2012 Webinar: Conflicts of Interest in the Wake of NIH's New Policy

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Overview

Compliance with the final rule on financial conflicts of interest (COI), issued by the National Institutes of Health (NIH) in August 2011, must be achieved by August 24, 2012. Any institution applying for or receiving NIH funding from a grant, cooperative agreement, or contract will need to be in adherence with all of the revised regulatory requirements by the aforementioned date. This webinar focused on the changes brought on by the new rule and will provide examples of possible implementation strategies and case studies.

The following topics were discussed during this presentation:

  • Background information on COI and the current state of affairs
  • What potential research participants want to know, and how this information influences decisions to participate
  • Current literature on the implications of COI: findings about the relationship between industry sponsorship of clinical research and industry-favorable research findings; the lack of empirical data on the impact of COIs or their management on research integrity; and emerging literature on the counterproductive impacts of disclosure
  • Operationalizing the new NIH COI policy: how the new rule will change what information is available to institutional review boards (IRBs) and COI programs and affect IRB decisions about what should be included in informed consent processes and documents
  • Difficult elements of the new policy: institutional determinations of when conflicts exist, travel disclosures, bias assessment, and mitigation plans
  • Changes to how conflicts will be formally assessed
  • Contextualizing COI: Variability among institutional approaches to COI and case studies to demonstrate how  institutions are dealing with complex scenarios

Audience

This intermediate-level webinar was of interest to those working in compliance and with human research protections programs and IRBs.

Faculty

Jeffrey R. Botkin, MD, MPH Jeff Botkin, MD, is a professor of pediatrics and an adjunct professor of human genetics at the University of Utah. Dr. Botkin also serves as chief of the division of medical ethics and humanities and associate vice president for research integrity. His research is focused on the ethical, legal, and social implications of genetic technology with a particular emphasis on research ethics, genetic testing for cancer susceptibility, biobanking, newborn screening, and prenatal diagnosis. Dr. Botkin is currently a member of the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. He chairs the National Institutes of Health embryonic stem cell working group and is an elected fellow of the Hastings Center. Previously, he served as chair of the committee on bioethics for the American Academy of Pediatrics, and was a former member of the Secretary’s Advisory Committee on Human Research Protections at the Department of Health and Human Services.

Ross E. McKinney, Jr, MD Ross McKinney, MD, is the director of clinical and translational research ethics, law, and policy and a professor of pediatrics at Duke University. He currently serves as the director of the Trent Center for Bioethics, Humanities and History of Medicine. Prior to this position, Dr. McKinney held the position of vice dean for research at the Duke University School of Medicine. Dr. McKinney arrived at Duke for his internship and residency in pediatrics in 1979, and continued at Duke for a fellowship in pediatric infectious disease, joining the Duke faculty in 1985. Dr. McKinney shifted his focus to pediatric HIV clinical research in 1987 and was first author of the key phase I and II papers regarding Zidovudine (AZT) use in children. Dr. McKinney continues to do research regarding the natural history, prevention, and treatment of pediatric HIV disease. In bioethics, his areas of research focus are conflict of interest and the process of informed consent. Dr. McKinney served two terms as chairman of the sub-board for infectious diseases of the American Board of Pediatrics (1998-2001). He was the chair of the steering committee for the Forum on Conflict of Interest in Academe for the Association of American Medical Colleges, and is currently chair of the Clinical Research Ethics Key Function Committee of the NIH Clinical Translational Science Award Collaborative Consortium.

Certificates of Attendance

Certificates of Attendance were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification Webinar participants holding the CIP credential who wish to apply credits from this webinar toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.