Arts and Humanities Commons^™

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 …

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.

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.

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 …

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

Offering To Return Results To Research Participants: Attitudes And Needs Of Principal Investigators In The Children's Oncology Group, Conrad Fernandez, Eric Kodish, Susan Shurin, Charles Weijer

Charles Weijer

PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants.

METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs.

RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the …

Therapeutic Obligation In Clinical Research, Charles Weijer, Paul Miller

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Community Consent For Genetic Research, Charles Weijer

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 …

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.

Rec Approval, Charles Weijer

Charles Weijer

No abstract provided.

The Research Subject As Entrepreneur, James Anderson, Charles Weijer

Charles Weijer

No abstract provided.

Reporting The Study Populations Of Clinical Trials. Clear Transmission Or Static On The Line?, Stanley Shapiro, Charles Weijer, Benjamin Freedman

Charles Weijer

In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories …

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

Charles Weijer

No abstract provided.

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 …

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?

Another Tuskegee?, Charles Weijer

Charles Weijer

No abstract provided.

Placebo-Controlled Studies In Schizophrenia: Ethical And Scientific Perspectives. Panel Discussion, T. Lemmens, P. Appelbaum, W. Carpenter, C. Mccarthy, C. Peterson, D. Streiner, Charles Weijer

Charles Weijer

No abstract provided.

Placebo-Controlled Trials In Schizophrenia: Are They Ethical? Are They Necessary?, Charles Weijer

Charles Weijer

The current controversy as to the proper role of the placebo control in the evaluation of new treatments for schizophrenia requires an analysis that is sensitive to both ethical and scientific issues. Clinical equipoise, widely regarded as the moral foundation of the randomized controlled trial (RCT), requires the use of best available treatment as the control in RCT. Scientific criticisms of the use of an active control are examined and none present an insuperable barrier to the use of an active control. Indeed, scrutiny of the most recent argument for the use of placebo controls, 'assay sensitivity', suggests that the …

Protecting Human Research Subjects: Case-Based Learning For Canadian Research Ethics Boards And Researchers, Françoise Baylis, A. Ireland, David Kaufman, Charles Weijer

Charles Weijer

No abstract provided.

Bioethics For Clinicians: 16. Dealing With Demands For Inappropriate Treatment, Charles Weijer, Peter Singer, Bernard Dickens, Stephen Workman

Charles Weijer

Demands by Patients or their Families for treatment thought to be inappropriate by health care providers constitute an important set of moral problems in clinical practice. A variety of approaches to such cases have been described in the literature, including medical futility, standard of care and negotiation. Medical futility fails because it confounds morally distinct cases: demand for an ineffective treatment and demand for an effective treatment that supports a controversial end (e.g., permanent unconsciousness). Medical futility is not necessary in the first case and is harmful in the second. Ineffective treatment falls outside the standard of care, and thus …

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 …