The NPRM of the Common Rule in human research protection provides for eight categories of exemption to IRB reviews and discusses a tool that investigators and others could use to determine whether a study is exempt.

Those categories include research involving benign interventions with adult subjects; research using educational tests, surveys, interviews or observations of public behavior — provided data security and privacy protection policies are followed; secondary research using identifiable private information collected originally as part of a non-research activity, and storing or maintaining biospecimens when a broad consent template was used.1

Benign interventions would be “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and it would be required that the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.”1

Research involving deception would not qualify for exemption unless the deception was authorized by the subject.1

Despite the NPRM’s definitions of what type of research qualifies for exempt status, an automatic exemption process would be a mistake, says Alan Stockdale, PhD, director of human protections program and IRB chair at the Education Development Center (EDC) in Waltham, MA.

The EDC’s IRB does very few full board reviews; most of its social-behavioral research is exempt, Stockdale notes.

“There are a lot of ambiguities as to what exemption means,” he explains. “Sometimes, determining exemption is not easy, and I would be concerned about people going to a website and filling in an algorithm to determine if it’s exempt — I would be very skeptical of that.”

For example, the NPRM refers to research in commonly accepted educational settings, but there is no commonly understood definition for that, Stockdale says.

“We have debates about that, and we tend to be more liberal in defining it than the researchers,” he adds. “People tend to understand that as schools, but we say it could be a library, depending on what’s going on there.”

Two things likely will happen if the determination of exemption is left to investigators and an exempt tool: One, some investigators will come to IRBs on their own to ask for help, and two, a small number of researchers might find a way to make their research exempt when it should not be exempt, Stockdale predicts.

As OHRP officials speak with IRBs at meetings, the question of bad actors sometimes comes up, says Ivor Pritchard, PhD, senior advisor to the director of OHRP.

“That is a concern,” Pritchard says. “Of course, in order for this exempt tool to be effective, it would need to be designed in such a way that it would be difficult to game the system that way.”

There is no exempt tool available yet, and it won’t be created until there is a final rule, says Julie Kaneshiro, deputy director of OHRP.

“We can’t give a specific date,” she adds. “But there would be a tight timeframe to develop it because the compliance date for these provisions would be a year after the publication date of the final rule.”

Another reason why the exempt status change might be a problem is because the process as it works now helps IRBs develop relationships with investigators — even when they never have a full board review, Stockdale says.

“We tend to have an interactive and much more collaborative relationship with our researchers, even though most of the research that comes through our office is exempt,” he adds.

“We have researchers who come back and have questions about what they need to do with informed consent, and I say, ‘You’re exempt, but we can have a discussion about the Belmont Report and research principles, and what might be reasonable for your project,’” he says. “That’s one thing that worries me: They’ll go off to a website, say, ‘I’m exempt,’ and then go away.”

Collaborative relationships between ethics boards and researchers will be weakened and likely disappear, Stockdale adds.

REFERENCE

  1. Federal policy for the protection of human subjects; proposed rules. Fed Reg. 2015;80(173):53933-54061.