Using Technology to Support NIH Policy

September 29, 2016

Industry professionals are searching for new technologies to support their trials following approval of an NIH policy supporting single IRB practices. Transparent and auditable systems can offer stakeholders the ability to more effectively monitor and report regulatory responsibilities.

The recent approval of the National Institute of Health’s (NIH) policy, Use of a Single Institutional Review Board (sIRB) of Record for Multi-Site Research, will require researchers to change current practices. As a result, many are looking for transparent, efficient, auditable and scalable technologies to support their trials, manage IRB oversight functions and navigate the changing research environment.    Fortunately, technology continues to evolve to support virtually every aspect of conducting a clinical study within this policy. Innovative technology can enable institutions conducting NIH-funded research to adapt and even thrive under its newest mandate.    The introduction of transparent and auditable systems will bring a new level of efficiency to monitoring and reporting of regulatory responsibilities and allow stakeholders to spend time on what is really important: protecting the rights and welfare of research participants. With the right support from an sIRB with transparent and easy-to-use technologies, therapies will move to market much faster.    Sites and other stakeholders have been given a year to make the adjustments needed to operate under the new sIRB framework. In preparation, the NIH has provided a few advisory, informational pieces to manage this change. However, choosing a quality sIRB for your study can mean more for your trial than simple policy compliance. The key is to find the balance between achieving startup efficiency and heeding ethical caution.   With all the options on the market, the difference in quality from one company to another usually lies in their technology and resources. It is important to be able to check in with your trial 24/7 and thus essential to choose a provider with efficient, auditable processes and knowledgeable, accessible people.    Ensure the IRB you choose: 

  • Is accredited. Standard accreditation for any sIRB is through the Association for the Accreditation of Human Research Protection Programs.

  • Has a track record of quality work and the capacity to handle large studies across multiple sites. To begin, look for an sIRB with a list of pre-approved sites. It is also beneficial if the sIRB assigns a unique project coordinator to every study it oversees.

  • Uses scalable, transparent systems to support study sites and research institutions. Ask your prospective sIRB if it provides the capability for stakeholders to audit what is happening throughout the study in real time. Then, consider sIRB partners that do not charge to use the system, that have user-friendly and easy-to-use systems and that are flexible enough to handle anomalies like contractual language variances.

The best sIRBs facilitate faster site selection and activation, earlier recruitment and enrollment, reduced time from site activation to first patient first visit, real-time transparency of key performance metrics and improved efficiency.   Taking the time to partner with the right sIRB will not only allow you to comply with policy, think outside the box and implement innovative solutions, but can ultimately help you complete your study in record time, benefiting study participants and patients around the world.   

Jeffrey Wendel

, President and CEO, Chesapeake IRB