The federal regulation governing financial conflict of interest in research has changed. In August, 2011, the U.S. Department of Health and Human Services issued the final rule that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought (45 C.F.R. Part 50) and Responsible Prospective Contractors (45 C.F.R. Part 94). Institutions are required to comply with this regulation no later than August 24, 2012.
The major changes of the new regulation include:
- Requirement for researchers to disclose all financial interests related to their institutional responsibilities (teaching, research, professional practice, etc.)
- Obligation for institution to determine which interests are related to an investigator’s research
- Reduction in the dollar threshold of what can create a financial conflict of interest (from $10,000/year to $5,000/year)
- Requirement for researchers to disclose income from private non-profit organizations
- Requirement for researchers to disclose reimbursed/sponsored travel except travel sponsored by universities, government agencies, or academic medical centers
- Mandatory training on financial conflict of interest
- Requirement for institution to make financial conflict of interest information accessible to the public
- Institutional monitoring of researchers’ compliance with management plans
- Prescriptive action for non-compliance
- Expanded requirements for institutions to report financial conflicts of interest to PHS funding agencies
The policy applies to all individuals involved in research at the University, regardless of job title, who contribute in a substantive way to the development, execution, and reporting of research, and who are granted a significant degree of freedom in exercising independent judgment.
Questions regarding the new UI policy or the federal regulations should be directed to Martha Hedberg, 319-384-4258. Your questions may also be answered by reviewing the Frequently Asked Questions document.
The Conflict of Interest in Research Committee (CIRC):
(i) reviews those cases in which an Investigator has disclosed significant financial interests that may be affected by the results of his/her research project and
(ii) recommends management strategies to the Vice President for Research.
The Conflict of Interest in Research Committee (CIRC) is appointed by the Vice President for Research. The CIRC is made up of faculty and staff representing the diversity of academic and research disciplines of the University.
Management strategies are developed and implemented to address conflicts of interest and to assure that the Investigator may satisfy his/her research obligations in an objective manner and to avoid and/or mitigate concerns of bias. Management strategies that may be considered in addressing conflicts range from no action required other than disclosure, to that of disqualification of the Investigator from participating in the project, as well as others.
IRB review of the study is contingent upon IRB receipt of the management strategy agreed upon by the investigator(s).
Direct questions to:
Martha Hedberg, MPA
COIR/HSO Operations Manager
105 Hardin Library for Health Sciences
(319) 384-4256
martha-hedberg@uiowa.edu
