Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 1, January, 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.

IRBs and Review of Studies

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Excerpt from pg. 3 … IRBs and Review of Studies When New Sites Are Added to Project

The federal Office for Human Research Protections (OHRP) has issued a new guidance for IRBs and others involved in multisite experiments involving human subjects. This new guidance helps to interpret how to implement changes set in place by the revised Common Rule.

On November 12, 2020, OHRP issued ‘OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements: Options for How New Sites Added to Ongoing Cooperative Research Can Follow the Same Version of the Common Rule.’

The guidance responds to questions from the regulated community on how institutions can maintain consistency in the version of the Common Rule that applies to a cooperative research project in situations where an Institutional review Board (IRB) approved the study at one or more sites before the general compliance date of the 2018 Requirements (i.e., the revised Common Rule), and other sites are added after the general compliance date of the 2018 Requirements.