HHS Tightens Financial Conflict of Interest Rules for Researchers

The U.S. Department of Health and Human Services today issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing, and ultimately avoiding investigators’ financial conflicts of interest Staff from the National Institutes of Health worked with others in HHS to revise the 1995 regulations to update and enhance the objectivity and integrity of the research process.

Major changes to the regulations include the definition of significant financial interest (SFI), the extent of investigator disclosure, the information reported to the Public Health Service (PHS) awarding component, the information made accessible to the public, and investigator training. For example, the revised regulations:

• Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
• Lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
• Require institutions to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed.
• Require institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.
• Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.

Additional details about the major changes to the regulations can be found at: (http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf).

The regulations will be implemented no later than 365 calendar days after publication of the final rule in the Federal Register.

Read more via http://www.nih.gov/news/health/aug2011/od-23.htm.

Funding Opportunity For Studies On Integrity in Collaborative Research

The Department of Health and Human Services has published a Funding  Opportunity Announcement (FOA) titled Research on Integrity in Collaborative Research (R21), with the Office for Human Research Protections (OHRP) listed as one of the participating organizations, along with the Office of Research Integrity (ORI) and the National Institutes of Health (NIH). In part, the purpose of this program is described as follows:

Applications must address the influence of collaborative interactions and/or activities on research integrity in at least one of the following areas that are of particular interest to the ORI and NIH: the clarification of community norms and standards, the effectiveness of self-regulation, the societal, organizational, group, or individual factors that affect integrity in research, both positively and negatively, or the impacts of non-adherence to accepted codes of conduct.

While OHRP is not participating in funding the opportunities described in the FOA, OHRP supports the importance of this program and the potential for research activities that could shed light on the operation of human research protection programs and how they could be improved.  OHRP notes that research activity proposals addressing the areas of particular interest in this program could include investigations of various aspects of collaborative activities related to or including the protection of human subjects in research.  OHRP hopes that high quality research proposals of this kind will be submitted for consideration.  The opening date is March 7, 2010 (the earliest date an application may be submitted to Grants.gov), the Letters of Intent receipt date is also March 7, 2010, and the Application due date is April 7, 2010.  Interested parties should review the announcement, which is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-10-001.html.

Faculty Conflict Of Interest Disclosure Statements

According to an announcement from the BSOM Office of Faculty Affairs, all faculty members must submit a conflict of interest disclosure statement and an acknowledgment of receipt and attestation of compliance of the Code of Faculty Behavior annually, and any time upon entering into a new or revised industry-sponsored activity that potentially affects their role as administrator, teacher, researcher, or clinician in the Boonshoft School of Medicine or with Wright State Physicians, Inc.

NOTE: Bargaining Unit Faculty Members are exempt from the following procedures and do not have to complete the online attestations.

See the policies on Pharmaceutical/Medical Device Industry Conflict of Interest and Code of Faculty Behavior. Use the online disclosure form. Faculty will need WSU usernames and passwords to login to the form.

The information provided is accessible to the public.

For more information, contact Stephanie Ours, coordinator in the Office of Faculty Affairs (937-775-2033; stephanie.ours@wright.edu)