A major revision of the Individual Conflict of Interest Policy was undertaken in 2009 and culminated with changes in federal financial regulations promulgated by the Department of Health and Human Service (DHHS) on August 25, 2011. The revised University policy takes effect August 24, 2012.
The changes to the policy are in compliance with all NIH, NSF, and FDA requirements. In general, the revised policy, rules and procedures apply the same requirements for the whole University community regardless of the source of funding. In certain circumstances, highlighted in italics below, we are only applying the DHHS standards to research funded by the Public Health Service (PHS).
Conflict of Interest Training
All individuals are required to complete the University’s on-line Conflict of Interest training prior to submitting a disclosure form and at least every four years. Training is required immediately under these designated circumstances:
- An Investigator/Employee is new to the University;
- Changes to the Individual Financial Conflict of Interest policy in a manner that affects Investigator requirements;
- The Individual Conflict of Interest Committee finds that an Investigator/Employee is not in compliance with the Individual Financial Conflict of Interest policy or approved management plan.
The Investigator or Employee must provide complete and accurate information about all Significant Financial Interests that reasonably appear related to his/her professional responsibilities to the University. The University, rather than the investigator or employee, is responsible for determining if a significant financial interest is relevant to a particular project or activity.
The University maintains records related to disclosures and management of financial conflicts of interest for at least five years after the completion of the research.
Significant Financial Interests
- For publicly traded business entities, any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the business entity as of the date of disclosure, when aggregated for the individual and the individual’s family member, exceeds $5,000.
- For non-publicly traded business entities, any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated for the individual and the individual’s family member, exceeds $5,000, or any equity interest.
- Intellectual property rights and interests (e.g., patents, copyrights), when the patent application is filed or when the copyright is asserted or upon receipt of income related to such rights and interests, including royalty income from intellectual property owned by the University of Utah Research Foundation.
Disclosures need to be updated regularly
Investigators and employees are required to update their disclosures at least annually and within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest that is related to their professional responsibilities to the University.
Disclosure of travel
Applies only to investigators participating in research sponsored by or applying for
funding from the Public Health Service.
The occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the discloser’s institutional responsibilities must be disclosed unless the travel is reimbursed or sponsored by the following: federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. All travel expenses reimbursed through the University are exempt from disclosure.
Confidentiality and Public Accessibility about Conflicts of Interest
The Conflict of Interest Policy indicates that the University will comply with federal and state laws that may require public disclosure of information relating to identified conflicts of interest. This includes making certain information available to the public about the conflicts of interest of senior/key personnel participating in PHS funded research. This information will be made available on a publicly available web site. Additionally, the University may require public disclosure on the web site as part of a conflict management plan when appropriate under other circumstances, such as conflicts of interest involving human subjects research.
Stricter Standard for Human Subjects Research
The policy requires the Individual Conflict of Interest Committee to apply a “rebuttable presumption” for human subjects research, as recommended by the AAMC-AAU.* This stricter standard requires the Committee to apply a presumption against the conduct of research with human subjects in any circumstance where the individual has a conflict of interest relating to the research. The Committee may approve conduct of the research by the individual only upon a finding of compelling circumstances and only when the Committee can craft an effective management plan to mitigate the conflict. Otherwise, the conflict must be eliminated or the conflicted individual may not be involved in the research project.
*AAMC-AAU (Association of American Medical Colleges-Association of American Universities). Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research. Washington, DC: AAMC; 2008.Report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research.
When the Individual Conflict of Interest Committee determines that a conflict of interest exists and requires a management plan, the plan will require investigators and employees to submit reports on a regular interval (usually annually) to certify their compliance with the approved management plan.
Non-compliance: retrospective reviews and mitigation reports
Whenever a conflict of interest is not reported or managed in a timely manner, the University may complete a “retrospective review” of the investigator’s activities and the research project to determine whether any research conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. Retrospective reviews are required if the research is sponsored by the Public Health Service (PHS). If bias is found, the University must notify PHS promptly and submit a mitigation report to the NIH.