November 18, 2016
WHAT YOU NEED TO KNOW ABOUT THE NIH sIRB POLICY
Earlier this year, the NIH released a new policy that all sites participating in human subjects research funded by NIH utilize a centralized, single IRB (sIRB). The sIRB will provide IRB review for all participating sites and all sites will be expected to accept the review and approval of the sIRB. Since the release, the IU Human Subjects Office (HSO) has received a number of questions.
Here’s what you need to know:
Not all NIH studies are affected
The NIH sIRB policy applies to new grant applications submitted to the NIH after May 25, 2017. In addition, grant applications which are resubmitted to NIH for competing review after that date will also be subject to the policy.
It’s important to note that ongoing, non-competing awards will not need to comply with the policy. Most current, ongoing NIH-funded studies will not be affected. These projects will not be expected to identify a sIRB and should not be transferred to a sIRB unless specifically approved by the HSO.
The policy is specific to US sites. International sites will not be subject to the policy; however, if a study involves both IU and non-US sites, the US sites will be expected to utilize a sIRB.
sIRB review isn't a new concept
Human research protection programs have been expecting and planning for single IRB review for years. Over the past five years, research collaborations have become more and more common, and the idea that utilizing a single IRB in lieu of site-specific review may increase efficiency has been a topic of discussion amongst IRB administrators around the country. Regional research consortiums began attempting single IRB several years ago and, today, IRB reliance is an every-day occurrence at many institutions. Many of the Big 10 institutions now have designated staff whose sole job is to facilitate single IRB review.
The single IRB concept entered the national debate with the publication of the Notice of Proposed Rulemaking for the Common Rule in September 2015, which included a specific provision that multi-site studies utilize a single IRB model. While we are unsure whether NPRM will become law, the NIH is moving the single IRB concept forward with its new policy.
We know what we don't know, but can't take action without more information
While single IRB is easy to accept in concept, operationalizing use of a sIRB for multiple sites is a much more difficult task. As always, "the devil is in the details." The NIH has promised additional guidance in several areas and, without that guidance, trying to provide specific instructions to our local research community is extremely difficult. As with any other business process, single IRB review can take many forms and it appears that the NIH is planning to endorse a particular business model which will define how single IRB review is implemented on an operational level. Until the additional guidance is available, we won’t be able to fully define a local process.
Review by the sIRB means fewer IRBs, but not less work
Single IRB may change the number of IRBs which are involved in the IRB review process for a single study, but it doesn't change the amount of work required to obtain IRB approval for a protocol or a specific site. Instead, that work is simply shifted from the participating sites to the site responsible for IRB review.
Lead Study Team Responsibilities
Collecting all the required information about multiple sites can be time- and resource-intensive and IRB offices generally aren’t in a good position to handle this task. Under the NIH’s proposed business model for single IRB, a lead site (usually the awardee institution) will be responsible for communications between the research sites and the sIRB providing review (i.e. collecting the required information from sites and compiling it for the sIRB, making IRB submissions on behalf of sites, and communicating IRB decisions and approved documents back to sites).
Most study teams aren’t currently prepared to handle this level of coordination and communication, so this will be a major change in responsibilities for those sites which receive NIH funds. Some larger research networks may have resources available to lead sites through these tasks. However, in many cases lead sites will need to be ready to handle this additional work themselves and may need to consider budgeting for additional staff.
Relying Site Study Team Responsibilities
Single IRB review is unlikely to result in less work, even for those sites which aren’t designated as lead. To start, most institutions (including IU) require a submission to the local IRB office which describes the protocol and requests that a sIRB be allowed to provide review for site’s participation. These submissions are generally much shorter than a full IRB application, but are required before the sIRB’s review can be accepted. After reporting to their own institution’s IRB, there is the matter of providing the required information to the sIRB. The sIRB often has additional forms which must be completed by each site and may even need local IRB input.
In addition to providing information, all sites must be prepared to follow the policies and procedures of the sIRB. There is no standard set of IRB policies and procedures, although many IRBs may have similar requirements. Each site is responsible for understanding the policies and procedures of the sIRB and conducting the research accordingly. Specifically, it is important for sites to understand the sIRB’s expectations for reporting adverse events, deviations, noncompliance, and other problems to the sIRB, as well as expectations for updating personnel and enrollment status, submitting amendments, and tracking subject enrollment and status, among other things. The lead site should be providing this information to the sites and helping study sites comply with sIRB requirements.
The IRB chosen to provide review, the sIRB, has to fulfill the same responsibilities of any other IRB. In fact, those same responsibilities become harder to carry out since the information which could previously be gathered from one site must now be gathered from multiple sites. The sIRB has to make the same determinations without the benefit of knowing the investigators, how they conduct research, and the resources available to them.
In order to provide appropriate IRB review for all sites, the sIRB reviews basic information about the protocol (e.g. procedures, risks, benefits, data safety monitoring, template consent language) to determine whether the protocol meets the federally-mandated criteria for approval. Then the sIRB considers each site individually and how each site will implement the protocol locally, collecting information about investigator qualifications and local context information, and incorporating site-specific language into template consent and authorization documents.
The sIRB also has to ensure that any institutional requirements applied by the participating sites have been completed (e.g. human subjects training, conflict of interest disclosure, scientific review, radiation safety review). These activities are often tracked on a local level using site-specific electronic systems which aren’t available to the sIRB. Therefore, that information also has to be collected and considered for all sites. And all of this just facilitates the initial review! Ongoing review, including amendments, renewal, and review of reportable events, requires additional information specific to the submission and the specific sites affected.
All in all, serving as the sIRB can be extremely complicated and requires a huge amount of coordination by IRB staff. Most institutions, including IU, are still in the process of enhancing our electronic IRB systems to help coordinate IRB review of multiple sites. In the meantime, additional site-specific forms are often required.
In order to utilize a sIRB for a project, the institutions involved have to enter into a contractual agreement which documents one institution’s willingness to rely on the sIRB, and outlines each sites’ responsibilities. These are often called reliance agreements or IRB authorization agreements.
The NIH has recommended that institutions use a model called SMART IRB which allows all institutions to sign one, single agreement, then utilize that agreement for all NIH funded studies requiring sIRB review. IU is currently in the process of joining SMART IRB.
Help is coming!
The HSO is working hard to draft policies, procedures, and processes for local implementation of single IRB review. Over the next six months, we will be providing regular communication about our progress and expect to release additional guidance and forms, as well as revisions to the KC IRB system, in early summer 2017.
In the meantime, if you are planning for an NIH proposal which will be submitted after May 25, 2017, please feel to contact Amy Waltz at firstname.lastname@example.org to discuss the sIRB components.
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