Ethical Concerns With Adolescents:

Before you consider involving adolescents in research, it is important to consider:

  • Whether the research actually needs to be done,
  • Whether the research will extend knowledge, and impact policy and practice
  • Whether adolescents actually need to be involved and in what capacity,
  • Whether there are sound and informed reasons for excluding adolescents,
  • Whether the research will benefit individual participants or a wide social group of adolescents,
  • What is the likely impact of the research on the lives of the adolescent?
  • Whether you have the resources, competence, expertise and capacity to include adolescents – ranging from 10 – 24 years of age.

Ethical challenges, issues and considerations are often in the space between the researchers, the organisations, the communities and others involved in the research process and therefore need to be negotiated. It is important that from the very outset of the research process that you engage with the critical issues, namely:

  • The purpose of the research.
  • The impact of participating in the research in terms of potential harms and benefits.

Adolescents have consistent concerns as they transition from childhood to adulthood, and are primarily concerned about:

  • Whether their emerging independence and agency is respected
  • Whether others respect their confidentiality and privacy
  • Whether they have been consulted in the decisions affecting their lives

 

Ethical research criteria:

Emanuel et al., (2000)1 listed seven criteria that they considered essential to the ethical conduct of clinical research (Table1).

Table 2: Requirements for an ethical clinical trial (Adapted Emanuel et al., 2000)

RequirementsExplanation
ValueEvaluate an intervention that has the potential to be of social or scientific value
Scientific validityUse methods that will produce reliable results.
Fair selection of participantsParticipant selection that avoids placing the vulnerable at undue risk and avoids preferential access of attractive interventions to the privileged
Favourable benefit/risk balanceMinimize risks and maximize potential benefits, with an estimate that benefits will likely outweigh risks
Independent reviewReview of design by individuals not directly affiliated with the research (for example, ethics review committees)
Informed consent:Provide information about purpose of research, procedures, and potential risks and benefits to enable participants to make voluntary decisions in a way that respects participant autonomy.
Respect for enrolled participants:Protect the rights and well-being of participants.


In addition to these ethical principles (Table 1) there are global guidelines on research ethics for undertaking specific studies. The best known are: Nuremberg Code (Informed consent); WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects; and The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. See link below.

 

Adolescents in Research:

Norms in the South African ethical-legal framework are not always harmonized, therefore researchers and Research Ethics Committees (REC) working with adolescents (persons 12-17) may find the following recommendations helpful.

  • National ethics guidance (SA DOH 2015) states that studies with minors should investigate a ‘problem of relevance’ to them and their participation should be ‘scientifically indispensable’.
  • Guidelines (SA DOH 2015) and regulations (SA DOH 2014) state that minors should participate in research that:
  • Poses/ involves no more than minimal risk of harm
  • Poses/involves more/greater than minimal risk but holds out/provides the prospect of direct benefit for the minor. The degree of risk of harm should be justified by the potential benefit; or
  • Poses/involves greater than minimal risk of harm, with no prospect of direct benefit to the minor, but is anticipated to yield/ has a high probability of generalizable knowledge. The risk of harm should be justified by the risk-knowledge ratio. Greater than minimal risk of harm should represent no more than a minor increase over minimal risk.
  • Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research is not greater than (commensurate with) that ordinarily encountered ‘in daily life in a stable society or in routine medical, dental, educational or psychological tests or examinations’ (SA DOH 2014; SA DOH 2015).

Researchers operating outside of South Africa must know and follow the national, state, funding and institutional regulations and must check the criteria used by the country in which the research is being undertaken as well as funding requirements.

Other things to consider:

South African government acts and legal regulations:

EXTERNAL LINK; South African government acts and legal regulations, which have been identified as forming the legal and ethical requirements of health research can be found at : https://www.gov.za/documents/acts and https://www.samrc.ac.za/research/ethics/about and are:

  • SA Department of Health. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Pretoria: Department of Health, 2006.
  • SA National Health Research Ethics Council. Ethics in Health Research: Principles, Structures and Processes. Pretoria: Department of Health, 2004.
  • South African Government. Regulations Relating to Research with Human Participants. Government Gazette No. R 719 of 19 September 2014.
  • Section 71 of the National Health Act No. 61 of 2003.
  • Section 5 of the Choice on Termination of Pregnancy Act No. 92 of 1996.
  • Section 130 of the Children’s Act No. 38 of 2005.
  • Section 129 of the Children’s Act No. 38 of 2005.
  • Section 134 of the Children’s Act No. 38 of 2005.
  • Section 12(8) and section 12(9-10) of the Children’s Act No. 38 of 2005.
  • Section 110 of the Children’s Act 38 of 2010.
  • Section 15 of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No, 32 of 2007.
  • South African Schools Act No. 84 of 1996.
  • The Basic Conditions of Employment Act No.75 of 1997.

Youth in prisons:

Data on health care services for the youth in prisons is very scant despite the international recognition of the increased exposure to HIV and TB infections in these confined spaces. Researchers and programmers interested in working with young people in prisons and other closed settings can follow the WHO guidelines on how to provide effective and acceptable comprehensive HIV and health services for their individual countries. The need to work with youth in prisons is exacerbated by the fact that in sub-Saharan Africa detainees have a higher HIV and TB prevalence than the general population. However, Telisinge (2016) identified some examples of promising practices of HIV and TB health interventions in some of the countries in sub-Saharan region:

  • Routine voluntary testing for HIV and screening for tuberculosis upon entry to South African and Zambian prisons.
  • Reforms to pre-trial detention in South Africa.
  • Integration of mental health services into a health package in selected Malawian prisons.
  • Task sharing to include detainees in care provision through peer-educator programmes in Rwanda, Zimbabwe, Zambia, and South Africa.

There remains a gap in the current services because they are targeting persons in prisons and closed settings as a homogenous group with no specific attention to the youth.

Overall, recommended behavioural interventions for young key populations include skills-based interactive and participatory approaches such as online, mobile health, peer and outreach programmes. Bekker (2015) recommends that at all times HIV prevention and treatment interventions must be adolescent centred and make use of technological inventions sensitive to the young people.

Special attention should be given to the country or countries in which you are doing your research as there are different social and legal frameworks for working with young key populations that will need to be applied and thus will have an impact on your research. There might be different legal and ethical considerations when working with pregnant young women in prison, or young people injecting drugs and are also in conflict with the law. In addition, in certain countries same sex relationships are illegal and these boundaries should be established prior to undertaking your research.

For example, what would be the considerations for designing an HIV prevention intervention for young female sex workers in a South African context where sex work is still criminalised. is provided by civil society organisations. Recommendations and guidance for working with young female sex workers are provided by civil society organisations. As such, examples of specific guidelines on working with key populations and best practice models for working with young key populations are provided.

Youth in prisons:

The benefits for increasing the involvement of young key populations in HIV and health research and services are numerous, and include:

  • Reducing the vulnerability of young key populations to HIV risk.
  • Improving young key populations’ visibility and meaningful participation in HIV and health research programmes
  • Improving evidence-based data that is specific to the health care needs of young key populations.

There are various opportunities for working with young key populations during HIV research and health interventions. For example:

  • Task sharing with key populations in prison to provide peer-education programmes in Rwanda, Zimbabwe, Zambia and South Africa.
  • To increase key population involvement and access to health care services, the Zimbabwean Ministry of Health & Child Care has developed a manual for healthcare providers. This training manual provides guidance on how to provide non-discriminatory health care services to key populations and can be adapted in other settings in the region.

You should check for country specific guidelines for working with key populations that may have an implication for working with young key populations.

BY YOLISWA NTSEPE (MA, PhD)
ADOLESCENT PROGRAMMES MANAGER

UPDATED NOV 22, 2023

TABLE OF CONTENTS:

REFERENCES & ADDITIONAL RESOURCES:

Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701-11.)

Emanuel EJ, Grady C, Crouch RA, et al (eds.). The Oxford Textbook of Clinical Research Ethics. Oxford: Oxford University Press, 2008.

Stobie, M., Strode, A. and Slack, C., 2006. The Dilemma of Enrolling Children in HIV Vaccine Research in South Africa: What Is in ‘The Child’s Best Interst’ ?.

Slack, C.M. and Strode, A.E., 2016. But is this really the ‘parent’ or ‘guardian’? Practical strategies for consent to child research in South Africa. South African journal of bioethics and law, 9(1), pp.35-38.

Wallace, M., Strode, A., Slack, C., Ronan, A. and Bekker, L.G., 2010. Ethical-legal challenges in conducting HIV prevention trial research with adolescents: A South African case study of tool development. Tropical Medicine & International Health, 15(8).

Gill, K., Pidwell, T., Dietrich, J., Gray, G., Bennie, T., Kayamba, F. and Bekker, L.G., 2017. A demonstration open label study to assess the acceptability, safety and use of Truvada pre-exposure prophylaxis in healthy, HIV-uninfected adolescents, 15–19 years of age. In 9th IAS Conference on HIV Science.

Essack, Z., Slack, C. and Strode, A., 2008. Overcoming key obstacles to adolescent involvement in HIV vaccine & microbicide trials: A roadmap for stakeholders. HIV AIDS Vaccines Ethics Group in collaboration with the Global Campaign for Microbicides.

U.S. Department of Health & Human Services website (Accessed August 23, 2021) https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.html provides links or access to

  • Nuremberg Code (Informed consent);
  • WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
  • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Council for International Organizations of Medical Sciences, World Health Organization provides free access to International Ethical Guidelines for Biomedical Research Involving Human Subjects, first issued in 1982, revised in 1993 and updated and expanded in 2000.
Available at https://cioms.ch/publications/product/biomedical-research-ethics-updating-international-guidelines-a-consultation/ (Accessed August 23, 2021)

The most detailed guidance for conducting ethical research with children, including adolescents, is provided by the international project Ethical Research Involving Children by UNICEF and partners, available at https://www.childethics.com/ in six languages.