Global Research Toolkit

Clinical Trials, Human, and Animal Subjects

Clinical Trials

The World Health Organization defines a clinical trial as…

…any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Intervention is the action or process of intervening, action taken to improve a situation, such as a medical condition. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.

When designing the delivery of a clinical trial, it is important to understand the project design, anticipated costs, and broader impacts for the participants and project stakeholders. A terrific place to begin is this 9-minute video from the NIH website.

Human Subjects Research

Overall, 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.

Some key points to keep in mind:
  • Before submitting a human participant research protocol for approval, consult with your institution’s institutional review board (IRB) for assistance with writing the informed consent document.  This is particularly important to consider for sites and populations who do not have a written language or have high illiteracy levels.
  • When writing your human participant research protocol, be sure you are crafting a culturally sensitive informed consent process that takes into account the diverse needs of the groups/individuals with whom you will be working.
  • When writing your human participant research protocol, be cognizant of subject payment methods, amounts, types of payments (trinkets, etc.) and what might be appropriate and inappropriate for your participant population.
  • Consider using widely available communication technologies (i.e., Skype) to allow for better collaboration with the local site or to help assist the local institutional review board to resolve any questions that arise.
  • Identify whether translation services will be required and if there will be additional costs for foreign reviews.
  • Investigate alternative online human subject protections training options in foreign languages for international investigators and collaborators.
  • Be sure you understand what the local IRB requirements are for protocol approval, amendments, annual reviews, etc., in case they are different from your institution’s requirements.

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 into the nine general areas of interest below. It may be useful for your principal investigators to familiarize themselves with potential regulatory issues in these areas early on in the project.

  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

Keep in mind that, globally, 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. A little extra research on the front end may solve fundamental misunderstandings later on in the process (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.

Other Resources