Letter to the HHS Secretary Regarding Corruption of the Process for Revising Federal Regulations for the Protection of Human Subjects

November 20, 2014

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Public Citizen today called on Secretary of Health and Human Services Sylvia Mathews Burwell to immediately reverse the recent decision by one or more senior officials in her immediate office, including at least her chief of staff, to abruptly transfer from the Office for Human Research Protections (OHRP) to the National Institutes of Health (NIH) the responsibility for rewriting key sections of a draft proposal to extensively revise the federal rules for the protection of human subjects. Given NIH’s obvious direct conflict of interest, such HHS action has corrupted the rulemaking process and undermined the authority of OHRP.

February 26, 2015, HHS Response to Letter Regarding NIH Role in Drafting NPRM.