Informed about Changes to Research Consents?

One Health of a Life

Isolated patients need clearer informed consents to engage fully in research.

If not, you’ll be surprised soon. The Common Rule is changing – 1st time since 1991. The US NIH NINR says, “The Common Rule contains regulations that protect individuals who participate in research and is followed by 18 federal agencies.” Translation: these are the rules that apply to informed consent forms that patients sign to join research studies.

Your input (yes, you!) actually matters. Here is what you can do:

  1. Brush up on proposed changes: check out the summary, the full text in Federal Register, the public comments, and start thinking about yours as you read on.
  2. Comment before 12/7/15 at the Notice of Proposed Rulemaking (NPRM). If you need the docket ID #, it’s HHS-OPHS-2015-0008.
    EDIT: the public comment period has been extended – post your comments before 1/5/2016.
  3. Be sure to remind them to STOP with this ‘research…

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  1 comment for “Informed about Changes to Research Consents?

  1. January 6, 2016 at 8:00 pm

    Thanks again, Jorge. I also posted instructions for making public comments at The comment period closes tonight (Jan 6) at 11:59pm Eastern Standard Time (NY time). I’ll also be posting my comments today or tomorrow (if I can get off conference calls long enough to do so). Happy New Year!

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