By Melinda Young, Author

The revised Common Rule changes will go into effect on Jan. 21, 2019, but it is quite likely IRBs will be adjusting their processes without all of the federal guidance they need. (http://bit.ly/2yAdD0Q)

“There have been scattering bits of guidance, but there are big chunks of it we don’t have guidance on,” says Bruce Gordon, MD, assistant vice chancellor for regulatory affairs, executive chairman of institutional review boards, and professor of pediatrics at the University of Nebraska Medical Center in Omaha.

Gordon was a scheduled speaker about the new Common Rule at the recent 2018 Advancing Ethical Research Conference, sponsored by PRIM&R, held Nov. 14-17, 2018, in San Diego.

“We have lots of changes that sound good on paper, but we don’t have the details, and we’re close to January of 2019,” he adds. “So we have to take the good stuff and bad stuff and make the bad stuff as good as possible.”

The best parts of the Common Rule revisions are the changes to informed consent, he says.

“It’s the change I’m most excited about,” Gordon says. “The changes in the Common Rule are directed at the informed consent form — not so much the process.”

The Common Rule’s changes to informed consent provide an opportunity for boards to update their consent forms, using new strategies, says Ryan Spellecy, PhD, professor of bioethics at the Medical College of Wisconsin in Milwaukee.

For instance, IRBs could meet with stakeholders to find out what they would like to see in the informed consent document, he says.

“If your IRB is thinking about overhauling the consent form — which a lot of us are thinking about doing because of the Common Rule changes — then this is a good opportunity to reach out to patient advisory groups,” Spellecy says.

The informed consent process should focus on the things that are most important to people, and it should make these as comprehensible as possible, says Baruch Fischhoff, PhD, Howard Heinz University Professor at Carnegie Mellon University in Pittsburgh.

When a potential study participant reads a long consent form with incomprehensible information, then the potential subject believes the researchers do not really understand him or her, Fischhoff notes.

“But if the document goes to your strength — the things that people like you find to be interesting — then you think, ‘Oh, they’re working on my problem,’” he explains. (See story on improving informed consent in this issue.)

These Common Rule changes have the potential of making consent a more truly informed consent, Gordon says.

For example, IRBs have always been asked by regulators to make sure a consent process is directed toward the subject and easy to understand, eliminating extraneous information. “It should aid informed consent, not impede it, and now the regulatory language is pushing us in that direction,” Gordon says.

The chief change is the new Common Rule’s directive to use a concise and focused summary preceding the consent form. (http://bit.ly/2Gorspk)

Regulators have not yet said what should be in the concise summary, but it is likely the priority information involves methods, risks, benefits, and other information research participants need before they decide whether to participate in a study, he says.

“We’re interpreting it as an executive summary — a one-page summary of what research is about,” Gordon says. “Our institution has required an executive summary along those lines and invoked it when the consent form was particularly onerous.”

“This forces investigators to do an elevator talk — a two-minute discussion of their research, rather than a 20-to-30-page consent form,” he explains. “The first page will have the key points people need to know.”

The new Common Rule reinforces the idea that the consent form has to be written in a way that is understandable. It should not just be a list of potential risks.

“Sponsors’ research has pages upon pages of potential risks,” Gordon notes. “The regulations call for reasonably anticipated risks, and informed consent forms went well beyond that, so the new regulations will take us back to this idea.”

On the negative side, the new Common Rule mandates establishing a single IRB of record, creating a new unfunded mandate.

“This won’t happen until 2020, and we’re already seeing trauma associated with that,” Gordon says.

If this Common Rule change follows the same pattern as previous changes requiring a single IRB of record, then chaos might follow — at least for a time.

The National Institutes of Health (NIH) in 2018 required all NIH-funded research to use an IRB of record. Research institutions have worked to create reliance agreements and new policies and procedures, but it has been a challenging process, Gordon says.

“While it’s a wonderful idea to reduce duplication among single IRBs, it was not well thought-out,” he says. “It’s not reducing burden, even for investigators, and we just don’t know how to do this well.”

It would take large IRB staffs and bigger budgets to make the single IRB change work well, he adds.

Most IRBs do not know how to handle this, and the implications are problematic as it will slow down research and not result in streamlined research, Gordon says. “In the short and medium time, it will disrupt things; most of us are scrambling to make the NIH mandate work.”

One of the chief problems is how to fund the change. Many institutions are adding one or two additional full-time equivalent positions to their staffs to handle the work of becoming a central IRB. Sometimes, the institutions have little choice when it comes to deciding whether to be a central IRB, so just deciding to rely on another organization is not an easy answer.

For example, investigators apply for NIH funding and list their institution’s IRB as the central one.

“Then they come to the IRB and say, ‘I got my grant funded, and you guys are the central IRB, so what do I do now?’” Gordon says. “We say, ‘We don’t know how to be the central IRB — we can’t negotiate with 20 different sites.’”

Some institutions will go ahead and become the IRB of record for these researchers’ studies. Others will say, “No,” and let investigators know that if they want the IRB to take on that role, they will have to meet with the IRB before applying for funding.

“That’s just the bad side if it,” Gordon says. “The idea of a single IRB review is fundamentally sound. There are advantages to be had by not having 12 IRBs review the same study and make 112 sets of requirements.”

On the other side of the debate, there are benefits to having different IRBs review the same study. Sometimes, one IRB will pick up on a problem that others missed. And the local context is more difficult to manage with one IRB of record, he says.

“We know our investigators, and we know which ones need hand-holding and which ones have 15 projects open and are stretched too far, so we’ll evaluate them differently,” he explains. “But we don’t know the investigators at the [relying] institution. We don’t know their local community’s feeling toward research.”

A third option of hiring a commercial IRB to be the IRB of record might be the easiest path to take, but it often is not an affordable option, especially for federally funded studies with limited budgets. “It can be a big line item, so it’s cheaper to go through your local IRB,” Gordon says.

Big changes like the Common Rule’s changes to IRBs can take years for institutions to absorb.

These kinds of systematic changes require IRBs to develop new systems, new policies and procedures, and educate and train stakeholders. Then they likely will not function well for a while, he says.

“Five years ago, we didn’t use any commercial IRBs. Then we chose one commercial IRB that we’d allow our investigators to use, and the first few years were very difficult,” Gordon says. “We worked it out and are better at it now, but it took us a while.”

Once the Office for Human Research Protections issues more guidance on how to make this transition to a single IRB of record for multisite studies, the change will be a little easier, he adds.

Also, the recently passed 21st Century Cures Act requires that FDA regulations and Health and Human Services regulations be congruent. Until this happens, IRBs will have to deal with making one requirement for federally funded studies and expect some resistance from investigators of FDA-regulated studies, where that requirement is not in force, Gordon says. (http://bit.ly/2JihLaa)

“Relying IRBs are going to have to develop new systems that also complicate things, and their investigators are going to have to learn new patterns, but it’s not a bad thing,” he explains. “It’s potentially a very good thing — but it’s a steep learning curve.”