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. Consider, for example, the September 28, 2000, statement by Greg Koski, OHRP's first director. He explains OHRP's mission as coordinating regulation and guidance across agencies, not of providing independent oversight of NIH or any other funding agency.
If anything, HHS created OHRP to be less confrontational than its NIH predecessor, following Gary Ellis's drastic enforcement actions of 1998-2000. Nor can Public Citizen point to a time when OHRP acted as an aggressive, independent watchdog; to the contrary, its letter bemoans what it considers OHRP's inaction on the SUPPORT study controversy.
I think of OHRP as an agency that has passed the buck on IRB reform efforts, focused on form rather than substance in overseeing institutions, communicated its work in opaque "determination letters" that say little about the underlying ethical challenges, and has been slow to act on SACHRP recommendations or public responses to Federal Register notices.
My question, then, is when was the golden age of OHRP to which Public Citizen would like to return? And if there was none, why does it matter who drafts the NPRM?