Arts and Humanities Commons^™

Researchers’ Perceptions Of Ethical Challenges In Cluster Randomized Trials: A Qualitative Analysis, Andrew Mcrae, Carol Bennett, Judith Belle Brown, Charles Weijer, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Allan Donner, Martin Eccles, Jeremy Grimshaw, Merrick Zwarenstein, Monica Taljaard

Charles Weijer

Background

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.

Methods

Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.

Results

Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to …

Ethical Issues Posed By Cluster Randomized Trials In Health Research, Charles Weijer, Jeremy Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein

Charles Weijer

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. …

Conceptual Problems In Research Ethics, Charles Weijer

Charles Weijer

This poster addresses these issues:
• What good is medical research?
• What is owed to the study subject?
• When is research risk acceptable?
• How should we conduct research in developing countries?
• How should we conduct research involving communities?

Ethical Challenges In Icu Research, Charles Weijer

Charles Weijer

No abstract provided.

When Can Physicians Say “No” To Families And Patients?, Charles Weijer

Charles Weijer

No abstract provided.

Helsinki Discords: Fda, Ethics, And International Drug Trials, Jonathan Kimmelman, Charles Weijer, Eric Meslin

Charles Weijer

No abstract provided.

U.S. Federal Regulations For Emergency Research: A Practical Guide And Commentary, Andrew Mcrae, Charles Weijer

Charles Weijer

Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB …

Evaluating Benefits And Harms In Clinical Research, Paul Miller, Charles Weijer

Charles Weijer

No abstract provided.

Revisiting The Ethics Of Hiv Prevention Research In Developing Countries, Charles Weijer, Guy Leblanc

Charles Weijer

Issues: We present key aspects of our paper, commissioned by UNAIDS in 2005, entitled, “Revisiting the ethics of HIV prevention research in developing countries.” In 2004 and 2005 we witnessed the closure or suspension of three international clinical trials testing tenofovir in the prevention of HIV infection in high risk groups due to the failure to provide free treatment to those who seroconvert during the conduct of the study. We examine critically moral claims for the provision of treatment to those who seroconvert in HIV prevention trials and ask whether it is a matter of moral obligation or moral negotiation? …

Evaluating Risks Of Non-Therapeutic Research In Children, Paul Miller, Charles Weijer

Charles Weijer

No abstract provided.

A Critical History Of Individual And Collective Ethics In The Lineage Of Lellouch And Schwartz, Charles Heilig, Charles Weijer

Charles Weijer

The notions of individual and collective ethics were first explicitly defined in the biostatistical literature in 1971 to motivate a mathematical solution to a posed ethical dilemma. This paper reviews key antecedents to these concepts and traces explicit references to them over time, primarily in the biostatistical literature. Following a historical exposition of these texts, a critical thematic analysis shows the following: the normative force of these concepts has not been adequately argued. Individual and collective ethics do not solve the problem of how to use accumulating data to inform ethical action. The notions of the "individual" and the "collective" …

Bioethics In Social Context, Edited By Barry Hoffmaster, Charles Weijer

Charles Weijer

No abstract provided.

Matters Of Life And Death: Making Moral Theory Work In Medical Ethics And The Law, James Anderson, Charles Weijer

Charles Weijer

No abstract provided.

Continuing Review Of Research Approved By Canadian Research Ethics Boards, Charles Weijer

Charles Weijer

No abstract provided.

The Ethics Wars: Disputes Over International Research, Charles Weijer, James Anderson

Charles Weijer

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.

Trial By Error, Charles Weijer

Charles Weijer

No abstract provided.

Family Duty Is More Important Than Rights, Charles Weijer

Charles Weijer

No abstract provided.

Protecting Communities In Biomedical Research, Charles Weijer, E. Emanuel

Charles Weijer

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its …

The Sum Of My Parts, Charles Weijer

Charles Weijer

No abstract provided.

A Philosophical Disease: Bioethics, Culture, And Identity, Charles Weijer

Charles Weijer

No abstract provided.

Bioethics: An Anthology, Charles Weijer

Charles Weijer

No abstract provided.

The Ethical Analysis Of Risks And Potential Benefits In Human Subjects Research: History, Theory, And Implications For U.S. Regulation, Charles Weijer

Charles Weijer

This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research:

1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)?
2. What conceptual framework should guide the ethical analysis of risk?
3. What changes to U.S. regulations would the implementation of such a framework require?

Protecting Communities In Research: Current Guidelines And Limits Of Extrapolation, Charles Weijer, Gary Goldsand, Ezekiel Emanuel

Charles Weijer

As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto …

We’Re Alright Jack, Charles Weijer

Charles Weijer

No abstract provided.

Getting Doctors To Listen: Ethics And Outcomes Data In Context, Charles Weijer

Charles Weijer

No abstract provided.

Why I Am Not A Futilitarian (Review Of When Doctors Say No: The Battleground Of Medical Futility), Charles Weijer

Charles Weijer

No abstract provided.

Consensus-Seeking Roundtable On Placebos In Clinical Research, Charles Weijer

Charles Weijer

No abstract provided.

Medical Futility: Physicians, Not Patients, Call The Shots, Charles Weijer

Charles Weijer

No abstract provided.

The Analysis Of Risks And Potential Benefits In Research, Charles Weijer

Charles Weijer

No abstract provided.

Integrating Bioethics And Health Law Into The Canadian Institutes Of Health Research, Susan Sherwin, FrançOise Baylis, Alan Bernstein, Timothy Caulfield, Bernard Dickens, Jocelyn Downie, Bartha Knoppers, ThéRèSe Leroux, Neil Macdonald, Michael Mcdonald, Janet Storch, Charles Weijer

Charles Weijer

No abstract provided.