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Comment & Response |

Regulation and Comparative Effectiveness Research—Reply

Richard Platt, MD, MS1; Nancy E. Kass, ScD2; Deven McGraw, JD, LLM, MPH3
[+] Author Affiliations
1Harvard Pilgrim Health Care Institute, Boston, Massachusetts
2Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland
3Manatt, Phelps & Phillips LLP, Washington, DC
JAMA. 2014;312(9):964. doi:10.1001/jama.2014.7667.
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In Reply Our proposed approach does not call for abandoning research protections for all comparative effectiveness research; instead, we argued for a more tailored application of the protections based on a research activity’s degree of risk, the expectations of patients, and the norms of clinical practice. In the bathing regimens example, the regimens tested were in common use and there was equipoise; the choice of bathing regimen was ordinarily made by institutions rather than individual clinicians; and we are unaware of any hospital that engages its patients in the intensive care unit—individually or collectively—in decisions about which bathing agent they prefer or even discloses information about bathing agents.

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September 3, 2014
Lynn E. T. Shaffer, PhD
1OhioHealth Research and Innovation Institute, Columbus
JAMA. 2014;312(9):963-964. doi:10.1001/jama.2014.7655.
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