After over five years of discussion—from the advance notice of proposed rulemaking and two implementation delays—the revised Common Rule finally went into effect on January 21, 2019. The delays in implementation, while frustrating at times, also gave institutions more time to plan and discuss best practices. Through all this discussion, however, many areas of ambiguity were identified including challenges on how to implement the changes. To help address these issues, PRIM&R held a panel on Operationalizing the Revised Common Rule at the 2018 Advancing Ethical Research Conference (AER18).
While the revised Common Rule applies to all Federally funded research approved after the implementation date, many studies under IRB review may not be subject to these new changes. This includes federally funded research that was started prior to the implementation date, research funded by agencies, including the Department of Justice, which have not signed on to the revisions, and studies which are neither FDA regulated nor federally funded. Adding to the regulatory complexity, under the revised Common Rule, institutions no longer have the ability to “check the box” on the FWA to certify that they will apply uniform standards across all research. This poses unique challenges in states like Maryland and New York where research, if not regulated under federal jurisdiction, could be subject to restrictive state research laws.
The AER session discussed varying approaches that institutions are taking in navigating this complexity and planning their implementation process. Some institutions, for simplicity of application and efficiency, are planning to apply the revised Common Rule as broadly as possible (e.g. to existing federally funded studies and non-federally funded/non-FDA regulated studies). By trying to minimize the regulatory oversight variability, the process becomes more streamlined and training of investigators and IRB staff is simplified. This approach, however, reduces flexibility for studies where the revised Common Rule would not need to be applied. While long-term oversight of research would be simplified, transitioning all existing studies to comply with the revised Common Rule may be challenging.
Another popular approach is to create a hybrid model with a clear outline of which regulations apply in which cases. This allows maximum flexibility for both the IRB office and research teams as well as a customized transition approach (or a decision not to transition existing studies). A hybrid model typically involves institutions drafting a set of “equivalent” protections, which may pull some parts of the new and old Common Rule requirements for research where the revised Common Rule need not be applied (e.g. non-federally funded or FDA regulated research). The challenges of this approach lie in documenting the different requirements and when they apply, educating the HRPP staff and research community, and reviewing a high-volume of submissions where additional checks need to be made for each review to determine which set of requirements apply. One presenter discussed their approach to a hybrid model. They have created (1) a Definition Policy which defines three rules: Original Rule, Revised Rule, and a Hybrid Rule which incorporates some provisions of the revised rule with more flexibility; (2) an HRPP Plan policy which defines when each rule is applied; and (3) updated SOPS, Checklists and Worksheets to outline what to do depending on which rule is being applied to the research.
Some institutions may havealready taken advantage of the ability to implement three “burden-reducing” provisions that went into effect in July 2018. Studies where changes were partially implemented (e.g. no continuing review) will have to be brought into full compliance with the revised Common Rule. To apply the flexibility in the new rule, such as the elimination of continuing reviews for non-FDA regulated minimal risk research, all the other changes in the revised Common Rule, such as additional informed consent requirements and posting of a consent form for clinical trials must also be met. SACHRP released recommendations on November 13, 2018 which are helpful as institutions consider some of the decisions around implementing the revised Common Rule and transitioning research.
The most important pieces to think about in implementing the revised Common Rule are determining which approach will work best for your institution, how existing studies will be handled, ensuring all forms/systems and SOPs are up to date, and providing training to the HRPP staff and research community on these changes. Subscribing to regulatory listserves (such as OHRP and SACHRP), PRIM&R’s blog Ampersand and the IRB Forum, and connecting with others in the regulatory community are all great ways to stay up to date and learn strategies and best practices. Many institutions are also making their revised Common Rule training materials and updated SOPs and forms publicly available. While change can be challenging, working together to share ideas and best practices can help ensure the transition goes as smoothly as possible.
Heather Cathrall, MBE, CIP, is the Assistant Director of the Children’s Hospital of Philadelphia Institutional Review Board. She has a Master’s degree in Bioethics from the University of Pennsylvania and Bachelor’s degrees in Cognitive Science and Psychology from the University of California, Berkeley. She has worked for the Children’s Hospital of Philadelphia IRB for over 13 years and was a research coordinator prior to her IRB work.
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.