Adolescent Risk-Benefit Analysis

Ethical issues in adolescent health research in resource-limited countries.

Before embarking on any research with adolescents, the key question is whether it is absolutely necessary to include or exclude adolescents. This question – to include or exclude adolescents – can be answered by considering and evaluation of the following:

  • Is there a sound reason to include adolescents in the research, or can the information be found from an alternative age group?
  • Will the research extend knowledge and potentially influence policy and practice?
  • Will the research contribute to new knowledge?

Harm-benefit analysis

Potential harm and benefit assessment is not a straightforward process as it relies on balancing – like a see-saw – what is defined as acceptable levels of risk (harm) with the potential benefit to be obtained from the research.

Harm in research

Harm in research may take a variety of forms that arise from the research question, the research topic and research methods irrespective of whether it is qualitative, quantitative or clinical trial or other types of research.

  • It is critical that the research methodology is sound, with appropriate methods for data collection and analysis.
  • The ethical principles of beneficence and non-maleficence are relevant beyond the completion of data collection.

Types of harm that should be considered

  • Physical or social harm as a direct consequence of the research
  • Physical retribution, punishment or harm from other participants in the research
  • Distress, anxiety and or loss of self-esteem.
  • Stigmatisation as a consequence of participation
  • Disappointment or failure to meet participant expectations
  • Conflict between participants and community members involved in data collection.

If participants are at risk of harm an immediate and sensitive response is required from the researcher, as well as provision made for follow-up support or referral to appropriate services.

In addition, you should be aware that harm may occur after participation in the research; that harm may occur as a result of research dissemination of findings, or implementation of results; and that harm may result from ineffective policy recommendations, methodological research errors, researcher bias as well as interpretation of data, findings and conclusions.

Benefits from research

Research benefits, which are predominantly future-orientated, should benefit adolescents as a social group, and not only the particular individuals involved in the research as participants.

In 2004, scholars developed an ethical framework for research in low- and middle-income countries. The benchmarks identified help identify and systematize the ethical issues relevant to the conduct of research with adolescents in such settings: social value, scientific validity, fair subject selection, collaborative partnership, acceptable risk/benefit ratio, independent review, informed consent, and ongoing respect for enrolled participants.

Table 1 summarizes these principles and benchmarks, and the relevant applications to adolescents and other vulnerable populations.

Table 1: A Summary of the Ethical Principles and Benchmarks Pertaining to Multinational Clinical Research Involving Adolescent and Other Vulnerable Populations

PrincipleBenchmarks (Adolescents and Vulnerable Populations)
Social valueEnsure that the research question is valid and relevant to the vulnerable population Justify the involvement of the vulnerable population to stakeholders.
Scientific validityDetermine whether the scientific objectives cannot be achieved through adult enrolment alone Ensure that the objectives will be met through rigorously designed research.
Fair selectionDesign selection criteria based on scientific considerations Consult communities and ensure that they understand rationale and strategies for selecting adolescent populations.
Collaborative partnershipsEnsure partnerships with various stakeholders Consult with community for unrecognised risks Consult with youth stakeholders including youth community advisory boards (CAB) or youth members Invest in structures and mechanisms for engagement.
Favourable risk-benefit ratioKnow the ethical-legal framework for acceptable risk levels for research procedures and interventions conferring both direct and no direct benefit. Articulate risk-benefit ratios clearly Minimise research risks Capacity sites and site staff to work with youth.
Independent reviewConduct audit of ethical-legal requirements for inclusion of adolescents. Encourage networking between IRBs where necessary. Anticipate and address ethical-legal complexities.
Informed consentAudit ethical-legal requirements for consent for adolescent research Involve adolescents in decision making even when guardian consent is required. Ensure cultural, age and linguistic appropriateness Give sufficient time and resources to consent procedures.
Ongoing respect for participants and participating communitiesAudit legal requirements for privacy and mandatory reporting. Prepare consent materials and processes that take privacy and mandatory reporting requirements into account. Prepare appropriate study compensation in collaboration with relevant stakeholders Prepare for ancillary care needs and set up appropriate referral systems and partnerships where necessary.


Key questions you should ask when assessing whether to include or exclude adolescents in research:

Does this research need to be done?

  • Will the research contribute new knowledge?
  • Have you ensured that the information being sought is not available elsewhere?
  • Is child/adolescent/young adult participation in the research necessary or can the information be obtained in other ways? (Excluding endorsing adults speaking on behalf of adolescents in preference to adolescents speaking for themselves)
  • What form will the child/adolescent/young adult’s involvement in the research take?

Do you have the resources necessary to do the research?

  • What resources (money, time, staff, equipment etc) are necessary to obtain the best possible local knowledge and to undertake the research, and are those readily available? If not, is there a plan for how these are obtained/managed?
  • How much time needs to be allocated for obtaining necessary resources to undertake the research project ethically?

How well prepared are you, the researcher to meet with adolescents?

  • What do you know about the child/adolescent/young adult who you want to involve?
  • How will you find out what you need to know about the child/adolescent/young adult and their lives?
  • Do you have the necessary skills (technical and interpersonal) to involve child/adolescent/young adult in research?
  • What experience do you have of dialogue with child/adolescent/young adults?
  • What do you know of adolescent development?
  • What means or methods will you use to address the power difference that exists between you and adolescents?
  • How will the research be inclusive of all adolescents?
  • What steps are taken to identify marginalized or hard to reach adolescents and ensure they are included in the research?
  • If it is not your intention to include adolescents, on what basis will they be excluded and why?

How will you ensure the safety of adolescent research participants?

  • Are there any identifiable risks for adolescents?
  • Are there any risks posed if the findings of the research are made public?
  • What plans can be put in place to reduce risk?
  • Are they adolescents whose particular circumstances place them at high risk? If yes, who are they and why?
  • How will you find out what community and/or professional resources and services are available to adolescents in need?
  • What actions will you need to take to respond appropriately if a participant (child/adolescent/young adult) discloses harm or abuse?
  • Who will you need to inform about these actions?
  • What are the legal requirements for reporting abuse in the area the research is taking place?
  • What possible stigma may attach to child/adolescent/young adult participants if they participate in the research, and what will you do about this?
  • Do you need to develop and or implement safety protocols or policies to protect child/adolescent/young adults during and/or following the research? If so, why and what protocols are these?
  • Have you considered instigating a post-interview check-in by someone who is a known and trusted support, familiar with the child/adolescent/young adult’s usual behaviour, and can read the signs if additional help is needed?

How will you respond to adolescent participants should they become distressed?

  • Do you have experience and/or skills to respond to distressed participants?
  • What supervision or support do you need to have in place for research team members?
  • What arrangements do you need to make to support child/adolescent/young adults who become distressed? And how will you ensure that their concerns or issues were attended to?

Ten recommendations for Adolescent studies in South Africa.

  • Recommendation 1: Adolescents should only be enrolled in socially valuable research that poses acceptable risks
  • Recommendation 2: Parents or guardians should generally provide consent for adolescent enrolment, unless a waiver can be ethically justified
  • Recommendation 3: Adolescent participants should self-consent to relevant components, even where proxy consent is obtained for enrolment, and enjoy confidentiality for this
  • Recommendation 4: Adolescent participants should enjoy confidentiality for risk behaviour, even where proxy consent is obtained
  • Recommendation 5: Adolescent participants should be encouraged to obtain support through the disclosure of otherwise confidential information to trusted adults in certain instances
  • Recommendation 6: If adolescent participants are being abused or neglected this should be reported to authorities and adolescents should be assisted
  • Recommendation 7: If adolescent participants are engaged in underage consensual sexual relationships that are exploitative, this should be reported to authorities and adolescents should be assisted
  • Recommendation 8: If adolescent participants disclose other ‘offenses’ this should not be reported to authorities and adolescents should be assisted
  • Recommendation 9: The consenting party (parties) should understand what information will be disclosed to proxy consenters or to authorities
  • Recommendation 10: Stakeholders that represent the interests of adolescents should be engaged by adolescent researchers in an early and sustained manner


UPDATED NOV 22, 2023



Ten Recommendations for Adolescent Studies in South Africa.
Strode, A., & Slack., C. (2020).  HIV AIDS Vaccines Ethics Group, University of KwaZulu-Natal.

What makes clinical research in developing countries ethical? The benchmarks of ethical research.
Emanuel, Ezekiel J., David Wendler, Killen J et al. Journal of Infectious Diseases 189.5 (2004): 930-937

What makes clinical research ethical?
Emanuel, Ezekiel J., David Wendler, and Christine Grady.  JAMA 283.20 (2000): 2701-2711

Adapted to include child/adolescent/young adults as participants in a research study.

JAIDS Journal of Acquired Immune Deficiency Syndromes
Bekker, Linda-Gail; Slack, Catherine; Lee, Sonia; Shah, Seema; Kapogiannis, Bill 65:S24-S28, January 1, 2014. doi: 10.1097/QAI.0000000000000036.