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HHS Public Hearing: "Matters related to protection of human subjects and research considering standard of care interventions"

Last Updated: Sep 3, 2013

The conversation in Washington today may impact how you consent patients tomorrow!

Linda Parreco's Image

 There's a pretty fascinating discussion happening at the U.S. Department of Health and Human Services (HHS) today that will interest all of you who participate in the informed consent process. HHS is holding a public meeting to seek input on how IRBs should assess the risks of research involving randomization to one of more treatments within the standard of care. The hearing stems from the HHS Office of Human Research Protections (OHRP) response to “The Surfactant, Positive Pressure, and Oxygenation Randomized Trial” (SUPPORT) clinical trial. You may have read about the trial and the ensuing public debate. A transcript (and I believe video) of today’s hearing will be available on the OHRP website, http://www.hhs.gov/ohrp.

Linda Parreco's Image

Everyone--video presentations from the public meeting have been posted here. The story was also picked up in this article, "A Sticky Issue in Medical Ethics"  in the Washington Post. The part of the hearing that has really stayed with me over the past week was testimony given by parents of premature infants enrolled on the trial. Remember that this trial is comparing two standard therapies and the issue at hand is the description of risks attributed to standard therapy in the consent. The disturbing aspect was the parent's genuine lack of understanding about the study, it's design, and the associated risks. What they heard was that their terribly, fragile premature child would be taken care of. One mother said that the title of the study, SUPPORT, was misleading. She believed that she was signing up for a support group. Take a look at the videos by Shawn Pratt and Sherissa Cook. My trust in clinical trial professionals allows me to believe that appropriate information was provided, but these videos serve as a reality check about the importance of asking questions and ascertaining the participants level of understanding. I hope you take a few minutes to watch these videos--as well as others from the hearing. 

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