Scientific and Ethical Review Group
Reproductive health involving adolescents
Adolescents are individuals who are between childhood and adulthood, in the process of reaching sexual maturity. WHO defines the adolescent age range as the second decade of life, 10-19 years. However, it must be recognized that adolescence is a combination of physical, psychological and social changes which are culturally based. This is an important issue when consent and the involvement of parents (and guardians) is considered since the degree of autonomy of decision making is considerably varied across cultures and stages of adolescence.
Statement of the problem
The justification for conducting research on reproductive health in adolescents is the same as that for any biomedical or behavioural research: only by carrying out well-designed studies can adequate information be gained that will enable delivery of appropriate preventive and therapeutic services to this population group. Therefore, research on reproductive health involving adolescents should be undertaken in order to enhance scientific knowledge specific to these individuals. The omission of such research can perpetuate inadequate understanding of the particular reproductive health needs of adolescents and result in failure to deliver adequate services to this group.
Legal and Ethical Issues
There are no clear ethical justifications for excluding from research adolescent subjects below the age of legal majority. If there are reproductive health problems that are restricted to, or occur also in, adolescents which cannot be solved with existing knowledge, there is an ethical duty of beneficence and justice to conduct appropriate research to address these problems.
Parents (or guardians) have legal and ethical responsibilities to provide dependent adolescents with preventive and therapeutic health care. Sound research equips parents to discharge such legal and ethical responsibilities. Parents have the best interest of their children at heart, and therefore should have no reason to deny dependent adolescents participation in sound research that could improve preventive and therapeutic care.
In general, the law does not grant parents veto power over decisions of mature (that is, competent) adolescents who decide to participate in research on their reproductive health. In such cases where adolescents are or are about to be sexually active, investigators commit no legal offence in undertaking research that promises a favourable benefit-risk ratio. However, where the law specifically denies decision-making authority to mature or competent adolescents below a given age, that provision must be respected.
- Before undertaking research involving adolescents, investigators must ensure:
(a) that the information to be gained could not scientifically be obtained from adult subjects;
(b) that a goal of the research is to obtain knowledge relevant to the health needs of adolescents;
(c) that the risk presented by interventions having no direct benefit to the individual subject is low and commensurate with the importance of the knowledge to be gained; and
(d) that the interventions intended to provide direct benefit are at least as advantageous to the individual subject as any available alternative. Among adolescents, younger subjects should not be enrolled when older adolescents are scientifically suitable for recruitment as research subjects. When the specific objective of the research is to gain information about young adolescents, for example, about pregnancy or lactation in 12-year-olds, then research involving this age group is ethically justified.
- Unless specific legal provisions exist, consent to participate in research should be given by the adolescent alone. Capacity to consent is related to the nature and complexity of the research. If adolescents are mature enough to understand the purpose of the proposed study and the involvement requested, then they are mature enough to consent.
Rationale: Since the requirements for obtaining informed consent include the provision that subjects be capable of understanding the purpose, procedures, risks, benefits, and alternatives of the research, the participation of adolescents who satisfy this condition is ethically justified.
- The ethical principle of confidentiality must be adhered to in research involving adolescents.
- Even when consent to the participation of adolescents is granted by parents or by both adolescents and their parents, confidentiality must be maintained.
Rationale: Research on reproductive health, including contraception and abortion, involves sensitive issues about which adolescents have an interest in, and a right to, confidentiality being maintained. For example, some adolescents may be at risk of physical or psychological harm if others learn that they are sexually active. Moreover, without ensuring confidentiality, some important research could not be carried out since adolescents may refuse to participate if they are told that information they reveal might be disclosed to others.
- Institutions participating in research involving adolescents must be sensitive to the needs of adolescents and should have the appropriate staff and facilities to care for this population group.
- In circumstances where researchers believe they are obligated to report adolescent behaviour to any authorities, the adolescent subject must be made aware of the possibility of such reporting prior to their involvement in the research.