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Walden and Murphy Raise a Flag on Medical Research Protocol that Does Not Appear to be Consistent with FDA Rules

Jun 27, 2017
Letter Stems from Constituent’s Concern About Paramedics’ Failure to Give Him a Chance to Object to Wife’s Participation in Research Program

WASHINGTON, DC – Energy and Commerce Committee Chairman Greg Walden (R-OR) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) today sent a letter to the National Institutes of Health (NIH) regarding NIH-sponsored emergency medical research that is conducted without informed consent.

The inquiry comes on behalf of a constituent who reached out to their member of Congress. The constituent lost his wife, who went into cardiac arrest.

“A few days later, the constituent received a letter from a medical research center informing him that his wife had participated in an out-of-hospital study with the county paramedics as part of the Resuscitation Outcomes Consortium (ROC), sponsored by the National Heart, Lung, and Blood Institute (NHLBI). As part of this study, emergency medical service (EMS) personnel were told that they could administer one of three unmarked medications to someone appearing to be in cardiac arrest—two were heart-related medications and one being a placebo,” write Chairmen Walden and Murphy. “The constituent later learned that an individual would have to actively opt out of the study in order to not be a participant. Because his wife was unconscious, she could not provide her consent to participate, and was automatically enrolled in the study. The constituent, who was present when his wife went into cardiac arrest, was not given an opportunity to object to his wife’s participation in the study before EMS personnel resuscitation attempts.”

The constituent reached out to his local fire chief for more information on the study. In their communication, the fire chief wrote saying “Direct notification of family members (informed consent) was not required by the National Institute [sic] of Health or the FDA for this particular study. It was not included in the paramedic training rollout for this fire departments. …Simply put, they [paramedics] did not obtain your consent because they were not told or trained to obtain your consent.”

The leaders raised a number of concerns with the steps that took place in this incident and posed a series of questions for the NIH, which can be viewed here.

Click HERE to read a copy of the letter.