Health Law Review

A professional journal examining issues of concern for lawyers and health care professionals. Presents current issues connected to the medical-legal field.

Articles from Vol. 13, No. 2-3, Spring-Fall

A Cultural Understanding of Research Ethics Governance
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 provide...
At the Institute
The HLI is excited to publish this special double edition of the Health Law Review with a focus on "Canadian Governance for Ethical Research Involving Humans." We appreciate the efforts of Dr. Michael McDonald, our guest editor for this edition, in...
Commentary: An Independent Voice? Conflicts of Interest and Research on Ethical, Legal and Social Issues
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 industry...
Consent Revisited: Points to Consider
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 consent...
Contrasting Modes of Governance for the Protection of Humans and Animals in Canada: Lessons for Reform
"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) However,...
Ethics Review of Multi-Centre Clinical Trials in Canada
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 Conduct for...
Evidence-Based Practice of Research Ethics Review?
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 the importance...
Federal Regulation of REB Review of Clinical Trials: A Modest but Easy Step towards an Accountable REB Review Structure in Canada
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, focusing...
Legal and Ethical Issues Associated with Patient Recruitment in Clinical Trials: The Case of Competitive Enrolment
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 the drug...
Professional Responsibility and the Protection of Human Subjects of Research in Canada
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 and roles...
Research Ethics across the 49th Parallel: The Potential Value of Pilot Testing "Equivalent Protections" in Canadian Research Institutions
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 U.S. National...
Research Governance, Bio-Politics and Political Will: Recent Lessons from Newfoundland and Labrador
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 that legislation...
Special Issue: Canadian Governance for Ethical Research Involving Humans
Dedication This double issue of the Health Law Review is dedicated to the memory of our friend and colleague T. Douglas Kinsella, CM, MD, FRCP. Doug Kinsella was a leader in the effort to bring about the reform of Canadian governance for research...
The Long Arm of Administrative Law: Applying Administrative Law Principles to Research Ethics Boards
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 informed,...
Translating Ethics into Law: Duties of Care in Health Research Involving Humans
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 research...
Trends in Collection, Use and Disclosure of Personal Information in Contemporary Health Research: Challenges for Research Governance
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 research...
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