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Full-Text Articles in Arts and Humanities
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
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
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 …
Research Governance Lessons From The National Placebo Initiative, Heather Sampson, Charles Weijer, Daryl Pullman
Research Governance Lessons From The National Placebo Initiative, Heather Sampson, Charles Weijer, Daryl Pullman
Charles Weijer
No abstract provided.
Heads Or Tails: Randomized Placebo-Controlled Trials, Charles Weijer
Heads Or Tails: Randomized Placebo-Controlled Trials, Charles Weijer
Charles Weijer
No abstract provided.
When Are Research Risks Reasonable In Relation To Anticipated Benefits?, Charles Weijer, Paul Miller
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 Ethics Of Placebo-Controlled Trials, Charles Weijer
The Ethics Of Placebo-Controlled Trials, Charles Weijer
Charles Weijer
No abstract provided.
Rehabilitating Equipoise, Paul Miller, Charles Weijer
Rehabilitating Equipoise, Paul Miller, Charles Weijer
Charles Weijer
When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood …
Is The Use Of Placebo Controls Ethically Permissible In Clinical Trials Of Agents Intended To Reduce Fractures In Osteoporosis?, Baruch Brody, Nancy Dickey, Susan Ellenberg, Robert Heaney, Robert Levine, Richard O'Brien, Ruth Purtilo, Charles Weijer
Is The Use Of Placebo Controls Ethically Permissible In Clinical Trials Of Agents Intended To Reduce Fractures In Osteoporosis?, Baruch Brody, Nancy Dickey, Susan Ellenberg, Robert Heaney, Robert Levine, Richard O'Brien, Ruth Purtilo, Charles Weijer
Charles Weijer
Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. …
Placebo Tribulations, Charles Weijer
Placebo Trials And Tribulations, Charles Weijer
I Need A Placebo Like I Need A Hole In The Head, Charles Weijer
I Need A Placebo Like I Need A Hole In The Head, Charles Weijer
Charles Weijer
No abstract provided.
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
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 …
Consensus-Seeking Roundtable On Placebos In Clinical Research, Charles Weijer
Consensus-Seeking Roundtable On Placebos In Clinical Research, Charles Weijer
Charles Weijer
No abstract provided.
Reb Review Of Research Proposals Involving Placebo Controls, Charles Weijer
Reb Review Of Research Proposals Involving Placebo Controls, Charles Weijer
Charles Weijer
No abstract provided.
The Placebo Effect, Charles Weijer
Ccnp Position Paper On The Use Of Placebos In Psychiatry, William Friend, Charles Weijer
Ccnp Position Paper On The Use Of Placebos In Psychiatry, William Friend, Charles Weijer
Charles Weijer
No abstract provided.
Placebo Controls Are Not Good Science, Charles Weijer
Placebo Controls Are Not Good Science, Charles Weijer
Charles Weijer
No abstract provided.
Down With Placebolatry, Charles Weijer, Carl Elliott
Down With Placebolatry, Charles Weijer, Carl Elliott
Charles Weijer
No abstract provided.
Placebo Orthodoxy In Clinical Research I: Empirical And Methodological Myths, Benjamin Freedman, Charles Weijer, Kathleen Glass
Placebo Orthodoxy In Clinical Research I: Empirical And Methodological Myths, Benjamin Freedman, Charles Weijer, Kathleen Glass
Charles Weijer
No abstract provided.
Placebo Orthodoxy In Clinical Research Ii: Ethical, Legal, And Regulatory Myths, Benjamin Freedman, Kathleen Glass, Charles Weijer
Placebo Orthodoxy In Clinical Research Ii: Ethical, Legal, And Regulatory Myths, Benjamin Freedman, Kathleen Glass, Charles Weijer
Charles Weijer
No abstract provided.