Beyond Informed Consent: Ethical Considerations in the Design and Implementation of Sexual and Reproductive Health Research Among Adolescents

Morenike Oluwatoyin Folayan, Bridget Haire, Abigail Harrison, Olawunmi Fatusi, Brandon Brown

Abstract

Interest in addressing the ethical issues related to adolescents’ engagement in research, especially sexual and reproductive health and rights (SRHR) research is increasing in view of the need to design and implement research that address peculiar SRHR needs of adolescents. These needs include issues of sexually transmitted infections, HIV, AIDS, adverse pregnancy outcomes, community, family and relationship violence and mental health. Unfortunately, adolescents’ voluntary participation in research has been limited due to their perceived potential to be coerced into participation, and concerns that they may not fully comprehend the issues related to research risks. As such, many of the regulations for engaging research participants have been defined by age rather than due consideration of psychological development. This paper examines the various potential ethical issues that may impact on decision making when adolescents are engaged in research. These include the need to minimise therapeutic misconception, considerations for recruitment and retention, types and amounts for reimbursement, and engagement of communities of adolescents on advisory boards of studies that involve their population. The potential challenges associated with recruitment of adolescents in early child marriages were also highlighted.  (Afr J Reprod Health 2014; 18[3]: 118-126)

 

Keywords: Adolescents, ethics, sexual and reproductive health, research  

Résumé 

L’intérêt dans le traitement des questions éthiques liées à l'engagement des adolescents dans la recherche, la santé et les droits en particulier sexuelle et reproductive (SSR) de recherche est en augmentation en raison de la nécessité de concevoir et mettre en

œuvre des recherches qui répondent à des besoins particuliers de la SSR des adolescents. Ces besoins comprennent les questions d'infections sexuellement transmissibles, le VIH, le sida, les résultats défavorables de la grossesse, la communauté, la famille et la violence dans les relations et la santé mentale. Malheureusement, la participation volontaire des adolescents en matière de recherche a été limitée en raison de leur potentiel perçu d'être forcée à la participation, et les préoccupations qu’ils ne peuvent pas comprendre pleinement les questions liées à la recherche des risques. En tant que tel, de nombreux règlements pour engager participants à la recherche ont été définis par l'âge plutôt que tenant compte du développement psychologique. Ce document examine les diverses questions éthiques potentiels qui pourraient avoir une incidence sur la prise de décision lorsque les adolescents sont engagés dans la recherche. Il s'agit notamment de la nécessité de minimiser le malentendu thérapeutique, les considérations en matière de recrutement et de rétention, les types et les montants de remboursement, et l'engagement des communautés des adolescents au sein des conseils consultatifs des études qui impliquent leur population. Les défis potentiels liés au recrutement des adolescents dans les mariages précoces des enfants ont également été soulignés. (Afr J Reprod Health 2014; 18[3]: 118-126)

 

Mots-clés: adolescents, l'éthique, la santé sexuelle et reproductive, de la recherche

Full Text:

PDF

References

UNICEF. Progress report for children: a report card on adolescents. April 2012.

WHO. 10 facts on adolescent health. 2008. http://www.

who.int/features/factfiles/adolescent_health/en/index .html. Accessed 6th February 2014.

Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. Webbased Injury Statistics Query and Reporting System. 2010.

Lule E, Rosen JE, Singh S, Knowles JC, Behrman JR. Adolescent health program in: Jamison DT, Breman JG, Measham AR, et al. (Eds). Disease Control Priorities in Developing Countries. 2nd edition Washington (DC): World Bank. 2006.

Stanford PD, Monte DA, Briggs FM, Flynn PM, Tanney M, Ellenberg JH, et al. Recruitment and retention of adolescent participants in HIV research: findings from the REACH (Reaching for Excellence in Adolescent Care and Health) Project. J Adolesc Health. 2003; 32:192–203.

Kapogiannis BG, Handelsman E, Ruiz MS, Lee S. Introduction: Paving the way for biomedical HIV prevention interventions in youth. J Acquir Immune Defic Syndr. 2010; 54:S1-4.

Global Campaign for Microbicide. The question of enrollment of adolescents. Available at http:// www . global-campaign.org/clientfiles/chapter6.pdf. Accessed on 22nd July, 2014.

Folayan MO, Haire B, Harrison A, Brown B, Odetoyingbo M, Fatusi OA. Ethical Issues in

Adolescents’ Sexual and Reproductive Health Research in Nigeria. Dev World Bioeth. 2014; Jun

doi: 10.1111/dewb.12061

National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries. Bethesda (MD): National Bioethics Advisory Commission. 2001:48.

Lidz CW, Appelbaum PS, Grisso T, Renaud M. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med. 2004; 58(9):168997.

National Bioethics Advisory Commission. Chapter 3 - Voluntary informed consent. http://bioethics. georgetown.edu/nbac/clinical/Chapter3.pdf. Accessed 22nd February, 2014.

Guest G, Shattuck D, Johnson L, Akumatey B, Clarke EE, Chen PL, MacQueen KM. Changes in sexual risk behavior among participants in a PrEP HIV prevention trial. Sex Transm Dis. 2008;35(12):1002-8.

Vanichseni S, Martin M, Suntharasamai P, Sangkum U, Mock P, Leethochawalit M, et al. HIV-associated risk behavior among injecting drug users participating in an HIV pre-exposure prophylaxis trial in Bangkok. Presented at the 7th IAS Conference on HIV Pathogenesis and Treatment; Kuala Lumpur, Malaysia. 2009. [abstract MOLBPE27].

Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010; 329(5996):1168-74.

Bartholow BN, Buchbinder S, Celum C, Goli V, Koblin B, Para M, et al. HIV sexual risk behavior over 36 months of follow-up in the world’s first HIV vaccine e cacy trial. J Acquir Immune Defic Syndr 2005; 39: 90–101.

Schechter M, do Lago RF, Mendelsohn AB, Moreira RI, Moulton LH, Harrison LH. Behavioral impact, acceptability, and HIV incidence among homosexual

men with access to post exposure chemoprophylaxis for HIV. J Acquir Immune Defi c Syndr 2004; 35: 519–25.

Martin JN, Roland ME, Neilands TB, Krone

MR, Bamberger JD, Kohn RP, et al. et al. Use of post exposure prophylaxis against HIV infection following sexual exposure does not lead to increases in high-risk behavior. AIDS 2004; 18: 787–92.

Underhill K, Operario D, Mimiaga MJ, Skeer MR, Mayer KH. Implementation science of pre-exposure prophylaxis: preparing for public use. Curr HIV/AIDS Rep. 2010; 7(4):210-9.

Foss AM, Vickerman PT, Heise L, Watts CH. Shifts in condom use following microbicide introduction:

should we be concerned? AIDS 2003; 17:1227–37.

Sood N, Goldman D. HIV breakthroughs and risky sexual behavior. Q J Econ. 2006; 121:1063–102.

Ethics in Health Research. Principles, Structures and Processes. Pretoria: Department of Health; 2004.

UNAIDS/WHO. Ethical considerations in biomedical HIV prevention trials. Geneva: UNAIDS. Available at: http://www.unaids.org/en/media/unaids/ contentassets/documents/unaidspublication/2012/jc13 99_ethical_considerations_en.pdf. Accessed 26th February, 2014.

UNAIDS/AVAC. Good participatory practice: guidelines for biomedical HIV prevention trials. Geneva: UNAIDS. 2011. Available at: http://www. unaids.org /en/media/unaids/contentassets/documents/unaidspubl ication/ 2011/JC1853_GPP_Guidelines_2011_en.pdf. Accessed August 1, 2013.

Sarojini N, Deepa V. Trials and tribulations: an expose of the HPV vaccine trials by the 72nd Parliamentary Standing Committee Report. India Journal of Medical Ethics. 2013; 10(4): http://216.12 .194.36 /~ijmein / index.php/ijme/article/view/562/1444. Accessed 1st February, 2014.

Research compliance services. University of Oregon. http://orcr.uoregon.edu/index.cfm?action=irb⊂=pa ssive Accessed 1st February, 2014.

Stubbs JM, Achat HM. Individual rights over public good? The future of anthropometric monitoring of school children in the fight against obesity. Med J Aust. 2009;190(3):140-2.

Lacy K, Kremer P, de Silva-Sanigorski A, Allender S, Leslie E, Jones L, Fornaro S, Swinburn B. The appropriateness of opt-out consent for monitoring childhood obesity in Australia.Pediatr Obes. 2012; 7(5):e62-7.

Mathews C, Guttmacher SJ, Flisher AJ, Mtshizana Y, Hani A, Zwarenstein M. Written parental consent in school-based HIV/AIDS prevention research. Am J Public Health. 2005; 95(7):1266-9. Miles J. Power analysis, statistical significance, and effect size. My environmental education evaluation resource assistant. Available at: http://meera. snre. umich.edu/plan-an-valuation/related- topics/power-analysis-statistical-significance-effectsize. Accessed on the 12th June, 2014.

Miles J. Power analysis, statistical significance, and effect size. My environmental education evaluation resource assistant. Available at: http://meera.snre. umich.edu/ plan-an-evaluation/related-topics/power-analysisstatistical-significance-effect-size. Accessed on the 12th June, 2014.

Oyedeji K, Ukpong M, Ezechi O. Addressing coercion in the conduct of clinical trials in microbicides’, paper presented at the 2010 International Microbicides Conference: Building Bridges in HIV Prevention, Pittsburgh, PA, 22_25 May 2010. Abstract 374.

Wendler D, Rackoff JE, Emmanuel EJ, Grady C. The ethics of paying for children’s participation in research. J Pediatr 2002; 141:166-71.

Geissler PW. Transport to where? Reflections on the problem of value and time a propos an awkward practice in medical research: In: Ann Kelly, P. Wenzel Geissler (Eds). The Value of Transnational Medical Research: Labour, participation and care. Routledge, Taylor and Francis Group, 7625 Empire Drive, Florence, Kentucky 41042-2919, USA. 2012.

Bagley SJ, Reynolds WW, Nelson RM. Is a "wagepayment" model for research participation appropriate for children? Pediatrics. 2007; 119(1):46-51.

Folayan MO, Allman D. Clinical Trials as an Industry and an Employer of Labour: In: Ann Kelly, P. Wenzel Geissler (Eds). The Value of Transnational Medical

Research: Labour, participation and care. Routledge, Taylor and Francis Group, 7625 Empire

Drive, Florence, Kentucky 41042-2919, USA. 2012.

Miller L, Folayan MO, Allman D, Nkala B, Kasirye LM, Mingote LR, Calazans G, Mburu R, Ntombela F, Ditmore M. How Ethical is Your Clinical Trial. International Journal of Clinical Practice 2010; 64(9):1179 – 82.

Bekker LG, Slack C, Lee S, Shah S, Kapogiannis B. Ethical issues in adolescent HIV research in resourcelimited countries. J Acquir Immune Defic Syndr. 2014; 65:S24-8.

Ott MA, Alexander AB, Lally M, Steever JB, Zimet GD; Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions. Preventive misconception and adolescents’ knowledge about HIV vaccine trials. J Med Ethics. 2013; 39(12):765-71.

Lee S, Kapogiannis BG, Flynn PM, Rudy BJ, Bethel J, Ahmad S, et al. Comprehension of a simplified assent form in a vaccine trial for adolescents. J Med Ethics. 2013; 39:410–2.

Hosek S, Siberry G, Bell M, Lally M, Kapogiannis B, Green K, et al. The acceptability and feasibility of an HIV pre-exposure prophylaxis (PrEP) trial with young men who have sex with men. J Acquir Immune Defic Syndr. 2013; 62:447-56.

Kapogiannis BG, Mattison DR. Adolescents in clinical trials. Clin Pharmacol Ther. 2008; 84:655–9.

Kapogiannis BG, Lee SS. Rolling up our sleeves now to reap the benefits later: preparing the community for an adolescent HIV vaccine. Curr Opin HIV AIDS. 2007; 2:375–84.

Cunningham CK, Rudy BJ, Xu J, Bethel J, Kapogiannis BG, Ahmad S, et al. Randomized trial to determine safety and immunogenicity of two strategies for hepatitis B vaccination in healthy urban adolescents in the United States. Pediatr Infect Dis J. 2010; 29:5304.

Mulligan K, Harris DR, Monte D, Stoszek S, Emmanuel P, Hardin DS, et al. 2010. Obesity and dyslipidemia in behaviorally HIV-infected young women: Adolescent Trials Network study 021. Clin Infect Dis. 2010; 50:106–14.

Kiser JJ, Fletcher CV, Flynn PM, Cunningham CK, Wilson CM, Kapogiannis BG, et al. 2008. Pharmacokinetics of antiretroviral regimens containing tenofovir disoproxil fumarate and atazanavir-ritonavir in adolescents and young adults with human immunodeficiency virus infection. Antimicrob Agents Chemother. 52:631–7.

Ellen JM, Wallace M, Sawe FK, Fisher K. Community engagement and investment in biomedical HIV prevention research for youth: rationale, challenges, and approaches. J Acquir Immune Defic Syndr. 2010; 54(1): S7-11. doi: 10.1097/QAI.0b013e3181e25779.

Refbacks

  • There are currently no refbacks.