Participant protection with the use of records: ethical issues and recommendations.

This article explores the ethical concerns and protections that may be required when individually identifiable data originally collected solely for clinical or administrative purposes are used in research or evaluation. It asks the following broad question with respect to the interim policy developed by the Substance Abuse and Mental Health Services Administration (SAMHSA) to protect the rights and welfare of participants in its programs: For those programs and projects not classified as research, are the protections and system for review adequate? Background information on SAMHSA's interim policy is provided, along with issues and questions related to the use of clinical and administrative records in research and evaluation. The article concludes with recommendations for modifying the existing participant protection guidelines, based on the preceding discussion of issues and questions.