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OHRP Educational Webinars

OHRP offers educational webinars that provide information about the requirements of HHS regulations for the protection of human subjects in research. 
 
Additional webinars will be posted here as they are produced. We welcome any feedback or suggestions on content, format, or any other aspect of these training materials. Please send your comments and suggestions to OHRP-Edu@HHS.GOV.
 
These webinars are also included in the OHRP YouTube Playlist or are on the NIH videocast system.
 
Available webinars include:
 
Misti Ault Anderson, Senior Advisor for Public Health Education, provides an overview of the role of the HHS Office for Human Research Protections (OHRP), the “Common Rule”, and how the HHS regulations on human research protections are applied. Her presentation provides examples to demonstrate for viewers how and when the regulations apply to research. This webinar is intended for investigators or IRB professionals that seek basic training or a refresher on the HHS regulations for the protection of human subjects in research.
 
Watch: Back to Basics: Does My Project Fall Within the Scope of the Regulations?        
 
Jaime Hernandez, Public Health Advisor, examines the structure and the roles of Institutional Review Boards (IRBs) in a presentation that he gave for the Trinity Health 2016 Virtual Research Summit. His presentation discusses the regulatory criteria for IRB reviews with the goal of providing participants with a good understanding of why the regulatory criteria matter, what IRBs look for and what it takes to have research approved. The presentation is geared towards investigators with the goal of giving them the knowledge and skill to get their research protocols through IRB review smoothly.
 
Watch: What You Should Know About IRB Review of Research        
 
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015.
 
In order to help the public better understand the goals and impact of the new proposals, OHRP developed six webinars covering key aspects of the NPRM. The webinars aim to explain the NPRM proposals that are most relevant to each topic. As such, there is a fair amount of overlap in content and material covered in the webinars.
 
It is important to remind the audience that information provided in these webinars is necessarily simplified. For a complete and fully accurate description of the proposed changes, the audience is advised to refer to the full NPRM document (PDF 1063 KB).
 
6 key topics covered by the webinars:
  1. Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
    Watch: Overview of the NPRM
     
  2. Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
    Watch: Exclusions and Exemptions
     
  3. Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
    Watch: Informed Consent
     
  4. IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
    Watch: IRB Review and Operations
     
  5. Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
    Watch: Research with Biospecimens
     
  6. Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP
    Watch: Secondary Research Use of Data
 
 
Dr. Kristina Borror, Director of OHRP’s Division of Compliance Oversight, addresses the HHS regulatory requirements that apply to reporting incidents, and discusses strategies for managing regulatory considerations, including the regulatory background; what needs to be reported; time frames for reporting; common areas of noncompliance reported to OHRP; OHRP processing of reports; corrective actions; institutional considerations; and the future of reporting.
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.
Watch: Guidance on Reporting Incidents to OHRP        
 
In this lecture, Laura M. Odwazny, Senior Attorney with the HHS Office of the General Counsel, 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 is available 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.
 
Carol J. Weil, from the National Cancer Institute, and Samantha Smith, former staff member of OHRP, discuss ethical and regulatory controversies involving the collection, storage, and research use of biospecimens.  Issues covered include regulatory background, informed consent frameworks, privacy concerns, the identifiability of genomic data, various models for data sharing, and the return of research results.
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.
 
Dr. Irene Stith-Coleman, Director of OHRP’s Division of Policy and Assurances, and former OHRP staff members Hal Blatt and Jean Makle discuss 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.
 
Michelle Feige, former OHRP staff member, 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.
 
Elyse Summers, JD, former Director of the Division of Education and Development discusses the history and requirements of the HHS regulations for the protection of human subjects in research.  
 
Dr. Kristina Borror, Director of OHRP’s Division of Compliance Oversight, discusses how to respond to allegations of noncompliance and how to prepare for an investigation.
 
 
 
 

 

Content created by Office for Human Research Protections
Content last reviewed on March 4, 2016