Acceptable risk in biomedical research : European perspectives
https://libcat.nshealth.ca/en/permalink/provcat40982
Sigmund Simonsen.
--Dordrecht:
Springer
, c2012.
- Available Online
- View e-Book
- Location
- Online
- Available Online
- View e-Book
- Author
- Simonsen, Sigmund, 1972-
- Responsibility
- Sigmund Simonsen
- Place of Publication
- Dordrecht
- Publisher
- Springer
- Date of Publication
- c2012
- Physical Description
- 1 online resource (xv, 293 p.)
- Series Vol.
- v. 50
- ISBN
- 9789400726789
- 9789400726772 (print ed.)
- Subjects (MeSH)
- Ethics, Research
- Human Experimentation - ethics
- Human Experimentation - legislation & jurisprudence
- Risk Assessment - legislation & jurisprudence
- Other Subjects
- Europe
- Contents
- Part. I Initial Issues -- 1. Introduction -- 2. Method and Material -- 3. Initial Conceptual Clarifications -- 4. Origins of the Requirement of Proportionality -- 5. The Purpose of the Requirement of Proportionality -- Part II. Which Risks, Burdens, and Potential Benefits Are Relevant, and How Should They Be Estimated? -- 6. Introduction -- 7. Which Risks, Burdens and Potential Benefits Are Relevant? -- 8. How to Estimate Risks, Burdens, and Potential Benefits -- Part III. The Assessment of Proportionality -- 9. The Requirement of Proportionality – Initial Clarifications -- 10. Therapeutic Research -- 11. Nontherapeutic Research -- 12. Nontherapeutic Research on “Vulnerable” Participants -- 13. Non-interference with Necessary Clinical Interventions and The No Harm Rule -- 14. Especially on Randomised Clinical Trials, Including Placebo Controlled Clinical Trials -- 15. Acceptable Risks and Burdens to Others than the Participant -- 16. Later Developments During the Course of the Research -- 17. Legal Effects of the Requirement of Proportionality -- Part IV. Summary and Conclusions -- 18. Summary of Results -- 19. Recommendations -- 20. Perspectives -- Appendix A: Legal Instruments -- Appendix B: Case-Law -- Appendix C: Case Examples.
- Format
- e-Book
- Location
- Online
Clinical Trials in Latin America : Where Ethics and Business Clash
https://libcat.nshealth.ca/en/permalink/provcat39618
Nuria Homedes, Antonio Ugalde, editors.
--Cham:
Springer
, c2014.
- Available Online
- View e-Book
- Location
- Online
The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in…
- Available Online
- View e-Book
- Other Authors
- Homedes, Nuria
- Ugalde, Antonio
- Responsibility
- Nuria Homedes, Antonio Ugalde, editors
- Place of Publication
- Cham
- Publisher
- Springer
- Date of Publication
- c2014
- Physical Description
- 1 online resource (xvi, 291 p. : 9 illus.)
- Series Vol.
- 2
- Series Title
- Research ethics forum
- ISBN
- 9783319013633
- 9783319013626 (print ed.)
- ISSN
- 2212-9529
- Subjects (MeSH)
- Clinical Trials as Topic - ethics
- Drug Industry - ethics
- Human Experimentation - ethics
- Human Rights Abuses
- Other Subjects
- Latin America
- Abstract
- The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.
- Contents
- 1. Introduction -- 2. A Review and Critique of International Ethical Principles -- 3. Globalization and Clinical Research in Latin America -- 4. The Regulatory Framework and Case Studies from Argentina -- 5. Politics and Clinical Trials in the Province of Cordoba -- 6. Brazil: The System for the Protection of Voluntary Participants in Research -- 7. Progress and Challenges of Clinical Research with New Medications in Brazil -- 8. A Small Country for Big Pharma: Costa Rica -- 9. Cervical Cancer and the Development of HPV Vaccines in Guanacaste, Costa Rica -- 10. Ethical Guidelines for Clinical Trials in Mexico: Theory and Practice -- 11. Who Decides? Informed Consent for Cancer Patients in Mexico -- 12. A View from Inside: Regulation and Ethical Conflicts in Peru -- 13. Conclusion.
- Format
- e-Book
- Location
- Online
Gene transfer and the ethics of first-in-human research : lost in translation
https://libcat.nshealth.ca/en/permalink/provcat27747
Kimmelman, Jonathan.
--Cambridge:
Cambridge University Press
, 2010.
- Available Online
- View e-Book
- Location
- Online
- Available Online
- View e-Book
- Author
- Kimmelman, Jonathan
- Place of Publication
- Cambridge
- Publisher
- Cambridge University Press
- Date of Publication
- 2010
- Physical Description
- 205 p.
- Series Title
- Cambridge medicine
- ISBN
- 9780511642364
- Format
- e-Book
- Location
- Online
Human subjects research after the Holocaust
https://libcat.nshealth.ca/en/permalink/provcat33862
Sheldon Rubenfeld, Susan Benedict, editors ; foreword by Arthur L. Caplan.
--Cham, Switzerland:
Springer
, c2014.
- Available Online
- View e-Book
- Location
- Online
'An engaging, compelling and disturbing confrontation with evil...abook that will be transformative in its call for individual and collective moral responsibility." - Michael A. Grodin, M.D., Professor and Director, Project on Medicine and the Holocaust, Elie Wiesel Center for Judaic Studies, Boston University. Human Subjects Research after the Holocaust challenges you to confront the misguided medical ethics of the Third Reich personally, and to apply the lessons learned to contemporary human …
- Available Online
- View e-Book
- Other Authors
- Rubenfeld, Sheldon
- Benedict, Susan
- Responsibility
- Sheldon Rubenfeld, Susan Benedict, editors ; foreword by Arthur L. Caplan
- Place of Publication
- Cham, Switzerland
- Publisher
- Springer
- Date of Publication
- c2014
- Physical Description
- 1 online resource (xvi, 308 pages)
- ISBN
- 9783319057026 (electronic bk.)
- 9783319057019
- Subjects (MeSH)
- Bioethics
- Ethics, Medical
- Ethical Review
- Human Experimentation - ethics
- National Socialism - history
- Nontherapeutic Human Experimentation - history
- Research Subjects
- Subjects (LCSH)
- Human experimentation in medicine - Moral and ethical aspects
- Human experimentation in medicine - Germany - History - 20th century
- Theory of Medicine/Bioethics
- History of Science
- History of Medicine
- Human Rights
- Abstract
- 'An engaging, compelling and disturbing confrontation with evil...abook that will be transformative in its call for individual and collective moral responsibility." - Michael A. Grodin, M.D., Professor and Director, Project on Medicine and the Holocaust, Elie Wiesel Center for Judaic Studies, Boston University. Human Subjects Research after the Holocaust challenges you to confront the misguided medical ethics of the Third Reich personally, and to apply the lessons learned to contemporary human subjects research. While it is comforting to believe that Nazi physicians, nurses, and bioscientists were either incompetent, mad, or few in number, they were, in fact, the best in the world at the time, and the vast majority participated in the government program of 'applied biology.' They were not coerced to behave as they did-they enthusiastically exploited widely accepted eugenic theories to design horrendous medical experiments, gas chambers and euthanasia programs, which ultimately led to mass murder in the concentration camps. Americans provided financial support for their research, modeled their medical education and research after the Germans, and continued to perform unethical human subjects research even after the Nuremberg Doctors' Trial. The German Medical Association apologized in 2012 for the behavior of its physicians during the Third Reich. By examining the medical crimes of human subjects researchers during the Third Reich, you will naturally examine your own behavior and that of your colleagues, and perhaps ask yourself "If the best physicians and bioscientists of the early 20th century could do evil while believing they were doing good, can I be certain that I will never do the same?" Presents relatively unknown aspects of human subjects research during the Third Reich Reveals surprising relationships between German and American human subjects research Dispels myths about Nazi human subjects research Compels introspection and self-examination by today's medical and research practitioners Addresses contemporary bioethical issues affecting vulnerable populations Brings together experts in the history of medicine during the Third Reich and thoughtful new voices.
- Contents
- Introduction: How Did It Go So Wrong? -- Twin Experiments at Auschwitz: A First-Person Account -- Eugenics and Racial Hygiene: Applied Research Strategies before, during, and after National Socialism -- Medical Ethics and Medical Research on Human Beings in National Socialism -- Sulfonamide Experiments on Prisoners in Nazi Concentration Camps: Coherent Scientific Rationality Combined with Complete Disregard of Humanity -- Stages of Transgression: Anatomical Research in National Socialism -- Nurses and Human Subjects Research during the Third Reich and Now -- Involuntary Abortion and Coercive Research on Pregnant Forced Laborers in National Socialism -- Abusive Medical Practices on "Euthanasia" Victims in Austria during and after World War II -- Medical Research and National Socialist Euthanasia: Carl Schneider and the Heidelberg Research Children from 1942 until 1945 -- Victims of Human Experiments and Coercive Research under National Socialism: Gender and Racial Aspects -- The White Rose: Resisting National Socialism, with an Introduction by Susan Benedict -- The Origins and Impact of the Nuremberg Doctors' Trial -- In the Shadow of Nuremberg: Unlearned Lessons from the Medical Trial -- The Ethics of Medical Experiments: Have We Learned the Lessons of Tuskegee and the Holocaust? -- Human Subjects Research during and after the Holocaust: Typhus Vaccine Development and the Legacy of Gerhard Rose -- Ethics in Space Medicine: Holocaust Beginnings, the Present, and the Future -- Reproduction Then and Now: Learning from the Past -- Promoting Clinical Research and Avoiding Bad Medicine: A Clinical Research Curriculum -- The Psychophysiology of Attribution: Why Appreciative Respect Can Keep Us Safe -- Confronting Medicine during the Nazi Period: Autobiographical Reflections -- Teaching the Holocaust to Medical Students: A Reflection on Pedagogy and Medical Ethics -- No Exceptions, No Excuses: A Testimonial.
- Format
- e-Book
- Location
- Online
Informed consent : a guide to the risks and benefits of volunteering for clinical trials
https://libcat.nshealth.ca/en/permalink/provcat21041
Getz, Kenneth.
--Boston, MA:
CenterWatch
, 2002.
- Call Number
- W 20.55 .H9 G394i 2002
- Location
- Dickson Building
- Call Number
- W 20.55 .H9 G394i 2002
- Author
- Getz, Kenneth
- Other Authors
- Borfitz, Deborah
- Place of Publication
- Boston, MA
- Publisher
- CenterWatch
- Date of Publication
- 2002
- Physical Description
- 306 p.
- ISBN
- 1930624093
- Subjects (MeSH)
- Research Subjects
- Informed Consent
- Human Experimentation - ethics
- Clinical Trials as Topic - ethics
- Format
- Book
- Location
- Dickson Building
- Loan Period
- 3 weeks
Institutional review board : member handbook
https://libcat.nshealth.ca/en/permalink/provcat40914
Robert Amdur, Elizabeth A. Bankert.
(Third edition)
--Sudbury, MA:
Jones and Bartlett Publishers
, c2011.
- Call Number
- W 20.5 A4971 2011
- Location
- Dickson Building
Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. Thi…
- Call Number
- W 20.5 A4971 2011
- Author
- Amdur, Robert J
- Other Authors
- Bankert, Elizabeth A
- Responsibility
- Robert Amdur, Elizabeth A. Bankert
- Edition
- Third edition
- Place of Publication
- Sudbury, MA
- Publisher
- Jones and Bartlett Publishers
- Date of Publication
- c2011
- Physical Description
- xii, 215 pages
- ISBN
- 9781449647445
- 9780763780005
- Subjects (MeSH)
- Biomedical Research - ethics
- Ethical Review - standards
- Ethics Committees, Research - organization & administration
- Ethics, Medical
- Human Experimentation - ethics
- Abstract
- Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.
- Format
- Book
- Publication Type
- Handbook
- Location
- Dickson Building
- Loan Period
- 3 weeks
The Oxford textbook of clinical research ethics
https://libcat.nshealth.ca/en/permalink/provcat24550
Emanuel, Ezekiel J.
--Oxford, England:
Oxford University Press
, 2008.
- Call Number
- W 20.55 .H9 O98 2008
- Location
- Halifax Infirmary
- Call Number
- W 20.55 .H9 O98 2008
- Author
- Emanuel, Ezekiel J
- Place of Publication
- Oxford, England
- Publisher
- Oxford University Press
- Date of Publication
- 2008
- Physical Description
- 827 p.
- ISBN
- 9780195168655
- Subjects (MeSH)
- Human Experimentation - ethics
- Ethics Committees, Research
- Ethics, Research
- Research Subjects - legislation & jurisprudence
- Format
- Book
- Location
- Halifax Infirmary
- Loan Period
- 3 weeks
Protecting study volunteers in research : a manual for investigative sites
https://libcat.nshealth.ca/en/permalink/provcat22639
Cynthia McGuire Dunn, Gary L. Chadwick.
(3rd ed.)
--Boston, MA:
Thomson CenterWatch
, c2004.
- Call Number
- W 20.55 .H9 D923p 2004
- Location
- Halifax Infirmary
- Dickson Building
- Call Number
- W 20.55 .H9 D923p 2004
- Author
- Dunn, Cynthia McGuire
- Other Authors
- Chadwick, Gary L
- Responsibility
- Cynthia McGuire Dunn, Gary L. Chadwick
- Edition
- 3rd ed.
- Place of Publication
- Boston, MA
- Publisher
- Thomson CenterWatch
- Date of Publication
- c2004
- Physical Description
- 383 p.
- ISBN
- 1930624441
- 9781930624443
- Subjects (MeSH)
- Biomedical Research - organization & administration
- Human Experimentation - ethics
- Human Experimentation - standards
- Research Subjects - legislation & jurisprudence
- Other Subjects
- United States. Food and Drug Administration
- Other Subjects
- United States
- Format
- Book
- Location
- Halifax Infirmary
- Dickson Building
- Copies
- 2
- Loan Period
- 3 weeks
