Resources: International Human Subjects Research
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…
2015 Proposed Revisions
to the 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects
These are revisions to the existing CIOMS International Guidelines, proposed in September 2015. These proposals are not yet final.
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…
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.
The Canadian federal regulations for research with humans.
This treaty sets forth ethical principles with regard to biomedical research involving interventions on human beings.
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.
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.
This guidance document places particular emphasis on the ethical issues surrounding pharmaceutical drug development in developing nations.
This foundational article provides a framework for ethical research in developing countries, addressing standard of care, post-trial access, and informed consent.