Yesterday, the NIH issued a draft policy encouraging the use of single Institutional Review Boards (IRBs) in all NIH-funded multi-site clinical trials. The rationale behind this new policy was spelled out simply:

When regulations for protection of human subjects were first published, most clinical research was conducted at a single institution. Since then the research landscape has evolved, and many studies are carried out at multiple sites and within large networks. Multi-site studies often are able to recruit more individuals from diverse populations and generate important results in less time. However, working through IRB review at each site can add delay without increasing the ethical protections for the research participants in the study. (NIH Clinical Research Policy)

CTTI’s Central IRB Project came to similar conclusions. One of the key takeaways from this project was that sites could become more comfortable using this streamlined review model if government and commercial sponsors required the use of a single IRB as a condition for participating in a particular multi-center trial. We are pleased to see a policy in accordance with our recommendations, and that CTTI’s work was cited. We are confident that these steps will improve the efficiency of clinical trials in the US.

In their concluding remarks, the NIH points out some of the potential hurdles for adopting their guidance:

Despite enthusiasm for central IRBs, there is confusion about the optimal structure for central IRBs as well as how best to meet regulatory requirements. There are questions about the loci of responsibilities and whether the IRB or institutions will bear the blame if adverse events occur. (NIH Clinical Research Policy)

Serious adverse event reporting of is one of the items discussed in the CTTI-developed guide, known as the Considerations Document. The guide can be used by institutions and central IRBs when negotiating legal and ethical responsibilities for multi-center clinical trial.

On Friday April 25, 2014, the NIH Collaboratory’s free webinar series known as the Grand Rounds: Rethinking Clinical Research will host the web conference titled CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives. The focus of this webinar will be the adoption of a single IRB of record for multi-center clinical trials, as encouraged in CTTI recommendations. Two speakers, both of whom serve as team leads for CTTI’s Central IRB Advancement Project, will be featured:

• Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
• Petra Kaufmann, M.D., M.Sc., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

We invite you to attend this presentation, and encourage you to share this opportunity with your colleagues.

Time: 1:00-2:00 p.m. ET

Webinar Login:

1. Log in to the URL first: https://dukemed.webex.com/dukemed/j.php?MTID=m30760324061a749812cd1c966d1bfde0
2. Click “Audio Conference”
3. Choose “I will call in” and select the Toll Free number.
4. Dial in using the information from the dialog box that appears. Be certain to use the Access Code AND the Attendee ID.

*Note: If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 739 773 050
Meeting Password: 1234

For additional webinar details, please visit the NIH Collaboratory’s Grand Rounds Calendar.

We would like to thank Cynthia Hahn, Petra Kaufmann, and the rest of the Central IRB Advancement Team for their dedicated efforts to encourage implementation of CTTI’s recommendations. It is through these dissemination activities that methods to increase the quality and efficiency of the clinical trials enterprise are shared, and changes in practice are effected.