Arts and Humanities Commons^™

Ethical Issues Associated With The Introduction Of New Surgical Devices, Or Just Because We Can, Doesn’T Mean We Should, Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry Mcmillan, Joyce Schachter, Chander Gupta, Charles Weijer

Charles Weijer

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate …

Ethics And Schizophrenia, A. Rudnick, 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 …

Ethics Of Surgical Training In Developing Countries, Kevin Ramsey, Charles Weijer

Charles Weijer

The practice of surgical trainees operating in developing countries is gaining interest in the medical community. Although there has been little analysis about the ethical impact of these electives, there has been some concerns raised over the possible exploitation of trainees and their patients. An ethical review of this practice shows that care needs to be taken to prevent harm. Inexperienced surgeons learning surgical skills in developing countries engender greater risk of violating basic ethical principles. Advanced surgical trainees who have already achieved surgical competence are best qualified to satisfy these ethical issues. All training programs need to develop a …

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

Charles Weijer

No abstract provided.

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.

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.

Obligations In Offering To Disclose Genetic Research Results, Conrad Fernandez, Charles Weijer

Charles Weijer

No abstract provided.

Trust-Based Obligations Of The State And Physician-Researchers To Patient-Subjects, Paul Miller, Charles Weijer

Charles Weijer

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial …

Revisiting The Ethics Of Hiv Prevention Research In Developing Countries, Charles Weijer, Guy Leblanc

Charles Weijer

Issues: We present key aspects of our paper, commissioned by UNAIDS in 2005, entitled, “Revisiting the ethics of HIV prevention research in developing countries.” In 2004 and 2005 we witnessed the closure or suspension of three international clinical trials testing tenofovir in the prevention of HIV infection in high risk groups due to the failure to provide free treatment to those who seroconvert during the conduct of the study. We examine critically moral claims for the provision of treatment to those who seroconvert in HIV prevention trials and ask whether it is a matter of moral obligation or moral negotiation? …

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.

Risk In Emergency Research Using A Waiver Of/Exception From Consent: Implications Of A Structured Approach For Institutional Review Board Review, Andrew Mcrae, Stacy Ackroyd-Stolarz, Charles Weijer

Charles Weijer

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold.

METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent published between July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study …

Meaningful Work As Due Inducement, Charles Weijer

Charles Weijer

No abstract provided.

Disclosure Of Research Result To Research Participants: Needs And Attitudes Of Adolescents And Parents, Conrad Fernandez, Shaureen Taweel, Eric Kodish, Charles Weijer

Charles Weijer

BACKGROUND: Researchers have a moral responsibility to offer to return research results to participants, but the needs and attitudes of parents and adolescents with cancer in paediatric oncology regarding the issue are relatively unknown.

OBJECTIVES: To explore the needs of potential research participants or their guardians with respect to the offer of a return of research results. METHODS: A questionnaire was used in a focus group and in telephone interviews with eight adolescents and 12 parents of children with cancer. The participants were asked to respond to the questions and to comment on the inclusiveness of the questionnaire.

RESULTS: The …

A Death In The Family: Reflections On The Terri Schiavo Case, Charles Weijer

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Protecting Communities In Research: From A New Principle To Rational Protections, Ezekiel Emanuel, Charles Weijer

Charles Weijer

No abstract provided.

Clinical Trials, Charles Weijer

Charles Weijer

No abstract provided.

Evaluating Risks Of Non-Therapeutic Research In Children, Paul Miller, 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.

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

Charles Weijer

No abstract provided.

The Ethical Analysis Of Risk In Intensive Care Unit Research, Charles Weijer

Charles Weijer

Research in the intensive care unit (ICU) is commonly thought to pose 'serious risk' to study participants. This perception may be at the root of a variety of impediments to the conduct of clinical trials in the ICU setting. Component analysis offers a promising approach to the ethical analysis of ICU research. Because clinical trials commonly involve a mixture of study interventions, therapeutic and nontherapeutic procedures must be analyzed separately. Therapeutic procedures must meet the requirement of clinical equipoise. Risks associated with nontherapeutic procedures must be minimized consistent with sound scientific design, and be deemed reasonable in relation to the …