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.
May 8, 2014 -- Conducting Internet Research: Challenges and Strategies for IRBs
Laura M. Odwazny is a Senior Attorney with the Office of the General Counsel, U.S. Department of Health and Human Services. Ms. Odwazny’s primary client is the Office for Human Research Protections.
In this lecture, Ms Odwazny addresses how specific requirements of the HHS protection of human subjects regulations apply to research using the Internet and discusses strategies for managing the relevant ethical issues and regulatory considerations, including assessing the privacy and identifiability of subject information obtained via the Internet; the use of the Internet for subject recruitment and retention; informed consent procedures; and maintaining confidentiality in an online environment.
- Webinar on NIH videocast system.
CE: 1:00 CIP Unit available. Unfortunately, OHRP is unable to provide documentation of your participation in this event. Please give detailed information (date, time, title, website) about the event on your CIP recertification application.
- 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.
- 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.
- 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.
- 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.