From the Deputy Director for Intramural Research

A New Centralized Institutional Review Board

BY MICHAEL GOTTESMAN, DDIR, AND JONATHAN GREEN, OD

As you almost certainly have heard by now, the NIH Intramural Research Program is in the process of centralizing and consolidating the Institutional Review Board (IRB) system. The 12 independent IRBs will be transitioning to one IRB office, and the three different protocol and data-management systems are being consolidated into one. The goal is to improve the consistency of IRB review and the overall efficiency of the IRB system.

This type of IRB reorganization has been deployed successfully at universities around the country not only to enhance human-research protections but also to benefit principal investigators on clinical protocols by ensuring an efficient review process. The IRB reorganization will also ensure that we are compliant with the revised Common Rule [https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html] (also known as the Federal Policy for the Protection of Human Subjects), which becomes effective on January 21, 2019.

We have brought on two new team members to lead this effort, Jonathan Green as the director of the Office of Human Subjects Research Protections (OHSRP) and Tiffany Gommel as the director of IRB Operations (IRBO), a new centralized administrative office. Jonathan joins us from Washington University School of Medicine in St. Louis, where he was professor of medicine, pathology, and immunology, associate dean for Human Studies, and executive chair of the university’s IRB. Tiffany was executive director of the Research Subjects Review Board Office at the University of Rochester (Rochester, New York).

We are close to completing one step of the centralization process: the migration of protocol information from three different information-technology systems to one central-tracking and data-management system—iRIS, short for integrated-research information system.

The IRBO will handle all protocol submissions for the intramural research program; make exempt and nonhuman subjects determinations; and conduct expedited reviews of minimal-risk research. The office will conduct in-depth pre-reviews before sending protocols to a new, central NIH Intramural IRB committee. During this process, we hope to identify and address any issues that could delay approval. The pre-review will be done by trained professional IRB analysts with consultation from IRB chairs, human-research protection program leadership, and other experts as needed.

The new NIH Intramural IRB—consisting of all current NIH IRB members—will use an innovative “flexible IRB” model and will begin meeting in January 2019. Panels will meet multiple times per week, conducting shorter meetings with fewer agenda items than are on current committee schedules. In this way, once ready, protocols can be scheduled for meetings with less delay.

The revisions to the Common Rule constitute the first substantive changes since its publication in 1991. There are several provisions that will affect all investigators including changes to the informed-consent process, new exemptions, and the elimination of continuing review for some minimal-risk research.

To ensure compliance with the new rule, all new studies slated for initial approval on or after January 21, 2019, will be processed by the IRBO and reviewed by the NIH Intramural IRB. All studies approved before January 21 will remain under the old rule and do not need to comply with any of the revised Common Rule requirements. Amendments and continuing reviews will continue to be handled by the current NIH IRBs. Over the course of the next several months, we will transition each of the committees into the new structure.

We are confident that the new IRB system will be an improvement for everyone. For investigators, there should be greater consistency in IRB review and more efficient turnaround times. For IRB members, meetings will be shorter with fewer agenda items, allowing for greater preparation and participation.

We thank you in advance for your patience and understanding as we undertake this initiative. There will almost certainly be some bumps in the road as we get going, but with your help we will achieve smooth sailing soon.

Jonathan Green, M.D., M.B.A., is the director of the Office of Human Subjects Research Protections. For more information, go to irbo.nih.gov.