Medicine and Health Sciences Commons^™

Caritas In Communion: Theological Foundations Of Catholic Health Care, M. Lysaught

M. Therese Lysaught

No abstract provided.

Researchers’ Perceptions Of Ethical Challenges In Cluster Randomized Trials: A Qualitative Analysis, Andrew Mcrae, Carol Bennett, Judith Belle Brown, Charles Weijer, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Allan Donner, Martin Eccles, Jeremy Grimshaw, Merrick Zwarenstein, Monica Taljaard

Charles Weijer

Background

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.

Methods

Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.

Results

Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to …

Eight Is Enough?: The Ethics Of The California Octuplets Case, Scott Paeth

Scott R. Paeth

The recent California octuplets case raises a number of important issues that need to be addressed in the context of the increasingly widespread practice of in vitro fertilization. This paper explores some of those issues as looked at from the perspective of protestant theological ethics and public theology, examining the moral responsibilities of the various participants in the process, both before and after the octuplets’ birth, including the mother, her doctors, the health care bureaucracy, the wider society, and the media. Each of these participants failed in significant respects to consider the ethical implications of the births in this complicated …

Ethical Issues Posed By Cluster Randomized Trials In Health Research, Charles Weijer, Jeremy Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein

Charles Weijer

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. …

Of Mice But Not Men: Problems Of The Randomized Clinical Trial, Samuel Hellman, Deborah Hellman

Deborah Hellman

No abstract provided.

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?

Ethical Challenges In Icu Research, Charles Weijer

Charles Weijer

No abstract provided.

When Can Physicians Say “No” To Families And Patients?, Charles Weijer

Charles Weijer

No abstract provided.

How Experience Confronts Ethics, Barry Hoffmaster, Cliff Hooker

C. Barry Hoffmaster

Analytic moral philosophy's strong divide between empirical and normative restricts facts to providing information for the application of norms and does not allow them to confront or challenge norms. So any genuine attempt to incorporate experience and empirical research into bioethics--to give the empirical more than the status of mere 'descriptive ethics'--must make a sharp break with the kind of analytic moral philosophy that has dominated contemporary bioethics. Examples from bioethics and science are used to illustrate the problems with the method of application that philosophically prevails in both domains and with the conception of rationality that underlies this method. …

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

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 …

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

Charles Weijer

No abstract provided.

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? …

What Does Vulnerability Mean?, Barry Hoffmaster

C. Barry Hoffmaster

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" …

Respect: Or, How Respect For Persons Became Respect For Autonomy, M. Therese Lysaught

M. Therese Lysaught

This article provides an intellectual archeology of how the term “respect” has functioned in the field of bioethics. I argue that over time the function of the term has shifted, with a significant turning point occurring in 1979. Prior to 1979, the term “respect” connoted primarily the notion of “respect for persons” which functioned as an umbrella which conferred protection to autonomous persons and those with compromised autonomy. But in 1979, with the First Edition of Principles of Biomedical Ethics by Beauchamp and Childress, and the report of the Ethical Advisory Board (EAB) of the (then) Department of Health, Education, …

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

Charles Weijer

No abstract provided.

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

Charles Weijer

No abstract provided.

Attitudes Regarding Organ Donation From Non-Heart-Beating Donors, Sean Keenan, Barry Hoffmaster, Frank Rutledge, Jeannette Eberhard, Liddy Chen, William Sibbald

C. Barry Hoffmaster

PURPOSE: To determine the attitudes toward organ donation from non-heart-beating cadaver donors in a sample of the general public and health care workers.

MATERIALS AND METHODS: A moderator-administered questionnaire was completed by members of the general public, recruited randomly from a professional consumer research group's database, and health care workers recruited from the same database, family practice clinics, and local hospitals. Two primary scenarios were tested: (1) patient in coma, not going to survive intensive care unit (ICU), and (2) patient lapsing in and out of consciousness, lifetime institutional care.

RESULTS: Sixty members of the general public and 68 health …

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.

Trial By Error, Charles Weijer

Charles Weijer

No abstract provided.

Family Duty Is More Important Than Rights, Charles Weijer

Charles Weijer

No abstract provided.

Expensive Medical Technologies And “Indication Extrapolation”: The Case Of Implantable Cardioverter-Defibrillators, Christopher Simpson, George Klein, Barry Hoffmaster

C. Barry Hoffmaster

No abstract provided.

Protecting Communities In Biomedical Research, Charles Weijer, E. Emanuel

Charles Weijer

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its …

The Sum Of My Parts, 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.

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?