Arts and Humanities Commons^™

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 …

Heads Or Tails: Randomized Placebo-Controlled Trials, Charles Weijer

Charles Weijer

No abstract provided.

The Quest For Legitimacy: Comment On Cox Macpherson's 'To Strengthen Consensus, Consult The Stakeholders', 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.

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 …

Placebo Trials And Tribulations, Charles Weijer

Charles Weijer

No abstract provided.

I Need A Placebo Like I Need A Hole In The Head, Charles Weijer

Charles Weijer

No abstract provided.

When Argument Fails, Charles Weijer

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

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.

The Future Of Research Into Rotavirus Vaccine, Charles Weijer

Charles Weijer

No abstract provided.

Clinical Equipoise And Rct Design, Charles Weijer

Charles Weijer

This presentation addresses these questions:
• “Upon what ethical grounds may the physician offer RCT enrollment to a patient?”
• Which is the preferred moral basis of the RCT?

Ethical Challenges Of The Randomized Controlled Trial, Charles Weijer

Charles Weijer

No abstract provided.

Why Should We Include Women And Minorities In Randomized Controlled Trials?, Charles Weijer, R. Crouch

Charles Weijer

No abstract provided.

Assessing The Interpretation Of Criteria For Clinical Trial Eligibility: A Survey Of Oncology Investigators, Charles Weijer, Benjamin Freedman, Stanley Shapiro, Abraham Fuks, Myriam Skrutkowska, Maria Sigurjonsdottir

Charles Weijer

OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty.

DESIGN: Survey questionnaire.

PARTICIPANTS: Cancer investigators from the United States and Canada.

INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they would enrol the patient in a trial and how sure they were of this decision. Demographic characteristics of the investigators …

The Breast Cancer Research Scandal: Addressing The Issues, Charles Weijer

Charles Weijer

The three claims put forward by Dr. Roger Poisson to rationalize his enrollment of ineligible subjects in clinical trials do not justify research fraud. None the less, certain lessons for the conduct of clinical research can be learned from the affair: experimental therapies should be made available to technically ineligible subjects when no effective therapy exists for their disease; further research must investigate the possible benefits of clinical-trial participation; broadly based, pragmatic trials must be regarded as the ideal model; and each eligibility criterion in a clinical-trial protocol should be justified.