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:
- 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.
- 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.
- Be sure to remind them to STOP with this ‘research…
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