The 2018 Advancing Ethical Research Conference (AER18) presentation titled “It’s Not as New as You Think: Understanding How to Operationalize the Revised Common Rule” provided information regarding the history of the Common Rule and the recent changes to it. The Common Rule is a federal policy for the protection of human subjects in medical research. The overriding purpose of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” when it was published in 1991 was to create internal consistency, uniformity, and ethical standards in human subjects research conducted or funded by any federal agencies. The evolving nature of medical research has resulted in updates to the Common Rule—the revised Common Rule that just went into effect on January 21, 2019. It is important that IRB professionals and staff become familiar with these revisions, as they have important implications for the oversight and the conduct of medical research.
The presentation from Jeffrey A. Cooper, MD, MMM; Kristin Craun, MPH, CIP; Jessica Huening, JD; Heather Pierce, JD, MPH, helped to clarify much of the confusion concerning the recently revised regulations. Key changes in the revised Common Rule were emphasized. An important part of the presentation delineated what happens as these revised rules become effective. This was helpful in understanding how to transition from the “original” Common Rule to the revised Common Rule.
The following are some of the important changes relevant to my practice that were highlighted in the presentation:
Limited IRB Review and Exemption Determinations: This section pertains to the involvement of the IRB in the determination of exemptions, or waivers. All exemption determinations are to be decided by the IRB. The revised Common Rule broadens the types of research that qualify for exemption; several exemption categories have been revised, and there are new categories of exemptions. These changes to exemptions are applicable to either federally funded or supported research. IRBs now have the discretion to make the expedited review process less convoluted.
Continuing Review: The revised Common Rule removes the requirement for the continuing review of minimal risk research. As a principal investigator, I am concerned because this removes shared responsibility. From my perspective, all responsibility has now been placed on the shoulders of the Principal Investigators (PIs) to ensure that the study remains in compliance with the regulations. Even when continuing review is not required, investigators still remain responsible for continuing to inform the IRB about any developing adverse events and other unanticipated problems. They are also required to seek IRB approval for changes in personnel, protocol amendments, recruitment materials, and informing the IRB when the research has been completed. It is important that institutions develop and maintain a mechanism for continued monitoring throughout the entire study process.
Broad Consent: This refers to a new form of informed consent provided under the revised Common Rule pertaining to storage, maintenance, and secondary research including identifiable private information, or identifiable biospecimens. For such secondary research, broad consent is applicable. This secondary type of research involves materials that are collected for either research studies distinct from the current research proposal, or for materials that are collected for non-research purposes.
What are the operational considerations for the IRBs? The process of transitioning pertains to research based upon the “original” Common Rule versus the revised Common Rule, and may be very cumbersome. There may be some confusion initially, as two parallel tracks for ongoing studies may be required: one to conform to the “original” Common Rule, and a second track conforming to the revised Common Rule. If a study was approved prior to the January 19, 2019 effective date of the new rule, it will remain under the old rule until its next scheduled Continuing Review. Therefore, transitioning from old research to the revised Rule may be a better option.
I had assumed it would be better to disregard the original Common Rule. However, this may not be practical if an institution has a large number of studies. Further guidance would be required for continuing research projects.
As an IRB professional, I worry about the significant amount of work needed to revise and update the consent and waiver templates. Frequent review of parameters outlined in the revised Common Rule, and close supervision of ongoing research is therefore essential.
Muhammad Waseem, MD, MS, CIP, CPI, CCRP, is currently Professor of Emergency Medicine in Clinical Pediatrics at Weill Cornell Medical College, New York. He completed a residency in Pediatrics and a fellowship in Pediatric Emergency Medicine. He also holds Master's degrees in Clinical Investigation and Epidemiology & Health Services Research from Cornell University, New York. He serves as the Research Director for the Department of Emergency Medicine and Vice chair for the IRB at Lincoln Medical Center Bronx, New York.
His special interests are ethical issues involving children and protection of vulnerable populations. He addresses these interests via his work in the pediatric emergency department as an investigator and educator. He has been serving an under-represented population in an urban community for over 20 years.
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