There is plenty to say about the proposed changes to the Common Rule that the Office of Human Research Protections announced in September. But it’s striking to consider what is left unsaid—that the regulations will need to be revised again in the near future.
When the final revisions are published (in late 2016, so they say), the rules should include a plan to revise again in ten years. This plan is already in place in for a few areas covered in the proposed revisions, but it is imperative that OHRP extend this requirement to the entire new rule.
All the lessons of the past show that research techniques and moral sensibilities change over time. Most recently, Dr. Marcia Angell made this point in a two-part article published the New York Review of Books. Angell sketched the history of modern medical ethics and, in effect, showed that science practices and ethical instincts are dynamic, while regulations are static once set down in law. The lesson of her review would seem to be that the fresh regulations she advocated (and, as we all know, are now being written) will be stale in short order.
It stands to reason that any new regulations should build in a plan to be revised—or at least revisited—every few years. This is common in most countries. Unfortunately, Angell failed to drive home this point in her high-profile review, and the NPRM does not include this requirement.
There is another month remaining for public comment on the NPRM, and I hope to see more commentators point out this silence in the NRPM. Despite its strengths, the NPRM can be even better. I highlighted this shortcoming when I spoke at NIH’s “town hall” meeting about the NPRM on November 5 in Evanston, IL. Other speakers, like Zach Schrag, amplified the point. I hope others will join the chorus–in the name of the past but with an eye on the future.