Thursday, November 19, 2015

The Coming Changes to Informed Consent

You could fit the Golden Rule — Do unto others as you would them do unto you — into a single Tweet and have 96 characters to spare. #Clear&Concise.
The Common Rule, by contrast, runs into the hundreds of pages. #WordyFeds
But at the center of the Common Rule is informed consent, a process that is rarely clear or concise but can be summed up in a Tweetable phrase: Nothing about me without me.
The Common Rule is a set of federal regulations protecting human subjects in government-funded research. Much like the field of bioethics itself, the Common Rule came in response to research abuses, notably including the decades-long Tuskegee syphillis study, where curative penicillin was kept from impoverished African American subjects without their knowledge.  
A new Common Rule is being written and is expected in 2016. Central to this revision is the role of consent at a time when genomic information and vast stores of data and biospecimens (blood, tissue, etc.) hold tremendous potential for development of cures and treatments. But that history of abuse infuses the process with caution, especially as relates to changing consent.
An informative series of forums have been held around the country and are available for viewing on YouTube (one example).
A summary of what is known as the #NPRM (Notice of Proposed Rulemaking) is available here.
Comments are invited until December 7. See details below.
It is the sort of bureaucratic undertaking that makes many Americans’ eyes glaze over. And yet the impact of this policy will be felt for years — on scientific research, medical treatment and the care and trust of the public, especially its most vulnerable members. 
To comment, go to http://www.regulations.gov/#!home, search for docket number HHS-OPHS-2015-0008, and click “Comment Now.” Or, comment by mail to: Office for Human Research Protections (OHRP), 1101 Wootton Parkway, Suite 200, Rockville, MD 20852

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