Regulatory Issues Encountered When Conducting Longitudinal Substance Abuse Research

Abstract

Our research summarizes challenges unique to obtaining institutional review board (IRB) approval for longitudinal substance abuse research, focusing on solutions and lessons learned. Thirteen senior principal investigators with experience conducting research on substance abuse treatment and health services outcomes recalled instances from the prior five years when obtaining UCLA and non-UCLA IRB approval, which were hampered by differences in the interpretation of regulatory guidelines, and how those differences were resolved. Comprehensive yet flexible research protocols regarding (a) informed and voluntary consent, (b) participant payment, and (c) recontact efforts are essential for securing IRB approval of longitudinal substance abuse studies. Specific examples of lessons learned are provided. These experiences can help researchers provide appropriate and explicit justification for longitudinal substance abuse research protocols, thereby minimizing the burden and cost associated with meeting regulatory requirements as well as enhancing the efficiency, quantity, and quality of data collected.

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