fund future studies in Dr. Galloway’s lab. Dr. Galloway happens to carry stock in the company.

Dr. Galloway decides to do the study, and he assigns a postdoc to serve as PI. Dr. Galloway is still involved with some of the data analyses. Results are positive, and Dr. Galloway publishes these results. Drug Inc. subsequently funds several other studies in Dr. Galloway’s lab.

Does Dr. Galloway have a conflict of interest that should have been disclosed? Is Dr. Galloway avoiding this COI by assigning a different PI? Was it wrong for the Drug Inc. rep to suggest that positive results would lead to future funding?

Mary Evelyn Armstrong MA, CRA