We’re working furiously to prepare for the implementation of the Revised Common Rule, now scheduled for Jan. 21, 2019. Below is a recap of some of the more notable changes in the rule, followed by an explanation of how we anticipate incorporating those changes at UAMS. Please note this is only the tip of the education iceberg regarding the revised rule; we’ll be doing other education as we get more information from OHRP on how certain important aspects of the rule should be implemented.
Continuing review will no longer be required for most minimal risk studies approved after the Jan. 21, 2019, implementation date. It will also no longer be required for any studies that have progressed to the point that it involves only one or both of the following: 1) Data analysis, including analysis of identifiable private information or identifiable biospecimens OR 2) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
UAMS Implementation of this rule provision: Well, it depends. Minimal risk studies approved before the implementation date will be required to undergo at least one more continuing review. We expect to transition minimal-risk studies to the revised rule on a case-by-case basis, depending on the particulars of each study. Some studies, e.g. those using a written consent form, would require significant revision if transitioned to the revised rule, whereas others, such as chart-review-only studies, could make the switch fairly painlessly. Full-board status studies approved before the implementation date would also no longer require continuing review once they are in data analysis only. The IRB will continue to require studies that are accessing follow-up clinical data and that were approved before the implementation date to undergo continuing review in accordance with the current rule. Long-term clinical data collection has informed consent implications that both PIs and the IRB would find burdensome if we switch these studies to the revised Common Rule.
Expedited review studies are those that involve only activities that appear on a list of activities created by the Secretary of DHHS under the new rule. The Revised Common Rule’s changes here are fairly subtle. We have a list of expeditable activities now (see IRB Policy 7.5). The current rule says these items may be expeditable. The revised rule clarifies that those activities are expeditable, unless the reviewer determines that the study activities involve greater than minimal risk and documents the rationale for that determination. Another change is that the DHHS Secretary is to re-evaluate this list every 8 years to see if any changes are needed.
UAMS Implementation of this rule provision: We anticipate that more minimal risk studies will qualify for expedited review status. We have not seen any updates to the list of expeditable activities yet, but will let the research community know when we do.
Exempt Categories of Research have been clarified and, in some cases, expanded. Changes of note for UAMS-affiliated researchers include:
- Educational practice research must be unlikely to adversely impact students’ ability to learn required material or the assessment of educators.
- Some research involving benign behavioral interventions will qualify for exempt status review.
- Notably, some research involving the use and recording of data and specimens including identifiers will qualify for exempt status review, which is a significant change from current practice
UAMS Implementation of this rule provision: Some exempt research categories will be subject to something the revised rule refers to as “limited IRB review.” We do not yet know what form this review is to take; OHRP guidance is expected. These changes will also greatly simplify the regulatory oversight of studies that are limited to medical chart review only, including prospective chart reviews. In fact, we encourage investigators contemplating that kind of research to wait until after Jan. 21, 2019, to initiate their studies if at all possible.
Informed Consent: Informed consent must begin with a “concise and focused” presentation of key elements that may influence a potential subject’s decision of whether or not to join the study. The new rule also requires the inclusion of two additional consent elements when applicable.
UAMS Implementation of this rule provision: We continue to await promised OHRP guidance regarding this summary. The plain language consent template will be updated to include this requirement. In the meantime, we encourage, and always have, investigators to create supplemental materials to their standard consent form that present key consent elements in an easily understood way. The two new “when applicable” consent elements pertain telling subjects of the potential use of specimens for commercial profit and whether they will share in that profit, and a statement of whether any clinically relevant research results, including individual research results, will be returned to subjects and if so, under what conditions. Note that the IRB already considers these items in current studies when they are applicable.
Single IRB of Record – Most federally-funded, multi-site research in the US will be required to use a single IRB (commercial, academic, or hospital-based) starting Jan. 20, 2020. This delay allows institutions more time to prepare their review systems and processes to accommodate this change. Note that the NIH has already implemented a Single IRB-of-Record policy, so this provision will apply to studies not subject to the NIH policy.
UAMS Implementation of this rule provision: The UAMS IRB already allows single IRB review of multisite studies, and will continue improving its systems and processes to streamline this type of oversight. If you are considering single IRB review for your multisite study, please send an email to singleIRB@uams.edu.