Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 2, February, 2021

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Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.

Human Subject Regulations

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Excerpt from pg. 4 … IRBs and Reviewing Certain “Live Case Presentations” (#8)

“We continue here with additional tips for IRBs when they review research proposals that involve the use of a “live case presentation.” Such studies usually involve the use of FDA-regulated products.

The current relevant FDA guidance is titled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff.”

We resume this month where we left off in last month’s HRR with the section of the guidance that is titled “V. Data Collection and Reporting.”

Although this particular area of the guidance does not have the overall importance as recommendations on issues such as informed consent, it is still important for IRBs.”