Arts and Humanities Commons^™

Reporting Of Patient Consent In Healthcare Cluster Randomised Trials Is Associated With The Type Of Study Interventions And Publication Characteristics, Andrew Mcrae, Monica Taljaard, Charles Weijer, Carol Bennett, Zoe Skea, Robert Boruch, Jamie Brehaut, Martin Eccles, Jeremy Grimshaw, Allan Donner

Charles Weijer

Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials.

Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication.

Results 82 (53.8%) of 160 studies reported obtaining …

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 …

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. …

Decision-Making By Adolescents And Parents Of Children With Cancer Regarding Health Research Participation, Kate Read, Conrad Fernandez, Jun Gao, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Raymond Barfield, Justin Baker, Darcy Santor, Charles Weijer, Eric Kodish

Charles Weijer

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer.

Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their …

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 …

Introduction, Oonagh Corrigan, John Mcmillan, Charles Weijer

Charles Weijer

This introductory chapter begins with a brief explanation of the impetus behind the book as well as its objectives. It then discusses the history of consent and the challenges for informed consent. An overview of the subsequent chapters is presented.

The Limits Of Consent: A Socio-Ethical Approach To Human Subject Research In Medicine, Oonagh Corrigan, John Mcmillan, Kathleen Liddell, Martin Richards, Charles Weijer

Charles Weijer

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy …

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 …

Is Clinical Research And Ethics A Zero-Sum Game?, Charles Weijer

Charles Weijer

No abstract provided.

Waiver Of Consent For Emergency Research, Andrew Mcrae, Charles Weijer

Charles Weijer

No abstract provided.

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.

Importance Of Informed Consent In Offering To Return Research Results To Research Participants, Conrad Fernandez, Eric Kodish, Charles Weijer

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Community Consent For Genetic Research, 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.

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.

Informing Patients Of Uncertainty In Clinical Trials, S. Halpern, J. Karlawish, Charles Weijer

Charles Weijer

No abstract provided.

Family Duty Is More Important Than Rights, Charles Weijer

Charles Weijer

No abstract provided.

Benefit-Sharing And Other Protections For Communities In Genetic Research, 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 …

Thinking Clearly About Research Risk: Implications Of The Work Of Benjamin Freedman, Charles Weijer

Charles Weijer

No abstract provided.

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 …

Protecting Communities In Research: Philosophical And Pragmatic Challenges, Charles Weijer

Charles Weijer

The issue of the protection of communities in clinical research first arose 10 years ago in studies conducted in technologically developing countries by scientists from technologically developed nations. The question was, which ethical standards ought to apply, those of the Western investigators or local standards?

Another Tuskegee?, Charles Weijer

Charles Weijer

No abstract provided.

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.

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.

Research Methods And Policies, 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

Charles Weijer

No abstract provided.

Placebo Orthodoxy In Clinical Research Ii: Ethical, Legal, And Regulatory Myths, Benjamin Freedman, Kathleen Glass, Charles Weijer

Charles Weijer

No abstract provided.