The US Office for Human Research Protections’ judgment of the SUPPORT trial seems entirely reasonableBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4637 (Published 23 July 2013) Cite this as: BMJ 2013;347:f4637
- Paul D P Pharoah, public health physician1
- 1University of Cambridge, Strangeways Research Laboratory, Cambridge CB1 8RN, UK
There has been substantial criticism of the investigation of the Office for Human Research Protections (OHRP) of the US Department of Health and Human Services into the informed consent process used when newborn infants were enrolled in the SUPPORT trial.1 2 3 4 The OHRP stated that the lead investigators were “in violation of the regulatory requirements for informed consent, stemming from …
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