This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identified several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interests approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, (...) and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence, and comparison of children's competence for treatment and research decisions. (shrink)
PURPOSE: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results. METHODS: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revised and provided to 30 parents and 10 adolescents in a (...) tertiary care oncology setting. RESULTS: The content validity index for individual questions and the overall questionnaires scored as 0.86 for both questionnaires. All 30 parents and 10 adolescents who agreed to participate returned questionnaires. The majority (>95%) indicated that they had a strong or very strong right to receive results. Letter or e-mail was a satisfactory means to return results described as good or neutral (66% parents, 100% adolescents) but more participants wished face-to-face disclosure of results with negative implications (50% parents, 60% adolescents). Very few wanted results disseminated through a Web site. The majority acknowledged the need for peer-review before disclosure (60% of adolescents and parents) but did not want "to be the last to know." CONCLUSIONS: Our data suggest that pediatric oncology patients and parents of children with cancer strongly feel that they have a right to research results, and that they wish to receive these in a timely manner. (shrink)
Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (...) (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their own research participation and cited factors that would influence their own decision to participate in, or to provide parental authorization for their child to participate in health research. Results: Completed questionnaire rates for AYAs and parents were 86 (46.5%) of 185 and 409 (65.2%) of 627, respectively. AYAs (n = 86 [67%]) and parents (n = 409 [85%]) cited that they would participate in research because it would help others. AYAs perceived pressure by their family and friends (16%) and their physician (19%). Having too much to think about at the time of accrual was an impediment to both groups (36% AYAs and 47% parents). The main deterrent for AYAs was that research would take up too much time (45%). Nonwhite parents (7 of 56 [12.5%]) were more apt to decline than white parents (12 of 32 [3.7%]; P < .01). Conclusions: AYAs identified time commitment and having too much to think about as significant impediments to research participation. Addressing these barriers by minimizing time requirements and further supporting decision-making may improve informed consent and impact on enrollment in trials. (shrink)
BACKGROUND: Researchers have a moral responsibility to offer to return research results to participants, but the needs and attitudes of parents and adolescents with cancer in paediatric oncology regarding the issue are relatively unknown.OBJECTIVES: To explore the needs of potential research participants or their guardians with respect to the offer of a return of research results. METHODS: A questionnaire was used in a focus group and in telephone interviews with eight adolescents and 12 parents of children with cancer. The participants (...) were asked to respond to the questions and to comment on the inclusiveness of the questionnaire.RESULTS: The majority of participants (18 of 20) wished to receive research results. Two somewhat unexpected findings are described. First, all participants in the present study felt that it was the primary responsibility of the participant to retain contact with the researchers for the purpose of obtaining research results. Second, few participants (n=2) indicated that the Internet would be a satisfactory way of transmitting these results. One-half of the participants wished to have face-to-face communication of results.CONCLUSIONS: These results provide preliminary guidance for the return of research results to participants and validate the use of the questionnaire in a larger study of this issue. (shrink)
PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants. METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs. (...) RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants. CONCLUSIONS: Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified. (shrink)
PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants. METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the results; reasons for and against (...) providing results; and barriers to providing results. RESULTS: Four hundred nine parents (including 19 of deceased children) and 86 adolescents responded. Most parents (n = 385; 94.2%) felt that they had a strong right to research results. For positive results, most wanted a letter or e-mail summary (n = 238; 58.2%) or a phone call followed by a letter (n = 100; 24.4%). If the results were negative, phone call (n = 136; 33.3%) or personal visits (n = 150; 36.7%) were preferred. Parents wanted the summary to include long-term sequelae and suggestions for participants (n = 341; 83.4%), effect on future treatments (n = 341; 83.4%), and subsequent research steps (n = 284; 69.5%). Understanding the researcher was a main concern about receiving results (n = 145; 35.5%). Parents felt that results provide information to support quality of life (n = 315; 77%) and raise public awareness of research (n = 282; 68.9%). Adolescents identified similar preferences. CONCLUSION: Parents of children with cancer and adolescents with cancer feel strongly that they have a right to be offered research results and have specific preferences of how and what information should be communicated. (shrink)
This study described parent participation in the informed consent conference for randomized clinical trials (RCTs) in childhood leukemia and documented the relationship of physician communication to parent participation. Parents of 140 children with newly diagnosed leukemia who were eligible for RCTs were studied at six sites using comprehensive methods involving direct observation and transcripts of parent-physician communication based on audiotapes. Parent participation during the informed consent conference reflected a wide range of content categories. Consistent with hypotheses, Physician Rapport and Partnership (...) Building related to parent participation in the informed consent conference but Information Giving did not. Higher parent socioeconomic status also was related to greater parent participation for two of three measures of parent participation. Findings suggest that physician behaviors that provide support and facilitate communication may enhance parental participation in the informed consent conference for RCTs in childhood leukemia. (shrink)
Leo Strauss»s Natural Right and History and Eric Voegelin»s New Science of Politics represented both a continuation of the Weimar conversation and a projection into the American context of the issues that defined that conversation. They each chose Max Weber as the pivotal figure in their animadversions regarding historicism, relativism, and the condition of social science, but, as in the case of Weber himself, the underlying issue, which animated the emigres across the ideological spectrum, was the relationship between theory (...) and practice or philosophy and politics. (shrink)
Leo Strauss and Eric Voegelin are two thinkers who seem to have much in common, yet they provide markedly different interpretations of Machiavelli. A comparison of their views on such a distinctive figure in the history of political thought reveals fundamental differences of philosophical outlook and scholarly temperament even as it occasions a re-examination of the ‘enigma’ of Machiavelli himself.
Eric Voegelin and Eugen Rosenstock-Huessy provide an interesting and important contrast in their Augustinian diagnoses of modernity and the role of revolution and faith in salvation in history. For Eric Voegelin the desolation of modern humanity springs from its unreal elevation of the self – its Gnostic inheritance – and its immanentization of God and the eschaton into history and progress. In keeping with this is the moderns’ failure to appreciate that the symbolic order required for a fulfilling (...) human community and experience relies upon the necessity of maintaining God as a beyond in relation to society, man and world. Rosenstock-Huessy is also concerned that the failure of the moderns to understand the sign and significance of God is disastrous. And like Voegelin he is deeply opposed to modern Gnosticism and the pathologies that emerge from it, but Rosenstock-Huessy is also interested in something that is not Voegelin’s primary concern – mainly the role of providence in history. (shrink)
Following its determination of a finding of scientific misconduct the Office of Research Integrity (ORI) will seek redress for any injury sustained. Several remedies both administrative and statutory may be available depending on the strength of the evidentiary findings of the misconduct investigation. Pursuant to federal regulations administrative remedies are primarily remedial in nature and designed to protect the integrity of the affected research program, whereas statutory remedies including civil fines and criminal penalties are designed to deter and punish wrongdoers. (...) This commentary discusses the available administrative and statutory remedies in the context of a specific case, that of former University of Vermont nutrition researcher Eric Poehlman, and supplies a possible rationale for the legal result. (shrink)
In this paper I offer three main challenges to James (2011). All three turn on the nature of philosophy and secure knowledge in Spinoza. First, I criticize James's account of the epistemic role that experience plays in securing adequate ideas for Spinoza. In doing so I criticize her treatment of what is known as the ‘conatus doctrine’ in Spinoza in order to challenge her picture of the relationship between true religion and philosophy. Second, this leads me into a criticism of (...) her account of the nature of philosophy in Spinoza. I argue it is less piecemeal and less akin to what we would recognize as ‘science’ than she suggests. Third, I argue against James's core commitment that Spinoza's three kinds of knowledge differ in degree; I claim they differ in kind. My argument will offer a new interpretation of Spinoza's conception of ‘common notions’. Moreover, I argue that Spinozistic adequate knowledge involves something akin to angelic disembodiment. (shrink)
(2007). Youth and Sexualities: Pleasure, Subversion, and Insubordination In and Out of Schools. Edited by Mary Louise Rasmussen, Eric Rofes, and Susan Talburt. New York: Palgrave Macmillan, 2004. 250 pp. $75.00 (hardcover), $24.95 (paper) Educational Studies: Vol. 41, No. 1, pp. 88-92.
Refusing to pursue recent and possible future developments in medical research is itself a morally momentous decision—and that inaction has consequences Cohen and other right-wing thinkers refuse to acknowledge. -/- .
Rand's metaethical objectivism consists not in the view that values lie outside of us—in an independent reality such that we can identify them or fail to do so. Rather, Rand's conception of "objectivity" regarding the foundation of ethics is what is often called "agent-relative" but not subjective. Or, as Rand states, ethical claims are "objectively conditional" (in her essay "Causality versus Duty"). In elaborating this perspective, Machan shows that it suffices to avoid the dreaded charge of subjectivism contained in both (...) Rasmussen's and Mack's discussion of her views. (shrink)
Germ-line therapy has long been regarded with great caution both by scientists and by ethicists. Even those who do not reject germ-line therapy in principle have tended to reject it in practice as carrying unacceptable risks in our current state of knowledge. For this reason, a recent paper by Rubenstein, Thomasma, Shon, and Zinaman is unusual in putting forward a serious proposal for the use of germ-line therapy in the foreseeable future.
In this paper I focus on the central role faith plays in the thought of Polanyi and Voegelin. I begin by indicating how both find the modern conception of scientific knowing seriously wanting. What Polanyi terms "objectivism" and Voegelin calls "scientism" is the modern tendency to reduce knowledge to only that which can be scientifically demonstrated. This errant view of knowledge does not occur in a vacuum, though, and both men draw a connection between this and the political pathologies of (...) the twentieth century. I then show the complementary ways in which these two thinkers believe recovery is possible: an epistemological solution encompassed in Polanyi's personal knowledge and an ontological reorientation that is the core of Voegelin's insistence that we must recover an awareness of human participation in transcendent reality. (shrink)
Technical, ethical, and social questions of germ-line gene interventions have been widely discussed in the literature. The majority of these discussions focus on planned interventions executed on the nuclear DNA (nDNA). However, human cells also contain another set of genes that is the mitochondrial DNA (mtDNA). As the characteristics of the mtDNA grossly differ from those of nDNA, so do the social, ethical, psychological, and safety considerations of possible interventions on this part of the genetic substance.