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(REQUIRED) Each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years.
NIH has compiled answers to the most frequently asked questions regarding the implementation of the revised regulations for grants and cooperative agreements. The questions are arranged by topic, indicating to whom (Institution and/or Investigator) they pertain.
Table summarizing major changes between the 1995 regulation and the 2011 regulation.
Examples of COI:
Examples that illustrate the range of activities that might constitute a conflict of interest
NIH Financial Conflict of Interest Tutorial:
(Optional) (08/02/2012, Adobe Flash Player is required) - This tutorial is related to the 2011 revised Financial Conflict of Interest (FCOI) regulation provided at 42 CFR Part 50 Subpart F on Promoting Objectivity in Research
Conflict of Interest (COI)
Report of Potential Conflict of Interest Activities & Relationships
Download forms needed. Print, complete and forward to your supervisor for approval.
Form 03.230
Form 03.230A
Form 03.230B
Form 03.230C
External Professional Activities for Pay
Sponsored Travel Disclosure Form - Required for Public Health Service Applicants and/or Recipients
Federal regulations require institutions to have policies and procedures in place to ensure that investigators disclose any significant financial interest that may present an actual or potential conflict of interest in relationship to externally sponsored projects. UNCW acknowledges that conflicts of interest will occur from research activity, technology transfer activities, and our investigators’ professional activities. We seek to identify and manage these conflicting relationships, restricting activities where necessary, to preserve transparency, independent decision-making, protection of research subjects, and integrity of the educational experience.
UNCW has drafted its policy changes to reflect the necessary revisions in order to be in compliance with the federal regulations outlined below. These changes will go into effect on August 24, 2012.
New Federal Regulation on Conflict of Interest in Research
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
Accordingly, the UNCW policy on conflict of interest in research has been revised and will be implemented August 24, 2012. The policy applies to all full-time and part-time faculty and EPA non-faculty employees insofar as their university responsibilities are concerned. In addition, there are new specific requirements for PHS applicants including additional training and reporting requirements.
Questions regarding the new UNCW policy or the federal regulations should be directed to Angie Kelly in the Office of Research services at ext. 2-7774 or kellya@uncw.edu. Your questions may also be answered by reviewing Frequently Asked Questions on the U.S. Department of Health & Human Services website.
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