Thursday, November 20, 2014

The secret plan to let NIH researchers rewrite research regulations

Here's the opening paragraph of a press release from Public Citizen:

"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 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. In its letter to the Burwell, Public Citizen highlighted the fact that NIH has an obvious, direct conflict of interest in this matter because, as the largest federal funder and conductor of human subjects research, it is subject to the very rules being considered for revision."

"According to documents Public Citizen recently obtained, NIH was asked — likely by Andrea Palm, HHS chief of staff and a senior counselor to Burwell — to rewrite key sections of a draft notice of proposed rulemaking (NPRM) to extensively revise the Federal Policy for the Protection of Human Subjects (known as the Common Rule). The Common Rule is intended to ensure that the rights and welfare of people enrolled in federally sponsored research are adequately protected."

Dr. Michael Carome, the director of Public Citizen Health Research Group, says this is "akin to asking the pharmaceutical and medical device industry to write the Food and Drug Administration’s regulations regarding the approval process for drugs and medical devices."

You can read the letter here.


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