PRIM&R has posted its draft comments on the NPRM. I have found something to agree with.
Over the past 25 years, the difficulty of getting all of the agencies to agree on the Common Rule was cited as the grounds for concluding that changing any provisions would require a Herculean effort. It may well be that revising the entire Common Rule at once is a task that can only be undertaken once in a generation.
But if the current NPRM, issued four years after the ANPRM to revise the Common Rule (July 26, 2011), underlines how daunting a comprehensive revision can be, it also shows that the best, evidence-based revisions will not emerge from a process that tries to make all needed revisions at once. By perpetuating the view that regulations cannot be revised when needed, the current approach risks locking in place for another 25 years a number of provisions in the NPRM that even its most enthusiastic supporters admit are flawed in important ways.
Instead, we recommend that the relevant agencies pursue an issue-by-issue approach in which it is possible to “drill down” on an issue, to consider all the sections of the regulations where it arises and all the evidence that is available—and that is needed—to resolve it well. Further, the agencies should address each issue more openly, developing and relying upon evidence, and allowing consensus to emerge and revisions to be crafted that will work well for all stakeholders. This approach would not only produce better results, but would signal that, once adopted, any provision can be changed if it does not work as well as intended.
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.