Public Citizen is upset that NIH will get to write much of the NPRM. I don’t understand why that matters.
As Public Citizen’s November 20 letter to HHS secretary Sylvia Mathews Burwell puts it,
NIH has been assigned responsibility for revising the preamble of the NPRM. The preamble will be the longest and most important part of the NPRM, as it will contain sections describing, among other things: (a) the summary and analysis of the public comments on the ANPRM; (b) the government’s response to those comments; (c) the resolution of key policy disagreements that were during the earlier drafting of the NPRM; (d) the proposed changes to the Common Rule; and (e) the rationale for making those changes, all of which ultimately will have a major impact on the actual final content of the proposed revised Common Rule regulatory text.
It continues, “We suspect that NIH orchestrated such involvement in a deliberate attempt to undermine OHRP’s regulatory authority and to achieve changes to the Common Rule that it desires. This shift of authority from the regulator to the regulated is unacceptable.”
I think this overstates the difference between NIH and OHRP.
Not mentioned in the Public Citizen letter is the fact that the existing Common Rule was also written by NIH, back in 1981, when the Office for Protection from Research Risks was part of NIH. So at worst, we’d be going from one set of NIH-drafted regs to another.
And while the Office for Human Research Protections has, since its creation in 2000, been separate from NIH, I don’t know that it has ever taken the independent position imagined by the Public Citizen message.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.