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AAMC Warns of “Chilling Effect” on Standard-of-Care Research

August 9, 2013—The AAMC Aug. 6 submitted comments  to the federal Office for Human Research Protections (OHRP) about appropriately assessing risks to human subjects in research that compares safety or effectiveness among current “standard of care” medical practices.  OHRP, an office of the Department of Health and Human Services, invited public comments in advance of an upcoming Aug. 28 meeting on this topic. 

The AAMC letter emphasizes that the risks inherent in the standard of care should not be conflated with the risks inherent in the research itself.  Such conflation is especially problematic for studies of procedures or interventions with populations already at high risk, but for which standards of care can be further improved or refined.  As the AAMC notes, “Uncertainty about the risks of various standard of care interventions is often the driving force behind conducting a study, and necessitates the research.” 

The AAMC further stated that where variations in the standard of care do exist, the process of randomizing patients among differing standards is not in itself a research risk (although in some cases, depending on acceptable variations in a study, randomization may present a minimal risk for some subjects). 

In the letter, the association expresses profound concerns about the potential “chilling effect” created by conflating such risks or projecting undue risks to randomization in study design, for example, OHRP's compliance action (since suspended) on a study comparing standards of care in administering oxygen levels to premature infants.  Based on OHRP’s initial action, the AAMC comments, “Physician scientists could reasonably decide that going with their clinical judgment even without strong evidence may be preferable to facing professional and personal risk in trying to obtain the best evidence….In the end, that hesitation could bring comparative effectiveness research to a grinding halt, leaving physicians in the untenable position of taking a reasonable guess, instead of ensuring that all patients receive treatment based on the best possible evidence.”

The AAMC also objects to using a study’s own findings retrospectively to criticize the original informed consent process or other aspects protecting subjects.  Often, variations in standards of care can pose some additional risk to patients over a competing practice.  The point of such research is to identify these risks, and the findings should not be used, absent other concerns, to cast aspersions on investigators’ ethics.


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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