IRB and research experts find many improvements in the final rule on the Federal Policy for the Protection of Human Subjects. After six years of debate, criticism, and waiting, the 543-page rule looks a lot better than the original proposal in 2011, but the biggest question now is whether the work will be upended with the stroke of a pen.
“I’m not sure what to make of it at this moment,” says Alan Stockdale, PhD, director of the human protections program and IRB chair at the Education Development Center in Waltham, MA.
“We’ve been waiting for the Common Rule for six years — a long time, and then it’s announced on the last day of the Obama administration, and everyone is saying this could all be undone,” Stockdale says. “It could be that in several months we’ll be back to the same old-same old, and I have no sense of whether or not that will happen.”
Stockdale spoke about the final rule in late January, just a few days before President Trump signed an executive order that required that “for every one new regulation issued, at least two prior regulations be identified for elimination.”
The “one-in, two-out” order created the potential for recently published regulations, including the new Common Rule, to be quickly and easily overturned. Another way the final rule could be shelved is through the Congressional Review Act, in which lawmakers can repeal regulations approved in the last 60 days of a congressional session.
“No one thinks this Common Rule will be pulled out for individual treatment,” says William Smith, JD, director of the IRB at Nova Southeastern University in Davie, FL.
Plus the Congressional Review Act’s method of repealing regulations could be subject to a filibuster, Smith says.
As of IRB Advisor’s publishing deadline, the outcome remains unsure.
One argument that might save the new Common Rule from being swept away is that it was created to reduce human research protection regulatory burden, says Erica Heath, CIP, a retired IRB director in San Anselmo, CA.
Heath’s advice to IRB offices is to make a list of potential changes under the final rule, but to not put too much time into creating new forms or standard operating procedures (SOPs) until everyone knows for certain if the Common Rule will stand.
Stockdale also recommends that IRB directors wait before implementing the changes and educating staff about the changes.
“I cannot imagine doing any of this until we’re certain these regulations will stay in place,” Stockdale says. “The uncertainty is a bit of a problem.”
In the event the Common Rule survives, the following are key points IRBs and research institutions should know:
- The new rule reduces some administrative burden. “Overall, I think it does reduce the administrative burden for a lot of IRBs,” Smith says. “It remains to be seen how it works because there is a requirement that federally funded studies use one IRB in the U.S. unless there’s a compelling reason not to.”
This could create complications as research organizations enter negotiations, he adds. (See story in this issue on where final rule succeeds and falls short.)
“It’s a requirement, but it places more emphasis on the fact that it’s not all clinical trials, just federally funded clinical trials,” Smith explains. “Requiring this of industry-sponsored ones would cause massive headache and stress.”
- Exemptions and expedited reviews are changed. “Operationally, almost all of the changes affect the low end of the review,” Heath says. “That is the expedited review, the exempt review.”
While the new Common Rule might not reduce the IRB’s workload, it will change classification of some studies, Stockdale notes.
“Looking at it so far, my sense is that it is going to be a lot of process changes for the IRB,” Stockdale says. “We can say, ‘You’re exempt,’ and we advise people on consent, but when they’re exempt, we don’t have to approve their consent forms.”
From the Education Development Center’s perspective, some things treated as expedited involve secondary data, such as information from school records, and there is no consent involved, he notes.
“But we have to make sure that the data are appropriately protected,” Stockdale says. “My understanding is that situation might be treated as exempt, but we would have to do a little extra IRB review to make sure there are appropriate data protections in there.”
The final rule deems a minimal risk study to be eligible for expedited review if it involves activities on the secretary’s list. This is expected to move more studies to expedited review, relieving some burden on IRBs.
Studies undergoing expedited review no longer need continuing review, although reviewers can justify an exception.
“That’s a big burden lifted on IRBs,” Heath says. “I think you could get a lot of arguments about whether it does or does not reduce protection.”
- There is more attention on data protections and privacy. “The changes reflect that data protection is a big issue, but we’d already gotten there as an institution years ago,” Stockdale says. “It’s like the regulations are catching up with reality: We were looking at data protection issues that weren’t necessarily in the old regulations, but we thought were important.”
Data privacy issues are among the biggest risks for social-behavioral research, Stockdale says.
“In doing educational research, protecting student privacy and compliance with the Family Educational Rights and Privacy Act [FERPA] is very important,” he says. “One of the main risks for us in most of the research we do, particularly in the more sensitive research, interviews, or surveys with people related to violence or HIV, is data privacy.”
- The informed consent changes need more guidance. “Consent needs a lot of guidance,” Smith says. “I like that they emphasized the process of informed consent, but a lot of these phrases they use and the wording used to emphasize the process is really going to result in people wondering what it means.”
- Pregnant women no longer are considered vulnerable. One change was to remove pregnant women from the list of vulnerable populations. “They’ve changed it to be vulnerable due to coercion or undue influence, such as children, prisoners, economically or educationally disadvantaged, and pregnant women are no longer vulnerable,” Heath says. “Pregnant women are special in subparts — it’s a change in viewpoint.”
- There is no self-determining exemptions. “One thing I was concerned about with the NPRM was the proposal to have a tool for investigators to self-determine their study’s exemption,” Stockdale says. “I’m very glad they took that out, as it was a terrible idea.”
There are more exemption categories, and these are complicated and will require time to review. But it’s better that they eliminated the self-determination possibility because it would have been a compliance problem, he says.