Arts and Humanities Commons^™

Does Clinical Equipoise Apply To Cluster Randomized Trials In Health Research?, Ariella Binik, Charles Weijer, Andrew Mcrae, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Raphael Saginur, Monica Taljaard, Merrick Zwarenstein

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, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have …

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. …

Ethical And Policy Issues In Cluster Randomized Trials: Rationale And Design Of A Mixed Methods Research Study, Monica Taljaard, Charles Weijer, Jeremy Grimshaw, Judith Brown, Ariella Binik, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Martin Eccles, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein, Allan Donner

Charles Weijer

Background: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main …

Minimal Risk And Large-Scale Biobank And Cohort Research, Timothy Caulfield, Charles Weijer

Charles Weijer

No abstract provided.

Ethical Issues Associated With The Introduction Of New Surgical Devices, Or Just Because We Can, Doesn’T Mean We Should, Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry Mcmillan, Joyce Schachter, Chander Gupta, Charles Weijer

Charles Weijer

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate …

Ethics Of Surgical Training In Developing Countries, Kevin Ramsey, Charles Weijer

Charles Weijer

The practice of surgical trainees operating in developing countries is gaining interest in the medical community. Although there has been little analysis about the ethical impact of these electives, there has been some concerns raised over the possible exploitation of trainees and their patients. An ethical review of this practice shows that care needs to be taken to prevent harm. Inexperienced surgeons learning surgical skills in developing countries engender greater risk of violating basic ethical principles. Advanced surgical trainees who have already achieved surgical competence are best qualified to satisfy these ethical issues. All training programs need to develop a …

Evaluating Benefits And Harms In Intensive Care Research, Charles Weijer, Paul Miller

Charles Weijer

No abstract provided.

Refuting The Net Risks Test: A Response To Wendler And Miller's "Assessing Research Risks Systematically", Charles Weijer, Paul Miller

Charles Weijer

Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their …

Politics, Risk, And Community In The Maya Icbg Case, Fern Brunger, Charles Weijer

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Risk In Emergency Research Using A Waiver Of/Exception From Consent: Implications Of A Structured Approach For Institutional Review Board Review, Andrew Mcrae, Stacy Ackroyd-Stolarz, Charles Weijer

Charles Weijer

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold.

METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study …

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

Charles Weijer

No abstract provided.

When Are Research Risks Reasonable In Relation To Anticipated Benefits?, Charles Weijer, Paul Miller

Charles Weijer

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk in research is required. Component analysis provides such a systematic approach.

The Ethical Analysis Of Risk In Intensive Care Unit Research, Charles Weijer

Charles Weijer

Research in the intensive care unit (ICU) is commonly thought to pose 'serious risk' to study participants. This perception may be at the root of a variety of impediments to the conduct of clinical trials in the ICU setting. Component analysis offers a promising approach to the ethical analysis of ICU research. Because clinical trials commonly involve a mixture of study interventions, therapeutic and nontherapeutic procedures must be analyzed separately. Therapeutic procedures must meet the requirement of clinical equipoise. Risks associated with nontherapeutic procedures must be minimized consistent with sound scientific design, and be deemed reasonable in relation to the …

Informing Study Participants Of Research Results: An Ethical Imperative, Conrad Fernandez, Eric Kodish, Charles Weijer

Charles Weijer

No abstract provided.

Lessons From Everyday Lives: A Moral Justification For Acute Care Research, Andrew Mcrae, Charles Weijer

Charles Weijer

Progress in emergency and critical care requires that clinical research be performed on patients who are incapable of granting consent for research participation. Analyses of the ethics of such research have left some questions incompletely answered. Why should we be permitted to expose vulnerable patients to research risks without their consent? In particular, how do we justify research interventions that have no potential benefit for participants (nontherapeutic interventions)? This article presents a moral justification for nontherapeutic interventions in emergency research. By relying on a framework for assessing research risks, and by drawing on the example of pediatric research, this justification …

I Need A Placebo Like I Need A Hole In The Head, Charles Weijer

Charles Weijer

No abstract provided.

When Argument Fails, Charles Weijer

Charles Weijer

No abstract provided.

Minimal Risk And Its Implications, Charles Weijer

Charles Weijer

No abstract provided.

The Ethical Analysis Of Risk, Charles Weijer

Charles Weijer

No abstract provided.

Moral Solutions In Assessing Research Risk, Paul Miller, 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?

Structuring The Review Of Human Genetics Protocols Part-Iii: Gene Therapy Studies, Kathleen Glass, Charles Weijer, Denis Cournoyer, Trudo Lemmens, Roberta Palmour, Stanley Shapiro, Benjamin Freedman

Charles Weijer

No abstract provided.

Why Should We Include Women And Minorities In Randomized Controlled Trials?, Charles Weijer, R. Crouch

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Monitoring Informed Consent In An Oncology Study Posing Serious Risk To Subjects, Myrian Skrutkowski, Charles Weijer, Stan Shapiro, Abraham Fuks, Adrian Langleben, Benjamin Freedman

Charles Weijer

No abstract provided.

The Irb's Role In Assessing The Generalizability Of Non-Nih-Funded Clinical Trials, Charles Weijer

Charles Weijer

No abstract provided.

Cardiopulmonary Resuscitation For Patients In A Persistent Vegetative State: Futile Or Acceptable?, Charles Weijer

Charles Weijer

No abstract provided.

Bioethics For Clinicians: 10. Research Ethics, Charles Weijer, Bernard Dickens, Eric Meslin

Charles Weijer

Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must …

Structuring The Review Of Human Genetics Protocols: Gene Localization And Identification Studies, Kathleen Glass, Charles Weijer, Roberta Palmour, Stanley Shapiro, Trudo Lemmens, Karen Lebacqz

Charles Weijer

No abstract provided.