This post is a part of our Bioethics in the News series
By Rose Mwangi
I am writing to respond to a recent statement from the Co-chair of the International Vaccine Task Force (IVTF) who, in a World Bank press release, said, “We must urgently prioritize clinical research both to save lives in low-income settings, and to generate valuable information that is a global public good.”
The purpose of this article is to highlight realities of the processes that will get us to that “valuable information.”
Researchers working with adolescents are confronted with ethical consent challenges attracting significant controversies over ethical guidelines regarding how decisions ought to be made in order for adolescents to participate in research.
Traditionally, parents have been the default decision-makers for adolescents regarding their health and/or participation in research. International guidelines also stipulate that informed consent must be given by adults, and that minors cannot provide informed consent for participation in research unless there is parental guidance or guardian permission to participate. But let’s look at the realities of the situation.
In March 2016, a study provided what they called “first-ever” national estimates of abortion incidences in Tanzania. The authors reported that 66,600 women received post-abortion care in health facilities for complications resulting from unsafe abortion in 2013 alone. Additionally, an estimated 100,000 women with complications failed to get the medical attention they needed. If we take this study as a tip of an iceberg—while we may not know whether the study was plagued by difficulty recruiting adolescent participants, or whether there are plans to further study unsafe abortion among adolescents—one may hypothesize that the majority of women under 18 in these groups did not have access to contraceptives because any intervention requiring parental consent would probably have been unfruitful, and they resulted to (unsafe) abortions against restriction by law. Thus, if we want to decrease maternal mortality among adolescents, we must ask more questions, for instance: In this study, who are these women? Could they be women of adolescent age who got pregnant, and secretly got involved in unsafe abortion because as minors they needed parental consent to use contraceptives?
Who is an adult?
The Tanzania guidelines for ethical clearance state that anyone below the age of 18 can only participate in research if a parent or guardian consents for their participation, and the concept of an emancipated minor may not be legally recognized. However, there’s clearly a conflict between the consent process in research, culture, religion, and what is legally constituted under the marriage act. In terms of religion, a Muslim girl can be married under the age of 18 years; the country’s constitution states that a boy can marry at 18 years and a girl at 15 years (Tanzania Marriage Act). The guidelines ambiguously talk about the category of emancipated minors as a legal mechanism by which the minor is freed from control by their parent. Although emancipation can be granted without due court process when a minor is bound to make a decision alone in the absence of the parents (in this case, marriage), in this conflict, does research participation call for a more stringent standard than getting married does?
Yet, in many instances in low-resource settings, poverty-driven young people below the age of 18 leave their parents in the rural areas and move to urban settings in search of greener pastures, whether to look for jobs to fend for themselves, and/or hopefully take care of their poor parents back in the rural areas. In the cities, they adopt independent lifestyles; girls may get married while the boys may take up social and economic activities, which even the parents/guardians may not know of. At present, this sort of economic independence is not recognized, and the minors cannot seek approval from the court or others to gain emancipated status.
Seeking adolescents’ consent in a low-resource setting
It is still not clear whether the assent should be verbal or signed by the adolescent, or who is the acceptable guardian where a parent is not available. This remains a silent dilemma to research ethics committees in low-resource settings. Who should consent for minors such as sex workers, hotel and bar workers, house helps, food vendors, hairdressers, etc., or young men who are involved in the transport industry and assist in loading or driving local public transport systems and other small businesses? Ironically, these are occupational activities that put the young population in these settings at risk of infectious and non-communicable diseases, an area where urgent interventions are required.
Parental informed consent among adolescents in these settings
According to the ethical guidelines, involving adolescents below the adult age of 18 would be considered a violation of the informed consent process. However, since emancipated minors are legally adults, it is high time that Tanzania and other countries in similar circumstances widened the legal recognition of adolescents other than by marriage, enabling them to participate in research on their own. Because in situations where adolescents are independent, obtaining legal consent becomes even more difficult when parents or guardians cannot be reached.
The obvious questions are: Is it realistic to look for parental consent from a parent who is solely dependent on the young adolescent for upkeep? Should these adolescents be excluded in health research? What should be the age limit for assent in such settings?
While one may argue that challenges to adolescent consent are the same across the world, there are more differences among low-income settings where cultural practices prevail, e.g., an adolescent in the U.S. is socialized in a setting where the development of society is based upon the rights of an individual, and autonomy is established when an individual reaches the age of 18. On the other hand, in an African setting, a 16-year-old may be operating at the level of a 25-year-old in terms of responsibility and decision-making, while an 18-year-old’s consent is still driven by centuries-old traditions that affirm the importance of community, society, and family. Thus, to emphasize the personal choice to participate in a clinical trial requires more interventions targeting the adolescents if we are to get valuable information that would help reduce mortality from unsafe abortions in settings restricted by law and poor resources.
With no clear empirical evidence on how many independent adolescents below the legal adult age are out there, it is difficult to make any generalizable conclusions. There is also no existing universal agreement as to what age minors can be taken as making competent decisions to participate in research among poverty-stricken hierarchical structures and cultural practices. Among the Masai, for example, the hierarchical structures and marriage practices are different from the majority of population; Masai can marry before the age of 18 years and the husband then becomes the guardian of the wife who is also below the legal adult age. Ironically, despite the legal restrictions, married adolescents across the continents who are below the age of 18 are considered emancipated minors. It would be interesting to establish whether emancipated female counterparts in U.S. and Europe would have a more independent decision over themselves in similar scenarios.
Participation of adolescents in health research: The impact
While debating on realities of informed consent among adolescents in low-resource settings, a significant number may be affected by reproductive health problems, among others. It is thus important to put all efforts toward collecting data from adolescents as sole decision-makers: massive exclusion of adolescents below 18 years of age in health research would prevent researchers from identifying actual targeted or enhanced lifetime risk of diseases, or from monitoring them in the future.
In low-income settings, young and independent adolescents can contribute a lot to research findings for diseases that are prevalent among adolescents. Excluding them on the basis of being below the age of 18 is quite unethical, unrealistic and unfair while reporting 21% new HIV infections among 13- to 24-year-olds. Furthermore in developing countries, the majority of participants in research have low literacy rates, yet it is assumed that parents and guardians will understand the complex informed consent processes on behalf of the independent adolescent. As indicated by Fletcher et al. (2018), the need to be more sensitive to the social, cultural, structural, as well as medical needs of all individuals is even more urgent.
The way forward is to first come up with empirical evidence, and to then enact laws and processes that enable the legal emancipation of minors who are 15-17 years old, whether they are married or not, particularly in low-resource settings. I strongly agree with other authors who have stipulated that adolescents should be granted more authority and rights over themselves, while at the same time protecting them from risks as independent human subjects (Iltis, 2013; Barina & Bishop, 2013; Kuther & Posada, 2004).
Ms. Rose Mwangi is a past beneficiary of an NIH Fogarty Fellowship at the Michigan State University Center for Ethics and Humanities in the Life Sciences. She has participated as an observer in Community Research IRBs at Michigan State University.
Ms. Mwangi is very involved in Pan-African Bioethics and does research ethics in Tanzania. She has been involved in international clinical trials playing a key role in developing consent processes for rural and low literate communities; she has done important systematic qualitative studies presented in international conferences advocating for social responsibility among global health researchers which is now a video training tool for bioethics at Kilimanjaro Christian Medical University College (KCMUCo). Ms. Mwangi Co-Chairs the Institute Review Board (IRB) and is the Bioethics and Research Ethics instructor at KCMUCo both for undergraduates and postgraduates.
Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, June 28, 2018. With your participation, we hope to create discussions rich with insights from diverse perspectives.
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- Barina R, Bishop JP. Maturing the minor, marginalizing the family: on the social construction of the mature minor. Journal of Medicine and Philosophy. June 2013;38(3):300-14. doi: 10.1093/jmp/jht016. Epub 2013 Apr 24. https://www.ncbi.nlm.nih.gov/pubmed/23615059.
- Centers for Disease Control and Prevention. HIV Among Youth. April 20, 2018. https://www.cdc.gov/hiv/group/age/youth/index.html.
- Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002. https://cioms.ch/shop/product/international-ethical-guidelines-for-biomedical-research-involving-human-subjects-2/.
- Fletcher FE, Fisher C, Buchberg MK, Floyd B, Hotton A, Ehioba A, Donenberg G. “Where Did This [PrEP] Come From?” African American Mother/Daughter Perceptions Related to Adolescent Preexposure Prophylaxis (PrEP) Utilization and Clinical Trial Participation. Journal of Empirical Research on Human Research Ethics. 2018;13(2):173-184. https://doi.org/10.1177/1556264618755919.
- Guttmacher Institute. Unsafe Abortion Is Common In Tanzania and Is A Major Cause of Maternal Death. March 31, 2016. https://www.guttmacher.org/news-release/2016/unsafe-abortion-common-tanzania-and-major-cause-maternal-death. Accessed 13 June 2018.
- Iltis AS. Parents, adolescents, and consent for research participation. Journal of Medicine and Philosophy. June 2013;38(3):332-46. doi: 10.1093/jmp/jht012. Epub 2013 Apr 21. https://www.ncbi.nlm.nih.gov/pubmed/23607974.
- Kuther TL, Posada M. Children and adolescents’ capacity to provide informed consent for participation in research; Advances in Psychology Research. 2004;32:163-73. https://www.ncbi.nlm.nih.gov/pubmed/16986221.
- World Bank Group. Strong Clinical Research Capacity in At-Risk Countries Key to Global Epidemic Prevention. May 22, 2018. http://www.worldbank.org/en/news/press-release/2018/05/22/strong-clinical-research-capacity-in-at-risk-countries-key-to-global-epidemic-prevention. Accessed 13 June 2018.
- World Health Organization. Ethical issues. In: Reproductive health involving adolescents, scientific and ethical review group. http://www.who.int/reproductivehealth/topics/ethics/adolescents_guide_serg/en/. Accessed 13 June 2018.