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Conducting Medical Research/Clinical Trials in Developing Countries

  1. Regulatory Issues

    1. Must obtain local host institution IRB approval, as well as foreign government approval.
    2. For new drugs or products, must meet approval of foreign FDA equivalent.
  2. Ethical Issues

    International Ethical Guidelines for Biomedical Research Involving Human Subjects Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)

    See page 25 for Guideline 8: Research Involving Subjects in Developing Communities