Use of single IRBs for multi-site studies: A case report and commentary from a National Drug Abuse Treatment Clinical Trials Network study.

ABSTRACT: Recent NIH policy stipulates that multi-site studies must use a single or IRB (Institutional Review Board) in order to streamline the review process while maintaining standards for human subjects protection. The Western States Node of the Clinical Trials Network (CTN) used a single IRB for protocol CTN-0067, a clinical trial testing the use of an opioid antagonist (extended-release naltrexone) versus opioid agonists (buprenorphine or methadone) for opioid use disorders among individuals living with HIV. This case study discusses the processes and challenges associated with use of a single IRB. These lessons are also informed by other single IRB experiences within the CTN. The intention of the NIH single IRB policy is to facilitate efficient IRB processes. Advanced planning and transparent

SUBMITTER: Nichols C 

PROVIDER: S-EPMC6329321 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature