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 Challenges In Icu Research, Charles Weijer

Charles Weijer

No abstract provided.

U.S. Federal Regulations For Emergency Research: A Practical Guide And Commentary, Andrew Mcrae, Charles Weijer

Charles Weijer

Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB …

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.

Ethical Issues In Palliative Care Research, Neil Macdonald, Charles Weijer

Charles Weijer

No abstract provided.

Continuing Review Of Clinical Research Canadian-Style, Charles Weijer

Charles Weijer

No abstract provided.

Rec Approval, Charles Weijer

Charles Weijer

No abstract provided.

Protecting Human Research Subjects: Case-Based Learning For Canadian Research Ethics Boards And Researchers, Françoise Baylis, A. Ireland, David Kaufman, Charles Weijer

Charles Weijer

No abstract provided.

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? …