Medicine and Health Sciences Commons^™

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 …