Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been less discussion of ethical issues surrounding families involved in observational studies of HIV transmission. This paper describes the process of ethical deliberation about how best to obtain informed consent from sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study aimed to assess the amount of HIV serodiscordance among (...) IDUs and their sexual partners, identify barriers to harm reduction, and explore ways to optimize intervention programs. Including IDUs, either HIV-positive or at high risk for HIV, and their sexual partners would help to gain a more complete understanding of barriers to and opportunities for intervention. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Rosamond Rhodes calls for a reconceptualization of research ethics and a fundamental shift in attitude toward both research subjects and scientific investigators. She recognizes the limits of the e...

Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...) participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)

Children’s intentions should be respected. Parents are the key persons involved in decision-making related to their children. In Japan, the appropriate ages and standards for a child’s consent and assent, approval, and decision-making are not clearly defined, which makes the process of obtaining consent and assent for clinical research complex. The purpose of this paper is as follows: to understand the attitudes and motives of parents concerning children’s participation in medical research and the factors influencing their decision-making. We also sought (...) to clarify who has the right to be involved in decisions regarding children’s participation in research. A semi-structured Internet survey on parents’ opinions and attitudes and preferences concerning medical research involvement was conducted. Children were divided into three age groups (6–10-year-olds, 11–14-year-olds, and 15–18-year-olds), with three illness severity categories. Possible correlations between the number of children, children’s ages, parents’ educational levels, and parents’ attitudes were examined. Among the participants, 42.3% recognized the term “informed consent.” The proportion of participants who understood “informed consent” increased with educational level. Four out of five participants did not know, or had not heard of, the term “informed assent.” Furthermore, the percentage of those who understood the term “informed assent” increased with academic level. Participants generally believed in prioritizing parents’ opinions over children’s, and that parents and children would ideally reach a joint decision. Although many parents favored collaborative decision-making, they also wanted their own will reflected in the decision and felt they should receive important information before their children do. Decision-making was affected by the condition’s severity and prognosis. This indicates that most Japanese parents believe that their children have the right to know their disease name and treatment; nonetheless, they should be protected. Parents’ values and judgments regarding medical intervention involving their children varied. Children’s ability to consent to treatment and research believed to be in their best interests should be assessed appropriately. They should be permitted to provide consent or assent, and their views should be respected. Involving children in decision-making fosters more open communication and transparency between medical professionals, parents, and children. (shrink)

Background The opioid epidemic has enabled rapid and unsurpassed use of big data on people with opioid use disorder to design initiatives to battle the public health crisis, generally without adequate input from impacted communities. Efforts informed by big data are saving lives, yielding significant benefits. Uses of big data may also undermine public trust in government and cause other unintended harms. Objectives We aimed to identify concerns and recommendations regarding how to use big data on opioid use in ethical (...) ways. Methods We conducted focus groups and interviews in 2019 with 39 big data stakeholders who had interest in or knowledge of the Public Health Data Warehouse maintained by the Massachusetts Department of Public Health. Results Concerns regarding big data on opioid use are rooted in potential privacy infringements due to linkage of previously distinct data systems, increased profiling and surveillance capabilities, limitless lifespan, and lack of explicit informed consent. Also problematic is the inability of affected groups to control how big data are used, the potential of big data to increase stigmatization and discrimination of those affected despite data anonymization, and uses that ignore or perpetuate biases. Participants support big data processes that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. Recommendations for ethical big data governance offer ways to narrow the big data divide, enact shared data governance, cultivate public trust and earn social license for big data uses, and refocus ethical approaches. Conclusions Using big data to address the opioid epidemic poses ethical concerns which, if unaddressed, may undermine its benefits. Findings can inform guidelines on how to conduct ethical big data governance and in ways that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. (shrink)

Biobanks are increasingly being created specifically for research purposes. Concomitantly, we are seeing significant and evolving shifts in research ethics in relation to biobanking. Three discrete shifts are identified in this article. The first extends the ethical focus beyond the protection of human subjects to the promotion of broader community benefits of research utilizing biobanked resources, and an expectation that these benefits will be shared. The second involves the evolution of the traditional consent paradigm for future research uses of biobanks (...) resources that are not in contemplation at the time of donation. The third involves a move away from single project management to more dynamic governance accountability to research participants and the public. These shifts may take different local and institutional forms but share common recognizable elements. (shrink)

To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of “daily life.” But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics often argue that “minimal (...) risk” should refer to healthy children or the subjects of the research. I argue that neither of these interpretations is successful. I propose a new interpretation in which minimal risk refers to children who are not unduly burdened by their daily lives. I argue that children are not unduly burdened when they fare well, and I defend a substantive goods account of children’s welfare. (shrink)

Volume 19, Issue 9, September 2019, Page 39-41.

Volume 19, Issue 9, September 2019, Page 37-39.

The exploitation of participants is a significant problem in biomedical research, especially in the developing world. However, there is a gap between this problem and the theoretical literature on exploitation. This thesis will attempt to bridge it, considering Wertheimer and Sample’s theories. Whereas Wertheimer holds that exploitation is merely an unjust distribution of the “social surplus” arising from a transaction, Sample, whose approach this thesis endorses, construes exploitation as a lack of respect for a person’s true value. This thesis will (...) show that codes of ethics with legal force take a Wertheimerian approach, and that the aspirational codes, which insist that research respond to local health priorities, are more Samplian. Finally, it will argue that the current system of research funding and oversight cannot guarantee that research is responsive to the needs of the developing world and thus fails to prevent exploitation. (shrink)

This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments (...) explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals. (shrink)