Adolescents as Research Subjects Without Permission of Their Parents or Guardians: Ethical Considerations

This paper is presented in five sections and demonstrates that current regulations may be interpreted to permit the conduct without parents or guardians permission of much more research involving adolescents than is currently being done.

Abstract

This paper is presented in five sections: I. The first is an overview of current ethical standards for all research involving children relating them to the recommendations of the National Commission for the Protection of Human Subjects (hereafter called The National Commission). II. The second section reviews the exceptions from the general requirements of the regulations for children permitted for some research involving adolescents. This section demonstrates that current regulations may be interpreted to permit the conduct without parents or guardians permission of much more research involving adolescents than is currently being done. This point notwithstanding I recommend that such interpretations should not be implemented without first having the relevant policies reviewed by an authoritative agency such as The National Commission. III. This section explains why I consider this an appropriate time to reconsider national policies regarding research involving adolescents. Current policies reflect the attitude of the time in which they were written--that research is both dangerous to and exploitative of persons particularly those who are vulnerable. They do not reflect the recent changes in the publics perception that participation in research is often beneficial particularly for some vulnerable populations and their individual members. IV. This section is an appraisal of the Guidelines for Adolescent Participation in Research proposed by The Adolescent Scientific Committee of the Pediatric AIDS Clinical Trials Group. The availability of this document affords a valuable opportunity to evaluate a carefully thought out comprehensive proposal. V. The final section presents my recommendations for guidelines for the conduct of research involving mature minors without permission of their parents or guardians. (excerpt)