In helping discover a cure for hepatitis C — a chronic infection that afflicts about 170 million people worldwide — Steve Flamm pioneered a new approach to clinical research at Northwestern.
Flamm, medicine: hepatology, became the first principal investigator at the University to use an external Institutional Review Board (IRB).
“Using a centralized IRB for our multisite studies has been fast and effective and the IRB Office’s communications with our coordinators has been easy and efficient,” says Flamm, who has relied on approved commercial IRBs 28 times since 2012. “Working with an external IRB has allowed us to be competitive and gain access to clinical trials that are innovative and beneficial to patients, and that we otherwise would not be chosen for. It is absolutely critical now for a successful clinical research program to have the ability to use an external IRB, especially for complex multisite studies.”
Under federal regulations, IRBs are charged with overseeing clinical trials to ensure they are conducted ethically. IRBs are responsible for approving research protocols and informed consent documents before a study can begin.
In recognizing the many benefits of using a single IRB, the National Institutes of Health, Northwestern’s largest funding source, will implement a new policy beginning January 25. The policy requires all NIH-funded multisite studies relying on the same protocol and involving human subjects to use a single IRB-of-Record (sIRB).
“Today, the time it takes to go from a sound research idea to the launch of a new, multisite clinical research study is too long,” said NIH Director Francis Collins, in a press release. “A major contributor to the delay is that too many institutional review boards are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants.”
The new NIH sIRB policy is meant to address this bottleneck and streamline the review process for NIH-funded, multi-site clinical research studies in the United States.
“Our research community should continue to pursue investigative studies involving cross-institutional sites,” says Nathalia Henry, executive director at Northwestern’s IRB Office. “In a federal funding environment that encourages collaboration, the new policy was not surprising nor wholly unexpected.”
Once the new NIH policy takes effect, investigators will be required to designate the single IRB-of-Record as part of the grant or contract application. This IRB can be housed at an accredited commercial entity, instead of Northwestern or at another academic institution.
“If you are a principal investigator who is developing a large and complex research proposal, the Office for Sponsored Research is here to support the proposal and management of that effort,” says Lynda Wolter, executive director of Sponsored Research. “The sooner OSR becomes a part of the project proposal process, the sooner we can identify potential incongruences or misalignments with these new NIH protocols.”
For more detailed information, including access to standard operating procedures for the use of External IRBs, or for when the Northwestern IRB serves as the IRB of record for multi-site research, visit the resources section of the IRB website. Additional information about recently posted guidance on how to incorporate new NIH policy requirements, including sIRB into your NIH funding applications, can be found here.
When the sIRB policy takes effect, Northwestern will initially evaluate on a case-by-case basis whether its IRB can effectively serve as the single IRB-of-Record for a proposed multisite project or if the University plans to cede IRB oversight to an external review board. Henry expects the University to have the infrastructure in place to handle IRB review of multisite studies, but the decision will also depend on factors such as the number of sites and study complexity. She expects the University’s capacity to handle studies with more sites and greater complexity will grow steadily over time, as Northwestern continues to bolster infrastructure.
“We will continue to make improvements and streamline our processes to manage the volume and complexity that this new policy will bring,” says Henry. “Northwestern has been working on an implementation and readiness plan behind the scenes for some time and we feel prepared to handle this change to the research landscape.”
For more information, visit the Office for Sponsored Research website, which features recently posted guidance on how to incorporate new NIH policy requirements, including sIRB into your NIH funding applications.
Editor’s note: January’s edition of Research News will explore NIH’s clinical trial definition, how the University’s sIRB implementation plan has developed, and the enhanced clinical trials resources are available to the research community.