Arts and Humanities Commons^™

Minimal Risk Remains An Open Question, Ariella Binik, Charles Weijer, Mark Sheehan

Charles Weijer

No abstract provided.

Ethics In Conduct Of Trials In Developing Countries, Charles Weijer

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Research Governance Lessons From The National Placebo Initiative, Heather Sampson, Charles Weijer, Daryl Pullman

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

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 …

Trust And Exploitation In Clinical Research, Paul Miller, Charles Weijer

Charles Weijer

This chapter attempts to derive, define, and specify norms governing the relationship between physician-researcher and patient-subject, and to explore their interconnection. It argues that rooting the relationship between physician-researcher and patient-subject in a normative theory of trust is promising. It enables the derivation, definition, and specification of norms governing the relationship and appreciation of their interconnection.

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.

Refuting The Net Risks Test: A Response To Wendler And Miller's "Assessing Research Risks Systematically", Charles Weijer, Paul Miller

Charles Weijer

Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their …

The Return Of Research Results To Participants: Pilot Questionnaire Of Adolescents And Parents Of Children With Cancer, Conrad Fernandez, Darcy Santor, Charles Weijer, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Jun Gao, Eric Kodish

Charles Weijer

PURPOSE: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results.

METHODS: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revised and provided to 30 parents and 10 adolescents in a tertiary care oncology setting.

RESULTS: The content validity index for individual questions and the overall questionnaires scored as 0.86 …

Equipoise And The Duty Of Care In Clinical Research: A Philosophical Response To Our Critics, Paul Miller, Charles Weijer

Charles Weijer

Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that it is wanting in several respects.

Evaluating Benefits And Harms In Clinical Research, Paul Miller, Charles Weijer

Charles Weijer

No abstract provided.

The Balm Of Gilead: Is The Provision Of Treatment To Those Who Seroconvert In Hiv Prevention Trials A Matter Of Moral Obligation Or Moral Negotiation?, Charles Weijer, Guy Leblanc

Charles Weijer

Must treatment be provided to subjects who acquire HIV during the course of a prevention study? An analysis of ethical foundation, regulation, and recent argumentation provides no basis for the obligation. We outline an alternative approach to the problem based on moral negotiation.

Fiduciary Obligation In Clinical Research, Paul Miller, Charles Weijer

Charles Weijer

Heated debate surrounds the question whether the relationship between physician-researcher and patient-subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician-researcher and patient-subject.

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

Charles Weijer

No abstract provided.

Clinical Trials, Charles Weijer

Charles Weijer

No abstract provided.

A Critical History Of Individual And Collective Ethics In The Lineage Of Lellouch And Schwartz, Charles Heilig, Charles Weijer

Charles Weijer

The notions of individual and collective ethics were first explicitly defined in the biostatistical literature in 1971 to motivate a mathematical solution to a posed ethical dilemma. This paper reviews key antecedents to these concepts and traces explicit references to them over time, primarily in the biostatistical literature. Following a historical exposition of these texts, a critical thematic analysis shows the following: the normative force of these concepts has not been adequately argued. Individual and collective ethics do not solve the problem of how to use accumulating data to inform ethical action. The notions of the "individual" and the "collective" …

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.

When Are Research Risks Reasonable In Relation To Anticipated Benefits?, Charles Weijer, Paul Miller

Charles Weijer

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk in research is required. Component analysis provides such a systematic approach.

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

Disclosure Of The Right Of Research Participants To Receive Research Results: An Analysis Of Consent Forms In The Children's Oncology Group, Conrad Fernandez, Eric Kodish, Shaureen Taweel, Susan Shurin, Charles Weijer

Charles Weijer

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group.

METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers.

RESULTS: The authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n …

Therapeutic Obligation In Clinical Research, Charles Weijer, Paul Miller

Charles Weijer

No abstract provided.

The Research Subject As Wage Earner, James Anderson, Charles Weijer

Charles Weijer

The practice of paying research subjects for participating in clinical trials has yet to receive an adequate moral analysis. Dickert and Grady argue for a wage payment model in which research subjects are paid an hourly wage based on that of unskilled laborers. If we accept this approach, what follows? Norms for just working conditions emerge from workplace legislation and political theory. All workers, including paid research subjects under Dickert and Grady's analysis, have a right to at least minimum wage, a standard work week, extra pay for overtime hours, a safe workplace, no fault compensation for work-related injury, and …

Continuing Review Of Clinical Research Canadian-Style, 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 …

Minimal Risk And Its Implications, Charles Weijer

Charles Weijer

No abstract provided.

The Research Subject As Entrepreneur, James Anderson, Charles Weijer

Charles Weijer

No abstract provided.