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OHRP Educational Webinars

The following educational webinars were developed by the Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The webinars represent OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777. 

OHRP anticipates the release of additional webinars in the future. We welcome any feedback or suggestions on content, format, or any other aspect of these training materials. Please send your comments to OHRPwebinars@hhs.gov.

These webinars are also included in the OHRP YouTube Playlist.

  • November 20, 2013 -- “Biobanking: When Issues with Tissues Come a’Knockin’," Carol J. Weil, National Cancer Institute, NIH and Samantha Smith, OHRP. Carol’s talk focuses broadly on current ethical and regulatory controversies involved with the collection, storage and research use of biospecimens.  Issues covered include regulatory background, informed consent frameworks, privacy concerns, the identifiability of genomic data, different models of data sharing, and the return of research results.
  • Webinar on YouTube

 

  • March 28, 2013 -- “When the Assurance Comes A Knockin' Everything You Need to Know About OHRP's FWA and IRB Registration Processes,” featuring Dr. Irene Stith-Coleman, Dr. Hal Blatt, and Ms. Jean Makle with the Division of Policy and Assurances, OHRP.  The presentation covers the requirements and processes involved in registering Institutional Review Boards (IRBs) and obtaining Federalwide Assurances (FWAs) under the HHS regulations at 45 CFR part 46. This webinar is a basic offering well-suited for those new to the field of human subjects’ protection and those not-so-new seeking to refresh and reinforce their understanding of these requirements.      

        Supporting materials: 

 

  • November 8, 2012 -- "When PIs Come a' Knockin': Everything Investigators Want to Know but are Afraid to Ask," presented by Michelle Feige, MSW, of the Division of Education and Development. This webinar discusses investigator obligations  under the HHS regulations at 45 CFR part 46 when conducting research with human subjects.  This webinar is a basic offering well-suited for those new to the field of human subjects’ protection and those not-so-new seeking to refresh and reinforce their understanding of the regulatory requirements.

        Supporting materials: 

 

  • June 7, 2012 -- "When the Regs Come a' Knockin': Nuts and Bolts of 45 CFR part 46," presented by Elyse Summers, JD, Director of the Division of Education and Development.  This presentation discusses the history and requirements of the U.S. Department of Health and Human Services regulations for the protection of human subjects research.  

Supporting materials: 

 

  • February 23, 2012 -- "When the Feds come a'Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program," Presented by Dr. Kristina Borror, Director of the Division of Compliance Oversight.  This presentation teaches you how to respond to allegations of noncompliance and how to prepare for an investigation.

 Supporting materials: