A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects
E. Lamas, M. Ferrer, A. Molina, R. Salinas, A. Hevia, A. Bota, D. Feinholz, M. Fuchs, R. Schramm, J. -C. Tealdi & S. Zorrilla
Journal of Medical Ethics 36 (12):750-753 (2010)
The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
References found in this work BETA
No references found.
Citations of this work BETA
Research Ethics in the Context of Transition: Gaps in Policies and Programs on the Protection of Research Participants in the Selected Countries of Central and Eastern Europe.Andrei Famenka - 2016 - Science and Engineering Ethics 22 (6):1689-1706.
Similar books and articles
The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation.Charles Weijer - unknown
Non-Human Primates: The Appropriate Subjects of Biomedical Research?M. Quigley - 2007 - Journal of Medical Ethics 33 (11):655-658.
A Global Comparative Analysis of the Global Survey of Business Ethics.Gedeon Josua Rossouw - 2011 - Journal of Business Ethics 104 (S1):93-101.
Against One-Size-Fits-All Research Ethics.Michelle N. Meyer - 2010 - Hastings Center Report 40 (5):10-11.
Privatized Biomedical Research, Public Fears, and the Hazards of Government Regulation: Lessons From Stem Cell Research. [REVIEW]David B. Resnick - 1999 - Health Care Analysis 7 (3):273-287.
Human Dignity in International Policy Documents: A Useful Criterion for Public Policy?Inmaculada de Melo-martín - 2011 - Bioethics 25 (1):37-45.
Research Ethics in Social Sciences: The Severina's Story Documentary.Debora Diniz - 2008 - International Journal of Feminist Approaches to Bioethics 1 (2):23 - 35.
The Ethics and Politics of Human Experimentation.Paul M. McNeill - 1993 - Cambridge University Press.
Protecting People in Research: A Comparison Between Biomedical and Traffic Research. [REVIEW]Sara Svensson & Sven Ove Hansson - 2007 - Science and Engineering Ethics 13 (1):99-115.
The Convention on Human Rights and Biomedicine of the Council of Europe.F. William Dommel & Duane Alexander - 1997 - Kennedy Institute of Ethics Journal 7 (3):259-276.
Moving Toward Evidence-Based Human Participant Protection.Michael McDonald & Susan Cox - 2009 - Journal of Academic Ethics 7 (1-2):1-16.
Added to index2010-09-13
Total downloads18 ( #271,957 of 2,172,708 )
Recent downloads (6 months)1 ( #325,028 of 2,172,708 )
How can I increase my downloads?