Arts and Humanities Commons^™

Ethics, Economics And The Regulation And Adoption Of New Medical Devices: Case Studies In Pelvic Floor Surgery, Sue Ross, Charles Weijer, Amiram Gafni, Ariel Ducey, Carmen Thompson, Rene Lafreniere

Charles Weijer

BACKGROUND: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.

METHODS/DESIGN: Our study involves three linked case studies using, as examples, selected pelvic …

Conceptual Problems In Research Ethics, Charles Weijer

Charles Weijer

This poster addresses these issues:
• What good is medical research?
• What is owed to the study subject?
• When is research risk acceptable?
• How should we conduct research in developing countries?
• How should we conduct research involving communities?

Decision-Making By Adolescents And Parents Of Children With Cancer Regarding Health Research Participation, Kate Read, Conrad Fernandez, Jun Gao, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Raymond Barfield, Justin Baker, Darcy Santor, Charles Weijer, Eric Kodish

Charles Weijer

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer.

Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their …

Providing Research Results To Participants: Attitudes And Needs Of Adolescents And Parents Of Children With Cancer, Conrad Fernandez, Jun Gao, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Raymond Barfield, Justin Baker, Darcy Santor, Charles Weijer, Eric Kodish

Charles Weijer

PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants.

METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the results; reasons for and against providing results; and barriers to providing results.

RESULTS: Four hundred nine parents (including 19 of deceased children) and 86 …

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

Charles Weijer

No abstract provided.

A Comparison Of Journal Instructions Regarding Institutional Review Board Approval And Conflict-Of-Interest Disclosure Between 1995 And 2005, Anne Rowan-Legg, Charles Weijer, J. Gao, C. Fernandez

Charles Weijer

OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure.

DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers.

RESULTS: During the period, the proportion of journals requiring IRB approval increased from 42% (95% CI 32.2% to 51.2%, p<0.001) to 76% (95% CI 66.4% to 83.1%, p<0.001). In 2005, an additional 9% referred to the Declaration of Helsinki or the International Committee of Medical Journal Editors' Uniform requirements for ethical guidelines; 15% (95% CI 8.5% to 22.5%, p<0.01) provided ambiguous or no requirements. The proportion of journals requiring COI disclosure increased from 75% (95% CI 66.6% to 83.3%, p<0.05) to 94% (95% CI 89.4% to 98.6%, p<0.05); 41% had comprehensive requirements, while some addressed only funding source (6%), were vague (10%) or both (14%). Criteria for authorship rose from 40% (95% CI 30.5% to 49.5%, p<0.05) to 72% (95% CI 63.3% to 80.7%, p<0.05). Journals with higher impact factors were more likely to require IRB approval (p<0.01). Journals in anaesthesia and radiology all required IRB approval; requirements in other disciplines varied.

CONCLUSIONS: Instructions to authors regarding ethical standards have improved. Some remain incomplete, especially regarding the scope of …

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 …

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

Charles Weijer

No abstract provided.

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.

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 …

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.

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 …

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 …

Bioethics In Social Context, Edited By Barry Hoffmaster, Charles Weijer

Charles Weijer

No abstract provided.

Community Consent For Genetic Research, Charles Weijer

Charles Weijer

No abstract provided.

Unethical Author Attribution, Charles Weijer, Akira Akabayashi

Charles Weijer

I am an M.D/Ph.D. student and work as a research assistant for the director of a division of the school of medicine who is an M.D. He assigned me to research a certain topic and gave me no guidelines or guidance as to how to do it. Nevertheless, I did the research and wrote it up. My supervisor liked the report and said that he thought it was so good that “I would like to offer you the opportunity to publish it and list you as the primary author.” Some bells went off when he so grandly offered to let …

Matters Of Life And Death: Making Moral Theory Work In Medical Ethics And The Law, James Anderson, Charles Weijer

Charles Weijer

No abstract provided.

Continuing Review Of Clinical Research Canadian-Style, Charles Weijer

Charles Weijer

No abstract provided.

Who Should Foot The Bill For Continuing Review Of Research?, Charles Weijer

Charles Weijer

No abstract provided.

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.

Rec Approval, Charles Weijer

Charles Weijer

No abstract provided.

Benefit-Sharing And Other Protections For Communities In Genetic Research, Charles Weijer

Charles Weijer

No abstract provided.

A Philosophical Disease: Bioethics, Culture, And Identity, Charles Weijer

Charles Weijer

No abstract provided.

Bioethics: An Anthology, 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?

Protecting Communities In Research: Current Guidelines And Limits Of Extrapolation, Charles Weijer, Gary Goldsand, Ezekiel Emanuel

Charles Weijer

As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto …

Another Tuskegee?, Charles Weijer

Charles Weijer

No abstract provided.