All Videos

When the Assurance Comes A Knockin': OHRP's FWA and IRB Registration Processes (31:47)

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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)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

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 (40:20)

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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)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

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

When the Feds come a'Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program (58:09)

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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)

 

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

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

Complex Issues with Research Involving Vulnerable Populations (28:12)

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In this dramatization, a fictional OHRP presenter ends her presentation and invites questions from the audience. She responds to questions regarding the protections for vulnerable research subjects described in subparts B, C, and D of the HHS regulations at 45 CFR part 46. (Sep 21, 2010)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: Complex Issues with Research Involving Vulnerable Populations

IRB Records, Part I (05:57)

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This video shows fictional characters learning about the IRB records requirements described at 45 CFR part 46. The fictional institution hired a consultant to evaluate its human subjects protections program, who made several observations regarding their compliance with the regulations.(Sep 21, 2010)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: IRB Records, part I

IRB Records, Part II (13:50)

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In this dramatization, the fictional characters meet to review the deficiencies observed in and requirements related to the IRB's meeting minutes and other IRB records. (Sep 21, 2010)

 

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: IRB Records, part II

General Informed Consent Requirements (18:38)

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This dramatization starts with a fictional investigator and IRB Chair talking about obtaining legally effective informed consent from potential research subjects. The second scene portrays the investigator obtaining appropriate informed consent from a potential subject. (Aug 24, 2010)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: General Informed Consent Requirements

Research Use of Human Biological Specimens and Other Private Information (22:42)

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OHRP's Julie Kaneshiro discusses the challenges and complexities of applying the HHS regulations to activities involving biological specimens and other private information, including when they do and do not apply. This video is best suited for those who already have basic understanding of the HHS regulations. (Jul 5, 2010)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: Research Use of Human Biological Specimens and Other Private Information

Institutional Review Board (IRB) Membership (16:04)

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In this dramatization, a Signatory Official meets with her staff to discuss establishing an IRB for their institution. The Human Subjects Protections Administrator provides guidance regarding a broad range of topics including IRB membership, quorum requirements, written procedures, and other important information. (Jul 5, 2010)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Watch: Institutional Review Board (IRB) Membership