Work

Regulatory Issues Encountered When Conducting Longitudinal Substance Abuse Research

Year: 2008

Type: article

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.

Source: Journal of Drug Issues

DOI: 10.1177/002204260803800404

Authors: Elizabeth Evans, Debra A. Murphy, Christine E. Grella, Michele Mouttapa, Yih-Ing Hser

Institutions: University of California, Los Angeles, California State University, Fullerton

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funders: National Institutes of Health, National Institute on Drug Abuse