There is quite a buzz in the IRB – research industrial complex these days as academics, researchers, pharmaceutical companies and lots and lots of lawyers gear up to comment on HHS’ Advance Notice of Proposed Rulemaking (ANPRM) Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators published in the Federal Register: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm. While all the interested parties run around like Chicken Little getting ready to comment and preparing for potential changes in the regulations, it is interesting that no one has commented on the fact that what HHS issued is an ANPRM as opposed to a Notice of Proposed Rulemaking (NPRM). It is important to understand the differences between an ANPRM and a NPRM because under the law, an aggrieved party can challenge one in federal court as “agency action” but not the other.
An agency issues a NPRM in order to fulfill the notice requirement under the Administrative Procedure Act (5 USC 553) http://www.law.cornell.edu/uscode/5/usc_sec_05_00000553—-000-.html. A NPRM will contain the actual text of the proposed regulation. An ANPRM on the other hand is not referenced anywhere in the United States Code and is actually only found in the Federal Register Document Drafting Handbook published by the National Archives and Records Administration, Office of the Federal Register: http://www.archives.gov/federal-register/write/handbook/ddh.pdf. An ANPRM is merely an inquiry of the public which informs of the areas in which an agency may regulate and seeks input from the general public. While a NPRM is required under federal law before enacting a regulation an ANPRM is not.
So what does this all mean? That there is a chance, perhaps a great chance, given the state of the economy and that any proposed regulations (NPRM) will likely not be announced until very close to the presidential election in 2012, that nothing will come of this until after the presidential race is decided. The recently published article in the New England Journal of Medicine by Jerry Menikoff, Director of OHRP, implies just as much:
The ANPRM offers a rare opportunity for needed modernization that is consistent with the President’s mandate to enhance protections while simultaneously eliminating unreasonable burdens. Not everyone will agree with every proposed change. But the ideal should not be the enemy of substantial progress in achieving these two important goals. If this reform effort fails, 20 years from now, someone might write an article for the Journal to bemoan the fact that the Common Rule has undergone essentially no change in 40 years.
Then again, given the way that Washington works and the influence of lobbyists, keeping the status quo may not be such a bad thing after all and in fact, may be better than the proposed “reform.”