Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 37, No. 5, May, 2022
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 Public Posting of Consent Documents (#1)
Due in part to questions raised by IRBs, researchers, and others, the federal Office for Human Research Protections (OHRP) recently published a new advice document on their Web site.
The document is titled “Informed Consent Posting Instructions.” We present here some key background highlights of this information, with more details to follow in future HRRs.
Note that, while IRBs do have options on how and where to post samples of their approved consent forms, they generally do not have the option to not do so.
“I. Scope of These Instructions
The revised Common Rule (also referred to as the 2018 Requirements)1 at 45 CFR 46.116(h) requires that for each clinical trial conducted or supported by a federal department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the federal department or agency component conducting the trial”…