Relief Possible for Revised Human Research Rule Transition

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By Jeannie Baumann

Researchers likely won’t have to chase after enrolled study participants to sign new consent agreements if revised human subject protection regulations apply, an HHS office head told Bloomberg Law.

If researchers choose to implement options designed to reduce burdens associated with the revised Common Rule, new consent requirements would be triggered. The Common Rule is a set of regulations adopted by nearly 20 federal agencies to protect human research subjects from undue harm (45 C.F.R. 46).

However, Jerry Menikoff, director of the Health and Human Services Office for Human Research Protections, told Bloomberg Law he doesn’t expect new consent requirements to apply to people who have enrolled in a study before Jan. 21. The revisions take effect on that date, and the burden-reducing options apply from July 19.

“We’re not saying you have to go back and re-consent people,” Menikoff told Bloomberg Law in a July 20 interview. But he stressed the OHRP hasn’t published any official notices or guidance on this matter. “This is part of the guidance that’s not out yet. But there’s a sense that the guidance would probably go in that direction.”

July 19 kicked off a six-month transition period, during which research institutions can adopt the three burden-reducing provisions. But taking this option means an institution has decided to transition that study onto the revised Common Rule, and all the new requirements kick in Jan. 21. If an institution doesn’t use the burden-reducing provisions, that study can continue to comply with the old rule.

In With the New?

Reducing burdens was one of the two main goals for updating the Common Rule from the 1991 version, along with updating the regulations to better align them with modern research practices. But with two delays to the start date, the revised rule has undergone a bumpy rollout. The past year and a half has left many institutions unclear about how to execute new requirements.

“The question is whether or not you’re going to save burden at the end,” David Borasky, a North Carolina-based research compliance executive who routinely handles these issues, told Bloomberg Law in a July 20 interview.

The burden-reducing provisions cover: a new definition of research that reduces the number of activities subject to the regulations; elimination of an annual checkup known as continuing review for some low-risk studies; and elimination of a requirement that ethics panels known as institutional review boards review grant applications.

New Requirements Triggered

If a study met the criteria for an expedited review—which qualifies it for the burden-reducing provision to end continuing review—doing away with the continuing review requirement could trigger a need to rewrite the consent form next January.

“Assuming they’re enrolling new subjects from January onward, for those subjects, it’s probably likely you’d have to revise the consent form in some way or another,” Menikoff said.

Consent requirements are the main part of the new Common Rule that would require studies to go back to an IRB for approval, said Borasky, who is vice president of IRB compliance for WIRB-Copernicus Group, a commercial provider of regulatory and ethical review services for clinical research. While it would be nice to eliminate some continuing review, Borasky said, it’s not a substantial burden.

The same goes for the elimination of IRB grant review, he said. “This is not the thing that makes or breaks an IRB office” in terms of managing their human research protection programs, Borasky said. “It’ll be nice not to have to do it when the whole rule goes into effect.”

A research project that has reached the point of data analysis also could qualify for elimination of continuing review, and Menikoff said those study participants wouldn’t need to be re-consented. Use of this provision might make more sense in this situation. “Those are studies that have less of a downside in terms of making a decision to transition them,” he said.

The HHS generally doesn’t comment on the status of guidances that haven’t been released publicly, but Menikoff said the OHRP is working on a number of draft documents to help institutions gear up for the new revisions. He said the office will factor in public comments when rolling them out, such as the call for more guidance on the key information requirement in consent forms.

Request Health Care on Bloomberg Law