Getting from A to IRB: Developing an Institutional Review Board at a Historically Black University

Abstract

Shaw University, the oldest historically black college or university in the southern USA, recently partnered with the University of North Carolina at Chapel Hill, a major research institution in North Carolina, to further develop Shaw’s research infrastructure. One aim of the partnership involved establishing a human research ethics committee and an accompanying administrative structure and research ethics education program. This paper describes the process of developing an entire human research protection program de novo through collaboration with and mentoring by the members of the human research protection program at a nearby major research institution. This paper provides a detailed description of the aims, procedures, accomplishments, and challenges involved in such a project, which may serve as a useful model for other primarily teaching institutions wishing to develop research infrastructure and ethical capacity.

Capacity Development of Research Ethics Administrators: Scoping Review

“…Of the 22 relevant literature studies analyzed, eight were quantitative ( Franzen et al, 2017 ; Jaoko et al, 2016 ; Kasule et al, 2016 ; Milford et al, 2006 ; Mokgatla et al, 2018 ; Moodley et al, 2020 ; Van Rensburg et al, 2017 ; Yakubu et al, 2017 ), six were qualitative ( Agunloye et al, 2014 ; Davies, 2020 ; Frantz et al, 2019 ; Henrikson et al, 2019 ; ILoghalu, 2018 ; Woodward-Kron et al, 2016 ), three were mixed method ( Hyder et al, 2019 ; Ndebele et al, 2014 ; Omosa-Manyonyi et al, 2014 ), while the remaining five studies were analysis and reports on the topic ( Choko et al, 2020 ; Gefenas & Lukaseviciene, 2017 ; Howard et al, 2010 ; Morton et al, 2013 ; Reston & Poliquit, 2020 ). The two literature studies ,which focused on capacity development of research ethics administrators, were empirical research studies that used quantitative and mixed-method research ( Kasule et al, 2016 ; Ndebele et al, 2014 ), the single literature study that conducted a needs analysis on IRB administrators in the United States followed qualitative approach ( Henrikson et al, 2019 ), while the literature study that established a new REC in the United States and therefore capacitated new administrators shared the findings through a report ( Howard et al, 2010 ).…”

“…One study focused on the capacity development efforts of REC members ( Omosa-Manyonyi et al, 2014 ), and one focused on establishing a REC and therefore capacity development of the entire REC structure ( Howard et al, 2010 ), while only two focused on capacity development efforts of research ethics administrators ( Kasule et al, 2016 ; Ndebele et al, 2014 ), and one study in the United States conducted a needs analysis of IRB administrators in genomics research ( Henrikson et al, 2019 ). While few studies reported on capacity development efforts of RECs in general, five studies either reported on the mapping of RECs, ( Mokgatla et al, 2018 ), performed assessments ( Jaoko et al, 2016 ), wrote analysis and reports ( Choko et al, 2020 ; Gefenas & Lukaseviciene, 2017 ; Howard et al, 2010 ; Morton et al, 2013 ) or surveyed RECs ( Agunloye et al, 2014 ; Yakubu et al, 2017 ) in Africa/LMICs, to determine what capacity development efforts would be needed.…”

“…The study was funded from the Global North, by the Global Health Research Initiative (GHRI) of Canada. The one study on the establishment of a REC and therefore capacity development of the entire REC structure reports that the training program was in the United States, 2005 (Howard et al, 2010). This study was funded from the Global North, by the National Center on Minority Health and Health Disparities Grants.…”

Ethical Considerations in Global Mental Health Research: Lessons Learned From Binational U.S.–Mexico Collaborations

“…OHRP provides support, guidance, education, and compliance oversight for IRBs in the United States (U.S. DHHS et al, 2017). Beyond governmental supports, a number of academic resources can also assist institutions in forming, training, and administering their own IRBs, including partnering with universities with an experienced IRB to facilitate the process (Dudley, 2009;Howard et al, 2010;Sugarman, 2000;U.S. DHHS, et al, 2017).…”