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By Melinda Young, Author
Among the bigger challenges with the new Common Rule, which went into effect on Jan. 21, are the new regulations involving exemption and informed consent.
“There are new categories of exemption that didn’t exist before, and the regulatory language from the Office for Human Research Protections (OHRP) doesn’t provide a lot of description of what it means to implement them,” says David Borasky, MPH, CIP, vice president of WIRB-Copernicus Group in Cary, NC.
The new rule also forces institutions to decide whether older studies should move forward under the new Common Rule or be grandfathered under the old rule, he adds.
“There have been a lot of questions about the transition and what to do with existing studies — the old versus the new,” Borasky says. “There is information out there, and we’ll know within the first 12 months how well the implementation is going and where there are points of friction.”
Also, regulatory harmonization is not yet a reality. “We’ll be operating under a few different regulations for the foreseeable future,” Borasky notes. “FDA rules and regulations are not updated.”
The FDA has stated that its goal is to align its rules with those of the new Common Rule, and the 20th Century Cures Act compels the FDA to harmonize. So far, the agency has taken what amounts to baby steps toward harmonization, he says.
“The FDA decided to use its enforcement discretion to allow IRBs to use the same waiver for informed consent as allowed under the Common Rule,” Borasky says. “But if you have an FDA-regulated study, you continue to follow FDA regulations, where those are more stringent than the revised Common Rule.”
Also, there are some informed consent requirements in the new Common Rule that go beyond FDA regulations. But this change is easier to deal with because research sites are allowed to go beyond what the FDA requires, he notes.
“The informed consent changes are not in the FDA regulations, but they do not conflict with the FDA regulations,” Borasky says.
“Keeping track of which requirements will apply to which studies is challenging,” he adds. “It depends on that institution and the IRB’s portfolio work.”
A main informed consent change involves adding a summary statement to the document research participants must sign.
“One of the requirements is that a succinct summary contain key information that a reasonable person would want to know to determine whether to participate in the study,” says Brian Moore, director of the IRB and the human research protection program at Wake Forest School of Medicine in Winston-Salem, NC.
“There are a lot of terms in that description that are pretty vague,” Moore says. “Instead of having one person sitting at a desk, thinking, ‘This is what I’d want to know,’ we wanted to pull together a group of people familiar with research and patients and who knew what they need and what’s important to them.”
The Wake Forest IRB worked on developing a template for the informed consent summary statement. (See story on creating informed consent summary statement in this issue.)
While developing the template, Moore and IRB members sought to answer these questions:
• What is the key information?
• How long is “succinct”?
• Who is the reasonable person?
• What are they expected to know when they make an informed decision?
Collaboration and work groups are how IRBs can implement multiple changes related to the new Common Rule and other new rules.
For example, the University of Texas at Arlington formed a work group to review and revise policies and procedures per reliance agreements and the new Common Rule.
“We wanted to understand everybody’s policies and procedures for reliance,” says Alyson Stearns, CIP, regulatory services manager at the University of Texas at Arlington.
“Sometimes, we would contact an institution, and their policies were so different from our policies, and we weren’t sure of who their contact was,” she says. “We had a whole lot of opportunity with the revised Common Rule to look at how we do not reinvent the wheel.”
The answer is a work group that was started in 2017 in preparation for the Common Rule.
“We reached out to every institution we could think of in the Dallas-Fort Worth area, and we have 12 institutions in the group and a mix of hospital and medical and nonmedical academic institutions, as well as a private university,” says Kirstin Morningstar, CIP, CPIA, director of regulatory services at the University of Texas at Arlington.
About 20 people attend the work group’s meetings, she adds. (See story in this issue on how to build collaboration between regional IRBs.)
Research institutions might struggle to become familiar with the new regulations because there is a lack of guidance from OHRP and other regulatory agencies, Borasky says.
Even in the absence of concrete guidance, there are pathways to being compliant, he says.
“Some organizations find the lack of guidance disconcerting, but others are less concerned and are moving forward with regulations, as they see fit,” he says. “Until IRBs and researchers have some practice with some of these new areas of regulations, there will be a time of sorting it out and figuring out best approaches and practices.”
Yet another challenge involves the logistics of revising electronic IRB submission systems.
For instance, an IRB system might automatically assign continuing review dates for every study. That no longer would be necessary for some studies. IRBs will need information technology help to make some of these logistical changes, Borasky says.
IRBs that review sociobehavioral research studies need to review the new exempt categories and develop implementation plans. “The impact will vary,” Borasky says. “Some pieces are easier to implement than others.”
OHRP has provided limited assistance and guidance to IRBs and institutions preparing for the new regulations.
IRBs should be caught up on updating their standard operating procedures (SOPs) and policies and procedures — but if they are not, there is no time like the present.
“A lot of work is required to get the SOPs up to date, but it’s not insurmountable,” Borasky says. “Resources are out there to help people with updates and revisions.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball is a consultant for Ethicon USA and Mobile Instrument Service and Repair.