At the 2017 Advancing Ethical Research Conference (AER17), I caught the plenary session, “New Frontiers: The Changing Landscape of Research Regulations.” One of the presenters, John R. Baumann, PhD, the Associate Vice President for Research Compliance at Indiana University, shared with us how his institution was approaching the upcoming changes to the Common Rule, including the elimination of continuing review.
Editor's note: Visit primr.org/CommonRule for the latest news and information about the revised Common Rule.
As a quick refresher, here is what is coming down the pipeline for continuing review:
- When the revised Common Rule goes into effect, the federal regulations will no longer require annual continuing review for minimal risk (expedited) studies. IRBs may still require continuing review on a study-specific basis, but must justify why continuing review would enhance protections of research subjects if they choose to make this a requirement. This justification must be documented by the IRB.
- For studies that are greater than minimal risk (full board), the revised Common Rule will continue to require annual continuing review, unless the research is found by the full board to be eligible for expedited review, or the only remaining study procedures are data analysis (including analysis of identifiable private information or identifiable biospecimens) or accessing follow-up clinical data that participants would undergo as part of clinical care.
- The revised common rule will not require continuing review for research that has undergone limited IRB review (as part of the revised exempt categories).
- Investigators will still be required to inform the IRB of any developments to the research project (including unanticipated problems or proposed changes to the protocol) under the revised common rule.
Dr. Baumann’s presentation highlighted some new challenges that institutions will face as a result of eliminating continuing review. Currently, continuing review serves as a mechanism for institutions to get a yearly picture of their research portfolio. Without annual review, institutions will lose this source of information and oversight.
As an IRB administrator, I do have some concerns about the implications of this loss of oversight. I know that one of the goals in revising the Common Rule is to promote respect for persons by improving communication and consent processes, but I worry that decreasing communication between investigators and IRBs could be at odds with this goal.
To give an example, continuing reviews are sometimes the only time we will see a study following initial approval, and as a result, these are our only opportunities for discovering non-compliance. In most cases, the non-compliance is benign and does not negatively impact participants (such as investigators having expired human subjects certifications).
Other times, however, we have discovered more serious non-compliance at the time of continuing review, such as a researcher collecting data without IRB approval (in this case, the PI had conditional approval as required by the funding agency, but not approval to conduct human subjects research). Ultimately, this study involved benign procedures and participants were not harmed. But without continuing review, I worry that more serious or ongoing noncompliance would go unchecked by the IRB, and that participants could be negatively impacted.
One suggestion Dr. Baumann proposed is to have researchers complete an annual check-in, where they report whether or not their research is still taking place. If they respond that their study is completed, it could be closed out in the system automatically, which would allow institutions to have a general snapshot of their ongoing research portfolio. If they respond that their study is still active, they would receive a reminder of their responsibilities as investigators (such as to report changes, problems and deviations to the IRB).
Annual check-ins to confirm that investigators have current certifications and are using current consent documents would also protect institutions from a compliance point of view (institutions could be in danger of losing funding or accreditation if they are found to be non-compliant with their policies).
The problem here is that having annual check-ins to confirm compliance and remind researchers of their responsibilities is starting to sound and look like continuing review, which is not the direction that the federal government wants us to go in. So the question remains: when it comes to continuing review, how will institutions handle conflicting charges to protect participants, guide researchers, reduce burden and cover themselves under the revised common rule?
Sarah Luery is an IRB Administrator at the University of Southern California and a member of the 2017 PRIM&R Blog Squad.
Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.
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