Determining risk in pediatric research with no prospect of direct benefit: time for a national consensus on the interpretation of federal regulations

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" ( section sign 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition ( section sign 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations section sign section sign 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria.     

Chisholm's Epistemic Principles

Abstract: An exposition and discussion of Chisholm's “epistemic principles.” These are compared with relevant views of Wilfrid Sellars and Richard Foley. A further comparison, with the approach favored by Descartes, is argued to throw light on the status of such principles.     

Development and Validation of the Workplace Age Discrimination Scale

Purpose

Workplace age discrimination research is proliferating, but researchers lack a valid measure with which to capture targets’ discriminatory experiences. We developed a measure of perceived workplace age discrimination that assesses overt and covert forms of discrimination and then compared older, middle-aged, and younger workers’ experiences.

Design/Methodology

In Study 1, we developed the Workplace Age Discrimination Scale (WADS) based on older workers’ experiences using a deductive approach, a qualitative study, and two quantitative surveys. In Study 2, we validated the measure among young employees using a qualitative and two quantitative surveys. In Study 3, we tested the WADS among middle-aged workers and tested models of invariance between age groups.

Findings

Participants frequently endorsed covert discriminatory experiences, which the WADS reflects. The WADS contains convergent and discriminant validity, high reliability, and a unidimensional structure across age groups. It demonstrates criterion-related validity among older and younger workers but not middle-aged workers, given their low experiences of age discrimination. Age discrimination frequency follows a U-shaped pattern across age groups.

Implications

Researchers can use the WADS to identify long-term outcomes of age discrimination and to further compare workers’ discriminatory experiences. Practitioners and policymakers can use the measure to develop interventions to ameliorate workplace age discrimination and inform policymaking.

Originality/Value

The WADS is the first validated measure of targets’ perspectives of workplace age discrimination. Our results challenge assumptions that only older workers experience age discrimination (younger workers’ means were highest) and that age discrimination is usually overt in nature (it is often covert).

     

Ethical analysis of research partnerships with communities

Community-researcher partnerships constitute one of the most important recent developments in biomedical ethics. The partnerships protect vulnerable communities within which research is conducted and help ensure that the communities benefit from the research. At the same time, they embody deep, core values about the social nature of persons and the value of community that significantly modify the radical individualism too often associated with the prevailing concepts of autonomy and respect for persons. This article examines the burgeoning literature on community-researcher partnerships to identify the main ways of thinking ethically about the obligations of investigators and the roles and rights of communities in scientific research. The paper helps to uncover the deep commonalities and differences that mark the current debate in this emerging arena of research ethics, a debate over the social nature of persons that is beginning to influence the understanding of other bioethical issues.     

Classical geometric illusion effects with nonclassical stimuli: Angular induction from decomposing lines into point arrays

Angular induction is the process by which one line segment can bias judgment of orientation and/or collinearity of another segment, and it has been established that the magnitude of error is a determinate function of the relative angle between the two. We examined how these known relationships are affected by decomposing the induction segment into an array of scattered points. The bias that was produced by such arrays was found to be consistent with a formal model of angular induction, with the strength of the effect decreasing as the scatter among the points was increased. This decline in strength was almost linear with a logarithmic transform of the dimensions of the stimulus array. We also evaluated the hypothesis that the induction stimulus is detected by one or more channels—for example, neurons—for which the sensitivity profiles are modeled as Gabor wavelets. The change in induction strength with increasing point scatter was not predicted by a single width of channel. However, the combined activity of an ensemble of channels that differed in width did match the perceptual effects if one also stipulated that each channel would respond maximally to a fine-line stimulus.