2011 Webinar: DHHS and FDA Regulations

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Overview

DHHS and FDA Regulations: What’s Different, What’s Similar, and What Does it all Mean for my HRPP? featured a discussion between the representatives of these two federal agencies.

Topics included:

  • Background information about the reasons for, and historical underpinnings of, the two sets of federal regulations
  • Overview of the U.S. Department of Health and Human Services (DHHS) regulations and recent guidance documents, including how they apply to research conducted internationally
  • Areas of overlap and divergence between the regulations of DHHS and the US Food and Drug Administration (FDA), and guidelines for determining which are applicable to the different kinds of research conducted at your institution

Audience

The topic of this webinar was of interest to HRPP professionals, IRB members, staff, administrators, and researchers.

Faculty

Lisa Buchanan, MAOM
Lisa Buchanan serves as a public health analyst in the division of compliance oversight, Office for Human Research Protections (OHRP), DHHS. Ms. Buchanan investigates allegations of noncompliance with HHS regulations for protection of human research subjects and has over 18 years of experience in the areas of regulatory compliance and IRB operations and training. Prior to joining the Office for Human Research Protections in 2008, she held human research protection leadership roles at the Chesapeake Research Review, Inc. (an independent IRB in Columbia, Maryland), the National Cancer Institute – Central IRB, George Washington University, the National Institute of Allergy and Infectious Diseases (intramural IRB), and Children’s National Medical Center in Washington, DC.

Richard Klein
Richard Klein is the HIV/AIDS Program Director with the US Food and Drug Administration (FDA) Office of Special Health Issues, serving as the primary interface between the agency and the HIV/AIDS patient and advocacy communities. He works extensively with HIV and other patient communities and within the agency’s scientific offices to address issues and concerns of the affected community in a variety of areas, including drug access, product safety, and clinical trial design. Mr. Klein has worked at the FDA in various capacities for more than 30 years, gaining a well-rounded understanding of the regulatory issues that affect patients. Immediately prior to becoming the HIV/AIDS Program Director, he was involved in human subject protection policy development for the agency, working closely with other federal agencies and the US Department of Health and Human Services (DHHS) to ensure consistent and meaningful policy for the protection of human subjects of biomedical research. He is a member of the FDA institutional review board (IRB), participating in the ethical review of research conducted by the agency.