Recommendations for Using Single IRBs for Multicenter Clinical Trials
Single IRB
Webinar Recording Now Available: CTTI’s Framework for Evaluating the NIH Single IRB Policy
A recording is now available of a CTTI webinar held on Thurs., Jan. 16, which provided a recap of resources available to help implement a sIRB model, as well as an overview of a recent project CTTI undertook to develop a framework that could help in evaluation of the NIH’s single IRB (sIRB) policy. The webinar was led by Cynthia Hahn (Integrated Research Strategy), Stephen Rosenfeld (Secretary’s Advisory Committee on Human Research Protections), and Heather Pierce (Association of American Medical Colleges).
CTTI has been involved in driving adoption of sIRBs for over a decade, but its recent work with the NIH is especially critical this month as changes to the Common Rule take effect, requiring all multi-site research studies to use a sIRB for review.
To develop its evaluation framework, CTTI conducted a literature review and interviews with a diverse set of stakeholders engaged in the process of sIRB adoption.
The webinar outlined the framework’s recommendations for measuring and continuously improving the sIRB model, including:
- Creating a database of organizations that are implementing the sIRB model, as well as which organizations are serving as an sIRB.
- Developing and testing a survey instrument to help evaluate sIRB function and collect metrics.
- Establishing, defining, and routinely collecting and sharing metrics, such as sIRB review time and time spent performing other sIRB-related activities. The team pointed out that although many metrics are quantitative, it is also important to have qualitative metrics to assess the overall quality of the sIRB process. Routine sharing of these metrics would serve to encourage improvement and eliminate unnecessary duplication.
Explore CTTI’s existing resources and recommendations for sIRB adoption on the CTTI website.
CTTI Webinar Will Highlight sIRB Adoption Resources & Evaluation Considerations
As more single institutional review board (sIRB) requirements from the Common Rule go into effect this month, CTTI can help organizations navigate the change. A webinar on Thurs., Jan. 16 at noon ET will provide an overview of existing CTTI sIRB work, as well as suggestions for sIRB evaluation.
CTTI has been at the forefront of the sIRB movement for nearly a decade, championing the thoughtful implementation of sIRBs for multicenter clinical trials to enhance patient safety, accelerate study start-up, and improve trial conduct.
The webinar will highlight CTTI’s suite of recommendations and resources, as well as discuss outcomes from a recent collaboration between CTTI and a NIH sIRB policy workgroup. Speakers will include:
- Cynthia Hahn, President, Integrated Research Strategy
- Heather Pierce, Senior Director for Science Policy and Regulatory Counsel, Association of American Medical Colleges
- Stephen Rosenfeld, Chair, Secretary’s Advisory Committee on Human Research Protections
Add the webinar to your calendar today.
IMPACT-AFib Shares Successes and Lessons Learned from Use of Single IRB
IMPACT-AFib (IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation) is a nationwide pragmatic clinical trial launched in 2017 by collaborators including CTTI. IMPACT-AFib is the first trial conducted under FDA-Catalyst, which incorporates the infrastructure of the FDA’s Sentinel System and enables direct contact with health plan members and providers. To help facilitate large-scale interventional research more efficiently, the collaborators followed CTTI’s recommendations of using a single institutional review board (sIRB).
The study team shared that the use of an sIRB had many positive results, including reducing study start-up time and alleviating administrative burden and costs on sites.
The study team also shared lessons that were learned through the process of using an sIRB:
- In a multi-center trial, each site has unique requirements, which must be taken into account by study leadership when identifying an sIRB that all sites will find acceptable. Selecting an sIRB that has national experience and is accustomed to dealing with different regulations across states is helpful. In addition, choosing an sIRB that many or all sites have used in the past expedites reliance agreements required between each site and the sIRB.
- Certain approaches can increase the efficiency of the sIRB approval process and reduce administrative burden for sites. For example, the team behind IMPACT-AFib expedited the process by submitting the initial protocol application to the sIRB that applied to all five sites. They then provided each site a template for the site submissions, noting items that might need to be adjusted according to site-specific considerations.
- Specific considerations around trial design, such as pragmatic studies leveraging claims data, should be taken into account when submitting to an sIRB. For example, sites for this study are virtual – with patient contact via mailings from their health plans – rather than contacting potential participants in-person at traditional clinical trial sites such as clinics or hospitals.
- Using an sIRB expedites the amendment process because only one submission is required, which is reviewed and approved for all sites.
Historically, each site’s local IRB has reviewed a trial’s protocol separately in multi-center trials, which results in lengthy approval processes, duplicative work, and differing protocol or informed consent changes among sites. The use of sIRBs can improve the quality and efficiency of multi-center trials by improving oversight and streamlining the review process.
Understanding of sIRB implementation has recently become even more critical; in 2018, the NIH began to require the use of an sIRB for all multi-center trials funded by the NIH, and by 2020, all U.S. institutions involved in U.S.-based cooperative research will be required to use an sIRB.
CTTI has championed the adoption of sIRB review for nearly a decade, developing recommendations and resources to address barriers and assist in the implementation of sIRBs. CTTI is also supporting an NIH workgroup to develop a comprehensive plan for assessing the NIH’s new sIRB policy.
Learn more about the IMPACT-AFib trial on ClinicalTrials.gov.
CTTI Unveils New Resources to Facilitate Implementation of Single IRB for Multicenter Trials
CTTI has announced new resources to facilitate the implementation of single IRB (sIRB) in multicenter trials. The tools walk research institutions, sponsors, and IRBs through considerations for determining engagement, and provide a library of available sIRB resources. They are enhancements to CTTI’s extensive work on the topic dating back to 2010, which was featured in a recent issue of Contemporary Clinical Trials Communications.
“For nearly a decade, CTTI has been at the forefront of the sIRB movement, championing the thoughtful implementation of sIRBs for multicenter clinical trials to enhance patient safety, accelerate study start-up, and improve trial conduct,” said Pamela Tenaerts, executive director of CTTI. “We are pleased to unveil new resources to address some of the most pressing sIRB challenges and information gaps that remain for researchers. These tools augment CTTI’s already robust set of resources to collectively make sIRB adoption more seamless for the clinical trials enterprise.”
CTTI’s new tools include:
- A set of Engagement Materials including:
- An Engagement Overview, which provides an introduction to the Engagement Materials, information about who has the authority to make engagement decisions, required information to assess, and responsibilities of an engaged institution.
- An Engagement Flowchart, which guides institutions through a set of questions for determining if its employees or agents are performing activities that constitute “human subjects research” on the institution’s behalf as defined by the Office for Human Research Protections (OHRP).
- An Engagement Scenarios Guide, which illustrates examples of institutional involvement in research that would be considered “engaged” versus “not engaged.”
- Engagement Definitions for terms used in the Engagement Materials.
- A Resource of Resources that offers a library of available sIRB guides, templates, and tools to help stakeholders to optimally prepare, engage, and implement sIRB.
More information on these new resources is available via a recent CTTI-hosted webinar that features Nichelle Cobb (University of Wisconsin-Madison) unveiling the tools and showcasing their utility. The webinar also includes an overview of CTTI’s previous and ongoing work on sIRB for multicenter clinical trials, as well as results of recent semi-structured interviews to assess current perceptions of sIRB benefits, process challenges and solutions, and informational needs for using an sIRB process for FDA-regulated studies.
CTTI Article Finds that Patients and IRBs are Amenable to Early Enrollment Strategy
A CTTI article recently published in JAMA Network Open shows that an early enrollment strategy for research on healthcare-associated pneumonia is acceptable to patients, investigators, and institutional review boards (IRBs). This strategy has the potential to speed enrollment in trials for critical new antibiotic therapies by allowing patients to be approached and consented to before being diagnosed with pneumonia.
Through its ABDD HABP/VABP Studies work, CTTI conducted qualitative interviews with 52 stakeholders—including patients at risk for pneumonia, caregivers, study investigators and coordinators, and IRB representatives—as part of formative research to assess the acceptability of the approach.
The study found that patients and caregivers had no concerns about patients being approached early and having their records monitored before they developed pneumonia. They believed that patients would be able to understand consent information before diagnosis, and shared their preferences for opt-out procedures.
IRB representatives were also supportive of an early enrollment strategy, and investigators and study coordinators indicated that the approach would not be burdensome.