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.

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Dr. Stahl presents at Summer Institute on Theology and Disability

Devan Stahl photoOn June 14, Center Assistant Professor Dr. Devan Stahl delivered the Jean Vanier Emerging Scholar Lecture at the Summer Institute on Theology and Disability in Raleigh, NC. Dr. Stahl was awarded this lectureship based on her dissertation work and letters of recommendation regarding her scholarship on disability. Dr. Stahl’s lecture was titled, “From Idol to Icon: Transforming Medical Images into DisArt.” Based largely on her recent book, Imaging and Imagining Illness, she discussed how fine art can transform medical images and challenge our cultural associations with disability. Dr. Stahl is the third Vanier Emerging Scholar and co-director of the PhD seminar at the Summer Institute.

To learn more about Imaging and Imagining Illness, listen to Episode 7 of the Center’s podcast, No Easy Answers in Bioethics.

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Dr. Fleck presents at Centre for Cancer Biomarkers Symposium in Norway

Leonard Fleck photoCenter Professor Dr. Len Fleck recently traveled to Bergen, Norway to present a keynote address at the 6th Annual Centre for Cancer Biomarkers (CCBIO) Symposium. Dr. Fleck’s presentation, “Just Caring Challenges: Visible Biomarkers and Invisible Rationing,” addressed some of the critical ethical issues related to the use of biomarkers in cancer research and clinical care.

Dr. Fleck addressed two main problems in his lecture. First, the ragged edge problem. One of the primary purposes of finding biomarkers is to determine whether a cancer drug is likely to be effective for a particular metastatic cancer patient. However, rarely will a biomarker yield a simple answer. Most often, the biomarker will be expressed along a continuum. If a drug were very inexpensive and side effects tolerable, it would be easy to say that the ethically right choice would be to respect patient autonomy. But these drugs all cost more than $100,000 for a course of treatment. Consequently, if a drug has a 20% chance of having a beneficial effect, there is a conflict between considerations of justice and respect for patient autonomy. Invisible rationing (just not offering the drug to the patient) can bypass this conflict, but invisible rationing is ethically problematic so far as justice is concerned.

Secondly, recent liquid biopsies can identify eight common cancers at a very early stage–in the form of circulating cancer cells in the blood–at a cost of $500. However, the critical question would need to be raised: How often would 170 million adults (all anxious about cancer) in the U.S. have a just claim to access that test? Every six months? Every year? Note that each such offering of that test to that population would cost $85 billion. Would that represent either a just or prudent use of health care resources?

The CCBIO symposium was well-attended by an international mix of junior and senior researchers and scholars. Dr. Fleck had the opportunity to meet with many European researchers to discuss their respective work in the field of cancer research.

Dr. Fleck also gave a public lecture at the University of Bergen’s Centre for the Study of the Sciences and the Humanities, titled “Precision Medicine, Ethical Ambiguity: Rough Justice, Ragged Edges.” Dr. Fleck addressed precision medicine as it currently exists, in particular the costly FDA-approved targeted cancer therapies. Treatments for patients with metastatic cancers, which are not curative, can cost $100,000 to $475,000 per treatment course. For example, 30% of patients who are candidates for CAR T-cell immunotherapy will not gain more than an extra year of life. As things are now, we do not know before the fact who those patients might be. But one goal of biomarker research is to identify before the fact who those marginal responders most likely will be, so that we could save money by denying those patients access to this therapy. As a citizen of a just and caring society, would you endorse the research to accomplish that result? Why or why not? This is what Dr. Fleck calls “rough justice.”

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Dr. Cabrera presents on neuroenhancement at Mexico City event

On May 17, Center Assistant Professor Dr. Laura Cabrera presented on “‘Neuroenhancement’ en países de habla hispana” on the panel “Neuroethics in Mexico: Considerations for development.” The panel part of the Academia Nacional Mexicana de Bioética conference series in Mexico City in conjunction with the Mexican Neuroethics Association (Asociación Mexicana de Neuroética). Dr. Cabrera’s presentation was based on an ongoing collaboration with Mexican Neuroethics Association President Dr. Karen Herrera-Ferrá, looking at examining the similarities and points of divergence between the Euro-American and the Hispanic discussions about neuroenhancement.

Cabrera presenting in Mexico City

Photo: Dr. Cabrera (right) presenting in Mexico City on May 17. Photo courtesy of Dr. Cabrera.

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Doctors, Technology Puzzles, and the Clinical Ethicist Detective

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

By Marleen Eijkholt, JD, PhD

I love puzzle rooms and detective novels. When medicine looks like a puzzle room, I become fascinated as a non-MD aspiring detective. When that medical mystery reveals an ethical problem, I really get in gear, as a clinical (neuro) ethicist.

Reading about the “Mystery of sonic weapon attacks at US embassy in Cuba” made me consider how physicians engage in a puzzle, and how piecing the story together leads to a hypothesis, as if in a puzzle room. Patients with strange and mysterious medical symptoms, suspicious circumstances, and the culprit? Uncertain – inexplicable narratives, patterns, and complaints that do not head in a clear prognostic direction. A story that continues to unravel. Doctors are detectives, and medicine can be a journey through a puzzle room to discover clues about the cause of ailments. Within the story, technology is the enemy but perhaps also a friend; providers embrace technology as it seems to promise a definitive answer.

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Image description: five white puzzle pieces are shown against a black background. Image source: Willi Heidelbach/Flickr Creative Commons.

The ethical problem: We do not make patients privy to the fact that medicine is something of a puzzle room, and that medicine’s technological tools carry substantial uncertainty. Instead, medical technology is presented as offering the path to a concrete solution. Uncertainty is rarely addressed by providers, or presented to patients who pay for expensive technologies, and equally who might suffer under their use. The medical world operates in a political and cultural system, which affects how providers want to see symptoms and technology. Patients get carried along with the tide. The embassy story made me think about the role of a clinical ethicist. Who challenges the patient, who challenges the doctor, who challenges the technology? Should clinical ethicists be detectives too?

What is/was going on in the Cuba case? Early news stories reported that a sonic weapon might have harmed American diplomats. Diplomats claimed hearing loss, speech problems, vision issues and nausea after perceiving high-pitched noises and thumps. Canadian diplomats (and their children!) might have been harmed too. Reports indicated uncertainty about the culprit: “None of this has a reasonable explanation.” Experts submitted that no detrimental sonic weapon with this power had yet been developed. However, plagued by symptoms, diplomats were called back for safety reasons; reasonably, they were not expected to endure permanent threats to their health, lives and livelihood.

Since the diplomats had not experienced blunt trauma, their condition was baffling. Research, as JAMA published, suggested that many of the 21 study participants showed various “objective” signs that could indicate neurologic injury, i.e., symptoms often found in individuals post-concussion. About the culprit, the authors stated: “The unique circumstances of these patients and the consistency of the clinical manifestations raised concern for a novel mechanism of a possible acquired brain injury from a directional exposure of undetermined etiology.” Per the study, MRI findings indicated a shift change in white matter, possibly suggesting a neurological foundation to the problem.

Critics of the study were less sure (see references 3, 5, 6, and 8 below). They questioned the MRI tool and laid out different approaches to the puzzle, in full public view. Critical analysists, including a Cuban author, labeled the symptoms as potentially psychosomatic, the result of a conversion disorder. Suggesting a mass-psychogenic illness, the authors submitted that the hype around Cuba generated a “bias,” creating anxiety and hypersensitivity. They contested the finding’s objectivity as based on self-report or subjective interpretations of the researchers. Hence objective conclusions were elusive. Critics offered that: “Medical diagnosis at any given time depends to some extent on the current state of scientific knowledge, historical and cultural context, and the framework through which a disease is conceptualized.” However, this context was explicitly ignored by another expert who favored a physical approach. In a Neurology Today article by Dan Hurley, Dr. Terry Fife stated: “Just because an MRI is normal doesn’t mean everything else is normal. Many conditions in the past that we thought were subjective turned out to be quite real.”

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Image description: a black silhouette of a figure walking, the figure’s head is a puzzle piece. The figure is against an orange background. Image source: Thomas Hawk/Flickr Creative Commons.

Intrigue around the sonic attacks made me consider how mechanistic conclusions are rarely called into question. In this case, the critical perspective came from fellow physicians, which is reassuring; the system does not often question mechanistic truths. I wonder what mechanisms exist in the real life clinic? I hear about cases in which the most powerful physician might reference MRI results, and oppose the withdrawal of life support. Contrary to the whole team of other providers, who describe the clinical picture as awful and exacerbating the patient’s suffering, as well the family, who indicate that the patient would not want continued life support, the physician objects to withdrawal, stating that the MRI tool does not confirm the clinical picture; this physician wishes to continue full steam ahead. Without questioning his tool (i.e., the MRI), or the technological questions of his colleagues, the patient is unreasonably made to suffer.

Tools to facilitate any type of “certainty,” like MRIs, are popular reference points used to instill trust in our patients and our families. Just as the detective’s magnifying glass stands for scrutiny and expertise, the stethoscope stands for the physician’s trustworthiness. In foggy medical settings, heart monitors and MRI machines are powerful symbols to generate certainty and clarity. The health care setting presents them as supersonic tools. In cases where the results are questioned, the setting proposes that the patient must be “wrong” and not the technology. As illustrated in the Cuban diplomats’ case, the alternative explanation for their symptoms goes straight to mass psychogenic illness. Instead of having a somatic origin, because we could not view something, the symptoms must be caused by a mental state.

What is the role of a clinical ethicist within this culture? The story made me consider how much we need to walk into the medical puzzle room. Especially where medical tools are obstacles because of their presumed “definitive” clarity. Where physicians ignore questionable methodologies, should ethicists then be the detective? Pull out their magnifying glass, and use their tools of critical questions? Who should ask what is real and what is not? Whose role is it to challenge the patient, the doctor, the technology?

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Marleen Eijkholt, JD, PhD, is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Obstetrics, Gynecology and Reproductive Biology in the Michigan State University College of Human Medicine. Dr. Eijkholt is also a Clinical Ethics Consultant at Spectrum Health System.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, May 31, 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

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Bioethics for Breakfast: Health Care Consolidations: Good News, Bad News, Fake News?

Bioethics for Breakfast Seminars in Medicine, Law and SocietyJohn Goddeeris, PhD, and Michael Herbert presented at the Bioethics for Breakfast event on May 10, 2018, offering perspective and insight on the topic, “Health Care Consolidations: Good News, Bad News, Fake News?” Leonard Fleck, PhD, moderated this session.

At the national level as well as in our state, the macro-level restructuring of health care delivery is impacting physician-patient clinical encounters, clinics, hospitals and health systems. As the engaged moderator for this session, Dr. Fleck guided those in attendance in examining downstream consequences of such restructuring and consolidations by posing questions to the two presenters: Dr. John Goddeeris, Professor of Economics, and Michael Herbert, Chief Executive Officer for the MSU HealthTeam.

Dr. Fleck asked the presenters to respond to the following questions: What are the basic statistics regarding health care consolidation? How does consolidation affect medical practice (and the core values of medicine)? Are patients better off as a result of consolidation? Does consolidation save the health care system money? Alternatively, does it give more pricing power to the hospital industry (against insurers who wish to demand discounts of various sorts)? Does this process have any significant effects for rural health care? Does this process increase or decrease disparities in the health care system, i.e., access to needed care for those less well off?

John Goddeeris
John Goddeeris, PhD, is a Professor of Economics in the Department of Economics in the College of Social Science at Michigan State University. Dr. Goddeeris’ expertise includes economic issues in health care, including health insurance and government programs. His research has been published widely in journals in economics, medicine, public health, and health policy. Dr. Goddeeris is a nonresident fellow in the Health Policy Center at the Urban Institute.

Michael Herbert
Michael Herbert, Chief Executive Officer for the MSU HealthTeam, is a consultant dedicated to assisting Academic Medical Centers in organizational design and operations, including hospital and faculty group practice operations, as well as Medical School operations, leadership development, strategic plan design and implementation and government policy development. He has served in a variety of high-level medical school and health system leadership positions in Michigan as well as in many other states, and was the Associate Deputy Regional Director in the Department of Veterans Affairs.

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.
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Episode 9: Reflecting on Early Bioethics: Fleck and Tomlinson

No Easy Answers in Bioethics logoEpisode 9 of No Easy Answers in Bioethics is now available! This episode features two senior Center faculty members, Director Tom Tomlinson, PhD, and Professor Len Fleck, PhD. Together they discuss and reflect on the accidental ways in which they entered the field of bioethics in the 1970s and ‘80s, also touching on the creation of the program that became the Center for Ethics around that same time. They discuss the changes they’ve seen around topics such as death and dying, advance directives, and advances in medical technologies. Finally, they speculate on where bioethics may be headed in the future.

Ways to Listen

This episode was produced and edited by Liz McDaniel in the Center for Ethics. Music: “While We Walk (2004)” by Antony Raijekov via Free Music Archive, licensed under a Attribution-NonCommercial-ShareAlike License. Full episode transcript available.

This episodes wraps up the first “season” of No Easy Answers in Bioethics! Catch up on previous episodes this summer, and tune in this fall for new discussions around bioethics and research in the Center for Ethics.

About: No Easy Answers in Bioethics is a podcast series from the Center for Ethics and Humanities in the Life Sciences in the Michigan State University College of Human Medicine. Each month Center for Ethics faculty and their collaborators discuss their ongoing work and research across many areas of bioethics—clinical ethics, evidence-based medicine, health policy, medical education, neuroethics, shared decision-making, and more. Episodes are hosted by H-Net: Humanities and Social Sciences Online.

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