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Integrating Clinical Research into Epidemic Response: The Ebola Experience (2017)

Chapter: Appendix C: Ethical Principles for Research with Human Subjects

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Previous Chapter: Appendix B: Clinical Trial Designs

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Suggested Citation: "Appendix C: Ethical Principles for Research with Human Subjects." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.

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
1. Scientific and Social Value	CIOMS Ethical Guidelines, 2016 Nuremburg Code, 1947 WMA Declaration of Helsinki, 2013 HHS Common Rule, 2009 Convention on Human Rights and Biomedicine, 1997	The knowledge to be gained through the conduct of the research must be of direct or incremental value to the development of clinical or public health advancements. The value of the research must be such that it (1) justifies any direct or indirect risks and burdens to participants and their communities and (2) justifies the allocation of resources away from other emergency response activities.

Seven Key Requirements Used to Review Trials Conducted During the 2014–2015 Ebola Outbreak

Source Guidance Documents

Key Principles

1. Scientific and Social Value

CIOMS Ethical Guidelines, 2016

Nuremburg Code, 1947

WMA Declaration of Helsinki, 2013

HHS Common Rule, 2009

Convention on Human Rights and Biomedicine, 1997

The knowledge to be gained through the conduct of the research must be of direct or incremental value to the development of clinical or public health advancements.
The value of the research must be such that it (1) justifies any direct or indirect risks and burdens to participants and their communities and (2) justifies the allocation of resources away from other emergency response activities.

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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 UNESCO Declaration, 2005 Belmont Report, 1979 Nuremburg Code, 1947 WMA Declaration of Helsinki, 2013 HHS Common Rule, 2009 Convention on Human Rights and Biomedicine, 1997	Research must honor the rights and welfare of participants by (1) providing prospective participants with clear and accessible information on the possible benefits and risks to participation and the research purpose; and (2) obtaining voluntary consent and ensuring that participants understand that they are able to withdraw consent at will and without reprisal.
3. Community Engagement	CIOMS Ethical Guidelines, 2016	Research activities must by centered on an ongoing commitment to sustaining community engagement focusing on communication about the research purpose, design, and possible risks and benefits at the individual and societal level and elicitation of community concerns and preferences.
4. Concern for Participant Welfare and Interests	CIOMS Ethical Guidelines, 2016 UNESCO Declaration, 2005 Belmont Report, 1979 Nuremburg Code, 1947 WMA Declaration of Helsinki, 2013 HHS Common Rule, 2009	Gratuitous risks to participants cannot be justified, and protections must be taken to limit violation of privacy and potential stigma associated with participation. Efforts must be made to increase benefits to participants to the extent possible, including access to interventions that are found to be efficacious.

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

UNESCO Declaration, 2005

Belmont Report, 1979

Nuremburg Code, 1947

WMA Declaration of Helsinki, 2013

HHS Common Rule, 2009

Convention on Human Rights and Biomedicine, 1997

Research must honor the rights and welfare of participants by (1) providing prospective participants with clear and accessible information on the possible benefits and risks to participation and the research purpose; and (2) obtaining voluntary consent and ensuring that participants understand that they are able to withdraw consent at will and without reprisal.

3. Community Engagement

CIOMS Ethical Guidelines, 2016

Research activities must by centered on an ongoing commitment to sustaining community engagement focusing on communication about the research purpose, design, and possible risks and benefits at the individual and societal level and elicitation of community concerns and preferences.

4. Concern for Participant Welfare and Interests

CIOMS Ethical Guidelines, 2016

UNESCO Declaration, 2005

Belmont Report, 1979

Nuremburg Code, 1947

WMA Declaration of Helsinki, 2013

HHS Common Rule, 2009

Gratuitous risks to participants cannot be justified, and protections must be taken to limit violation of privacy and potential stigma associated with participation.
Efforts must be made to increase benefits to participants to the extent possible, including access to interventions that are found to be efficacious.

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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 UNESCO Declaration, 2005 Belmont Report, 1979 WMA Declaration of Helsinki, 2013 HHS Common Rule, 2009 Convention on Human Rights and Biomedicine, 1997	The expected knowledge to be gained by the research must be justified in relation to the expected benefits and burdens associated with participation.
6. Justice in the Distribution of Benefits and Burdens	CIOMS Ethical Guidelines, 2016 Belmont Report, 1979 HHS Common Rule, 2009	The research must not focus inequitably on the health needs of a specific group, and, relatedly, a specific group should not disproportionately bear the burden and risks associated with the research.
7. Post-Trial Access	CIOMS Ethical Guidelines, 2016, UNESCO Declaration, 2005 WMA Declaration of Helsinki, 2013	There is an obligation to provide the communities that supported research with access to post-trial investigational products.

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

UNESCO Declaration, 2005

Belmont Report, 1979

WMA Declaration of Helsinki, 2013

HHS Common Rule, 2009

Convention on Human Rights and Biomedicine, 1997

The expected knowledge to be gained by the research must be justified in relation to the expected benefits and burdens associated with participation.

6. Justice in the Distribution of Benefits and Burdens

CIOMS Ethical Guidelines, 2016

Belmont Report, 1979

HHS Common Rule, 2009

The research must not focus inequitably on the health needs of a specific group, and, relatedly, a specific group should not disproportionately bear the burden and risks associated with the research.

7. Post-Trial Access

CIOMS Ethical Guidelines, 2016, UNESCO Declaration, 2005

WMA Declaration of Helsinki, 2013

There is an obligation to provide the communities that supported research with access to post-trial investigational products.

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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.