(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.
The NIH requires grantees to use the FCOI module, via eRA Commons, to submit FCOI reports. Beginning on April 25, 2014, two major changes will be implemented that will improve Institutional reporting and promote compliance.
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
(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
All faculty and EPA professional employees can now complete their Annual Conflict of Interest Disclosures through an online disclosure management system called “AIR” to report their Activities, Interests and Relationships. The AIR system can be reached at https://uncw.myresearchonline.org/air/index.cfm.
Annual disclosure is stipulated by University Policy and remains a condition of employment for all Faculty and EPA staff.
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 UNCW policy or the federal regulations should be directed to the COI Institutional Official, Ron Vetter, at ext. 2-3224 or firstname.lastname@example.org. Your questions may also be answered by reviewing Frequently Asked Questions on the U.S. Department of Health & Human Services website.