Exempt, expedited studies face ANPRM changes

Excused' would be the new exempt; list of expedited activities would grow

The Advance Notice of Proposed Rulemaking (ANPRM) proposes extensive changes to the way that exempt and expedited studies are currently handled, with an emphasis on streamlining the process for researchers who conduct minimal risk activities, particularly in the social sciences.

The proposed changes would substitute an "excused" level of review for exempt, expanding the current exemption categories to include research with adults that might include identifiable information, as long as data protection standards mandated by the new rule are in place. The excused category also would take in some new minimal risk social and behavioral research activities — for example asking subjects to watch videos, solve puzzles or read a paragraph, then asking them questions.

If a study fell into one of the excused categories, the investigator would file a one-page form registering the study, and shortly afterward begin collecting data. The ANPRM states that routine review of excused studies would be "neither required, nor even recommended," although there would be a requirement to audit a small number of these studies to ensure that they qualify.

In addition, the proposal would expand the list of minimal risk activities that qualify for expedited review and would ensure regular updates of the expedited activities list. There would be no continuing review of expedited studies, unless a reviewer deemed it necessary.

Under this proposal, the process of full board review would remain largely unchanged, except for continuing review, which would not be required in cases where the only activities remaining in a study are data analysis or assessing follow-up clinical data from routine medical procedures that patients would undergo as standard care.

The changes will benefit IRBs, who can be freed up from minimal risk activities to concentrate on protocols with real potential for risk to subjects, says C.K. Gunsalus, JD, director of the National Center for Professional and Research Ethics at the University of Illinois at Urbana-Champaign.

"I think the time of IRB members is a really valuable resource," she says. "Making sure that we use their time for things that are really important strikes me as all the way around a terrifically valuable contribution for improving things."

SBER institutions affected

But Paul Reitemeier, PhD, who chairs the Human Research Review Committee at Grand Valley State University in Grand Rapids, MI, says the proposed changes to the exempt and expedited categories may pose problems for institutions such as his own, which handle almost entirely social, behavioral and educational research (SBER).

"One way our institution has adapted to these (existing) regulations is by relying on the IRB and research protections office to do both a compliance review and a quality review over the design and the construct and the qualifications of the investigators," Reitemeier says. "Even though probably 45 to 50 percent of our total volume is currently eligible for exemption, we still find many opportunities to make suggested revisions, and improvements and strengthenings of those protocol submissions back to the researchers, whether they're students or faculty.

"And that's generally pretty well appreciated. It's not overly burdensome, it sharpens the focus, increases the scientific validity and merit."

Reitemeier says that if these studies fall into the new "excused" category — subject to only a one-page form filed with the institution and never necessarily reviewed by anyone — they lose that opportunity for improvement and for ethical assessment by someone other than the investigators themselves.

"Even though it might be consistent with the federal regulations' desire to minimize regulatory oversight, if you don't have a robust research infrastructure at your institution where everybody knows what's required and everybody's familiar with the regulations, you won't have any oversight (on research proposals that currently are exempt)."

Reitemeier also has concerns about eliminating continuing review of expedited studies, saying that while these studies may have been only minimal risk when they began, things can change over time.

"The first thing you ask in a continuing review is, Have you made any changes to this since the last time we saw it?'" Reitemeier says. "(Investigators) are supposed to have filed changes in protocol, but a lot of times they don't. They forget, or they thought somebody else did it, or they weren't aware that they were supposed to."

He says those changes can nudge what was a minimal risk study into something more risky.

If the ANPRM's proposed changes to the exempt and expedited categories become a part of the final regulation, Reitemeier says SBER institutions may find themselves needing to revamp their policies to fill in the gaps in oversight created by the revisions.

"There's nothing in the proposed new rule-making to prohibit them from instituting their own ethics review and their own standards and requirements, if they think the proposed new rulemaking goes too far," he says. "By taking away the IRB role in the big way that it has been there, we're inviting the institutions to either take the lazy low road of no oversight or, on their own authority, to institute the same type of review and protections consideration that the IRB formerly had provided."

The researcher/IRB relationship

Simon Craddock Lee, PhD, MPH, a medical anthropologist at the University of Texas Southwestern Medical Center in Dallas, sees the tension between social-behavioral researchers and IRBs from both sides, since he also serves on the UT Southwestern IRB.

He says many of the proposals in the ANPRM have the potential to ease those tensions. But Lee says there still is a need for researchers to explain their proposed work to an impartial outsider to ensure that the system they've set up to protect subjects is sufficient to do that.

"Most of the travesties of human subjects violations in our past, in any discipline, have come from people who at the time thought they were doing the right thing," he says. "The way that we ensure that we're doing the right thing is to have transparency."

He favors the idea of periodic audits of studies submitted as excused, to make sure that the studies actually meet the criteria.

Lee says that even if the changes outlined in the ANRPM are implemented, it doesn't eliminate the need for social behavioral researchers or IRBs to reach out to each other in order to achieve more effective reviews.

Researchers, he says, need to educate IRB members and staff about their work.

"Go meet your staff person at the IRB and talk to them about what you do," he says. "Stop thinking of the IRB as some black box that you submit a proposal to and then just cross your fingers and hope it comes back."

IRBs, on the other hand, must have the humility to know that they need to seek help when presented with proposals in disciplines that may be unfamiliar to them, Lee says.

"Our job is to educate ourselves, which means you should have staff able to find other specialists to consult if you have a protocol you don't understand. There should be inservice educations routinely, where people who look largely at clinical protocols learn about methods from other groups that we may occasionally need to look at."