Conflict of Interest
Conflicts of Interest exist in many forms and frequently are inherent to the nature of the research enterprise. A Conflict of Interests can arise in situations in which there exists discord between a primary duty and a secondary interest. While such interests can be either financial or non-financial, they, nevertheless, can yield conscious or subconscious bias in the conduct and/or interpretation of research, and, potentially can adversely impact the safety of human or animal research subjects. Often financial Conflicts of Interest will simply present an appearance of compromising an investigator's professional judgment in conducting or reporting the results of research. Accordingly, and whether real or only perceived, all identified conflicts of interests must be addressed.
Policy/Guidance
VCU Policy Conflicts of Interest in Research – Interim (approved 7/18/2012; phased in compliance as of 8/24/2012)
“AIRS for COI assessment” - Tutorial 3/18/2013
Who is a 'COI investigator' for AIRS? – guidance
***Annual Update due July 1st for all Research FIR users. |
Implementation and use of the VCU Activity and Interests Reporting System (AIRS):
- Phase 1 of implementation: Designated ‘COI investigators’ complete FIR in the AIRS for proposal/contract submissions (IAFs) to OSP as of 8/24/2012. COI disposition is determined for each ‘COI investigator’ before award distributed.
- Phase 2 IRB: Designated ‘COI investigators’ must complete FIR in the AIRS for protocol submissions and Continuing Reviews as of 10/1/2012. COI disposition for each ‘COI investigator’ required for protocol approval.
- Phase 3 IACUC: Designated ‘COI investigators’ must complete FIR in the AIRS for protocol submissions and Amendments as of 10/19/2012. COI disposition for each ‘COI investigator’ required for final approval.
Access AIRS: https://airs.research.vcu.edu
To access AIRS outside of VCU: Click here for VCU's VPN
Instructions on how to use the VCU AIRS
Research Conflict of Interests
Training: PHS Final Rule and VCU Policy
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PHS Final Rule
FINAL RULE ("Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors") regarding financial conflicts of interest in research was published in the Federal Register on August 25, 2011. This document is available as a PDF at: http://federalregister.gov/a/2011-21633 Institutions must be in compliance by August 24, 2012.
For more information see: NIH website on Financial Conflict of Interest |
Communication about the AIRS:
1/25/2013: Email communication from the Vice President for Research about updating Financial Interest Reports in the AIRS
9/27/2012: Email communication from the Vice President for Research about the AIRS activity as of 9/24/2012
8/17/2012: Email communication from the Vice President for Research about the 8/20 'go live' date of the AIRS and phased in implementation
8/7/2012: Email communication from the Vice President for Research about the status of VCU’s implementation of the Final Rule and VCU’s Policy and process. |
What are conflicts of interest in research?
Conflicts of Interest exist when financial or other personal interests or considerations of the Investigator, or members of his or her immediate family, may directly and significantly affect, or have the appearance of directly and significantly affecting, an Investigator’s professional judgment in exercising any University duty or responsibility, including the design, conduct or reporting of research. Investigator financial Conflicts of Interests occur when the Investigator, or any member of that person’s immediate family (spouse, or domestic partner, and any other person residing in the same household as the researcher, who is a dependent of the Investigator or of whom the Investigator is a dependent), possesses a financial interest in a research activity that involves his or her University responsibilities. For some activities, such as human subjects research, any financial interest may give rise to a finding of Competing Financial Interests whereas in other situations, only a Significant Financial Interest will give rise to a Conflict of Interests. See the VCU Conflicts of Interest Policy for more information.
VCU Policy - Conflicts of Interest in Research – Interim
VCU Research COI Management Matrix 
VCU IRB Written Policy & Procedure #VIII-10 - Evaluating Investigator Potential Conflicts of Interest
Guidance for faculty considering STTR/SBIR funding
Reporting Outside Professional Activities (VCU Faculty)
Conflict of Interests Committee
Conflict of Interests Committee (for research) is a standing committee of the University, composed of faculty and administrative personnel, as needed, and convened under the authority of the Vice President for Research by his or her designee. The Committee is charged to evaluate investigator reports of research related financial interests and determine an appropriate resolution, including the development of a management strategy, as appropriate. Committee members are responsible for adhering to applicable rules of privacy and confidentiality when commencing conflict of interest assessments.
Research Conflict of Interests Committee 2012-2013
| F. Douglas Boudinot, PhD |
Dean, Graduate School |
| Kai I. "Annie" Cheang, Pharm.D., M.Sc. |
School of Pharmacy, Pharmacotherapy & Outcomes Science |
Dan Conrad, PhD |
Microbiology & Immunology |
Anne- Marie Irani, MD (Alternate) |
Pediatric Allergy & Immunology |
Monika Markowitz, PhD
Chair |
Director, Office of Research Integrity and Ethics, Office of the Vice President for Research |
Mary Ann (Mimi) Peberdy, MD |
Internal Medicine, Cardiology |
Richard Sterling, MD |
Internal Medicine, Gastroenterology, Hepatology, and Nutrition |
Jennifer Wayne, PhD |
Biomedical Engineering |
Administrative support: Ms. Zena Bailey, ORIE Programs Manager
Educational Resources on Conflict of Interests
"Addressing Research Conflict of Interest for Individuals and the Institution"
Ross E. McKinney, M.D., Duke University School of Medicine – VCU Sanger Lecture in Ethics, November 2011
Click here for audio. This will require a media player that can play MP3 files.
News about Conflicts of Interest
FINAL RULE ("Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors") published in the Federal Register on August 25, 2011 regarding financial conflicts of interest in research. This document is available as a PDF at: http://federalregister.gov/a/2011-21633 )
This policy has been developed over the past 2 years, and replaces regulations that have been in place since 1995. The new regulations have a major impact on the identification, reporting, and management of financial conflicts, especially for individuals who are involved in research sponsored by the National Institutes of Health (NIH) and other agencies of the Public Health Service. The NIH has compared the 1995 and 2012 regulations, highlighting selected changes and this document can be downloaded at: http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc.
On May 21, 2010, the Department of Health and Human Services published in the Federal Register a Notice of Proposed Rulemaking (NPRM) concerning, "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors." The full NPRM is available on-line at: http://edocket.access.gpo.gov/2010/pdf/2010-11885.pdf.
NPRM Table is a very useful side-by-side comparison, prepared by NIH, of the current financial conflicts of interest regulations and the proposed regulations as described in the NPRM.
In addition, Drs. Francis Collins and Sally Rockey of NIH, have written a commentary on the proposal that was posted by JAMA on its web site. It has been made available to all at: http://jama.ama-assn.org/cgi/content/full/jama.2010.774.
The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG), How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health (NIH) (OEI-03-07-00700), November 19, 2009. The report is available on the OIG’s website at: http://www.oig.hhs.gov/oei/reports/oei-03-07-00700.pdf
Editorial
Uniform Format for Disclosure of Competing Interests in ICMJE Journals
J.M. Drazen and Others (2009) New England Journal of Medicine, October 13, 2009
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