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Ethical Review (ethical + review)

Distribution by Scientific Domains
Medical Sciences50%
Humanities and Social Sciences50%

Selected Abstracts

Think globally, act locally: collective consent and the ethics of knowledge production

INTERNATIONAL SOCIAL SCIENCE JOURNAL, Issue 195 2009
Maui Hudson
Ethical review is an integral part of the process of developing research and considering issues associated with the production of knowledge. It is part of a system that primarily legitimises western traditions of inquiry and reinforces western assumptions about knowledge and its benefit to society. Around the world the process of colonisation has excluded indigenous understandings. In New Zealand, M,ori (indigenous) knowledge has been similarly marginalised; this pattern is also reflected within ethical review. M,ori values, while acknowledged, are not yet considered to have equal weight in ethical deliberations. The notion of collective rights and the possibility of developing processes to allow collective consent to be recognised and mandated by ethics committees have been raised by communities but largely ignored by the ethical review system. While kaupapa M,ori researchers espouse the benefits of closer community involvement, policy makers and ethics committees have focused on "consultation" as the mechanism which confirms proof of engagement, the establishment of community support, and the relevance of the project. This article highlights the potential of the concept of collective consent in negotiations between researchers and communities. [source]

Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial

ACADEMIC EMERGENCY MEDICINE, Issue 6 2001
Thomas O. Stair MD
Abstract. Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26-62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. Conclusions: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration. [source]

Ethics of studies involving human volunteers I. Historical background

INTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 6 2007
P. A. Carson
The evaluation of personal products using panels of human volunteers is crucial to the continued development of the industry. Nowadays, however, it is increasingly important to ensure that such studies are both safe for the participants and are ethical. As a means of defining general rules for judging and justifying the ethics of human testing, historical milestones in the development of human experimentation are given. While most experience originates from biomedical research, findings help establish standards of ethical review of non-therapeutic human testing used in the cosmetics industry. [source]

Think globally, act locally: collective consent and the ethics of knowledge production

INTERNATIONAL SOCIAL SCIENCE JOURNAL, Issue 195 2009
Maui Hudson
Ethical review is an integral part of the process of developing research and considering issues associated with the production of knowledge. It is part of a system that primarily legitimises western traditions of inquiry and reinforces western assumptions about knowledge and its benefit to society. Around the world the process of colonisation has excluded indigenous understandings. In New Zealand, M,ori (indigenous) knowledge has been similarly marginalised; this pattern is also reflected within ethical review. M,ori values, while acknowledged, are not yet considered to have equal weight in ethical deliberations. The notion of collective rights and the possibility of developing processes to allow collective consent to be recognised and mandated by ethics committees have been raised by communities but largely ignored by the ethical review system. While kaupapa M,ori researchers espouse the benefits of closer community involvement, policy makers and ethics committees have focused on "consultation" as the mechanism which confirms proof of engagement, the establishment of community support, and the relevance of the project. This article highlights the potential of the concept of collective consent in negotiations between researchers and communities. [source]

Aboriginal and Torres Strait Islander participation in ethical review of health research

AUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 3 2006
Paul Stewart
No abstract is available for this article. [source]

Is Research-Ethics Review a Moral Panic?,

CANADIAN REVIEW OF SOCIOLOGY/REVUE CANADIENNE DE SOCIOLOGIE, Issue 1 2001
Will C. van den HoonaardArticle first published online: 14 JUL 200
Au cours des dix dernières années, nous avons été témoins de l'im-portance croissante accordée aux principes d'éthique appliqués à la recherche mais aussi de la popularité et de la pertinence grandis-santes de la recherche inductive, plus connue sous le nom de recherche et d'analyse qualitatives. Dans cet article, nous étudions le contexte social dans lequel se situe l'examen déontologique des travaux de recherche et son influence sur la recherche qualitative. Plus précisément, nous soutenons que, lorsque cet examen déontologique est fondé sur les principes et l'épistémologie de la recherche déductive, il a tendance à rogner et à entraver le dynamisme et l'ob-jet de la recherche qualitative. À l'aide de documents, de rapports de recherche formelle et d'après notre expérience personnelle et celle d'autres collègues, nous démontrons l'aspect disproportioné de l'examen déontologique de la recherche, qui semble favoriser la recherche quantitative - c'est-à-dire la recherche formelle fondée sur des hypothèses -, au détriment de la recherche qualitative. Nos exem-ples proviennent surtout du Canada, des États-Unis et d'Angleterre, en anthropologie, éducation, sciences infirmières, psychologie et so-ciologie. Nous affirmons que les processus sociaux qui sous-tendent l'analyse déontologique de la recherche s'apparentent à ceux que lon associe à une panique morale. The recent decade saw not only the rise of the importance of formal ethical research guidelines, but also witnessed the growing popularity and relevance of inductive research, better known as qualitative research and analysis. This paper addresses the social context of formal ethical review and its influence on qualitative research. Specifically, it suggests that when ethical review is based on the principles and epistemology of deductive research, it tends to erode or hamper the thrust and purpose of qualitative research. Using documents, formal research accounts, and the experiences of others and myself, the author indicates the lopsided nature of reviewing the ethics of research, which seems to work in favour of quantitative, formal hypotheses-driven research, to the serious disadvantage of qualitative research. The paper draws most heavily on evidence in Canada, the United States, and England, in the fields of anthropology, education, nursing, psychology, and sociology. The social processes underpinning research-ethics review, the author avers, are similar to those associated with a moral panic. [source]

Consent and capacity for dermatologists: an ethical review and update

CLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 6 2009
P. Lepping
Summary Changes in legislation and case law have brought about several changes in the way that doctors in England and Wales have to deal with consent and capacity issues. These changes affect dermatology in many ways regarding the way we gain consent and the information we have to share with the patient. This article will provide an update and overview on these changes and how they affect dermatology in particular. Legislation changes have opened up avenues to discuss difficult advance decisions with patients. It is hoped that these will reduce the number of ethical dilemmas arising from questions about the treatment of incapacitated patients. It is also necessary, following recent case law, to document and discuss any significant, unavoidable or frequently occurring side-effects of any proposed medication with patients. This means that the recent changes in legislation and case law bring opportunities to dermatologists, but also require improved documentation. [source]