Society of Family Planning Research Practice Support: Researcher and institutional review board considerations for sexual and reproductive health research with minor adolescents.

Abstract

This guidance document provides sexual and reproductive health (SRH) researchers, Institutional Review Boards (IRBs), research ethics committees, and funders with the knowledge and tools necessary for the appropriate inclusion of minor adolescents in SRH research. We provide an overview of the importance of explicit inclusion of adolescent minors in sexual and reproductive health research. We interpret ethical guidelines for researchers and IRBs. We urge researchers to avoid using age 18 as a cutoff for research inclusion since, in many jurisdictions, youth less than age 18 may provide self-consent for SRH care and research. We describe options for waiver of parental consent, waiver of signed consent, and Certificate of Confidentiality, when needed for protection of privacy or confidentiality. We define routine clinical care for adolescent minors to aid determinations about minimal risk research. Finally, we promote a research consent environment that considers developmental capacity for understanding research participation. Inclusion of adolescent minors in research is crucial to promote health equity and reproductive justice.