Medicine and Health Sciences Commons^™

Law And Social Change: Bioethics: 2001, Richard Haigh

Richard Haigh

Course number 2750C

Infertility And Moral Luck: The Politics Of Women Blaming Themselves For Infertility, Carolyn Mcleod, Julie Ponesse

Julie E Ponesse

Infertility can be an agonizing experience, especially for women. And, much of the agony has to do with luck: with how unlucky one is in being infertile, and in how much luck is involved in determining whether one can weather the storm of infertility and perhaps have a child in the end. We argue that bad luck associated with being infertile is often bad moral luck for women. The infertile woman often blames herself or is blamed by others for what is happening to her, even when she cannot control or prevent what is happening to her. She has simply …

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

M. Therese Lysaught

No abstract provided.

Ethical Challenges In Rheumatology: A Survey Of The American College Of Rheumatology Membership, Michele Meltzer

Michele Meltzer

Abstract Objective Despite the frequency of ethical issues arising in patient care, ethical discourse in the rheumatology literature is negligible. To better understand the scope of ethical problems occurring in our specialty, the American College of Rheumatology (ACR) Committee on Ethics and Conflict of Interest surveyed ACR members. Specific objectives of the survey were 1) to learn the perceived frequency of ethical issues in rheumatology, 2) to identify activities that pose ethical problems in rheumatologic practice, 3) to determine the extent of education on, and self-perceived knowledge about, ethics among ACR members, and 4) to determine member interest in, and …

Expanding Disease Definitions In Guidelines And Expert Panel Ties To Industry: A Cross-Sectional Study Of Common Conditions In The United State, Ray Moynihan, Georga Cooke, Jenny Doust, Lisa Bero, Suzanne Hill, Paul Glasziou

Jenny Doust

Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members' industry ties.

Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel

Diane Hoffmann

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.

Moral Gridlock: Conceptual Barriers To No-Fault Compensation For Injured Research Subjects, Leslie Henry

Leslie Meltzer Henry

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the …

Revising The Common Rule: Prospects And Challenges, Leslie Henry

Leslie Meltzer Henry

The annual Bioethics and Law Roundtable, jointly sponsored by the Law & Health Care Program at the University of Maryland Francis King Carey School of Law and the Johns Hopkins Berman Institute of Bioethics, convened in April 2012 to address "Human Subjects Research Regulations: Proposals for Reform." This paper serves as the introduction to the seven papers presented at the symposium that discuss the prospects and challenges of revising the Common Rule.

Reporting Of Patient Consent In Healthcare Cluster Randomised Trials Is Associated With The Type Of Study Interventions And Publication Characteristics, Andrew Mcrae, Monica Taljaard, Charles Weijer, Carol Bennett, Zoe Skea, Robert Boruch, Jamie Brehaut, Martin Eccles, Jeremy Grimshaw, Allan Donner

Charles Weijer

Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials.

Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication.

Results 82 (53.8%) of 160 studies reported obtaining …

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 …

Expanding Disease Definitions In Guidelines And Expert Panel Ties To Industry: A Cross-Sectional Study Of Common Conditions In The United State, Ray Moynihan, Georga Cooke, Jenny Doust, Lisa Bero, Suzanne Hill, Paul Glasziou

Ray Moynihan

Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members' industry ties.

Bioethics Methods In The Ethical, Legal, And Social Implications Of The Human Genome Project Literature, Rebecca Walker, Clair Morrissey

Clair Morrissey

While bioethics as a field has concerned itself with methodological issues since the early years, there has been no systematic examination of how ethics is incorporated into research on the Ethical, Legal and Social Implications (ELSI) of the Human Genome Project. Yet ELSI research may bear a particular burden of investigating and substantiating its methods given public funding, an explicitly cross-disciplinary approach, and the perceived significance of adequate responsiveness to advances in genomics. We undertook a qualitative content analysis of a sample of ELSI publications appearing between 2003 and 2008 with the aim of better understanding the methods, aims, and …

The Ottawa Statement On The Ethical Design And Conduct Of Cluster Randomized Trials, Charles Weijer, Jeremy Grimshaw, Martin Eccles, Andrew Mcrae, Angela White, Jamie Brehaut, Monica Taljaard

Charles Weijer

In cluster randomized trials (CRTs), the units of allocation, intervention, and outcome measurement may differ within a single trial. As a result of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated.

The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs.

A five-year mixed methods research project explored the ethical challenges of CRTs. Empirical studies documented the reporting of ethical issues in published CRTs, interviewed experienced trialists, and surveyed trialists …

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 …

Antenatal Risk Factors, Cytokines And The Development Of Atopic Disease In Early Childhood, Esther Chung, Rachel Miller, Michael Wilson, Stephen Mcgeady, Jennifer Culhane

Esther K. Chung

Atopic diseases are complex entities influenced by an array of risk factors including genetic predisposition, environmental allergens, antenatal exposures, infections and psychosocial factors. One proposed mechanism by which these risk factors contribute to the development of atopic disease is through alterations in the production of T helper type 1 (Th1) and type 2 (Th2) cytokines. The objectives of this review are to discuss antenatal exposures that are associated with pediatric atopic diseases, to discuss the influence of the intrauterine environment on neonatal immune responses, to provide an overview of the Th1 and Th2 pathways and how they relate to atopic …

What Is The Role And Authority Of Gatekeepers In Cluster Randomized Trials In Health Research?, Antonio Gallo, Charles Weijer, Angela White, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard

Charles Weijer

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining …

Neonatal Euthanasia, David Sugarman, Robin Montvilo, Colette Matarese

Robin K Montvilo

An attributional analysis of neonatal euthanasia was undertaken in two studies to compare the responsibility attributions of nursing and non-nursing students (Study 1) and nurses (Study 2) toward a physician for a critically ill neonate's death. In both studies, vignettes about a newborn's death differed with respect to the physician's treatment of the critically ill newborn. In the student study, the physician was attributed the least responsibility for the newborn's death when cardiopulmonary resuscitation was attempted but failed, followed by the physician's issuance of either a "Do Not Resuscitate" order or an order to turn off the infant's respirator. Greatest …

Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns

Maxwell L. Stearns

Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.

Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns

Leslie Meltzer Henry

Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.

Assessing The Motives Of Living, Non-Related Donors, Katrina Bramstedt, Francis Delmonico

Katrina A. Bramstedt

Extract

Cases such as the one described by Dr. Tan are not uncommon at transplant centers in the United States. The Internet and social media tools are now being used to facilitate access to transplantation [1, 2]. Most adults are users of the Internet in some format (e.g., web browsing, e-mail, blogs, Facebook, Twitter), so it is not surprising that it could be a resource for those with end-stage disease seeking an organ donor. Formal websites that attempt to link potential donors and patients include matchingdonors.com, kidneymitzvah.com, and kidneyregistry.org. Informal mechanisms include Internet chat rooms and message boards.

Society (and …

Ethical Issues In Open Adoption, Frederic Reamer, Deborah Siegel

Deborah H Siegel

Total secrecy and confidentiality no longer typify adoption in the United States. Today, most adoptions involve an exchange of information or some form of contact between the birth family and adoptive family - so-called open adoptions. This article provides a comprehensive overview of ethical issues associated with various forms of open adoption, including issues of privacy, confidentiality, self-determination, paternalism, conflicts of interest, deception, and truthtelling.We present guidelines for social work practice in open adoptions, based on current ethical theory and ethical standards in social work.

Patently Ours? Constitutional Challenges To Dna Patents, Vincent Ling

Vincent Y. Ling

This Comment analyzes constitutional issues raised by gene patenting and details how the issues apply to various types of DNA patents. In Association for Molecular Pathology v. U.S. Patent & Trademark Office, the Federal Circuit recently held that genes and DNA sequences are patentable under the federal statute for patent eligible subject matter, 35 U.S.C. § 101, but courts have thus far avoided addressing the constitutional challenges raised by plaintiffs. This Comment confronts those constitutional issues and makes a determination as to their strengths and weaknesses. Moreover, it explores additional constitutional issues that may become more salient over time. Ultimately, …

Charting Elsi’S Future Course: Lessons From The Recent Past, Rebecca Walker, Clair Morrissey

Clair Morrissey

Purpose: We sought to examine the ethical, legal, and social implications (ELSI) literature research and scholarship types, topics, and contributing community fields of training as a first step to charting the broader ELSI community’s future priorities and goals.

Methods: We categorized 642 articles and book chapters meeting inclusion criteria for content in both human genetics or genomics and ethics or ELSI during a 5-year period (2003–2008) according to research and scholarship types, topics, and the area of advanced training of the first-listed author. Research and scholarship type categories were developed and characterized through in-depth review of 95 randomly sampled publications …

The Publication Of Ethically Uncertain Research: Attitudes And Practices Of Journal Editors, Carla Angelski, Conrad Fernandez, Charles Weijer, Jun Gao

Charles Weijer

Background

Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas.

Methods

The Editor-in-chief of each of the 103 English-language journals from the 2005 Abridged Index Medicus list publishing original research were asked to complete a survey sent to them by email between September-December 2007.

Results

A response rate of …

Funding And Forums For Elsi Research: Who (Or What) Is Setting The Agenda?, Clair Morrissey, Rebecca Walker

Clair Morrissey

Background: Discussion of the influence of money on bioethics research seems particularly salient in the context of research on the ethical, legal, and social implications (ELSI) of human genomics, as this research may be financially supported by the ELSI Research Program. Empirical evidence regarding the funding of ELSI research and where such research is disseminated, in relation to the specific topics of the research and methods used, can help to further discussions regarding the appropriate influence of specific institutions and institutional contexts on ELSI and other bioethics research agendas. Methods: We reviewed 642 ELSI publications (appearing between 2003 and 2008) …

Ethical Minefields In Medical Tourism, Katrina Bramstedt

Katrina A. Bramstedt

Extract: Crystal blue waves lapping on the beach and glimmering shopping malls with bargains galore. Would you like a little sun, surf and safari with your surgery, all for a price much less than the surgery alone would cost in the United States? It only takes a few clicks of a computer mouse to find enticing lures bundled with cardiac bypass surgery, vision correction, bariatric surgery, organ transplants, dental implants, and total hip arthroplasty.

Impact Of Consort Extension For Cluster Randomised Trials On Quality Of Reporting And Study Methodology: Review Of Random Sample Of 300 Trials, 2000-8, N. Ivers, M. Taljaard, Stephanie Dixon, C. Bennett, A. Mcrae, J. Taleban, Z. Skea, J. Brehaut, R. Boruch, M. Eccles, J. Grimshaw, Charles Weijer, M. Zwarenstein, A. Donner

Charles Weijer

OBJECTIVE: To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials.

DESIGN: Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting.

DATA SOURCES: A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, …

Impact Of Consort Extension For Cluster Randomised Trials On Quality Of Reporting And Study Methodology: Review Of Random Sample Of 300 Trials, 2000-8, N. Ivers, M. Taljaard, Stephanie Dixon, C. Bennett, A. Mcrae, J. Taleban, Z. Skea, J. Brehaut, R. Boruch, M. Eccles, J. Grimshaw, Charles Weijer, M. Zwarenstein, A. Donner

Stephanie Dixon

OBJECTIVE: To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. DESIGN: Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. DATA SOURCES: A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, …

When Is Informed Consent Required In Cluster Randomized Trials In Health Research?, Andrew Mcrae, Charles Weijer, Ariella Binik, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin P Eccles, Raphael Saginur, Angela White, Monica Taljaard

Charles Weijer

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT …

Who Is The Research Subject In Cluster Randomized Trials In Health Research?, Andrew Mcrae, Charles Weijer, Ariella Binik, Angela White, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard

Charles Weijer

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact …