International Ethical Guidelines for Biomedical Research Involving Human Subjects

Council for International Organizations of Medical Sciences

These guidelines are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects, applying ethical standards in local circumstances, and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and needs of low-resource countries, and…

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2015 Proposed Revisions
to the 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects


September 2015

Council for International Organizations of Medical Sciences

These are revisions to the existing CIOMS International Guidelines, proposed in September 2015.  These proposals are not yet final.

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Declaration of Helsinki

World Medical Association

This Declaration is widely regarded as a cornerstone document of human research ethics, and sets forth a variety of standards for the conduct of ethical research, some of which are controversial (e.g., the Declaration’s stance on use of placebo controls). 

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The Nuremberg Code

This early and historically significant statement, crafted in response to the abuses of Nazi experimentation with humans during World War II, outlines the principles of research ethics.

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E6 Guideline for Good Clinical Practice

International Conference on Harmonisation

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and that the clinical trial data…

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Office for Human Research Protections, International

This site provides a variety of resources regarding international human subjects research, including an up-to-date compilation of international standards applicable to human subjects research in 104 countries, as well as standards from international and regional organizations.

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Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (Canada)

Interagency Secretariat on Research Ethics (2012),
2010

The Canadian federal regulations for research with humans.

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Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Research

Council of Europe

This treaty sets forth ethical principles with regard to biomedical research involving interventions on human beings.

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Medicinal Products for Human Use: Clinical Trials

European Commission

This site provides information on the requirements for conducting clinical trials in the EU. 

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Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries

National Bioethics Advisory Commission

This report makes recommendations to address the ethical issues that arise when clinical research that is subject to US regulation is sponsored or conducted in developing countries, with special attention to situations where local technical skills or resources are limited. 

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The Ethics of Research Related to Healthcare in Developing Countries

The Nuffield Council on Bioethics,
2002

This guidance document works toward a framework for balancing the urgent need for research to ameliorate the health burdens of developing nations with concerns over fairness and exploitation.

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Ethical Aspects of Clinical Research in Developing Countries

The European Group on Ethics in Science and New Technologies,
2003

This guidance document places particular emphasis on the ethical issues surrounding pharmaceutical drug development in developing nations.

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What Makes Clinical Research in Developing Countries Ethical?
The Benchmarks of Ethical Research

Journal of Infectious Diseases
Ezekiel J. Emanuel et al.

This foundational article provides a framework for ethical research in developing countries, addressing standard of care, post-trial access, and informed consent.  

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