Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (shrink)
I examine the dynamics of measure development using two case studies: temperature, and health-related quality of life. I argue, following Bas van Fraassen and Leah McClimans that in each case these dynamics have a hermeneutic structure. Measure development is plagued by epistemic circularity, as is the task of interpreting a text, and similar strategies can be used in both measure development and hermeneutics to overcome that circularity. I show that Hans Georg Gadamer’s philosophical hermeneutics in particular are an effective lens (...) through which to examine the development of the temperature standard as described by Hasok Chang. Despite similar grounding in hermeneutics, I note an important difference between measure development for temperature and for health-related quality of life. Namely, while the meaning of temperature can be standardized, the meaning of health-related quality of life cannot. This standardization of meaning for the temperature concept represents a limit to the analogy with hermeneutics. Finally, I argue that the indeterminacy we find in health-related quality of life measurement is a result not only of analogy with the hermeneutic task, but of full-fledged participation in it. (shrink)
Consumption--the flow of physical materials in human lives--is an important ethical issue. Be it fair trade coffee or foreign oil, North Americans' consumption choices affect the well-being of humans around the globe, in addition to impacting the natural world and consumers themselves. In this book, Laura Hartman seeks to formulate a coherent Christian ethic of consumption.
Climate engineering is subject to the “playing God” critique, which charges that humans should not undertake to control nature in ways that seem to overstep the proper scope of human agency. This argument is easily discredited, and in fact the opposite—that we should “play God”—may be equally valid in some circumstances. To revive the playing God critique, I argue that it functions not on a logical but on a symbolic and emotional level to highlight nostalgia for functional dualisms in the (...) face of the bewildering problem of climate change. It also raises significant questions about the virtue of those who might engineer the climate. These two concerns point to questions about the proper role of human agency. I use the scholarship of Aldo Leopold and H. Richard Niebuhr to argue for a model of human agency based on contextual awareness and responsive, communal responsibility. I conclude with some implications of this view for decision-makers engaging the topic of climate engineering. (shrink)
In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.
Feminist criticism of health care and ofbioethics has become increasingly rich andsophisticated in the last years of thetwentieth century. Nonetheless, this body ofwork remains quite marginalized. I believe thatthere are (at least) two reasons for this.First, many people are still confused aboutfeminism. Second, many people are unconvincedthat significant sexism still exists and aretherefore unreceptive to arguments that itshould be remedied if there is no largerbenefit. In this essay I argue for a thin,``core'' conception of feminism that is easy tounderstand and (...) difficult to reject. Corefeminism would render debate within feminismmore fruitful, clear the way for appropriaterecognition of differences among women andtheir circumstances, provide intellectuallycompelling reasons for current non-feminists toadopt a feminist outlook, and facilitatemutually beneficial cooperation betweenfeminism and other progressive socialmovements. This conception of feminism alsomakes it clear that feminism is part of alarger egalitarian moral and political agenda,and adopting it would help bioethics focus onthe most urgent moral priorities. In addition,integrating core feminism into bioethics wouldopen a gateway to the more speculative parts offeminist work where a wealth of creativethinking is occurring. Engaging with thisfeminist work would challenge and strengthenmainstream approaches; it should also motivatemainstream bioethicists to explore othercurrently marginalized parts of bioethics. (shrink)
Health policymakers employ utility measures to inform resource allocation decisions. They often rely on a conceptual tool called the quality-adjusted life year that discounts the value of years lived in a state of disability relative to years lived in full health. A representative sample of the general public is asked to place values on hypothetical health states as part of a standard gamble or time trade-off task. Policymakers use the resulting values to calculate the number of QALYs gained through particular (...) interventions. Utilitarian reasoning mandates that policymakers maximize QALYs gained per unit cost.Although many scholars have explored the problems of distributive justice that arise from this system... (shrink)
We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues.
Despite this virtue's history as an instrument of women's oppression, modesty, at its most basic, means voluntary restraint of one's power, undertaken for the sake of others. It is a mechanism that modifies unequal power relationships and encourages greater compassion and fairness. I use a Christian perspective with influences from Jewish and Muslim sources to examine modesty. The modest person, I argue, must be in relationship with others, must be honestly aware of her impacts on others, must be sensitive to (...) those impacts, compassionate toward others, and willing to hold back for others' sakes. Moreover, modesty is not only a virtue that pertains to sexuality and clothing, but it also can promote virtuous environmental behavior, particularly as it leads to awareness of, and sensitivity to, the effects of everyday behaviors on vulnerable others. (shrink)
The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent.
The field of ethics is enjoying a much-needed renaissance. Traditional theories and approaches are appropriately coming under fire, although not every new idea will stand time's test. Feminist thinking suggests that we at least emphasize the importance of women and their interests, focus on issues specially affecting women, rethink fundamental assumptions, incorporate feminist insights and conclusions from other areas, and be consistent with respect to our concerns about equality by paying attention to race and class.
Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation, but it also presents ethical challenges. To inform policy development on this issue, we conducted a survey of U.S. institutional review board chairs concerning the acceptability of recontacting genetic research participants about additional research and their views on the disclosure of individual genetic results as part of recruitment. Our findings suggest there is (...) unlikely to be a “one-size-fits-all” solution, but rather several ethically acceptable approaches to genotype-driven recruitment, depending on context. Disclosures made during the consent process for the original study and the clinical validity of the results are key considerations. Researchers must be prepared to communicate and answer questions in clear lay language about what is known and not known regarding the role of genetics in their proposed area of research. (shrink)
Neither the range of potential results from genomic research that might be returned to participants nor future uses of stored data and biospecimens can be fully predicted at the outset of a study. Informed consent procedures require clear explanations about how and by whom decisions are made and what principles and criteria apply. To ensure trustworthy research governance, there is also a need for empirical studies incorporating public input to evaluate and strengthen these processes.
Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)
Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.
Shulamith Firestone argues that for women to embrace equal rights without recognizing them for children is unjust. Protection of children is merely repressive control: they are infantilized by our treatment of them. I maintain that many children no longer get much protection, but neither are they being provided with an environment conducive to learning prudence or morality. Recognizing equal rights for children is likely to worsen this situation, not make it better.
Pronatalism—the social bias toward having children—is at the core of much violence against women. Its chief characteristic, and its moral Achilles heel, is that it undermines autonomous decision-making about childbearing. Together with its soulmates misogyny and geneticism, it harms children, male partners, and humanity as a whole, given the serious environmental challenges now facing us. But, of course, biology requires women to gestate offspring, and women are generally expected to be responsible for childrearing. Female gender roles incorporate these facts, and (...) thus pronatalism’s negative impact on women—both their bodies and their lives—is of another order of magnitude. Yet, this state of affairs is so taken for granted that it is almost invisible, and is therefore especially hard to eradicate. Attempts to do so are also often erroneously confused with, and undermined by, negativism about having children. (shrink)