Consent Challenges and Psychosocial Distress in the Scale‑up of Voluntary Medical Male Circumcision Among Adolescents in Western Kenya

August 5, 2019

In priority sub-Saharan African countries, on the ground observations suggest that the success of voluntary medical male circumcision (VMMC) programs should not be based solely on numbers of males circumcised. We identify gaps in the consent process and poor psychosocial outcomes among a key target group: male adolescents. We assessed compliance with consent and assent requirements for VMMC in western Kenya among males aged 15–19 (N = 1939). We also examined differences in quality of life, depression, and anticipated HIV stigma between uncircumcised and circumcised adolescents. A substantial proportion reported receiving VMMC services as minors without parent/guardian consent. In addition, uncircumcised males were significantly more likely than their circumcised peers to have poor quality of life and symptoms of depression. Careful monitoring of male adolescents’ well-being is needed in large-scale VMMC programs. There is also urgent need for research to identify effective strategies to address gaps in the delivery of VMMC services.

Appraising Harm in Phase I Trials: Healthy Volunteers’ Accounts of Adverse Events

July 17, 2019

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants’ interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity.

Geographic Location and Moral Arbitrariness in the Allocation of Donated Livers

July 17, 2019

The federal system for allocating donated livers in the United States is often criticized for allowing geographic disparities in access to livers. Critics argue that such disparities are unfair on the grounds that where one lives is morally arbitrary and so should not influence one’s access to donated livers. They argue instead that livers should be allocated in accordance with the equal opportunity principle, according to which US residents who are equally sick should have the same opportunity to receive a liver, regardless of where they live. In this paper, we examine a central premise of the argument for the equal opportunity principle, namely, that geographic location is a morally arbitrary basis for allocating livers. We raise some serious doubts regarding the truth of this premise, arguing that under certain conditions, factors closely associated with geographic location are relevant to the allocation of livers, and so that candidates’ geographic location is sometimes a morally non-arbitrary basis for allocating livers. Geographic location is morally non-arbitrary, we suggest, since by taking it into account, the UNOS may better fulfill its central goals of facilitating the effective and efficient placement of organs for transplantation and increasing organ donation.

The Role of Inclusion Benefits in Ethics Committee Assessment of Research Studies

May 24, 2019

The relationship between risks and benefits is central to the ethics of research involving human participants. Traditionally, to be ethically justifiable, risks should be reasonable in relation to anticipated benefits (if any) to subjects and to the potential social benefits resulting from research. This calculus is being further complicated by findings from an increasing number of social science studies that reveal that prospective and actual research participants frequently describe various types of inclusion benefits (for example, personal benefits such as access to or improved health care, increased knowledge about their disease or condition, and greater solidarity with the local community) as important to them. What is the ethical significance of such inclusion benefits, particularly those nonmedical in nature, for research ethics committees’ risk‐benefit assessment of research studies? We argue that, unless participants are clearly mistaken in their perceptions, ethics committees should take these types of inclusion benefits into account, and we suggest a few ways this might look in practice.

The power of suggestion Disclosure ideologies and medically assisted death

May 24, 2019

This article examines an ethical controversy that has received relatively little attention in public debates about the legalization of medical aid-in-dying (AID): should physicians inform patients that they have the option of hastening death? Drawing on ethnographic research about the implementation of AID in Vermont, I argue that how we understand the moral stakes of this debate depends on divergent views regarding language use in social interactions. Some stakeholders in this debate view a physician’s words as powerful enough to damage the patient-physician relationship or to influence a patient to hasten her death, while others believe that merely informing patients about AID cannot move them to act against their own values and preferences. I illustrate how these divergent perspectives are tied to competing language ideologies regarding clinical disclosure, which I call ‘disclosure ideologies’. My analysis of these two disclosure ideologies surrounding AID highlights disclosure practices in medicine as a rich site for medical anthropological theorizing on linguistic performativity and the social power of clinical language.

Surrogate Decision Making for Incarcerated Patients

May 21, 2019

When patients are too ill to make their own health care decisions and lack a previously designated decision maker, identifying the appropriate surrogate can be a complex process. For example, clinicians may use surrogacy ladders (hierarchical lists of individuals who could serve as decision makers), which are delineated in state statutes.1 Although patients with incapacitating illness are inherently vulnerable, there are additional considerations for people who are incarcerated, and these may not be addressed in state laws. We discuss the selection of surrogates for incarcerated patients and who should or should not serve in this role.

Women’s views about contraception requirements for biomedical research participation

May 13, 2019

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies–often irrespective of risks and benefits or a woman’s actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women’s reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement–in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them.

Attitudes Toward Genetics and Genetic Testing Among Participants in the Jackson and Framingham Heart Studies

May 9, 2019

Genetic analysis has become integral to many large cohort studies. However, little is known about longitudinal cohort study participants’ attitudes toward genetics and genetic testing. We analyzed data from a survey of participants in the Jackson Heart Study (n = 960), Framingham Heart Study (n = 955), and Framingham Heart Study–Omni Cohort (n = 160). Based on a three-question attitude scale, most participants had positive attitudes toward genetic testing (median score = 4.3-5/5). Participants were also asked to select words to describe their attitudes toward genetics. More respondents endorsed the positive words “hopeful” (60%-70%), “optimistic” (44%-64%), “enthusiastic” (35%-43%), or “excited” (28%-30%) than the negative words “cautious” (35%-38%), “concerned” (25%-55%), “worried” (6%-13%), “pessimistic” (2%-5%), or “horrified” (1%-5%). Characteristics associated with favorable attitudes were greater genetics knowledge, higher subjective numeracy, experience with genetic testing, less frequent religious attendance, and not being employed. These findings demonstrate variation in attitudes even among participants in long-standing cohort studies, indicating a need for ongoing participant engagement and education.

Sharing with Strangers: Governance Models for Borderless Genomic Research in a Territorial World

May 9, 2019

ABSTRACT. One of the practices that has defined the ethos of genomic research to date is a commitment to open and rapid sharing of genomic data and resources. As genomic research evolves into an international enterprise, this commitment is being challenged by the need to respect the interests of those it involves and implicates, from individual scientists and subjects to institutions and nations. In this essay, we first describe the types of claims that different stakeholders are making about the disposition of genomic data and samples. Next, we illustrate the complexities of these multiple claims by applying them to the case of one ongoing international genomics initiative, the H3Africa Consortium. Finally, in the light of these complexities, we conclude by comparing and contrasting four governance models for future international data-sharing policy and practices in genomics.