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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.

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 …

Why Should We Include Women And Minorities In Randomized Controlled Trials?, Charles Weijer, R. Crouch

Charles Weijer

No abstract provided.

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 …

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 …

Research Methods And Policies, Charles Weijer

Charles Weijer

No abstract provided.

Do Patients With Breast Cancer Participating In Clinical Trials Receive Better Nursing Care?, Myriam Skrutkowska, Charles Weijer

Charles Weijer

PURPOSE/OBJECTIVES: To examine differences in nursing care received by patients with breast cancer enrolled in clinical trials and those not enrolled in clinical trials.

DESIGN: Retrospective review of clinic charts.

SETTING: Oncology outpatient department of a tertiary-care hospital. SAMPLE: 90 women with early stage breast cancer. The mean age of the women was 53 years. More than half of the women (51 of 90) were treated in a clinical trial.

METHODS: Retrospective chart review of all the nurse-patient clinic encounters for a six-month period from date of cancer diagnosis. The content of each encounter was coded using a modified version …

Selecting Subjects For Participation In Clinical Research: An Empirical Inquiry And Ethical Analysis, Charles Weijer

Charles Weijer

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.

In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other …

Bioethics For Clinicians: 10. Research Ethics, Charles Weijer, Bernard Dickens, Eric Meslin

Charles Weijer

Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must …

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.

Evolving Ethical Issues In Selection Of Subjects For Clinical Research, Charles Weijer

Charles Weijer

Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon the view one has of the world. A person who is naive about medical facts may, for example, interpret …

Placebo Orthodoxy In Clinical Research I: Empirical And Methodological Myths, Benjamin Freedman, Charles Weijer, Kathleen Glass

Charles Weijer

No abstract provided.

Placebo Orthodoxy In Clinical Research Ii: Ethical, Legal, And Regulatory Myths, Benjamin Freedman, Kathleen Glass, Charles Weijer

Charles Weijer

No abstract provided.

Cruel And Unusual Treatment, Carl Elliott, Charles Weijer

Charles Weijer

No abstract provided.

Characterizing The Population In Clinical Trials: Barriers, Comparability, And Implications For Review, Charles Weijer

Charles Weijer

The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus on three empirical questions regarding the generalizability of clinical trials. (1) What proportion of diseased populations are studied in clinical trials? …

The Breast Cancer Research Scandal: Addressing The Issues, Charles Weijer

Charles Weijer

The three claims put forward by Dr. Roger Poisson to rationalize his enrollment of ineligible subjects in clinical trials do not justify research fraud. None the less, certain lessons for the conduct of clinical research can be learned from the affair: experimental therapies should be made available to technically ineligible subjects when no effective therapy exists for their disease; further research must investigate the possible benefits of clinical-trial participation; broadly based, pragmatic trials must be regarded as the ideal model; and each eligibility criterion in a clinical-trial protocol should be justified.

The Duty To Exclude: Excluding People At Undue Risk From Research, Charles Weijer, Abraham Fuks

Charles Weijer

The clinical trial is the major investigational tool of clinical medicine. Two recent reports highlight the fact that the most often quoted mechanisms for the protection of research subjects, viz., research ethics board review and eligibility criteria, are insufficient to achieve this end. In this paper, we argue that the prime mechanism for the protection of persons in clinical trials should be the clinical judgement of the physician-investigator. The clinical investigator has a duty to protect subjects from both harm and undue risk. It is argued that the clinical investigator has a duty to screen for, and exclude, potential research …

In Loco Parentis: Minimal Risk As An Ethical Threshold For Research Upon Children, Benjamin Freedman, Abraham Fuks, Charles Weijer

Charles Weijer

No abstract provided.

Demarcating Research And Treatment: A Systematic Approach For The Analysis Of The Ethics Of Clinical Research, Benjamin Freedman, Abraham Fuks, Charles Weijer

Charles Weijer

No abstract provided.