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Full-Text Articles in Medicine and Health Sciences
Inadequate Reporting Of Research Ethics Review And Informed Consent In Cluster Randomised Trials: Review Of Random Sample Of Published Trials, Monica Taljaard, Andrew Mcrae, Charles Weijer, Carol Bennett, Stephanie Dixon, Julia Taleban, Zoe Skea, Martin P Eccles, Jamie Brehaut, Allan Donner, Raphael Saginur, Robert Boruch, Jeremy Grimshaw
Inadequate Reporting Of Research Ethics Review And Informed Consent In Cluster Randomised Trials: Review Of Random Sample Of Published Trials, Monica Taljaard, Andrew Mcrae, Charles Weijer, Carol Bennett, Stephanie Dixon, Julia Taleban, Zoe Skea, Martin P Eccles, Jamie Brehaut, Allan Donner, Raphael Saginur, Robert Boruch, Jeremy Grimshaw
Charles Weijer
OBJECTIVES: To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices.
DESIGN: Review of a random sample of published cluster randomised trials from an electronic search in Medline.
SETTING: Cluster randomised trials in health research published in English language journals …
Inadequate Reporting Of Research Ethics Review And Informed Consent In Cluster Randomised Trials: Review Of Random Sample Of Published Trials, Monica Taljaard, Andrew Mcrae, Charles Weijer, Carol Bennett, Stephanie Dixon, Julia Taleban, Zoe Skea, Martin P Eccles, Jamie Brehaut, Allan Donner, Raphael Saginur, Robert Boruch, Jeremy Grimshaw
Inadequate Reporting Of Research Ethics Review And Informed Consent In Cluster Randomised Trials: Review Of Random Sample Of Published Trials, Monica Taljaard, Andrew Mcrae, Charles Weijer, Carol Bennett, Stephanie Dixon, Julia Taleban, Zoe Skea, Martin P Eccles, Jamie Brehaut, Allan Donner, Raphael Saginur, Robert Boruch, Jeremy Grimshaw
Stephanie Dixon
OBJECTIVES: To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices. DESIGN: Review of a random sample of published cluster randomised trials from an electronic search in Medline. SETTING: Cluster randomised trials in health research published in English language journals …
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
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 …
Equipoise And The Duty Of Care In Clinical Research: A Philosophical Response To Our Critics, Paul Miller, Charles Weijer
Equipoise And The Duty Of Care In Clinical Research: A Philosophical Response To Our Critics, Paul Miller, Charles Weijer
Charles Weijer
Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that it is wanting in several respects.
Will The Real Charles Fried Please Stand Up?, Paul Miller, Charles Weijer
Will The Real Charles Fried Please Stand Up?, Paul Miller, Charles Weijer
Charles Weijer
In response to the preceding commentary by Jerry Menikoff in this issue of the Journal, the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by itself does not supplant ill subjects' rights to personalized judgment and care embodied in Fried's equipoise.
Placebo Trials And Tribulations, Charles Weijer
The Ethics Of Placebo-Controlled Trials, Charles Weijer, Kathleen Glass
The Ethics Of Placebo-Controlled Trials, Charles Weijer, Kathleen Glass
Charles Weijer
No abstract provided.
When Argument Fails, Charles Weijer
A Critical Appraisal Of Protections For Aboriginal Communities In Biomedical Research, Charles Weijer, James Anderson
A Critical Appraisal Of Protections For Aboriginal Communities In Biomedical Research, Charles Weijer, James Anderson
Charles Weijer
As scientists target communities for research into the etiology, especially the genetic determinants of common diseases, there have been calls for the protection of communities. This paper identifies the distinct characteristics of aboriginal communities and their implications for research in these communities. It also contends that the framework in the Belmont Report is inadequate in this context and suggests a fourth principle of respect for communities. To explore how such a principle might be specified and operationalized, it reviews existing guidelines for protecting aboriginal communities and points out problems with these guidelines and areas for further work.
Clinical Equipoise And Not The Uncertainty Principle Is The Moral Underpinning Of The Randomised Controlled Trial, Charles Weijer, Stanley Shapiro, Kathleen Glass
Clinical Equipoise And Not The Uncertainty Principle Is The Moral Underpinning Of The Randomised Controlled Trial, Charles Weijer, Stanley Shapiro, Kathleen Glass
Charles Weijer
No abstract provided.
Protecting Communities In Research: Current Guidelines And Limits Of Extrapolation, Charles Weijer, Gary Goldsand, Ezekiel Emanuel
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 …
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
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.
Placebo-Controlled Studies In Schizophrenia: Ethical And Scientific Perspectives. Panel Discussion, T. Lemmens, P. Appelbaum, W. Carpenter, C. Mccarthy, C. Peterson, D. Streiner, Charles Weijer
Placebo-Controlled Studies In Schizophrenia: Ethical And Scientific Perspectives. Panel Discussion, T. Lemmens, P. Appelbaum, W. Carpenter, C. Mccarthy, C. Peterson, D. Streiner, Charles Weijer
Charles Weijer
No abstract provided.
Placebo-Controlled Trials In Schizophrenia: Are They Ethical? Are They Necessary?, Charles Weijer
Placebo-Controlled Trials In Schizophrenia: Are They Ethical? Are They Necessary?, Charles Weijer
Charles Weijer
The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of an active control. Indeed, scrutiny of the most recent argument for the use of placebo controls, 'assay sensitivity', suggests that the …
The Analysis Of Risks And Potential Benefits In Research, Charles Weijer
The Analysis Of Risks And Potential Benefits In Research, Charles Weijer
Charles Weijer
No abstract provided.
The Irb's Role In Assessing The Generalizability Of Non-Nih-Funded Clinical Trials, Charles Weijer
The Irb's Role In Assessing The Generalizability Of Non-Nih-Funded Clinical Trials, Charles Weijer
Charles Weijer
No abstract provided.
Structuring The Review Of Human Genetics Protocols: Gene Localization And Identification Studies, Kathleen Glass, Charles Weijer, Roberta Palmour, Stanley Shapiro, Trudo Lemmens, Karen Lebacqz
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.
[Demarcating Research And Treatment Interventions: A Case Illustration]: Commentary, Benjamin Freedman, Charles Weijer
[Demarcating Research And Treatment Interventions: A Case Illustration]: Commentary, Benjamin Freedman, Charles Weijer
Charles Weijer
No abstract provided.