Would You Like a Sack for That Harp?

About three times a year, I trek up the Red Line to lovely Rockville, Md., to cover a committee that makes recommendations on human subject protection issues. As an HHS advisory body, they usually discuss the “hot topics” in the human subject protection works. But at their last meeting, the hottest topic was what they couldn’t discuss.

You see, 10 days before the Secretary’s Advisory Committee on Human Research Protections (SACHRP, which they pronounce as “sack harp”) held its final meeting of the year, the White House Office of Management and Budget posted they are reviewing a proposed rule to delay the revised Common Rule.

You probably already know this if you are taking the time to read this blog, but the Common Rule is a set of regulations to make sure scientists aren’t doing super creepy unethical things to study volunteers, and that those volunteers know exactly what they are getting into before they agree to sign up.

This potential delay means a bunch of things might happen:

  • The revisions could go into effect as planned on Jan. 19
  • The proposed rule could come out right before Jan. 19
  • They could bust a move and get a final rule through before Jan. 19 and actually get a one-year delay
  • …or something else I hadn’t thought of.

But we don’t know and because there’s no actual proposed rule, HHS isn’t talking. And this, of course, is the big thing everybody is talking about.

So we’ll see. PRIM&R, the biggest research ethics conference, happens in a few weeks in San Antonio. And this will definitely come up there. It’s just a question of who can say what and when.

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