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Jocelyn Downie

Publications and source records attributed to Jocelyn Downie.

At least 19 recordsLinked to original sources
PubMed2005

The Olivieri case: lessons for Australasia.

The case of Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. vividly illustrates many of the issues central to contemporary health research and the safety of research participants. First, it exemplifies the financial and health stakes in such research. Second, it shows deficits in the ways in which research is governed. Finally, it was and remains relevant not only in Toronto but in communities across Canada and well beyond its borders because, absent appropriate policies, what happened in Toronto could have happened (and could well still happen) elsewhere. In Part One of this paper, we review the facts of the Olivieri case relevant to the issues we wish to highlight: first, the right of participants in a clinical trial to be informed of a risk that an investigator had identified during the course of the trial and the obligation of the investigator to inform participants (both her own and those of other investigators); and second, the obligation of institutions to protect and promote the well-being of research participants as well as academic freedom and research integrity, the obligations of research sponsors to inform participants, research regulators, and others about unforeseen risks, and the obligations of research regulators to ensure that participants are informed of unforeseen risks and to otherwise protect and promote research integrity. In Part Two, we relate these facts and issues to New Zealand and Australia. We also make detailed recommendations for changes to the various instruments used for the governance of research involving humans in Australasia.

Australia↗
PubMed2004

Unilateral withholding and withdrawal of potentially life-sustaining treatment: a violation of dignity under the law in Canada.

In this paper, I review Canadian law in relation to the unilateral withholding or withdrawal of potentially life-sustaining treatment, and I look at such questions as whether physicians are legally permitted to unilaterally put a do-not-resuscitate (DNR) order on a patient's chart. I explore who has the legal authority in Canada to decide on withholding and withdrawal of potentially life-sustaining treatment, and I conclude that unilateral withholding and withdrawal is a violation of the strong social commitment to dignity as it is understood and reflected in the law by the Supreme Court of Canada. I then offer a concrete proposal for institutional policy with respect to unilateral withholding and withdrawal of treatment in light of the law.

Advance Directives↗
PubMed1990

Brain death and brain life: rethinking the connection.

The connection between brain life and brain death is neither as simple nor as defensible as it might at first appear. The problem rests with the two dominant competing definitions of death:...the loss of that which is necessary for the organism to continue to function as a whole;....the loss of that which is essentially significant to the nature of the organism... If death is understood as the loss of that which is necessary for the continued functioning of the organism as whole, then the apparent symmetry breaks down. If...death could be understood as the loss of that which is essentially significant to the nature of the organism....consciousness, then the symmetry would hold. However, that definition of death is indefensible. Therefore...statements about the status of anencephalic infants and early human embryos based upon a connection between brain death and brain life are unfounded.

Adult↗
PubMedDate not supplied

The Canadian agency for the oversight of research involving humans: a reform proposal.

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada's current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of "frequently asked questions" about the proposed agency design such as "What about 'local context'?" and "Why not have a system of accreditation of institutional REBs instead?" In sum, radical reform is needed and, in this paper, I present a proposal for such reform.

Canada↗