Altruistic discourse in the informed consent process for childhood cancer clinical trials

Scholars have debated the role that altruistic considerations play--and should play--in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) "the future" and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.     

Children's living arrangements following separation and divorce: insights from empirical and clinical research

When parents separate, children typically enter into new living arrangements with each parent in a pattern determined most often by one or both parents or, failing private agreement, as a result of recommendations and decisions by lawyers, therapists, custody evaluators, or family courts. Most of these decisions have been based on cultural traditions and beliefs regarding postseparation parenting plans, visitation guidelines adopted within jurisdictions, unsubstantiated theory, and strongly held personal values and professional opinions, and have resulted since the 1960s in children spending most of their time with one residential parent and limited time with nonresident, or "visiting," parents. A large body of social science and child development research generated over the past three decades has identified factors associated with risk and resiliency of children after divorce. Such research remains largely unknown and untapped by parents and professionals making these crucial decisions about children's living arrangements. This article highlights empirical and clinical research that is relevant to the shape of children's living arrangements after separation, focusing first on what is known about living arrangements following divorce, what factors influence living arrangements for separated and divorced children, children's views about their living arrangements, and living arrangements associated with children's adjustment following divorce. Based on this research, it is argued that traditional visiting patterns and guidelines are, for the majority of children, outdated, unnecessarily rigid, and restrictive, and fail in both the short and long term to address their best interests. Research-based parenting plan models offering multiple options for living arrangements following separation and divorce more appropriately serve children's diverse developmental and psychological needs.     

Genetic research,adolescents, and informed consent

The participation of adolescents in genetic research engenders unusual problems concerning the nature of their informed consent. In this study we analyze 70 consent documents collected from genetics investigators in the United States who conduct research with children and adolescents. We find that many consent documents do not reflect either the current or the developing ethical and legal standards for research with adolescents and that in many cases the documents are simply confusing or unclear. We make recommendations for change to reflect more adequately the changing perspective concerning the autonomous decision-making capacity of adolescents.     

Participants' understanding of the process of psychological research: informed consent

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41% were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.     

Shading the truth in seeking informed consent for research purposes

I want to argue for two propositions. First, I suggest that what some researchers may take to be a simple trade-off between minor violations of the truth for the sake of access to far greater truths represents a profound miscalculation with far-reaching and cumulative reverberations. Second, I submit that today's research environment, as demanding, competitive, and sometimes bewildering as it is, offers genuine scope for what Murdoch calls truth-seeking, for imaging and questioning, and for relating to facts through both truth and truthfulness; but that, in so doing, it presents hard choices with respect to methods, and, in turn, to personal integrity--not only in particular research projects but also with respect to that fragile research environment in its own right.     

Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

When clinical care is like research: the need for review and consent

The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review and more extensive informed consent. In contrast, it is widely assumed that clinical care does not raise these ethical concerns because it is designed to promote the best interests of individual patients. The segregation of clinical research from clinical care has been largely effective at protecting research participants. At the same time, this approach ignores the fact that several aspects of standard clinical care, such as clinician training and scheduling, also pose some risks and burdens to present patients for the benefit of all patients. We argue that recently proposed learning health care systems offer a way to address this concern, and better protect patients, by developing integrated review and consent procedures. Specifically, current approaches base the need for independent ethical review and more extensive informed consent on whether an activity is categorized as clinical research or clinical care. An ethically sounder approach, which could be incorporated into learning health care systems, would be to base the need for independent ethical review and more extensive informed consent on the extent to which an activity poses risks to present patients for the benefit of all patients.