The Regulation of Research Review:
A Comparative International Workshop
June 16th to 18th, 2005
Faculty of Law
University of Toronto
Toronto, Ontario, Canada
This workshop is generously funded by a research grant provided by Genome Canada through
the Ontario Genomics Institute
Day 1, Thursday 16 June 2005
8.30
Breakfast in the Solarium, 84 Queen’s Park
9.00 - 9.10
Welcome and Workshop Opening Professor Trudo Lemmens
Faculty of Law, University of Toronto
Session 1:
Research Ethics Review Structures: International Comparisons
9.10 – 9.20
Regulatory Models of Research
Ethics Review
Tom Archibald, Research Associate, Faculty of Law, University of Toronto
9.20 – 10.45
 BRAZIL
Dr. Corina Bontempo, Executive Secretary, National Commission for Research
Ethics (CONEP), Brazil
 TANZANIA
Dr. Godwin Ndossi, Tanzania Food and Nutrition Centre, Dar es Salaam
 SOUTHEAST ASIA
Dr. Cristina E. Torres , Regional Coordinator, Forum for Ethical Review
Committees in Asia and the Western Pacific Region (FERCAP)
11.00 – 12.15
 Question and Answer Session
Refreshment Break
 RUSSIA
Dr. Asmik Asatrian, General Secretary,
Forum for Ethics Committees in the Confederation of Independent States (FECCIS)
 INDIA
Dr. Partha Majumder, India Statistical Institute, Kolkata
 SOUTH AFRICA
Dr. Jerome Singh
Howard College School of Law, University of KwaZulu-Natal, Durban
12.15 – 1.15
 Question and Answer Session
Lunch in the Rowell Room
Session 2:
1.15 – 3.00
Research Ethics Committee Oversight: Accreditation and Other Regulatory Mechanisms
 UNITED KINGDOM: The Central
Office for Research Ethics Committees
(COREC)
Professor Terry Stacey
 LITHUANIA: REC Approval and
Enforcement
Dr. Gytis Andrulionis
 CANADA: Accreditation and The
National Council on Ethics in Human
Research (NCEHR)
Dr. Richard Carpentier
U.K. Department of Health (Former Director of COREC)
Faculty of Law, Mykolas Romeris University, Vilnius
Executive Director, National Council on Ethics in Human Research
(NCEHR), Ottawa
 Question and Answer Session
Refreshment Break
Session 3:
3.30 – 5.00
Commercialization: Challenges for Research Ethics Review
 Commercialization of Research in the
North-American Context
Professor Trudo Lemmens
 Commercialization in India
Dr. Anant Bhan, Centre for Study in Ethics and Rights,
Faculty of Law, University of Toronto
Mumbai, and the University of Toronto Joint Centre for Bioethics
 Open Discussion
6.30
Special Workshop Dinner at Via Oliveto, 376 Bloor Street West, offered by Fasken Martineau
Day 2, Friday 17 June 2005
Session 4:
8.30
9.00 – 9.10
9.10 – 10.45
Specialized Review Bodies: Recent Initiatives, Future Possibilities
Breakfast in the Solarium, 84 Queen’s Park
 Summary of Day 1
Tom Archibald, Research Associate, Faculty of Law
 ESTONIA: Research Ethics Review of Genetic
Databank Research
Professor Ants Nömper,
 CANADA:
Ethics Review of Stem Cell Research
Dr. Michael Enzle, Chair, Stem Cell Oversight Committee,
 CANADA: Experience with the Public Advisory
Group on Xenotransplantation
Professor Thérèse Leroux, Centre de Recherche en Droit
Faculty of Law, University of Tartu
Canadian Institutes of Health Research
Public, Faculté de Droit, Université de Montréal
 Open Discussion
10.45
Session 5:
11.00 – 12.15
Refreshment Break
Specialized Review Bodies for Public Health Research
 SARS: Challenges for Research Ethics Committees
Robert S. Williams, Bioethicist,
The Scarborough Hospital, Toronto
 Emergency Preparedness and Human Subjects Research
Dr. Bernard Dickens,
Faculty of Law, University of Toronto
 Open Discussion
12.15 – 1.30
Lunch in the Solarium
Session 6:
1.30 – 3.00
Research Ethics Review: The Role of International Bodies
 Triple Burden or Triple Opportunity? WHO and
the Ethics of Health Research
Prof. Alexander M. Capron, Director
 The Role of the Council for International
Organizations of Medical Sciences
Dr. Juhana E. Idänpään-Heikkilä
Department of Ethics, Trade, Human Rights, and Health Law
World Health Organization, Geneva
Secretary-General, CIOMS
 Question and Answer Session
3.00 – 3.15
Session 7:
3.15 – 5.00
Refreshment Break
The Role of International Instruments in Research Ethics Review
 The Council of Europe: Steering Committee on Bioethics
(CDBI) and the Oviedo Convention
and
 The European Directive on Clinical Trials
Prof. Dr. Elmar Doppelfeld, Chair, CDBI.
 Latin American Forum for Ethics Review Boards
Dr. Andrés Peralta, Vice-Chairperson, FLACEIS
 The ‘Equivalent Protection’ Doctrine
Dr. James Lavery, Associate Professor, Public
Health Sciences, University of Toronto
Dr. Michael McDonald, Co-Chair, Standing
Committee on Ethics, Canadian Institutes of Health
Research, Ottawa
 Question and Answer Session
Dinner at a restaurant of your choice
Day 3, Saturday 18 June 2005
Session 8:
Promotion of Equitable Research Practices
8.30 – 9.00
Breakfast in the Solarium, 84 Queen’s Park
9.00 – 9.10
 Summary of Day 2
9.10 – 11.00
 The Concept of An International Duty of Care
Tom Archibald, Research Associate, Faculty
of Law
Dr. Solomon Benatar, Department of
Medicine, University of Cape Town, South
Africa, and Joint Centre for Bioethics, Toronto
 CAMEROON: An African Perspective:
Dr. Godfrey B. Tangwa, , Professeur Agrégé
de Philosophie, Université de Yaoundé
 CANADA: Guidelines for Health Research Involving
Aboriginal Peoples
 Open Discussion
11.00– 12.45
(optional) Visit to Royal Ontario Museum
12.45
(optional) Lunch in the Rowell Room
If you eat elsewhere, please save the receipt for reimbursement.
Dr. Geneviève Dubois-Flynn, Canadian
Institutes of Health Research
Session 9:
1.45 – 3.15
Liability in the Context of Research Review
 The Abdullahi v. Pfizer Case: Implications for Liability in
Research
Dr. Remigius Nwabueze
 AUSTRALIA: Common Law Liability Systems
Professor Colin Thomson, Faculty of Law,
Faculty of Law, University of Ottawa
University of Wollongong, New South Wales
 HUNGARY: Civil Law Liability
Dorottya Mogyorósi,
Medical Research Council of Hungary
3.15
Refreshment Break
3.30 – 5.00
Final Discussion and Closing
5.00 – 6.30
Closing Reception
Rowell Room