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Translating ethics into law: duties of care in health research involving humans.
March 22, 2005... In the field of health research, good governance has two primary goals: to ensure that the research conducted is scientifically valid, and that it is conducted in an ethical manner, protecting the physical and psychological integrity of the...
The long arm of administrative law: applying administrative law principles to research ethics boards.(Canada)(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... I. Introduction
Commentators have described the primary responsibility of research ethics boards (REBs) as that of ensuring that research projects involving human participants commence, or continue, only if the participants "are adequately...
Consent revisited: points to consider.(Canada)(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... Obtaining informed consent for research involving tissue samples and data is the Damoclean sword for both researchers and participants. It has become the focal point of research ethics review. Over time, and strongly influenced by models of...
Federal regulation of REB review of clinical trials: a modest but easy step towards an accountable REB review structure in Canada.(research ethics board)(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... Introduction: REB Review as Public Mandate
In 2000, a working group on the regulation of clinical trials, established by the Swiss Intercantonal Drug Regulatory Agency submitted a report on the regulation of clinical trials in the country,...
Ethics review of multi-centre clinical trials in Canada.(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... Human research conducted at institutions receiving funding from any of the three federal Canadian funding agencies must be reviewed and approved in advance by a human research ethics board (REB). The Tri-Council Policy Statement: Ethical...
Legal and ethical issues associated with patient recruitment in clinical trials: the case of competitive enrolment.
March 22, 2005... Introduction
The demand for patients for clinical trials continues to increase. There are more clinical trials being done (often involving patients with similar conditions), government regulators require an increasing amount of data for...
Evidence-based practice of research ethics review?
March 22, 2005... Introduction
In a recent editorial in the Journal of the American Medical Association, Jeremy Sugarman argues that, "The time is ripe for evidence-based ethics. Similar to evidence-based medicine, an evidence-based ethics would emphasize...
A cultural understanding of research ethics governance.
March 22, 2005... Introduction
Analyses of research ethics tend to characterize ethical review and its components as a linear process of submission, review, revision, research conduct and reporting. Recommendations to improve research ethics usually seek to...
Research governance, bio-politics and political will: recent lessons from Newfoundland and Labrador.(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... Introduction
For the past several years the province of Newfoundland and Labrador has been taking halting steps to introduce the legislative mechanisms necessary to establish a Provincial Health Research Ethics Board (PHREB). If and when...
Professional responsibility and the protection of human subjects of research in Canada.(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... Introduction
Protection of human subjects of research involves governments, research funding agencies, professional organizations, institutions, individual researchers and research participants. (1) This paper reviews the responsibilities...
Research ethics across the 49th parallel: the potential value of pilot testing "equivalent protections" in Canadian research institutions.
March 22, 2005... Abstract
Canada and the United States share the world's largest trade partnership and an increasing concern about divergent regulatory approaches to common industries. Canadian research institutes receive more research funding from the...
Contrasting modes of governance for the protection of humans and animals in Canada: lessons for reform.(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... "The cover of a recent edition of Time magazine features a research subject in a cage with the caption 'human guinea pigs,' signifying perhaps that human subjects are no more protected from research abuses than are laboratory animals." (1)...
Trends in collection, use and disclosure of personal information in contemporary health research: challenges for research governance.(Canada)(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... Background: Changes in the Nature and Use of Personal Information for Health Research
Health research encompasses a heterogeneous set of research activities. This paper focuses on challenges that arise in the governance of observational...
Commentary: an independent voice? Conflicts of interest and research on ethical, legal and social issues.(Canada)(Special Issue: Canadian Governance for Ethical Research Involving Humans)
March 22, 2005... Over the past few months there have been a number of well publicized controversies that have highlighted the impact of industry funding on the nature and tone research results. There is, for example, mounting evidence that involvement with...