Copyright 1998 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1998American Medical Association
THE ETHICAL ISSUES involved in protecting human subjects who participate in medical research in countries outside the United States will be reviewed by the National Bioethics Advisory Commission. The group's decision reflects growing concern about the conduct of medical research on human subjects in other nations, especially in so-called developing countries. The topic has been the subject of contentious debate.
At a meeting of the commission last July, Sidney M. Wolfe, MD, director of the Health Research Group, Washington, DC, drew attention to what he termed "unethical studies" in several countries involving the investigation of zidovudine (also known as AZT) in controlling fetal transmission of the human immunodeficiency virus (HIV). Despite evidence that treatment with zidovudine effectively reduced mother-to-infant transmission, placebo groups did not receive the drug. These studies, said Wolfe, denied women access to known effective treatment and would have been unethical if done in the United States. He noted that 9 of the 15 studies were funded by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).
Marwick C. Bioethics Group Considers Transnational Research. JAMA. 1998;279(18):1425. doi:10.1001/jama.279.18.1425-JMN0513-2-1