By Melinda Young, Author
Barring a last-minute reprieve, the new Common Rule — with all of its complex changes — will begin Jan. 19, 2018.
And at a least a few IRBs are ready.
“The new Common Rule has material implications, including changes to training and education of IRB staff and members of the research community,” says Jennifer Graf, manager of the human research protection program and research integrity at Cambridge Health Alliance in Cambridge, MA.
(Note: At press time, HHS submitted a delay in Common Rule implementation. For more information, see story in this issue.)
“Cambridge Health has taken the position that the start of every IRB meeting has dedicated time to go over various elements of the revised Common Rule,” Graf says. “So, we’re ready, and our IRB members and IRB office staff are prepared.”
Various organizations had asked the Office for Human Research Protections (OHRP) for a delay in the new Common Rule implementation. Since this delay had not occurred by the end of 2017, some IRBs proceeded with changes to their policies and procedures.
For example, the University of Wisconsin-Madison’s educational and social-behavioral science (Ed/SBS) IRB implemented a new policy in October 2017, based on the Common Rule changes.
“As of Oct. 2, 2017, our new campus policy is that if a study meets these six criteria, they can meet the exception for continuing reviews,” says Casey Pellien, CIP, Ed/SBS IRB director at the University of Wisconsin-Madison.
The six criteria are as follows:
• the study involves only one site;
• the study does not involve drugs, biologics, or medical devices;
• it is not federally funded;
• it is not regulated by the Veterans Administration;
• it does not enroll prisoners;
• it is eligible for expedited review, or it involves data analysis.
“We did this change in continuing review in anticipation for the new Common Rule,” Pellien says. “We were granted that ability.”
These are a few of the changes from the Common Rule regulations, published on Jan. 18, 2017:
• consent forms should provide clearer information about a project’s scope, risks, and benefits;
• many multisite studies will use a single IRB review, rather than separate IRB reviews per site;
• researchers can rely on broad consent for future research involving studies on stored identifiable data or identifiable biospecimens;
• new exempt categories of research are based on the level of risk they pose to participants, and there’s a new exemption for secondary research that involves identifiable private information, related to HIPAA rule protection;
• continuing review is no longer required for ongoing research studies in cases where the review does not contribute to protecting subjects.
“The new Common Rule offers greater flexibility for the application of regulations,” Graf says. “One of the major impacts is the elimination of continuing review.”
While the flexibility is welcome, the changes also present a challenge to IRBs. “Continuing review enables institutions to easily keep track of minimal-risk research,” Graf notes.
“Many institutions use the continuing review process to satisfy various institutional policies, like getting annual conflicts of interest disclosures,” she explains. “When the continuing review is eliminated, there is a need for new, reliable procedures — like having an annual check to keep track of the minimal-risk research that’s going on.”
IRBs might also want updates on adverse events, complaints, staffing, and retraining.
“With the elimination of continuing review, there will be a ripple effect in staffing and retraining,” Graf says. “Under current regulations, you might have multiple staff who process continuing reviews. With the continuing review elimination, it’s reasonable to infer there will be a shift in staff and resources.”
For instance, IRB workflow might shift to auditing and monitoring roles.
“This presents challenges because the skill set and temperament needed to be a successful auditor or monitor differs from the skills needed in an office administration support role,” Graf says. “It’s not a one-on-one transfer, and IRBs might have to let some people go, and other people might not have an interest in being retrained.”
It’s possible the change will result in a 90% reduction in continuing review, Graf says.
“There could be an increased emphasis on field audits,” she says. “I think that with the elimination of continuing review, there will be a genuine need for robust monitoring and auditing.”
This is a potentially positive change, Graf says.
“I think the continuing review in its current form doesn’t necessarily optimize what the goals are: the protection of human subjects,” Graf adds. “The protection of the safety and welfare of participants is better served by field auditing and monitoring than by continuing review information.”
Adding additional exemption categories might affect social-behavioral and education research IRBs the most. A new exempt category involves research with benign behavioral interventions — but the exemption is not applicable for research involving deceit.
Another new exempt category involves storage or maintenance of identifiable private information or specimens for potential secondary research use. It’s exempt if an IRB conducts a limited review.
“We believe a lot of protocols we see will fall under the exempt category,” Pellien says. “So I think we’ll move away from approving a lot of protocols through expedited review to a lot of protocols being exempted.”
The new Common Rule says that activities that do not meet the definition of research include the following:
• “scholarly and journalist activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship);”
• “public health surveillance activities authorized by a public health authority to assess onsets of disease outbreaks or conditions of public health importance;”
• “certain criminal justice and intelligence activities.”
Consent changes might have more of an effect on medical review boards.
“For social and behavioral research, we request consent forms be no more than two pages,” Pellien says. “In the new Common Rule, new information has to be at the top of the consent form. Well, we’ve been doing that for years.”
The IRB requires informed consent for every study, even if it’s secondary data or exempt research, Pellien says.
“Even with exempt research, we require them to have some sort of consent process,” she adds. “They either have a signed consent process, or we require a waiver of signed consent.”
Whenever there’s interaction with subjects, there must be some sort of consent document.
The new Common Rule also changes the definition of “human subject:” “Human subject means a living individual whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”