Strings Attached to Burden-Reducing Parts of Research Rule?

Research institutions want to make sure new options to cut paperwork don’t inadvertently cause more headaches once new regulatory requirements kick in next January.

The Health and Human Services Office for Human Research Protections plans to release the first-ever draft guidance document on revisions to the human subject protection regulations known as the Common Rule (45 C.F.R. 46). This draft guidance will address three “burden-reducing provisions” research institutions can adopt as of July 19, about six months ahead of the effective and compliance dates of the revised rule itself.

But adopting any of those burden-reducing provisions within those six months will trigger additional regulatory requirements Jan. 21, when the revised Common Rule goes into effect. Groups whose members are covered by these regulations said this situation raises questions about how institutions can determine whether it’s worth adopting these changes, or if it’s easier to stick with the status quo.

The OHRP is aiming to release draft guidance publicly about a week before the July 19 date, as the HHS Secretary’s Advisory Committee on Human Research Protections will meet July 10-11, and the draft document is on the agenda.

‘Any Guidance Is Helpful’

“Any guidance is helpful,” Elisa A. Hurley, executive director of Public Responsibility in Medicine & Research, told Bloomberg Law in a July 2 interview. “PRIM&R was looking for guidance in other areas but, it makes sense that this comes out first because this is about what’s going to be available as of July 19.”

PRIM&R is the professional society for human research protection professionals, particularly for those who administer and sit on ethics panels known as institutional review boards. IRBs must determine human subject research complies with the Common Rule before any volunteers can be enrolled.

Initially published Jan. 19, 2017, Common Rule revisions mark the first changes to the regulations since they came out in 1991. The HHS announced June 18 it would delay the effective date for the Common Rule to Jan. 21, 2019. This delay meant institutions generally must continue to follow the old Common Rule until a full year after the original effective date. But to ease regulatory burden, the HHS announced institutions could choose to adopt three parts of the revised rule sooner:

• the revised definition of research, which deems certain activities not to be regulated under the rule;
• removing the annual checkup requirement known as continuing review for certain low-risk studies in which the human subjects’ part has ended; and
• eliminating a requirement IRBs must review research grant applications.

Opt to Adopt?

Institutions that don’t adopt any of these burden-reducing provisions can decide on Jan. 21 whether any ongoing studies should roll over onto the new rule or if they want to keep the studies on the old requirements. Any studies that use one of these-burden reducing provisions between July 19 and Jan. 21 must then comply with the new rule in its entirety on Jan. 21, noted Heather H. Pierce, senior director of science policy and regulatory counsel for the Association of American Medical Colleges. Studies that don’t adopt any of the burden-reducing provisions early can either be “grandfathered"—and continue to operate under the old regulations—or an institution can decide to transition them to the revised Common Rule in January.

As such, Pierce told Bloomberg Law June 29, it would be important to include in the draft guidance information about what needs to happen when the provisions are adopted before the Jan. 21 effective date for research that will continue beyond January 2019.

“For example, if an institution decides to forgo continuing review for a study that has reached the stage of data analysis only, in January 2019 it will need to be in compliance with the new Common Rule provisions. As a practical matter, what does that mean the institution must do with respect to that study?” Pierce asked.

Hurley also said it would be helpful for draft guidance to include some examples about what it would mean come January to adopt these provisions. “If guidance could shed some light on the factors that one might consider in making these decisions, that would be helpful.”

More Guidance Needed

Both Pierce and Hurley said the OHRP needs to issue additional guidance in other areas, including a new requirement in the revised rule that “key information” must be at the top of informed consent forms, which is the first topic SACHRP will address in its meeting. Both also called for more specific direction about what activities count as “benign behavioral interventions” that are exempt from the regulations.

“In order to fully and reliably implement the revised regulations, there are other additional guidance documents that are important and that the preamble to this final rule acknowledges are needed,” Pierce said.

Research institutions would also benefit from a better understanding of “limited review,” which Hurley noted is a new term in the revised rule. She said guidance should address the scope of limited review, and what implementing this term might look like without getting too prescriptive. “The community is clamoring for some more clarity,” Hurley said. “But if the whole intent of this is in part to reduce burden, to be overly prescriptive about the way that you would fulfill these various requirements will be just as burdensome.”