2/13/2017

The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.

The NIH’s Single IRB (sIRB) policy is one of the initiatives developed to streamline the review process for NIH-funded, multi-site clinical research studies in the United States. In multisite research the use of only one IRB can simplify the review, communication and oversight of the study and in turn enhance human subject protection. The new policy was issued to both the Federal Register and the NIH Guide to Grants and Contracts on June 21st 2016 although it does not take effect until September 25th 2017. In developing the policy, NIH considered input from a range of stakeholders who commented on a 2014 draft version and can be reviewed here.

Most of the responses to the policy were positive although there were some areas of concern such as:

Disagreement by primarily academic institutions and local IRBs about mandating the use of sIRB instead of only incentivizing it.
Lack of harmonization with other federal policies particularly the recently released Common Rule update and Provisions of the 21st Century Cures Act.
Many commenters noted that over the past several decades the IRB’s role has been expanded to include functions beyond ethical review and are concerned about moving away from ensuring appropriate human subject protection instead being more concerned with protecting the institution from legal liability.
Others cite the lack of consideration for local norms and customs, and the concern for conflict of interest brought about by the use of a single IRB.
The need to define clear responsibilities and processes for the adoption of this new policy.
Finally, there were concerns about the shifting of expenses and funding required for implementing the policy.

The NIH addressed the commenters concerns by developing the tools and guidance available below as well as by being very narrow in the intent of the policy, which only applies to studies where the same research protocol is being carried out at multiple sites in the US and allowing a 15-month period to implement the policy.

Among the NIH Clinical Research Policy IRB Review website the following tools are listed to help prepare for the implementation of the policy:

A detailed FAQ document where 50+ important questions and clarifications have been addressed including the difference between central IRBs and single IRBs, whether the policy applies to delayed onset research and much more, we encourage you to review this tool.
The National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards (CTSA) program is developing the SMART IRB Reliance Platform to serve as a roadmap for investigators of multisite studies to implement the NIH sIRB policy, to read more about this initiative click here.
A model authorization agreement and guidance titled “Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research” available here.

Other interesting outcomes from this new policy include the recognition of new terms such as Single IRB and Central IRB along with other industry initiatives like WCG’s Single Review Solution™ (SRS). For clarification:

Single IRB (sIRB) and central IRB (cIRB) can be used interchangeable and both intend to note the “IRB of record” for the study and seems to be the most consistent industry term.
The Single Review Solution™ (SRS) by WIRB-Copernicus Group (WCG) launched in 2013 and is one of the earliest solutions developed to provide single IRB review.

Schulman IRB will be holding a Free Symposium on Federal Initiatives Toward Single IRB Review on February 15th to discuss the impact of this new rule and other evolving regulations. Our company will be attending this event. Feel free to contact us if you plan to attend and we can network! Additionally, Schulman IRB will host a webinar on 2/28 on Federal Initiatives Toward Single IRB Review for which you can register here.

In the upcoming months there will be more discussion on the Single IRB Review initiative as the implementation date of September 25th 2017 approaches, stay tuned for further post on the subject!

For more information, contact SAM at samsather@clinicalpathwaysresearch.com or laidy@clinicalpathwaysresearch.com.

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Thank you!