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Prisoner Research 1: 45 CFR 46 Subpart C - Basics

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

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 

Back to Basics: Does My Project Fall within the Scope of Regulations?

OHRP's Misti Ault Anderson provides an overview of OHRP, the Common Rule, and how the HHS regulations on human research protections are applied. This video is for investigators or IRB professionals seeking basic training or a refresher on the HHS regulations for the protection of human subjects. (Jul 12, 2016)

Watch: Back to Basics: Does My Project Fall within the Scope of Regulations?

What You Should Know About IRB Review of Research

OHRP's Jaime Hernandez discusses the structure and roles of IRBs. He presents the regulatory criteria for IRB approval of research to help investigators understand what it takes to submit a successful research protocol. (Presented at the Trinity Health 2016 Virtual Research Summit, Apr 14, 2016.)

Watch: What You Should Know About IRB Review of Research

The OHRP Webinar Series on the Common Rule NPRM has been moved to the Education & Outreach Archived Materials webpage. Click here to access the OHRP Webinar Series on the Common Rule NPRM. (Sep 30, 2015)

Guidance on Reporting Incidents to OHRP

OHRP’s Kristina Borror addresses the HHS regulatory requirements that apply to reporting incidents and strategies for managing regulatory considerations. Topics include: the regulatory background, what needs to be reported and when, common areas of noncompliance, and institutional considerations. (Jul 24, 2014)

CE: 1:00 CIP Unit (OHRP doesn't provide documentation but viewers can provide the date, time, title, and URL on the CIP recertification application.)

Watch: Guidance on Reporting Incidents to OHRP      

Conducting Internet Research: Challenges and Strategies for IRBs

Laura Odwazny, from the HHS Office of the General Counsel, addresses how the HHS regulations apply to research using the Internet. Topics include: assessing privacy and identifiability of subject information, using the Internet for recruitment and retention, informed consent, and maintaining confidentiality. (May 8, 2014)

CE: 1:00 CIP Unit (OHRP doesn't provide documentation but viewers can provide the date, time, title, and URL on the CIP recertification application.)

Watch: Conducting Internet Research: Challenges and Strategies for IRBs

The Research Clinic

The HHS Office of Research Integrity (ORI) and OHRP developed this interactive training video to educate clinical and social researchers on the importance of protecting research subjects and avoiding research misconduct. Viewers assume the role of one of four characters and determine the outcome by making various decisions.

Watch: The Research Clinic

Biobanking: When Issues with Tissues Come a’Knockin’

Carol J. Weil, from the National Cancer Institute, and former OHRP staff, Samantha Smith, discuss ethical and regulatory issues involving the collection, storage, and research use of biospecimens including, informed consent frameworks, privacy concerns, the identifiability, models for data sharing, and return of research results. (Nov 20, 2013)

CE: 1:00 CIP Unit (OHRP doesn't provide documentation but viewers can provide the date, time, title, and URL on the CIP recertification application.)

Watch: Biobanking: When Issues with Tissues Come a’Knockin’

When the Assurance Comes A Knockin': OHRP's FWA and IRB Registration Processes

OHRP's Irene Stith-Coleman discusses the requirements and process for registering IRBs and obtaining Federalwide Assurances (FWAs) under the HHS regulations at 45 CFR part 46. This video is for those new to human subjects protection and those seeking to refresh their understanding of the requirements. (Mar 28, 2013)

Watch: When the Assurance Comes A Knockin': OHRP's FWA and IRB Registration Processes