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McMaster University is pleased to present this year’s Bourns Lecture in Bioethics, a lectureship made possible by Dr. Arthur Bourns, President Emeritus, whose generous gift enables the university to invite a distinguished expert in the field of bioethics to present a public lecture to the community at large.
Research Ethics: The obligation to include pregnant women in research
Too often researchers exclude pregnant women from clinical trials and require all women of child bearing potential to have a pregnancy test as a condition of participation in research. Thereafter, women are to use an approved double-barrier method of birth control. This common practice is deeply problematic insofar as pregnancy is not an automatic exclusion criterion. Pregnant women should only be excluded from research when there is a sound ethical or scientific reason to do so.
For pregnant women to receive appropriate care for themselves and their fetuses, their treating clinicians need pregnancy-specific data about safety, toxicity, dosage, side effects and contraindications both for pregnant women and their fetuses. The most effective way to get reliable data of this kind is to routinely include pregnant women in clinical trials, except when there is a compelling scientific or ethical reason not to do so. This presentation will outline the benefits and limitations of two different starting points for the routine inclusion of pregnant women in research of potential health benefit. The first option would have stand-alone phase I trials for pregnant women initiated at the same time as late phase II or phase III trials in the general population. The second option would have phase I trials for pregnant women embedded into late phase II or phase III trials, with enhanced monitoring for pregnant women similar to that done in a stand-alone phase I trial.
This is
a free public lecture.
All are welcome!
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Françoise Baylis is Professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University in Halifax. She is an elected Fellow of the Royal Society of Canada and an elected Fellow of the Canadian Academy of Health Sciences. Professor Baylis publishes extensively on ethical issues relevant to women's reproductive health, research involving humans and novel technologies. Her current research focuses on innovative, responsible and accountable bioethics, with a view to developing and promoting ethical policy in the fields of health, science and biotechnology.
Professor Baylis’ work in research ethics spans several decades, and much of this work focuses on the problem of exclusion from trial participation. Initially Professor Baylis focused on the unjust exclusion of children from research. In later years, the focus shifted to the unjust exclusion of women from research. Now that it is widely accepted in principle, if not always in practice, that research involving children and research involving women benefits children and women respectively, Professor Baylis has turned her attention to the unjust exclusion of pregnant women from research. The common thread for this work is the belief that persons should not be unfairly excluded from the benefits of research, or the benefits of research participation. In addition to her academic writing on fair inclusion/exclusion criteria, Professor Baylis has advocated for relevant policy changes to both editions of the TCPS.
Tuesday February 14, 2012
The Hamilton Spectator Auditorium (Directions/Map)
Doors open at 6:30 p.m. Lecture begins at 7 p.m.
To reserve your seat:
e-mail sciencecity@mcmaster.ca
Or by phone 905-525-9140, extension 24934
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