Arts and Humanities Commons^™

Minimal Risk And Large-Scale Biobank And Cohort Research, Timothy Caulfield, Charles Weijer

Charles Weijer

No abstract provided.

Helsinki Discords: Fda, Ethics, And International Drug Trials, Jonathan Kimmelman, Charles Weijer, Eric Meslin

Charles Weijer

No abstract provided.

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 …

Evaluating Benefits And Harms In Intensive Care Research, Charles Weijer, Paul Miller

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Waiver Of Consent For Emergency Research, Andrew Mcrae, 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.

The Ethics Of Placebo-Controlled Trials, Charles Weijer

Charles Weijer

No abstract provided.

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. …

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

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.

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.

Continuing Review Of Research Approved By Canadian Research Ethics Boards, Charles Weijer

Charles Weijer

No abstract provided.

The Ethics Wars: Disputes Over International Research, Charles Weijer, James Anderson

Charles Weijer

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.

The Research Subject As Entrepreneur, James Anderson, Charles Weijer

Charles Weijer

No abstract provided.

The Ethical Analysis Of Risk, Charles Weijer

Charles Weijer

No abstract provided.

Moral Solutions In Assessing Research Risk, Paul Miller, 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 …

The Ethical Analysis Of Risks And Potential Benefits In Human Subjects Research: History, Theory, And Implications For U.S. Regulation, Charles Weijer

Charles Weijer

This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research:

1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)?
2. What conceptual framework should guide the ethical analysis of risk?
3. What changes to U.S. regulations would the implementation of such a framework require?

What's The Price Of A Research Subject?, Charles Weijer

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

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?

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.

The Irb's Role In Assessing The Generalizability Of Non-Nih-Funded Clinical Trials, Charles Weijer

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 Human Radiation Experiments: Final Report Of The Advisory Committee On Human Radiation Experiments, 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.