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 Considerations In The Conduct Of Vaccine Trials In Developing Countries, Charles Weijer, C. Lanata, C. Plowe

Charles Weijer

No abstract provided.

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 …

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 …

Revisiting Equipoise: A Response To Gifford, Paul Miller, Charles Weijer

Charles Weijer

The authors respond to objections Fred Gifford has raised against their paper "Rehabilitating Equipoise." They situate this exchange in the wider context of recent debate over equipoise, highlighting substantial points of agreement between themselves and Gifford. The authors offer a brief restatement of "Rehabilitating Equipoise" in which they amplify some of its core arguments. They then assess Gifford's objections. Finding each to be unfounded, they argue that there is no justification for "pulling the plug" on clinical equipoise.

Clinical Trials, Charles Weijer

Charles Weijer

No abstract provided.

Continuing Review Of Clinical Research Canadian-Style, Charles Weijer

Charles Weijer

No abstract provided.

Ethical Challenges Of The Randomized Controlled Trial, Charles Weijer

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Down With Placebolatry, Charles Weijer, Carl Elliott

Charles Weijer

No abstract provided.

Do The Right Thing, Charles Weijer

Charles Weijer

McGill ethicists help ensure that medical research conforms to the highest scientific and ethical standards.

Characterizing The Population In Clinical Trials: Barriers, Comparability, And Implications For Review, Charles Weijer

Charles Weijer

The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus on three empirical questions regarding the generalizability of clinical trials. (1) What proportion of diseased populations are studied in clinical trials? …

The Revolution In Clinical Trials: From Burden To Benefit And Back Again, Charles Weijer

Charles Weijer

No abstract provided.