A Plan for Real Research Improvements

Looks like 1,772 of us posted public comments about medical research informed consents to the NPRM docket! I realize this sounds obtuse, but bear with me through this post - please! So, What's the Big Deal? The final regulation will affect millions of patients, researchers, institutions, and companies. These rules last changed in 1991. You know, before the … Continue reading A Plan for Real Research Improvements

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Last Chance to Say Your Word on NPRM

I posted "Informed about Changes to Research Consents?" on 11/15/15. You now have until 1/6/2016 at 11:58pm EST to send your comments about the changes that will affect hundreds of thousands of patients, researchers and institutions (at least). PLEASE send in your comments! Here's how: Read my blog post on 11/15/15 to refresh yourself, and feel free … Continue reading Last Chance to Say Your Word on NPRM

Informed about Changes to Research Consents?

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 … Continue reading Informed about Changes to Research Consents?