I should note that when we started to receive comments on what was to become the NIH DMS Policy, one thing in particular stood out to us. Many commentors told us it would be helpful to have clear information on how to protect the privacy and respect the autonomy of participants when sharing data. Now, we all know that cliffhangers build anticipation, so without further delay, I want to share with you some of the tools NIH has been working on to answer that call.
The revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all NIH-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit. See Guide Notice NOT-OD-19-050.