Tag Archives: Multisite studies

NIH Issues Final Policy on Use of Single IRB

Institutional review boards, Policy, Regulatory issues, , , ,

The NIH has issued a final policy requiring the use of a single institutional review board (sIRB) for multi-site non-exempt human subjects research funded by the NIH. The policy will take effect May 25, 2017.

According to the policy announcement, “while the NIH anticipates that that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of sIRBs will outweigh any costs and, ultimately, reduce burdens to the research process.”

In proposals submitted to the NIH, applicants will be expected to include a plan identifying the sIRB that will serve as the IRB of record for all study sites. It will be the applicants’ responsibility to assure that the sIRB is qualified to serve. NIH acceptance of the submitted plan will be incorporated as a term and condition in the award. Awardees will be responsible for ensuring that the authorization agreements between IRBs (“reliance agreements”) are in place.

According to the policy, “The additional costs associated with sIRB review may be charged to grants or contracts as direct costs, provided that such costs are well-justified and consistently treated as either direct or indirect costs according to applicable cost principles in the NIH Grants Policy Statement and the FAR 31.202 (Direct Costs) and FAR 31.203 (Indirect Costs).”

Before the policy takes effect, the NIH will be issuing guidance and resources to assist with implementation.

Read the full policy for additional details.

Findings from STOP CRC on Pragmatic Trial Recruitment

Clinical trials, Pragmatic clinical trials, , ,
Gloria Coronado, PhD, and Beverly Green, MD, MPH, Principal Investigators, STOP CRC Trial
Gloria Coronado, PhD, and Beverly Green, MD, MPH, Principal Investigators, STOP CRC Trial

Drs. Beverly Green and Gloria Coronado and colleagues have published an article in Clinical Trials describing the challenges of recruiting participants into large, multisite pragmatic clinical trials—particularly at the health system level. STOP CRC is one of the NIH Collaboratory’s pragmatic clinical trial Demonstration Projects, which are intended to provide a framework of implementation methods and best practices to enable participation of varied health care systems in clinical research.

STOP CRC is testing a culturally tailored, health care system–based program to improve colorectal cancer screening rates in a community-based collaborative network of federally qualified health centers. The authors observed that recruiting sites to participate in pragmatic trials is time-intensive and involves both preparing materials and organizing face-to-face meetings with staff and clinic leaders. Yet little is known about the characteristics of nonparticipating sites and clinic-level factors that may influence willingness to participate in a pragmatic trial.

“Our findings underscore the importance of assessing and reporting recruitment success at the organizational and/or clinic level in order to know the external validity of the findings and may inform future efforts to select and recruit health systems to participate in pragmatic research.” (Coronado, et al. Clin Trials 2015)