By Melinda Young

Federal regulations provide some room for interpretation in how IRBs might handle exempt determinations under the revised Common Rule. Research programs need to revise their own rules about who makes the determination and how these are handled, given the expansion of the exempt status.

Even before the 2018 revised Common Rule expanded the definition of exempt, IRBs would see some studies submitted for expedited review when they could be exempt from review, says Christine DeLussey, CIP, MS, IRB operations supervisor at Children’s Hospital of Philadelphia (CHOP). Investigators also might apply for exempt status when their research should undergo an expedited review. This is why IRBs should revise policies and procedures to ensure consistency in these determinations.

Some research institutions might ask for more details about a project that is proposed for exempt status, says Adrienne Bonilla, Esq., assistant vice president for research at University at Albany, State University of New York. “The IRB’s role is to evaluate the research project to make sure it’s meeting the regulatory requirement for human subjects research,” Bonilla says. “But if something goes wrong, it will be the university in the headlines.”

This is why IRBs need to clarify their interpretations and requirements, setting guidelines or checklists. “They might feel they have a responsibility for their organization in reviewing the study, and there’s a mission creep of the IRB that often happens,” Bonilla adds. “That is where you have organizations that do not want to let go or to follow the flexibilities of the regulations.”

For instance, a study might be eligible for exemption, based on the Common Rule criteria, but the research institution is concerned about litigation if there is no review. IRB mission creep might ensue. “That’s what affects different organizations when they are implementing the regulations,” Bonilla says. “That’s where you get overprotectiveness by institutions — their institutional fears.”

When investigators make mistakes, and fail to apply for the correct review status, or when they do not submit a project at all, thinking — incorrectly — that it is not human subjects research, it is mostly because they did not understand the definitions, says Erica Heath, CIP, an IRB consultant and retired IRB director in San Anselmo, CA.

“I don’t think people are trying to get away with things,” Heath says. “I don’t think it’s intentional; the definitions are hard to understand — at least the nuances — and it may be difficult for people.”

DeLussey, Bonilla, and Heath offer these suggestions for how IRBs and HRPPs can handle exempt determinations and Common Rule changes:

• IRBs could use the same process for handling both exempt and expedited reviews. HRPPs could ask researchers to complete the same form for expedited reviews and exempt determinations.

“I had an eye-opening experience the other day when I was talking with some IRB staff people,” Heath says. “My evaluation said they weren’t separating the exempts and expedited reviews enough.”

Then, Heath realized that there was no difference. “They can be handled the same way,” she says.

For instance, if an IRB’s employees are listed as alternate members of the board, then they can perform an expedited review and an exempt determination. “You have to document they meet the criteria for expedited or exempt,” Heath says. “Other than that, the way you handle it is identical.”

• Provide online screening forms, guidance, and in-person education. IRBs should have tools on hand to assist with exempt and expedited forms and reviews.

“These can be in an electronic system where the system checks the category that was chosen,” Heath says. “Someone would read the application and see if it fits into the category.”

IRB staff or members could use a checklist to see if criteria are met for exempt status or expedited review, she adds. “We keep updated information for investigators, including changes in the Common Rule, as a resource they can always go to,” DeLussey says. “We also have regular office hours with one or two staff members available for investigators to ask questions. We get a lot of questions that are related to the Common Rule and how investigators should proceed.”

Research programs can post guidance online about the differences between expedited review studies and exempt research, noting the expanded definition of exempt under the 2018 Common Rule. “They can start from the assumption that it might need IRB review, and then contact us,” Bonilla says. “We have a screening form, a couple of pages that they need to complete, to see if it needs IRB review.”

The form asks these kinds of simple questions:

- Is the activity supported by external funding?

- What is the intent of the project?

“It goes through a decision tree to see if it’s human subjects research, because it’s not always clear, and it depends on what a person is going to do and why,” Bonilla says. “Most studies at our school are exempt eligible, and that’s the bulk of what goes through our office.”

Since the new Common Rule was implemented, there have been only slight changes in the University of Albany’s volume of exempt studies, she notes.

“In the psychology department, we have had a handful of projects that moved from expedited to exempt,” Bonilla says. “But our process has not changed with the new Common Rule.”

• Assign people to make exempt determinations. CHOP has always required investigators to have the research institution make the exempt determination, DeLussey says. “We have IRB chairs and other individuals, such as myself and analysts, who are performing the exempt reviews,” she says.

“In general, investigators want to submit their studies under the lowest level of oversight, so we might see about 10% that come in as exempt, but don’t qualify,” DeLussey adds. “The types we see the most are chart review studies, under category 43.”

The IRB has trained investigators about what exempt means and how to know if a project is exempt, she adds.