Many researchers wish their National Institutes of Health (NIH)-funded studies were easier to set up in compliance with the single IRB (sIRB) mandate, and lament the difficulties with communication and documentation across the sites involved. A tool that simplifies compliance with the sIRB mandate and lays out an easy-to-follow compliance road map would be invaluable for NIH-funded researchers.
This desire for assistance with the sIRB mandate triggered development of SMART IRB, allowing investigators to focus on executing the best research possible rather than spending excessive resources untangling the complex requirements surrounding NIH-funded research.
What is SMART IRB?
SMART IRB stands for Streamlined, Multisite Accelerated Resources for Trials, and is a free web-based IRB reliance management system developed by major universities with funding by the National Center for Advancing Translational Sciences (NCATS). Harvard Catalyst, Dartmouth Synergy, and the University of Wisconsin’s Institute for Clinical and Translational Research all took part in developing this platform on a national scale.
At a basic level, SMART IRB is a free organizing tool that maintains and documents reliance agreements between institutions and IRBs in a manner such that documentation is clear and easily produced if a sIRB compliance audit is necessary. It also documents relationships between institutions, investigators, and research sites.
Setting Up SMART IRB
The first step in using SMART IRB is for the home institution of the investigator to register with SMART IRB. Although an easy process, the investigator may have to encourage institution leadership to participate if that leadership is unfamiliar with the program. Next, the investigator creates a personal account, through which they will manage the study documents, reliance agreements, and study progress. Within the account structure, the investigator can designate individuals that may act on their behalf for each study, while the investigator may view all studies under their purview at once.
Submitting a Study for sIRB Review Using the SMART IRB Website
Submitting a study is very straightforward, with only four steps to complete:
- The SMART IRB website prompts the investigator or designee to provide basic details about the protocol and research methods used, and select SMART IRB-participating sites.
- The investigator’s home institution evaluates the request and either determines that they are qualified and willing to be the reviewing IRB or proposes an alternate IRB from the directory in SMART IRB. If an outside IRB is needed, the home institution submits a reliance request to the reviewing IRB, again through the SMART IRB website.
- The proposed reviewing IRB issues a determination of whether they can review the research.
- The participating sites confirm they are willing to accept the reviewing IRB’s oversight and are able to fulfill requirements set by same.
All of the letters, confirmations, and other documents are retained in a researcher’s SMART IRB page, and can easily be produced to satisfy any question during the research process or an audit if necessary. Every approval, document exchange, and reliance agreement is confirmed and tracked.
Should My Institution Join SMART IRB?
If your organization receives NIH funding or may conduct NIH-funded research in the future, there really is no downside to completing the institutional profile on SMART IRB. Even if you are not conducting NIH-funded research yourself, and your institution may participate as a reviewing body or research site, registering through SMART IRB can help form relationships with other institutions using the platform.
SMART IRB is emerging as a powerful tool to help reduce administrative and organizational burdens on researchers and enhance participant safety through its built-in audit trail format. Quorum Review IRB was on of the first independent IRBs to join the SMART IRB initiative, and we would gladly serve as your research partner for NIH-funded research. Contact us if you’re interested in designating Quorum as your sIRB.