Appendix C
Ethical Principles for Research with Human Subjects
TABLE C-1 Basic Ethical Principles That Should Govern Research with Human Subjects
Seven Key Requirements Used to Review Trials Conducted During the 2014–2015 Ebola Outbreak | Source Guidance Documents | Key Principles |
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1. Scientific and Social Value |
CIOMS Ethical Guidelines, 2016 |
|
Seven Key Requirements Used to Review Trials Conducted During the 2014–2015 Ebola Outbreak | Source Guidance Documents | Key Principles |
---|---|---|
2. Respect for Persons |
CIOMS Ethical Guidelines, 2016 |
|
3. Community Engagement |
|
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4. Concern for Participant Welfare and Interests |
CIOMS Ethical Guidelines, 2016 |
|
Seven Key Requirements Used to Review Trials Conducted During the 2014–2015 Ebola Outbreak | Source Guidance Documents | Key Principles |
---|---|---|
5. Favorable Risk–Benefit Ratio |
CIOMS Ethical Guidelines, 2016 |
|
6. Justice in the Distribution of Benefits and Burdens |
|
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7. Post-Trial Access |
|
REFERENCES
CIOMS (Council for International Organizations of Medical Sciences). 2016. International ethical guidelines for biomedical research involving human subjects. http://www.cioms.ch/ethical-guidelines-2016 (accessed January 20, 2017).
COE (Council of Europe). 1997. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine. Kennedy Institute of Ethics Journal 7(3):277–290.
HHS (U.S. Department of Health and Human Services). 2009. 45 CFR 46, Common Rule for the Protection of Human Subjects in Research.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014. Washington, DC: U.S. Government Printing Office.
Nuremberg Code (1947). 1996. BMJ 313(7070):1448.
UNESCO (United Nations Educational, Scientific and Cultural Organization). 2006. Universal declaration on bioethics and human rights. Paris, France: UNESCO. http://unesdoc.unesco.org/images/0014/001461/146180E.pdf (accessed January 25, 2017).
WMA (World Medical Association). 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 310(20):2191–2194.