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Complex Issues with Research Involving Vulnerable Populations

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)

Watch: Complex Issues with Research Involving Vulnerable Populations

IRB Records, Part I

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)

Watch: IRB Records, part I

IRB Records, Part II

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)

 

Watch: IRB Records, part II

General Informed Consent Requirements

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)

Watch: General Informed Consent Requirements

Reviewing and Reporting Unanticipated Problems and Adverse Events

Michael Carome, formerly of OHRP, discusses the criteria for determining if an incident or outcome is an unanticipated problem involving risk to subjects or others (according to the HHS regulations), the differences between adverse events and unanticipated problems, and how to respond . (Jul 5, 2010)

Watch: Reviewing and Reporting Unanticipated Problems and Adverse Events

Research Use of Human Biological Specimens and Other Private Information

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)

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

Institutional Review Board (IRB) Membership

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)

Watch: Institutional Review Board (IRB) Membership