Office of Research Compliance News

New federal COI regulations – impact on PIs conducting human subject research

Posted: January 5, 2012

On August 25, 2011, the federal Department of Health and Human Services (HHS) enacted new, more stringent rules regarding financial conflicts of interest (FCOI) in research.  As implemented, the regulations will substantially impact principal investigators (PIs) on research involving the use of human subjects, who have personal financial interests in the sponsor of their research, or in companies providing investigational drugs, devices or other financial support to their HHS-funded projects.

The most significant change for PIs in the new regulation is a reduction in the monetary interest considered to be a “significant” financial interest – from the current $10,000 threshold to $5,000 received within the past twelve (12) months. Under the new regulations, receipt of $5,000 or more from a research sponsor in consulting income, honoraria, stock or equity ownership, or personal payment of travel expenses by a sponsor will now be considered significant and require formal disclosure of the PI’s interest to HHS and a FCOI management plan. Additionally, the new regulations now cover financial interests received from any source (with the exception of federal and state agencies, U.S. colleges and universities, and academic medical centers), which may relate to all professional activities of an investigator – not just his/her research-related activities.

Importantly, the new rule may impact the ability of investigators with significant financial interests in companies or organizations providing financial support to their studies (including providing investigational drugs or devices) to remain as PIs on their current trials – or to function as PI on future human subjects research projects. Specifically, Ohio State follows best practice guidelines developed by the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) concerning investigators with financial interests involving human subject research. These AAMC/AAU guidelines include an express presumption that a PI with a significant financial interest in a company or organization cannot serve as PI on a human subject project, which is sponsored or financially supported by that company or organization.  A financially-interested PI can only rebut this presumption by demonstrating facts that, in the opinion of the Ohio State University COI Advisory Committee (COIAC), constitute compelling reasons to allow the PI to conduct the research under conditions specified by the COIAC and approved by the responsible IRB. Additional information on the AAMC/AAU guidance can be found at https://www.aamc.org/download/75302/data/firstreport.pdf.

As a result of the more stringent federal requirements, we suggest that PIs with personal financial interests in sponsors or other organizations supporting their research strongly consider decreasing their interests well before the new regulations take effect on August 24, 2012, in order to stay below the lowered $5000 threshold for significant financial interests.

Please contact Ashlie Depinet, the University’s Conflict of Interest Administrator, at conflictinfo@osu.edu to discuss the impact of the new federal conflict of interest regulations on your research.

Change Impact on Principal Investigators
The monetary threshold considered to be a “significant” financial interest will be reduced from the current $10,000 to a new threshold of $5,000 received in the twelve months preceding the annual disclosure; Any equity interest in a non-publicly traded company, i.e., a start-up company, will be automatically considered to be a “significant” financial interest; Ohio State follows the AAMC/AAU best practice guidelines for Principal Investigators (PI) on research involving the use of human subjects. The guidance includes a presumption that any PI with a significant financial interest in a company cannot serve as PI on a human subject project sponsored or financially supported by that company – unless the University’s COI Advisory Committee finds s a compelling reason to allow the investigator to remain the PI. If you are currently a PI on a project and have or expect to receive $5,000 or more in the twelve (12) months preceding August 24, 2012 (the date the new rules take effect) from a company sponsoring or providing other support to the project, the new rule will impact your ability to remain PI.
PIs, co-investigators, and key research personnel will be required to disclose the occurrence of any reimbursed travel or sponsored travel related to his/her institutional responsibilities – not just research. The only reimbursed travel that is excluded from disclosure is that which is sponsored by a federal, state or local government agency or by a U.S. institution of higher education (an accredited college or university). This disclosure includes: the purpose of the trip, the sponsor/organizer, the destination and the duration. Ohio State has not previously collected this detailed travel information. When it is disclosed, the University’s conflict of interest administrator and Conflict of Interest Advisory Committee will determine if additional travel information is needed and whether the sponsored travel represents a potential financial conflict of interest.
The new regulation requires that PIs, co-investigators and key research personnel update their annual e-COI disclosures within thirty days of acquiring a new significant financial interest. Investigators will need to more frequently update their COI disclosures as new financial interests are received. If a significant new financial interest is acquired and not disclosed within 30 days, the new rules require that the University conduct a formal retrospective review of the investigator’s research and a formal mitigation plan will be required.
The federal regulations have a public accessibility requirement. The university will be required to make certain information available concerning identified financial conflicts of interests (FCOI) by a written response to any requestor within five business days of the request. The information required includes: the name of the faculty (or key research personnel), his/her position with respect to the research, the nature of the significant financial interest, and the range of the financial interest. The Ohio Open Records law already provides public access to most investigator and research staff FCOI information on formal request. Public requests for information under the new federal requirements will be handled by the conflict of interest administrator and the conflict of interest advisory committee. This rule should have only a minor impact on PIs.
PIs, co-investigators and key research personnel will be required to complete formal FCOI training every four years. The current Ohio State plan is to require investigators to complete on-line training through the Collaborative Institutional Training Initiative (CITI) of which Ohio State is a member. Investigators who have taken the CITI Human Subjects Training program within the last two (2) years will be ‘grandfathered’ for the first four years of this requirement. Ohio State investigators and key personnel who have not already taken CITI training must take the soon to be available CITI FCOI training module available at https://www.citiprogram.org before August 24, 2012.
Category : COI / General