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Mini-Tutorials

OHRP understands that everyone is busy and may not have time for an hour-long video. To meet this need, OHRP created a series of short tutorials (15 minutes or less) that focus on specific aspects of HHS human subjects regulations and policy. These mini-tutorials are designed to help human research protections professionals build on their knowledge. OHRP’s materials are intended for public use and distribution, and we invite you to share or link to them from your website.

 

 

Prisoner Research 1: 45 CFR 46 Subpart C-Basics (16:23)

OHRP's Julia Gorey discusses the history and requirements of subpart C for research with prisoners, including who is considered a prisoner, IRB review of research with prisoners, allowable categories of prisoner research, and subpart C certification. (Feb 13, 2017)

Watch: Prisoner Research 1: 45 CFR 46 Subpart C-Basics    

 

Prisoner Research 2: Considerations When a Subject Becomes a Prisoner (18:16)

OHRP's Julia Gorey discusses the ways prisoners may become involved in research and trigger subpart C protections, the relevant areas of regulatory concern, and IRB review of subpart C research. (Feb 13, 2017)
 

Watch: Prisoner Research 2: Considerations When a Subject Becomes a Prisoner

 

Relevant OHRP guidancePrisoner FAQsPrisoner research certification, and Prisoner Involvement in Research.

Reporting to OHRP 1: What's Necessary, What's Not (11:47)

OHRP staff member Lisa Buchanan explains what constitutes unanticipated problems, adverse events, serious non-compliance, and continuing non-compliance, in addition to discussing IRB suspensions and terminations. She also explains requirements for written procedures for reporting to OHRP. (Mar 3, 2017)

Watch: Reporting to OHRP 1: What's Necessary, What's Not

 

Reporting to OHRP 2 (12:55)

OHRP staff member Lisa Buchanan discusses what investigators should do when a reportable incident occurs, actions that IRBs need to take, when to report an incident to OHRP, and how OHRP will process incident reports. (Mar 3 , 2017)

Watch: Reporting to OHRP 2

 

Relevant OHRP guidance: Guidance on Reporting Incidents to OHRP

 

 

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