Global Research Toolkit

Clinical Trials, Human, and Animal Subjects

Human Subjects Research and Clinical Trials

Human subject research conducted outside the United States must conform to both the same ethical and regulatory standards to which research conducted in the United States is held as well as to applicable local laws and norms of the host country. The International Compilation of Human Research Standards is a compilation of over 1,000 laws, regulations, and guidelines that govern human subjects research in 130 countries. It also contains standards from a number of international and regional organizations as well. For each country, these standards are compiled for nine general areas of interest:

  1. General human subjects research
  2. Drugs and Devices
  3. Clinical Trial Registries
  4. Research Inquiry
  5. Social-Behavioral Research
  6. Privacy/Data Protection
  7. Human Biological Materials
  8. Genetic
  9. Embryos, Stem Cells, and Cloning

Ethical Considerations

Existing ethical guidelines regarding clinical research and children diverge in significant ways. Some of these include issues of risk, age definition of a “child,” the extent to which existing guidelines cover children if not specifically mentioned, health allowances of participant children, and payments to participants (Bero in Sauer Sloan and Arrison, 2011).

In a 2014 workshop on international collaborations and culture, Professor Benjamin Caballero of Johns Hopkins University identified five principles of collaboration that should be addressed when conducting international [health] research (p. 16-17). These include:

  • Any study designed to be conducted in a developing nation should be relevant to the local population, scientists, and Ministry of Health. It should NOT be undertaken for the sake of convenience, cost, or expediency.
  • Risks should be shared across populations or by protocols designed to do so.
  • The regulatory framework over the collaboration should be acceptable internationally and adhere to the existence of ethical principals in conducting experiments on humans that go beyond culture. It should also be sustainable by all parties.
  • Strong local expertise should be integral to the project.
  • Funding should be unbiased and driven by the size of the study and not by operations or convenience. It should also be controlled locally whenever possible.

For projects to be sustainable, however, there must be strong social and political support for science in the partner countries and defined strategic goals for research in general. Furthermore, basic accountability principals and ethical standards should be present and there needs to be the potential for capacity building and two-way learning opportunities. Western ethics should not be given priority, but common behavioral and accountability principles should be identified and agreed upon before any deep collaboration begins.

Animal Use

For some, animal research is a controversial topic. But the use of animals to advance medicine and science when there are no non-animal alternatives is at times necessary, and researchers strive to perform it in an ethical and humane way. The AAALAC International is one private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. Resources complied by them on international regulations include: