Balancing act: Reducing regulatory burdens without increasing risks

"Unchecking the box" works for one site

It might seem too daring to make changes to human subjects oversight programs by easing ethics review procedures. But several research organizations have found that some measured changes can help reduce investigators' regulatory burden without increasing risk to subjects.

For instance, one program has expanded the number of studies that qualify for exemptions and is working on a project to give principal investigators (PIs) more flexibility in making minor modifications to projects without seeking IRB approval.

Another has reduced its IRB review application form from 25 pages to four. And still another institution has tackled the issue of IRB "mission creep."

That's not to say the changes were made easily. In each case, research officials worked carefully to identify areas that could be changed without impacting the protection of human subjects.

They started with goals of reducing regulatory burden through practical changes and greater efficiency.

For example, the Ann Arbor, MI-based University of Michigan's research office began this project with the goal of developing projects that will reduce regulatory burden while requiring minimal policy changes, says Judith Birk, JD, regulatory affairs associate in the office of the vice president for research at the University of Michigan.

The institution has included in policies and procedures its process for making changes. These involve demonstration projects of nonfederally-funded studies and exclude research regulated by the Food & Drug Administration (FDA).

"We put this in our standard operating procedures (SOPs)," Birk says. "We have a page of guidance on each project, and then we have a separate workflow diagram and top level policies that are specific to our institution."

An audit of the demonstration projects showed that PIs and the IRB stayed within the parameters of the project, she adds.

Currently federal regulations require annual review even when these do not provide additional protection to human subjects.

"We developed two projects," Birk says. "One was to move some annual reviews into an exemption category, and the other was to move to a two-year continuing research approval, depending on study characteristics."

For example, there are projects that had full oversight at the beginning and have now gone through their life cycles, and the only remaining activity is analysis of identifiable data, Birk explains.

"We can move those projects into the exemption category, and they don't have to come back to the IRB for an annual review," Birk says.

Define boundaries, ensure transparency

At the University of Texas Health Science Center in Houston, TX, the goal to make changes was prompted by concern over IRB mission creep, says Peter Davies, MD, PhD, executive vice president for research at the University of Texas Health Science Center. The University of Texas, which includes more than a dozen academic and health-related campuses, has a task force reviewing the missions and situations with IRBs.

"We were also interested in obtaining cooperation among our campuses, coming from our involvement in the clinical and translational science awards (CTSA) movement, Davies says.

"CTSAs have an emphasis on lowering barriers to research, and one barrier involves IRB issues," he adds. "Overall, our concern is on the expanding pressures on all the participants and investigators to meet increasingly complex regulatory requirements."

The task force was charged with a broad mandate to review the situation and identify areas in which there were opportunities to fix problems and make recommendations.

The result was an effort to define research boundaries, ensure transparency, provide pre-review to address scientific issues, and take practical measures like eliminating redundancy in IRB reviews, and build a culture of trust in research ethics.

"It took over a year and a series of meetings with representatives from many campuses," Davies says. "We heard from experts in the field of human subjects research; we did teleconferences and met with consultants."

After hearing what other universities were doing about this issue and hearing the university's own problems described by campus representatives, the task force reached several conclusions.

"The bottom line is we first of all felt that a great deal of effort was being expended by institutions to provide appropriate levels of protection to participants of research," Davies says. "The system was working well, but was under a lot of strain."

The task force came up with eight different classes of recommendations.

The goal at one small institution was more modest, but equally important to its human subjects research program. The Southern College of Optometry in Memphis, TN, expected faculty members to participate in research, but very little actually was taking place.

"Not a lot of research had been done in the last couple of years," says Patricia M. Cisarik, OD, PhD, associate professor and IRB chair.

One reason for this was that the IRB review process seemed too daunting to many of the professors, she notes.

For instance, although many of the studies qualify for expedited review, the IRB review application was 25 pages long.

"I couldn't see our people being thrilled about filling out a 25-page document so I streamlined it to four pages," Cisarik says. "Most research we do here does not require full IRB review and doesn't have great morbidity and mortality associated with it."

Rather than make researchers wade through pages of questions regarding special populations who rarely, if ever, are seen by the college's clinicians, Cisarik removed these pages, leaving them accessible through an online link.

So if an investigator does have study participants who would qualify, he or she can easily obtain the extra pages to complete.

The University of Michigan's research office has also made it possible for some investigators of non-federally-funded projects involving identifiable datasets to obtain an initial review exemption, Birk says.

Previously, the exemption was made only for dataset studies involving non-identifiable data, say Birk and Jan Hewett, BSN, JD, director of the University of Michigan Medical School IRB.

"The medical school side has not initiated this exemption yet because we have to worry about privacy board review," Hewett adds. "The privacy board sees all of the studies, whether or not they're federally-funded, so this exemption mostly was done on the behavioral health science side."

The University of Michigan also changed the continuing review cycle for some research projects. The university's social-behavioral IRB sees many projects that are of minimal risk, and yearly reviews provide no further protection to human subjects, Birk says. These have been extended to reviews every two years, she adds.

These changes to increase the number of exempt studies and to move to a two-year continuing review cycle have affected 38% of projects seen by the social and behavioral IRB and 20% of new projects submitted to the health sciences IRB, Birk says.

Flexibility for minor changes

Principal investigators also are burdened by the requirement to seek IRB approval each time their project is modified in any way. So the university addresses this with a new proposal, Birk says.

"We're looking for a unit to pilot this with," she explains. "This is a project where we give flexibility to principal investigators to make minor modifications to projects without seeking advance IRB approval."

For example, suppose a PI is working on a study in the field, somewhere off-campus either in the United States or overseas, Birk says.

"Suddenly the study interviewer stumbles on a situation that requires him to make changes to study parameters, adding a few minor questions to the survey instrument," she explains. "This proposal would allow PIs to make those changes without having to seek IRB approval."

They could make the changes under a broader study approval, and, theoretically, this could decrease risk to subjects, she adds.

"We think this will reduce noncompliance because they won't have to seek IRB approval to make the change," Birk says. "And, again, this would involve nonfederally-funded studies with no more than minimal risk."

The criteria for studies to be given this type of flexibility would be whether or not they hold a National Institutes of Health (NIH)-issued certificate of confidentiality, Birk says.

"Those certificates disallow any modifications to procedures," she explains. "Similarly, some research contracts might disallow modifications."

Some nonfederally-funded studies still can have the NIH-issued certificate.

Before making these types of changes, research institutions need to "uncheck the box" on their Federal-Wide Assurance (FWA), Birk and Hewett say.

An institution's research policies and procedures should include information about how the institution will handle demonstration projects.

"That's the document we can point to and say, 'Here we are engaged in doing demonstration projects,'" Hewett says.

"We talked with OHRP [Office for Human Research Protection] about how the institution was setting up its demonstration projects, Birk says. "OHRP felt it was an appropriate model."