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J Drug Issues. 2008 Oct 1;38(4):1003-1026.

Regulatory Issues Encountered when Conducting Longitudinal Substance Abuse Research.

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1
UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, 1640 South Sepulveda Blvd., 200, Los Angeles, CA 90025, USA.

Abstract

OBJECTIVE:

To summarize challenges unique to obtaining Institutional Review Board (IRB) approval for longitudinal substance abuse research, focusing on solutions and lessons learned.

METHODS:

Thirteen senior Principal Investigators with experience conducting research on substance abuse treatment and health services outcomes recalled instances from the prior 5 years when obtaining UCLA and non-UCLA IRB approval was hampered by differences in the interpretation of regulatory guidelines and how those differences were resolved.

PRINCIPAL FINDINGS:

Comprehensive yet flexible research protocols regarding (1) informed and voluntary consent, (2) participant payment, and (3) re-contact efforts are essential for securing IRB approval of longitudinal substance abuse studies. Specific examples of lessons learned are provided.

CONCLUSIONS:

Experiences can help researchers to 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.

PMID:
20379383
PMCID:
PMC2850543
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