Multi-Center Research: Challenges of Recruitment and IRB Review Process

Dandreaux, Danielle M.

Purpose:

Multi-center clinical trials are important to translation science but present many challenges. Challenges include site recruitment, obtaining multiple Institutional Review Board (IRB) approvals, and retention. The current study aims to train providers in 24 school based health centers located in six states on the current guidelines for obesity care and motivational interviewing.

Methods:

Centers were recruited by study staff in collaboration with multiple national organizations. Contact with centers was recorded into a spreadsheet with a checklist to ensure sites met recruitment criteria. IRB correspondence with all organizations and universities were sent to project director to record all modifications/revisions required.

Results:

Sixty-eight organizations were approached to participate in the study. To date, 31 providers have been recruited (45.6% of organizations approached) and 28 have been consented (90.3% of those recruited). Initially, IRB approval was obtained at the sponsoring institution’s IRB. This IRB was accepted at 9 organizations, an additional 9 organizations required 1 or more additional IRB approvals. The study has currently obtained IRB approval from 15 IRBs. Two of these IRBs did not require any revisions; however, they were both affiliated with university IRB’s that did require revisions. The number of revisions of the other 13 IRB’s ranged from 1 – 4. The most common revision involved consent forms. Approval letters were gathered from centers in all six states for grant approval; however, due to the length of time for grant approvals, many changes occurred and new sites were recruited. Attrition has occurred for a variety of reasons resulting in an ongoing recruitment process to maintain 24 providers.

Conclusion:

Multi-site trials are essential for the translation of science into practice; however, the complexity of the studies presents many challenges including recruitment, IRB approval process, and retention. These challenges increase costs and can cause many delays in the research process.