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# Tufts Asks for Examples in IRB Meeting Minutes Guidance
- URL: https://www.fdaweb.com/tufts-asks-for-examples-in-irb-meeting-minutes-guidance/
- Published: 2016-01-07T12:00:00.000Z
- Updated: 2026-09-15T02:25:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134368

> Tufts Health Sciences says FDA should include more examples to help IRBs understand its draft guidance on “Minutes of Institutional Review Board (IRB) Meetings.” The document was released in November to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings by providing requirements for minutes and recommendations for meeting the regulatory requirements for minutes. It was also developed because some IRBs have been cited for failing to prepare and maintain adequate minutes, the guidance says.  
>  
> In [comments](http://www.regulations.gov/contentStreamer?documentId=FDA-2015-D-3638-0007&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) to FDA, Tufts says more detail is needed in the draft’s section about summarizing the discussion of controverted issues because many IRBs struggle with the amount of detail that is necessary to satisfy this regulatory requirement. “It would be particularly helpful to have examples of controverted issues as well as points that are not considered controverted issues, with an acceptable way to record these,” Tufts says.  
>  
> Additionally, Tufts asked for examples on satisfying the draft’s recommendation that any such waiver of documentation of informed consent be documented in the minutes with protocol-specific information justifying the IRB’s decision. “Consider including in the guidance specific examples of acceptable ‘protocol-specific information’” that would justify these waivers,” it says.