Is it time to change how clinical research subjects are treated?

As a result of my participation in the NIH GDNF Gene Therapy trial made me aware of the need for care in case of injury

On February 4, 2015, I took part in the National Institutes of Health (NIH) Bioethics Grand Round: "Should we compensate subjects for research related injuries?" Mr. Kenneth Feinberg, JD, 911 Fund, and Boston Marathon Fund, responded to my "ask". His talk was fascinating, but not exactly what I was expecting.

Ironically, research participants are the only people in the clinical research process who do NOT receive compensation, which in this case is Long Term Care in the event of catastrophic brain injury. In fact, my Informed Consent says if I am injured, I would receive 30 days hospital care, and beyond that I could sue the Federal Government. (Really!! Can you imagine!?)

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How about no-fault insurance coverage? (See Elizabeth Pike*)

* Pike ER. Recovering from research: a no-fault proposal to compensate injured research participants. Am J Law Med 2012;38:7-62

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View this video in full screen videocast as posted on NIH videocast.

Did you know?

Researchers are paid.
Doctors are paid.
Nurses are paid.
Technicians are paid.
Pharma employees are paid.
University staff are paid.
Study participants are NOT paid.
People with Parkinson's (PWP) may risk their health by taking part in research.
If PWP are injured during research, they rarely receive health care.
There is no guarantee your expenses will be covered in studies / trials.

Do we want to continue volunteering under these conditions? Is it right that human trial participants are asked to take huge risks, but are told to "sue the Federal Gov't" if they are injured? Isn't it time to take a hard look at how clinical research is run in the U.S. and how research participants are treated? What do you think? I would really like to know.

jean

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