2. 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

3. 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

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

5. Patient safety Influence on the integrity of MUSC operations (research integrity, 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

6. Tough lessons learned

7. Jesse Gelsinger June 18, 1981 – September 17, 1999 He suffered from a rare metabolic disorder, BUT he was not sick – his condition was under control. He signed up for a gene therapy trial at University of Pennsylvania to help test the safety of a treatment for babies. A few days after receiving the injection, Jesse experienced organ failure and passed away at 18 years old.

8. Jesse’s informed consent form did not include disclosure that two monkeys had died in pre-clinical animal studies. Researchers did not disclose that human volunteers in the study had suffered adverse reactions. No disclosure of related financial interests:  Genovo held licensing rights to the study intervention and provided $4 million to the institute pursuing the study.  The University held 3.2% equity interest in Genovo, reportedly valued at $1.4 million when the company was later acquired by Targeted Genetics in 2000.  Lead investigator James Wilson's equity stake was 30%. This was valued at $13.5 million when Genovo was later acquired by Targeted Genetics in 2000.

9. “The Biotech Death of Jesse Gelsinger” By Sheryl Gay Stolberg November 28, 1999 The New York Times “Targeted Genetics' Deal for Genovo Leads to a Windfall for Researcher” By Scott Hensley Updated Aug. 10, 2000 The Wall Street Journal “The ethics of human gene transfer” Jonathan Kimmelman, Nature Reviews Genetics 9, 239-244 (March 2008) “Ten Years Later: Jesse Gelsinger’s Death and Human Subjects Protection” Osagie Obasogie, 10/22/2009 The Hastings Center

10. Department of Health and Human Services  Effective August 24, 2012  42 CFR Part 50 Subpart F (Grants): Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought 42 CFR Part 50 Subpart F (Grants): Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought  45 CFR Part 94 (Contracts): Responsible Prospective Contractors 45 CFR Part 94 (Contracts): Responsible Prospective Contractors Purpose:  Promotes objectivity in research  Establishes standards that provide a reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from Investigator financial conflicts of interest

11.  Significant Financial Interest (SFI) – one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:  Publicly traded entities: any remuneration and/or equity in the previous 12 months exceeding $5,000.  Privately held entities: any remuneration received in the previous 12 months exceeding $5,000 and any equity interest.  Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.  Investigators also must disclose the occurrence of any reimbursed or sponsored travel, including sponsor, purpose, destination and duration.

12. FCOI’s must be managed.  Management measures may include:  Disclosure in the Informed Consent Form  Disclosure to students and trainees  Disclosure in publications and presentations  Independent or outside periodic reviews  Restrictions from receiving personal remuneration related to the research project (e.g., consulting fees, company shares)

13. Issues  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

14. http://academicdepartments.musc.edu/grad/students/curr_students/forms_guidelines/

15. www.musc.edu/coi

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

17. 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 valued at $8,000.

18. 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.

19. 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?

20. Mary Evelyn Armstrong MA, CRA 2-5907 armsme@musc.edu