Reducing the Single IRB Burden: Streamlining Electronic IRB Systems

Abstract

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.

Keywords:

• Electronic IRB systems (eIRB)
• single IRB (sIRB)
• institutional review boards (IRB)
• interoperability
• research ethics

Acknowledgments

The authors thank all of the study participants and sIRBs for their time and important contributions to this research.

Conflicts of interest

No potential conflict of interest was reported by the author(s).

Author contributions

Please provide a brief statement regarding the contributions of the listed authors regarding the conception, design, data collection, and/or drafting of the manuscript. (See the International Committee of Medical Journal Editors’ Uniform Requirements for manuscripts for more information: http://www.icmje.org/ethical_1author.html.) All authors contributed to the drafting and revisions to this manuscript. Ekaterina Pivovarova and Robert Klitzman were also interviewers and integral to the data collection process.

Ethical approval

This study was approved by the institutional review boards at University of Massachusetts Medical School and the New York State Psychiatric Institute IRB.

Human subjects protection statement

The study received IRB approval from the University of Massachusetts Medical School IRB and the New York State Psychiatric Institute IRB.

Notes

1 A single IRB (sIRB) can also be referred to as a centralized or central IRB (CIRB)

2 An electronic IRB (eIRB) is a term commonly used to refer to computer systems that process, track, and manage protocol submissions, modifications, and other IRB related tasks.

3 A commercial IRB is an IRB that is not affiliated with a research institution and organized as, or owned by, a for-profit entity.

4 IREx was formerly called the SMART IRB Exchange Portal. Please note that this is not the same as the SMART IRB agreement.

Additional information

Funding

This study was funded through the National Institute of General Medical Sciences Grant # 1R01GM113640, titled Central IRBs: Enhanced Protections for Human Research Participants.