Philosophy Commons^™

The Ottawa Statement On The Ethical Design And Conduct Of Cluster Randomized Trials, Charles Weijer, Jeremy Grimshaw, Martin Eccles, Andrew Mcrae, Angela White, Jamie Brehaut, Monica Taljaard

Charles Weijer

In cluster randomized trials (CRTs), the units of allocation, intervention, and outcome measurement may differ within a single trial. As a result of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated.

The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs.

A five-year mixed methods research project explored the ethical challenges of CRTs. Empirical studies documented the reporting of ethical issues in published CRTs, interviewed experienced trialists, and surveyed trialists …

What’S Right About The Medical Model In Human Subjects Research Regulation, Heidi Li Feldman

Georgetown Law Faculty Publications and Other Works

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the social and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of …

What Is The Role And Authority Of Gatekeepers In Cluster Randomized Trials In Health Research?, Antonio Gallo, Charles Weijer, Angela White, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard

Charles Weijer

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining …

The Ethics Of Vaginal Birth After Cesarean, Sonya Charles

Philosophy and Religious Studies Department Faculty Publications

The decline in providers and facilities that will allow a trial of labor after cesarean forces many women to choose a repeat cesarean. The choice is frequently not much of a choice, however, since the full range of options are often not on the table. This limited 'choice' violates obstetricians' obligations both to respect patients' autonomy and to offer them good care. There has been a vigorous but so far not very fruitful debate in the last few years about the lack of access to a trial of labor after cesarean. Some recently released documents express concern about the limited …

Sacrée Et Inviolable: The Hiv+ Mother In Ivoirian Health Policy, Amber Alaniz

Annual Undergraduate Conference on Health and Society

« La personne humaine est sacrée (2)… Le domicile est inviolable. Les atteintes ou restrictions ne peuvent y être apportées que par la loi. (4) La famille constitue la cellule de base de la société. L'État assure sa protection. (5)» Constitution of La Côte d’Ivoire, Articles 2,4,5[1]

The Ivoirian national constitution, authored and enacted in July of 2000, while expressing a devotion to democratic thought (Preamble) and to the sovereignty of the individual (Article 2), also acknowledges the primacy of the Ivoirian family and collective identity as the basis of society and advances a moral duty on the part …

Knowledge, Wisdom, And Service: The Meaning And Teaching Of Professionalism In Medicine, Matthew K. Wynia

Center for the Study of Ethics in Society Papers

Papers presented for the Center for the Study of Ethics in Society Western Michigan University. Presented September 29, 2011.

Animal Models For Human Disease – Reflections From An Animal Researcher’S Perspective, Imke Tammen

Between the Species

Neuronal ceroid lipofuscinoses (NCL) are a group of lethal inherited neurodegenerative disorders in humans and many animal species. Critical reflections on a range of ethical issues concerning NCL have been instigated by my research on sheep and cattle affected with NCL, the claim that these sheep and cattle are useful models for the disease in humans, and engagement with families and support groups. My reflections on moral status of animals and validity of animal models are outlined in this paper.

Why There Is No Duty To Die, Gary W. Levvis, Margaret M. Levvis

Torrington Articles

John Hardwig argues that patients have a duty to end their lives when their continued existence imposes serious hardship on their caregivers. Hardwig has deflected many critics’ objections concerning the practical implications of his position. Our goal is to demonstrate the self-contradictory nature of the duty-to-die thesis. Once we eliminate the vagueness (over the essential conditions subtending a presumed duty to die) and the ambiguity (implicit in Hardwig’s use of the term “duty”), we find that the essential conditions for such a duty cannot be simultaneously satisfied. The problem is that the very process by which the duty to die …

Locke And Berkeley At Twenty Paces, Frederick J. White Iii

Frederick J White III

Does the world exist? Or more properly questioned, does anything of the world exist beyond our ideas of it? Locke and Berkeley have become seconds at twenty paces on this dichotomy, and we are asked to consider the outcome of the duel.

The Nature Of Suffering: Moving Beyond Definition To Understanding, Barry Hoffmaster

C. Barry Hoffmaster

No abstract provided.

The Nature Of Moral Compromise: Principles, Values, And Reason, Cliff Hooker, Barry Hoffmaster

C. Barry Hoffmaster

No abstract provided.

Re-Reasoning Ethics, Cliff Hooker, Barry Hoffmaster

C. Barry Hoffmaster

No abstract provided.

The Publication Of Ethically Uncertain Research: Attitudes And Practices Of Journal Editors, Carla Angelski, Conrad Fernandez, Charles Weijer, Jun Gao

Charles Weijer

Background

Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas.

Methods

The Editor-in-chief of each of the 103 English-language journals from the 2005 Abridged Index Medicus list publishing original research were asked to complete a survey sent to them by email between September-December 2007.

Results

A response rate of …