1. CONFLICT OF INTEREST IN RESEARCH: YOUR CHALLENGES AND RESPONSIBILITIES AS A RESEARCHER WVU Office of Research Integrity and Compliance Research Bootcamp SoPH Spring 2016

2. The developing dynamic between academic research and industry funding Increased public demand for transparency including recent legislative action surrounding COI cases Public Health Service (PHS) Final Rule: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought … Published in Federal Register August 25, 2011 Implementation by August 24, 2012 Why the Recent Focus on Conflict of Interest?

3. A history of collaboration Bayh –Dole Act (1980) Academic Research and Industry Collaboration

4. Federal funding is becoming increasingly more difficult to obtain. This creates an environment where industry support is the only rational alternative As those collaborations become more complex and encompassing, conflicts of interest, commitment, and competing interests become more difficult to balance without guidance An Increase in Industry Funded Research

5. Public Demand for Transparency: Following the Gelsinger Case 18 yr old subject enrolled in a University of Pennsylvania trial designed to test gene therapy for a genetic liver disorder Following administration of a large dose of genetically engineered viruses, Gelsinger experienced multi-system organ failure and died in Sept. 2000 A federal Investigation following the incident revealed that monkeys given similar injections by Penn researchers before Gelsinger enrolled had experienced similar reactions, not reported to the FDA and not mentioned on the consent form

6. Public Demand for Transparency: Following the Gelsinger Case Principle Investigator Dr. James Wilson and the University of Pennsylvania each held stock in Genovo, the study sponsor. Genovo was founded by Wilson and provided 20% of the funding for Wilson’s lab A malpractice claim was eventually filed and the defendants included the PI, the University and IRB members.

7. Public Demand for Transparency: Following the Gelsinger Case NIH sent a circular reminding gene therapy investigators that all adverse events must be reported 652 new adverse event reports were received from 80 institutions, including reports of 7 prior deaths

8. Public Demand for Transparency: Senator Grassley (R-IA) Legislators have launched their own creative approach to address the issue Senator Grassley has been the force behind the strongest effort toward transparency

9. Federal Register published August 25, 2011 Implementation was required no later than 365 days after publication of the final rule in the Federal Register, i.e. August 24, 2012  Expanded the definition of “Investigator”  Required at least annual disclosure  Requires training at least every four years  Requires disclosure for sponsored travel PHS Final Rule

10. Perceived or actual compromised objectivity in designing and conducting research, especially in regard to research subjects Perceived or actual compromised objectivity in medical education Perceived or actual bias in analyzing and reporting research results (Integrity of Investigators) Threatens the public trust in research Why Do We Care?

11. The Challenges and responsibilities you face as researchers, where conflict of interest and other related conflicts are concerned, and how the WVU Office of Research Integrity and Compliance (ORIC) can help you to avoid, recognize, and manage those challenges. Today’s Discussion

12. Situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a faculty member’s or an investigator’s professional judgment in conducting, analyzing, interpreting, or reporting research, and also in hiring staff, procuring materials, sharing results, choosing protocols, using statistical methods, and training students and fellows. Conflict of Interest in Research

13. Consulting for a company or organization Service on Scientific Advisory Board Service on a Board of Directors Ownership of Stock and Stock Options Technology Licensing agreements Founding a company Establishing a loan with a company Giving Talks for a company Accepting Gifts from A company Examples

14. WHO MUST FILE A DISCLOSURE OF INTEREST IN RESEARCH (DOIR) FORM? All investigators must submit a DOIR form. An investigator is defined as anyone responsible for the design, conduct, or reporting of research, regardless of their title or role on the project or the receipt of funding. This definition includes adjunct faculty, students, volunteers, subcontractors, consultants, collaborators, research coordinators, research assistants, and other research staff.

15. WVU Investigators are required to file a DOIR form annually, and on an ongoing basis within 30 days of discovery or acquisition of a new financial interest. Investigators should review and make any necessary revisions to the annual DOIR form: 1) With each new, continuation, or revised grant or contract application submitted to the Office of Sponsored Programs, and 2) With each new protocol involving animal or human subjects. HOW OFTEN SHOULD AN INVESTIGATOR FILE A DOIR FORM?

16. The DOIR Form is posted on the WVU Office of Research Integrity and Compliance (ORIC) website. WHAT IS THE DISCLOSURE PROCESS

17. ANNUAL DISCLOSURE OF INTEREST IN RESEARCH FORM (DOIR)

18. Grant proposals and contracts will not be submitted if you are listed as personnel, Funds from grant or other sponsored program awards will not be distributed, IRB and IACUC will not release the final letter of approval, The granting or sponsoring agency will be notified, if applicable. FAILURE TO COMPLETE THE DOIR FORM ELICITS THE FOLLOWING CONSEQUENCES:

19. Each investigator is required to complete the Conflict of Interest in Research CITI training prior to the release of any grant funding, regardless of the funding source. COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI) CONFLICT OF INTEREST IN RESEARCH MODULES To access the required COIR training, go to the CITI Website at https://www.citiprogram.org/. https://www.citiprogram.org/

20. COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI) CONFLICT OF INTEREST IN RESEARCH MODULES Choose “Add a course or update your learner groups for West Virginia University”

21. COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI) CONFLICT OF INTEREST IN RESEARCH MODULES Click on “Continue” at the bottom and complete the required modules.