Tag: health research

The Ethics of Becoming an Adult in a Health Research Setting in Africa

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Rose Mwangi

It is three years since the Centers for Disease Control and Prevention (CDC) reversed course to recommend that 11- to 12-year-old girls receive two doses of HPV vaccine to protect against cancers caused by human papillomavirus (HPV) infections, administered at least six months apart. This then overruled the previous “three dose” recommendation – but the CDC added the caveat that “teens and young adults who start the series later, at ages 15 through 26 years, will continue to need three doses of HPV vaccine to protect against cancer-causing HPV infection.”

When either recommending a health intervention or conducting research among adolescents (11-12 years), ethical principles require that in addition to the rightful consent processes, privacy and confidentiality especially should be observed. In that light, countries need to ensure that they meet some requirements of legal, ethical and moral issues pertaining to such situations. However, when it comes to adolescents, there commonly is some uncertainty about a proper ethical balance between protection from risks, confidentiality, privacy and the possible countervailing need for parental consent.

Global health
Image description: a black and silver stethoscope is curved around a small globe on a white background. Image source: Marco Verch/Flickr Creative Commons.

In resource-poor African settings, health access barriers are paramount, and they present major impediments to national and regional development across the continent. Additionally, before recommendations such as the aforementioned CDC HPV advice can be implemented, the pragmatic reality of the particular circumstances needs to be taken into consideration. There are other similar recommendations that are influenced by the vulnerabilities of women’s reproduction that fall into this same uncertainty.

A lack of clarity in ethical guidelines within African nations makes any attempt to follow the CDC recommendations a challenge. Moreover, there are additional dilemmas encountered when trying to follow basic ethical principles. These complexities influence the follow-up treatment for adolescents. In many cases it is the adolescent’s parents who take the primary role in decision making, oftentimes excluding those children in making decisions about their own health, and sometimes even denying them the potential benefits of health-preserving interventions. In essence, such African adolescents are left in a confused state of being both children and adults.

Using illustrative examples below, I draw from experience and insight in Tanzania. I make the case that the need for parental consent needs to be revisited so as to best customize the fit of that need to certain settings in reproductive health.

Contraceptive services
In many African countries the law is silent on the age a young person may access contraceptives. For example, according to a research conducted in Tanzania, 15 is the youngest age at which girls use contraceptives. Yet girls can obviously conceive before that age, and there is no law that prevents the usage of contraceptives at any age. Therefore, I argue that the default legal position requiring parental consent should be overruled; this would allow more freedom for young girls who wish to have access to reproductive control.

Age of consent for HIV testing
The age of consent for HIV testing is 16 years in Tanzania. Testing of persons under the age of 16 must be carried out with the consent of parents or legal guardians. However, the law does not stipulate a particular age at which an adolescent’s HIV status can be reported directly to him/her. It says only that test results are confidential and shall be shown only to the tested person with an exception of those under 18 years of age.

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Image description: The flag of Tanzania waves on a flagpole with blue sky in the background. Image source: Stefano C. Manservisi/Flickr Creative Commons.

Age of consent for Antiretroviral Therapy (ART)
In Tanzania, the 2001 national AIDS control policy provides universal access to ART. However, there are no explicit rules regarding either age specification or consent. The policy specifies that “people living with HIV and AIDS have the right to comprehensive health care and other social services including legal protection against all forms of discrimination and human rights abuse.” Parental consent for minors therefore should not have a role in accessing ART.

Age for consent and access for Pre-exposure Prophylaxis (PreP) and Post-exposure Prophylaxis (PEP)
In the same way that HIV-infected young people should have the rights and obligations to which they are entitled, so too should they have ready access to PreP and PEP. However, since no explicit rule is in place with regard to the age of consent, might we then safely/ethically assume that any person irrespective of age should have access to PreP? Similarly, it is not clear whether an adolescent should be allowed access to, or alternatively, be prohibited from PEP as the law and guidelines are silent on access for young persons.

Abortion and post-abortion care
In Tanzania, as in all other African countries, abortion is illegal. Tanzanian law is very clear on the consequences. However, there are no age-specific-rules regarding the age of consent for access to antenatal care (ANC). Indeed, when an adolescent becomes pregnant, regardless of the young woman’s age, health workers do not require parental consent for ANC. Therefore, I maintain that this dis-equal access amounts to a contradiction in the ethics of care.

Access to HPV vaccines and cervical cancer screening and treatment
Returning to my first point, globally, Tanzania has one of the highest incidences of cervical cancer. To address this health concern, the country recently has agreed to provide HPV vaccine for girls aged 9-13 years. What then is the parental role?

This message from CDC Director Tom Frieden, MD, MPH, in a 2016 press release could perhaps be viewed as clear and feasibly be implemented in a developed country:

“Safe, effective, and long-lasting protection against HPV cancers with two visits instead of three means more Americans will be protected from cancer. This recommendation will make it simpler for parents to get their children protected in time.”

This CDC claim about simplicity presumes that such parental consent would be forthcoming and would therefore equate to full HPV protection for the adolescent. But as I’ve pointed out, that might not be the case in Tanzania and other developing countries.  Perhaps we then should take a new approach in dealing with ethical issues related to accessing health in low-resource settings. Parents have an important role in ensuring the health of the adolescents, yet as I’ve demonstrated in the above, in those areas of a sensitive reproductive nature, the parental role may need to be secondary so as to ensure the adolescent’s health and well-being. If reproductive health interventions among adolescents are to succeed, perhaps we need to reach out directly to adolescents. When considering the daunting health risks adolescents face in low-resource settings, there is a need to lower access barriers and allow adolescents to consent on their own behalf. This then would give them the freedom to decide when and with whom they wish to share such sensitive information, and to directly benefit from available health interventions. This needed policy shift would place the ethics of becoming an adult in resource-challenged settings on another level.

Rose Mwangi photoMs. 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 advocating for social responsibility among global health researchers. Her recent milestone is leading the development and integration of Bioethics curriculum at Kilimanjaro Christian Medical University College (KCMUCo) as part of the European and Developing countries Partnership (EDCTP) in which UK and Tanzania are key stakeholders. Ms. Mwangi Co-Chairs the Institute Review Board (IRB) and is the Bioethics and Research Ethics instructor at KCMUCo and other medical institutions in Tanzania.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, July 11, 2019. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

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Assistant Director Libby Bogdan-Lovis a co-investigator on breastfeeding project

Libby Bogdan-Lovis photoCenter for Ethics Assistant Director Libby Bogdan-Lovis is a co-investigator on the project “Buffers, Barriers, and Resiliency in Breastfeeding Behaviors of Asian American Mothers.” The project is funded by the Trifecta Initiative for Interdisciplinary Health Research, a collaboration between the Colleges of Communication Arts & Sciences, Engineering, and Nursing at Michigan State University.

The interdisciplinary research team includes principal investigator Joanne Goldbort of the College of Nursing, Mary Bresnahan of the College of Communication Arts & Sciences, and Jie Zhuang of the Bob Schieffer College of Communication at Texas Christian University.

Project Summary: While Asian American (AA) mothers are described as high initiators of breastfeeding, no previous studies have conducted a randomized trial of AA mothers’ breastfeeding and formula use behaviors and whether these mothers continue to breastfeed exclusively for the recommended six months. Using an online Qualtrics customized panel, we will conduct a systematic investigation of the breastfeeding behaviors and timing of the introduction of complementary foods, and use of formula of AA mothers over a one-year period. We will recruit 1200 women between the ages of 18 and 35, as follows: 400 AA mothers with children one-year or younger; 400 pregnant AA women; and 400 American mothers from all race/ethnic groups will serve as the control group. This longitudinal study will track pregnant AA women through the birth of their babies, and will assess breastfeeding support and behaviors after the initial data collection, at 3-months, 6-months, and at one-year.

Visit our website to learn more about current research projects in the Center for Ethics and Humanities in the Life Sciences.

Informed Consent in Africa for Adolescents’ Participation in Health Research

Bioethics in the News logoThis 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.”

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Image description: an individual in Kenya is photographed from the side while looking into a microscope. Image source: GSK/Flickr Creative Commons.

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.

Empirical evidence

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.

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Image description: an illustrated cartoon depicts children in a classroom. A speech bubble above the children reads, “If we don’t know which drugs are safest and most effective for pregnant women and children, why don’t they just let us into more clinical trials?” The speech bubble from the teacher reads, “To protect you from untested drugs.” Image source: Hilda Bastian/statistically-funny.blogspot.com.

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.

Conclusion

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).

Rose Mwangi photoMs. 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.

You must provide your name and email address to leave a comment. Your email address will not be made public.

Click through to view references

Drs. Kelly-Blake and Holmes-Rovner co-authors of shared decision making article

Kelly-BlakeHolmes-RovnerCenter Assistant Professor Dr. Karen Kelly-Blake and Professor Emerita Dr. Margaret Holmes-Rovner are among the co-authors of the article “Implementing shared decision making in federally qualified health centers, a quasi-experimental design study: the Office-Guidelines Applied to Practice (Office-GAP) program,” published on August 2, 2016 in the open-access journal BMC Health Services Research. The study was authored by MSU researchers Adesuwa Olomu, William Hart-Davidson, Zhehui Luo, Karen Kelly-Blake and Margaret Holmes-Rovner.

Abstract
Background: Use of Shared Decision-Making (SDM) and Decision Aids (DAs) has been encouraged but is not regularly implemented in primary care. The Office-Guidelines Applied to Practice (Office-GAP) intervention is an application of a previous model revised to address guidelines based care for low-income populations with diabetes and coronary heart disease (CHD). Objective: To evaluate Office-GAP Program feasibility and preliminary efficacy on medication use, patient satisfaction with physician communication and confidence in decision in low-income population with diabetes and coronary heart disease (CHD) in a Federally Qualified Healthcare Center (FQHC).

The full article is available on the BMC Health Services Research website.

NIH research grant awarded for project led by Tom Tomlinson and Raymond De Vries

tomlinsonTom Tomlinson, PhD, recently received a research grant from the National Human Genome Research Institute, NIH. Titled “Public Preferences for Addressing Donors’ Moral Concerns about Biobank Research,” the project is being led by Tomlinson and co-PI Raymond De Vries, PhD, of the University of Michigan.

To date, the dominant research ethics framework has focused on protecting research participants against the risks to their welfare that might be created by their participation in health research. This 3-year project is concerned with a different kind of “risk”—the risk that donated, de-identified biospecimens and health information might be used in research that is contrary to the donors’ moral, social or religious beliefs or values. How much do such concerns matter to people’s decisions whether to contribute specimens to research biobanks using a “blanket consent,” that gives one-time permission to use the contribution in any way the biobank deems acceptable? How should information about biobank-supported research projects be provided to potential donors? These and other questions will be answered using a nationally representative survey, coupled with a series of democratic deliberations that ask members of the public to develop recommendations for biobank policies regarding these issues. For more information, click here.

This project continues a line of research that Dr. Tomlinson began in 2010.