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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Bioethics for Breakfast: Biobanking Tissue: Trash or Treasure?

Bioethics for Breakfast Seminars in Medicine, Law and SocietyJennifer Carter-Johnson, PhD, JD, and Tom Tomlinson, PhD, presented at the Bioethics for Breakfast event on December 6, 2018, offering their perspectives and insight on the topic “Biobanking Tissue: Trash or Treasure?”

“Big data”—repositories of biological, medical and demographic information about large numbers of people—is a critical platform for discovery of the causes of disease and potential new avenues for its treatment.

This data must come from us, the general public. Data about you might end up in a biobank because you’ve generously agreed to provide it, perhaps by agreeing to join the National Institutes of Health’s All of Us project that aims to recruit a broad representative sample of one million Americans.

Or it might already have been provided for use in research without your knowledge or consent. Research using specimens and medical information collected during your clinical care, once de-identified, doesn’t count as research on a “human subject” under the Federal regulations. Thus, your consent is not required. This source probably provides the great majority of information used in big data research, and acquiring and distributing it has become a multimillion dollar business.

This practice raises a host of questions. Doesn’t my specimen and my medical information belong to me, rather than to the hospital or clinic that collects it? Or have I thrown it away like my trash sitting on the curb each week? Although many people may feel comfortable providing this information for research, others might not. So isn’t it a simple act of respect to ask first? Or are researchers simply the medical equivalent of college students dumpster diving for cheap furniture that has been thrown away? Additionally, if we ask, and too many people say “no,” won’t critical research be hampered, to the detriment of all of us?

Dr. Tomlinson asked attendees to consider this question: Should clinically-acquired specimens and other medical information be treated like the trash that you have no control of once it has left your curb?

Dr. Tomlinson referred to a national study that his research team conducted in 2014 regarding willingness to give blanket consent, focusing on the fact that people care about more than risk – they have concern about how their materials may be used, and they worry about how much they should trust the research establishment. Dr. Tomlinson’s overarching argument was that respect for persons, a fundamental bioethics principle, requires informed consent.

Dr. Carter-Johnson also offered a question: whose treasure is it? Biospecimens and related data can be donated by patients and the public, can be clinically collected de-identified materials, and they can be samples given to private companies like 23andMe or Ancestry.com. Dr. Carter-Johnson also discussed a new startup offering to sequence your genome for free, and highlighted the variety of health and fitness apps that we give our data too. “When something is free, you are the product,” she said. A show of hands revealed that a minority of the attendees had gotten their DNA sequenced.

Dr. Carter-Johnson offered a legal perspective on tissue and genetic data in relation to property and privacy rights. She explained that individuals do not own their own tissue, citing the cases Moore v. Regents of California and Greenberg v. Miami Children’s Hospital Research Institute. However, there have been exceptions, and there are legal ways to “sell” your body (think plasma, bone marrow, sperm, or clinical trials).

When discussing privacy, Dr. Carter-Johnson used 23andMe and Ancestry.com’s privacy policies as examples. These policies are contractual, they are updated frequently, and they are often ignored by the consumer. However, push from consumers as well as bioethicists have led to these policies being more available and accessible.

Audience discussion brought up the famous Henrietta Lacks case, the future of biobank donor policies, and newborn screening programs and biobanks.

Jennifer Carter-Johnson, PhD, JD
Jennifer Carter-Johnson is an Associate Professor of Law at the Michigan State University College of Law and holds both a JD and a PhD in Microbiology. Professor Carter-Johnson uses her interdisciplinary training to study the intersection of law and scientific research.

Tom Tomlinson, PhD
Tom Tomlinson was Director of the Center for Ethics and Humanities in the Life Sciences from 2000 to 2018, and is a Professor in the Department of Philosophy. He chairs the Ethics Committee at Sparrow Health System, and has published widely on the ethics of biobank-based research.

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.

Worried about your privacy? Your genome isn’t the biggest threat.

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

By Tom Tomlinson, PhD

It was good news to learn last month that the “Golden State Killer” had at last been identified and apprehended. A very evil man gets what he deserves, and his victims and their families get some justice.

The story of how he was found, however, raised concerns in some quarters. The police had a good DNA sample from the crime scenes, which with other evidence supported the conclusion that the crimes were committed by the same person. But whose DNA was that? Answering that question took some clever detective work. Police uploaded the DNA files to a public genealogy website, GEDmatch, which soon reported other users of GEDmatch who were probably related to the killer. More ordinary police work did the rest.

Most of the concern was over the fact that the police submitted the DNA under a pseudonym, in order to make investigative use of a database whose members had signed up and provided their DNA only for genealogical purposes.

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Image description: a black and white photo of the panopticon inside of Kilmainham Gaol in Dublin, Ireland. Image source: Craig Sefton/Flickr Creative Commons.

My interest in this story, however, is the way it both feeds and undermines a common narrative about our DNA—that it is uniquely identifying, and that therefore any uses of our DNA pose special threats to our privacy. As The New York Times expressed this idea, “it is beginning to dawn on consumers that even their most intimate digital data—their genetic profiles—may be passed around in ways they never intended.”

It’s true that a sample of DNA belongs uniquely to a particular individual. But the same is true of a fingerprint, a Social Security number, or an iris. More importantly, by themselves none of these pieces of information reveals who that unique individual is.

As the Golden State Killer story illustrates, it’s only when put in the context of other information that any of these admittedly unique markers becomes identifying. If the GEDmatch database contained nothing but genetic profiles, you could determine which genomes the killer was related to. But you’d have no idea who those genomes belonged to, and you’d be no closer to finding the killer.

Although an individual genome can’t by itself be identifying, it can provide a link that ties together different information sources which include that genome. It can then be that collection that points to an individual, or narrows the list of possibilities to increase the odds of identification, and the threats to privacy. Imagine the state police maintains a database of forensic DNA linked to records of criminal convictions, and provides that database to criminologists, stripped of any names or other direct identifiers. Imagine as well that one of the hospitals provides researchers with DNA from their patients along with their de-identified medical records (which can include patients’ age, race, first 3 ZIP numbers, and other demographic information).

If we put those together we can do some interesting research: use the DNA link to identify those who both committed various crimes and had a psychiatric history, so we can compare them to convicted felons without a psychiatric history.

But now it may take very little additional information to identify someone in that combined database and invade their privacy. If I’m a researcher (or hacker) who knows that my 56-year-old neighbor was convicted of assault, I can now also find out whether he has a record of psychiatric illness—and a lot more besides. What he had thought private, is no longer so.

The point of this somewhat fanciful example is that as more information is collected about us, from more sources, the threats to our privacy will increase, even if what’s contained in individual sources offers little or no chance of identification.

For this reason, the prospect of merging various data sources for “big data” health research will challenge the current research regulatory framework. Under both the current and the new rules (which haven’t yet gone into effect), the distinction between identifiable and non-identifiable research subjects is critical. Research using information that can be linked to an individual’s identity requires that person’s consent. To avoid this requirement, research data must be “de-identified”. De-identification is the regulatory backbone on which much of the current “big data” research relies, allowing the appropriation of patient medical records and specimens for use in research without consent; and it provides the regulatory basis for uploading the data collected in NIH-supported research into a large NIH-sponsored database, the database of Genotypes and Phenotypes (dbGaP), which most NIH-supported genomic studies are required to do. Data from dbGaP can then be used by other researchers to address other research questions.

The possibilities of merging such “de-identified” databases together for research purposes will only increase, including facial recognition databases being collected online and on the street. As the mergers increase, it will become more difficult to claim that the people represented in those databases remain non-identifiable. As Lynch and Meyer point out in the Hastings Center Report, at this point there will be two choices. We can require that all such research will need at least broad consent, which will have to be reaffirmed every time a person’s data is used in new contexts that make identification possible. Or we will have to fundamentally reassess whether privacy can play any role at all in our research ethics, as the very idea of “privacy” evaporates in the panopticon of everyday surveillance.

Tom Tomlinson photoTom Tomlinson, PhD, is Director and Professor in the Center for Ethics and Humanities in the Life Sciences in the College of Human Medicine, and Professor in the Department of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, July 12, 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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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

Dr. Tomlinson and co-authors published in ‘European Journal of Human Genetics’

Tom Tomlinson photoCenter Director and Professor Dr. Tom Tomlinson is first author of the article “Effect of deliberation on the public’s attitudes toward consent policies for biobank research,” published in the February 2018 issue of the European Journal of Human Genetics. The work of Dr. Tomlinson and co-authors Raymond G. De Vries, H. Myra Kim, Linda Gordon, Kerry A. Ryan, Chris D. Krenz, Scott Jewell, and Scott Y. H. Kim was supported by the NIH-funded project “Public Preferences for Addressing Donors’ Moral Concerns about Biobank Research.”

Abstract: In this study, we evaluate the effect of education and deliberation on the willingness of members of the public to donate tissue to biobank research and on their attitudes regarding various biobank consent policies. Participants were randomly assigned to a democratic deliberation (DD) group, an education group that received only written materials, and a control group. Participants completed a survey before the deliberation and two surveys post-deliberation: one on (or just after) the deliberation day, and one 4 weeks later. Subjects were asked to rate 5 biobank consent policies as acceptable (or not) and to identify the best and worst policies. Analyses compared acceptability of different policy options and changes in attitudes across the three groups. After deliberation, subjects in the DD group were less likely to find broad consent (defined here as consent for the use of donations in an unspecified range of future research studies, subject to content and process restrictions) and study-by-study consent acceptable. The DD group was also significantly less likely to endorse broad consent as the best policy (OR = 0.34), and more likely to prefer alternative consent options. These results raise ethical challenges to the current widespread reliance on broad consent in biobank research, but do not support study-by-study consent.

The full text is available online through Springer Nature (MSU Library or other institutional access may be required to view this article).

Dr. Tomlinson presents at 3rd Annual Great Lakes Biorepository Network Scientific Meeting

tomlinson-crop-2016The 3rd Annual Great Lakes Biorepository Network (GLBRN) Scientific Meeting was held on October 28, 2016 at the University of Michigan in Ann Arbor. Center Director and Professor Dr. Tom Tomlinson spoke on “Preferences for Biobank Consent Policy are Sensitive to Concerns about Future Research Uses.”

The current research ethics framework gauges the level of ethical protections to the degree of risk to the participant. The lower the risk, the less stringent the requirements for informed consent; when the risk is virtually zero, as with the research uses of de-identified biospecimens and related clinical and demographic data, it is no longer research on a human “subject.”

This framework forgets why people donate their specimens and data to biobanks. They are not merely concerned with what later research will do to or for them. They are hoping their donation may do some good; and correlatively, assuming that it will do no wrong, in ways they would find morally concerning:

  • Some research might threaten a donor’s world view –such as research to better understand human evolution and history.
  • Some donors might be concerned by research that might lead to the stigmatization of others –such as research that looks at genes associated with violence.
  • Or some research may be contrary to the moral, cultural, or political values of the donor – such as research related to abortion or research leading to large commercial profits.

To emphasize the contrasts with the conventional framework, Dr. Tomlinson and his colleagues call these people’s non-welfare interests in later research uses of their donations.

In the talk Dr. Tomlinson presented evidence that such concerns affect people’s preferences among various biobank consent policies, drawn from both a national survey that his research team conducted in 2014 and a series of democratic deliberations held in 2015. The evidence shows that the more people are aware of the range of possible research uses of biobank donations that might be of concern to them or others, the more negative their attitudes are toward blanket consent. In this consent, a donor gives permission up front to any future uses that the biobank would allow, without any further consent or information provided. This is the most common form of biobank consent, but their research shows that a bare majority finds it “acceptable,” and a sizeable minority (38%) think it’s the “worst” option among those presented. Interestingly, the team found similar attitudes expressed toward specific, study-by-study consent, the option that gives each donor the most control over later research uses.

For more analysis of the national survey, see: De Vries RG, Tomlinson T, Kim HM, Krenz C, Haggerty D, Ryan KA, Kim SY. Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey. PLoS One. 2016 Jul 14;11(7).

Dr. Tomlinson is an Executive Board Member of the Great Lakes Biorepository Network and Incoming President for 2017.

Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey

PLOS ONE logoA new research article from Dr. Tomlinson and his research team was published on July 14, 2016 in the open-access peer-reviewed journal PLoS ONE. The article, “Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey,” is authored by Raymond Gene De Vries, Tom Tomlinson, Hyungjin Myra Kim, Chris Krenz, Diana Haggerty, Kerry A. Ryan, and Scott Y. H. Kim. The research is part of the NIH-funded project “Public Preferences for Addressing Donors’ Moral Concerns about Biobank Research.”

Abstract: Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket—or broad—consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using “real-time”—or study-by-study—consent, but this policy places a significant burden on biobanks. In order to better understand the public’s preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

“Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey” is available to read in full on the PLoS ONE website.

Would you donate to a biobank?

Tom TomlinsonCenter Director Dr. Tom Tomlinson and Raymond G. De Vries, Co-Director of the Center for Bioethics and Social Sciences in Medicine at University of Michigan, have co-authored the article “Americans want a say in what happens to their donated blood and tissue in biobanks.” The authors discuss biobank donations, precision medicine, genetics, privacy, and consent.

The last time you went to a hospital, you probably had to fill out forms listing the medications you are taking and updating your emergency contacts. You also might have been asked a question about what is to be done with “excess tissues or specimens” that may be removed during diagnosis or treatment. Are you willing to donate these leftover bits of yourself (stripped of your name, of course) for medical research?

If you are inclined to answer, “Sure, why not?” you will join the majority of Americans who would agree to donate, allowing your leftovers, such as blood or unused bits from biopsies or even embryos, to be sent to a “biobank” that collects specimens and related medical information from donors.

But what, exactly, will be done with your donation? Can the biobank guarantee that information about your genetic destiny will not find its way to insurance companies or future employers? Could, for example, a pharmaceutical company use it to develop and patent a new drug that will be sold back to you at an exorbitant price?

These questions may soon become a lot more real for many of us.

Read the full piece at The Conversation.

Related reading: “Understanding the Public’s Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey” published July 14, 2016 in PLoS ONE, an open-access peer-reviewed journal. Authors: Raymond Gene De Vries, Tom Tomlinson, Hyungjin Myra Kim, Chris Krenz, Diana Haggerty, Kerry A. Ryan, Scott Y. H. Kim.

Signed Off: Unconsented-To Cesarean Section, A Quarter Century After A.C.

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. Visit this page for more information.

By Deborah Fisch, JD

The Texas case awaiting a decision from the Supreme Court heralds a new understanding of abortion rights in the line of cases from Roe (1973) through Casey (1992). However, another reproductive rights case about having children is also worth revisiting.

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Image description: text under an illustrated image of a uterus reads “don’t tread on me.” Image by Liz McDaniel.

The subject of In re A.C. (1990) is Angela Carder, a cancer patient in her last days of life, who refused a c-section at 26 weeks’ gestation. A physician unrelated to her case obtained a court order that authorized the hospital to proceed. Both Carder and the baby died within two days after surgery. An appeals court overturned the order, thereby setting a precedent for the right of a pregnant patient1 to refuse care. Although this precedent was limited to the District of Columbia, it was felt to be sufficiently influential to guide other state court decisions. In the intervening years, however, A.C. has often failed to provide the envisioned protection.

1 On language: this article refers to “pregnant patients” or “pregnant people,” with the goal of including those who give birth who do not identify as women.

Court-Ordered C-Section

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Image description: text on a green colored background reads “It’s not consent if you make me afraid to say no.” Image by Liz McDaniel.

In 1999, Laura Pemberton sued a Florida hospital that procured a court order to forcibly transport her to the hospital for a c-section. The court’s analysis in finding against her was telling: in response to Pemberton’s claim that her constitutional rights had been violated to bodily integrity, refusal of treatment, and family privacy, the court conducted a cursory balancing test between Pemberton’s right to bodily autonomy and the safety of the fetus – in opposition to A.C., which explicitly rejected such a test. The opinion cited A.C. only once, to distinguish Pemberton’s situation from Carder’s: it claimed that because surgery did not risk Pemberton’s death, the hospital was justified in making the decision for her based on the relative risks to parent and fetus.

In addition to disregarding A.C., this finding turns the medico-legal doctrine of informed consent on its head. Under it, providers bear a duty to inform the patient of the risks and benefits of proposed treatments, while patients possess the right to consent or refuse, based on their risk perception as combined with their values and circumstances. If relative medical risk were the sole criterion for decision-making, as the Pemberton Court seems to suggest, a patient’s consent would be irrelevant.

The Pemberton Court justified its decision with Roe, which grants the state an interest in the fetus late in pregnancy – and thus, an ability to intervene. Roe, of course, addressed abortion rights, whereas Pemberton was a pregnant patient who wished to bear her child. This misapplied doctrine continues to follows the offspring of A.C.

Physician-Ordered C-Section

Court-ordered c-sections are now rare, perhaps thanks to A.C. More common are medical malpractice cases that challenge unconsented-to c-sections performed without court authority. Most such cases are still in process through the courts.

The New York case filed by Rinat Dray in April 2014 immediately made headlines. An on-call physician forcibly performed a c-section, noting (unwisely!) in Dray’s chart, “The woman has decisional capacity. I have decided to override her refusal to have a c-section.”

The A.C. Court reaffirmed that failure to provide informed consent is considered malpractice. However, patients like Dray are hard-pressed to find a willing attorney. The contingency fee model of financing requires the prospect of a significant damage award to offset the $50,000 average cost of mounting a case. Attorneys, judges, and juries alike generally do not acknowledge a recompensable injury when both parent and baby emerge from birth alive and nominally healthy. Sadly, Dray may have succeeded in bringing her case to court in part because she suffered an additional physical injury during surgery.

Physician-Coerced C-Section

ScarboroughSwitzer_Lindsay Askins
Image description: Lindsay Scarborough Switzer is seated on a couch with her hands in her lap, looking directly at the camera. Image by Lindsay Askins/spotofserendipity.com.

A refinement on c-sections performed without consent are those in which consent was obtained by coercion. New Jersey attorney Lindsay Scarborough Switzer was already in the pushing phase of her son’s birth when the on-call physician arrived and abruptly demanded a c-section. After the physician warned of brain-damage to the baby, threatened calls to a magistrate to compel the surgery, withheld requested pain medication, and alluded to a possible removal of Switzer’s older child by child welfare services, Switzer finally signed the consent form that was put in front of her.

Switzer is a healthy, educated, determined attorney, who was attended in labor by her husband, a nurse-midwife, and a doula. It is difficult to imagine a patient better situated to hold out against coercion. That she could not indicates that patients in labor are particularly vulnerable to this sort of intimidation, as perhaps may be better understood by considering coercion in sexual assault. Switzer made the full records of her case available to the public before it was settled in late 2015.

Michigan Law on Unconsented-To C-Section

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Image description: Michigan state seal. Public domain image.

Although Michigan statute does not grant child welfare authorities jurisdiction over children not yet born, the state’s interpretation of relevant case law suggests that when a fetus is believed to be in danger, that barrier may be demolished. A 1987 bioethics article explored several Michigan cases, one of which had been explored in depth in 1984. The possibility of court-ordered c-sections in Michigan is real; the existence of coercive c-sections is already a reality.

Conclusion

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Image description: an illustrated silhouette of a pregnant person. Image source.

In spite of the legal authority of A.C., the right of competent parents to refuse surgery is often compromised, and their ability to seek redress is limited. Those who reach court are members of relatively privileged classes; what does this mean for everyone else?

By asking these questions, this article does not suggest we vilify physicians or deify patients; we are all influenced by the systems in which we live and work – and give birth. Extensive practice guidelines and other resources are in place to support physicians with concerns about possible conflict between patient autonomy rights and physician duty to patients. Institutions ranging from hospitals to the courts must reinforce the policy that the best decision-maker for a potential child is its parent, particularly the one in whose body it resides.

deb-fischDeborah Fisch is a Michigan attorney with a solo practice that offers defense of health care providers against state disciplinary actions. She is also employed at AwakenMichigan: Reproductive and Sexual Justice Project. Her interest in childbirth and maternity care is expressed through her legislative work on midwife licensure through Friends of Michigan Midwives, her legal advocacy and organizational efforts through Birth Rights Bar Association, and her intermittent pronouncements at Mama’s Got a Plan. She was a contributing author to the amicus curiae brief submitted by Human Rights in Childbirth for the Rinat Dray case.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, April 21, 2016. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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A Non-Standard Practice of Medicine

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Event Flyer

In the mid-1950s, physician James Burt began modifying episiotomy repair; two decades later, he offered ‘love surgery’ as an elective. In early 1989, shortly after several women accused him on national television of performing an experimental surgery on them without their consent, Burt relinquished his medical license. The popular media mostly portrayed Burt as practicing outside the norms of medical practice, allowed to do so by his peers. But this narrative fails to consider questions about routine medical innovation the Burt story brings forth. Historians (and bioethicists) have, for the most part, focused on infamous – think Tuskegee – unethical medical research. But what can the development of ‘love surgery’ tell us of about normative surgical development, routine medical innovation, and informed consent for routine procedures since the 1950s?

mar-18-bbagJoin us for Sarah B. Rodriguez’s lecture on Wednesday, March 18, 2015 from noon till 1 pm in person or online.

Sarah B. Rodriguez, PhD, is a lecturer in the Medical Humanities and Bioethics Program in the Feinberg School of Medicine and in the Global Health Studies Program in the Weinberg College of Arts and Sciences at Northwestern University. Her area of research is in women’s reproductive and sexual health since the early twentieth century. Her first book, Female Circumcision and Clitoridectomy: A History of a Medical Treatment, was published in the fall of 2014.

In person: This lecture will take place in C102 East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? All webinars are recorded! View our archive of recorded lectures (over 30 lectures and counting!).