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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

When PIs Come a'Knockin': Everything Investigators Want to Know but are Afraid to Ask

OHRP staff presentation on investigator obligations when conducting research with human subjects under the HHS regulations. This video is for those new to the field of human subjects research and those seeking to refresh and reinforce their understanding of the regulatory requirements. (Nov 8, 2012)

Watch: When PIs Come a' Knockin': Everything Investigators Want to Know but are Afraid to Ask

When the Regs Come a' Knockin': Nuts and Bolts of 45 CFR part 46

Former OHRP staff, Elyse Summers, discusses the history and requirements of the HHS regulations for the protection of human subjects in research. (Jun 7, 2012)

 

Watch: When the Regs Come a' Knockin': Nuts and Bolts of 45 CFR part 46

When the Feds come a'Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program

Director of OHRP's Division of Compliance Oversight, Kristina Borror, discusses how to respond to allegations of noncompliance and how to prepare for an investigation. (Feb 23, 2012)

 

Watch: When the Feds come a' Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program