WORLD HEALTH ORGANIZATION – Guidance on ethical considerations in planning and reviewing research studies on sexual and reproductive health in adolescents
Adolescence – defined by the World Health Organization (WHO) as the second decade of life – is a time when enormous physical, psychological and social changes occur. This is a time when individuals initiate and experiment with “adult behaviours”, such as sexual activity and substance use (1). These behaviours can result in negative health outcomes, such as unintended pregnancy and sexually transmitted infections, and negative social outcomes, such as school dropout and social exclusion (2,3). Research relating to this population is crucial. However, the participation of adolescents in health research poses legal and ethical challenges, particularly when the research focuses on sexual and reproductive health. This document highlights some of these challenges and outlines how they may be addressed. It is intended to provide practical guidance to people involved in sexual and reproductive health research with adolescents.
In order to identify the issues this document should address, we elicited the opinions of a culturally and geographically diverse panel of 34 experts from various stakeholder groups. We posed the following open-ended question: “What would be some of the key elements that the guidance should capture?” The responses to this question were incorporated into the initial draft of the document, and subsequent iterations were sent to the experts for review and feedback. Of those consulted: 50% were from low- and middle-income countries (LMICs) and 50% from high-income countries; 67% were female and 33% male; and 41% were from academia, 35% from international nongovernmental organizations, 21% from United Nations agencies, and 3% from governmental bodies. This document is based on the four broad themes that emerged from this consultative process.
Section 1 highlights the significance of accurately and uniformly describing a proposed study population. In doing so, it surveys a sample of terms that are used to typically describe or characterize adolescents. Section 2 explores the notions of autonomy, informed consent and assent, and how to determine an adolescent’s capacity and maturity in the research context. Section 3 explores the nature and implications of the principle “best interests of the child”, and how this notion should be applied when researchers encounter a conflict between their ethical and legal obligations in relation to adolescent research participants. Section 4 explores information-sharing in relation to adolescents in the research context.
This document is designed to inform people involved in sexual and reproductive health research with adolescents. This includes (but is not limited to) researchers, research ethics committee members, programme planners and sponsors.
FULL TEXT: World Health Organization 2018 ; Español ; Français