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August 23/30, 2000

Long-term Obligations to Human Subjects in Clinical Trials

Author Affiliations

Stephen J.LurieMD, PhD, Contributing EditorIndividualAuthorPhil B.FontanarosaMD, Executive Deputy EditorIndividualAuthor

JAMA. 2000;284(8):960-961. doi:10.1001/jama.284.8.956

To the Editor: Issues relating to clinical trials in developing countries have been debated in different forums.13 We have identified an additional aspect that relates to the moral duties that researchers should address after the termination of a clinical trial.4 To illustrate this point, we will describe our experience with a clinical trial in which we participated between 1993 and 1998.5 The 181 participants at our site in Mexico City received benefits during the trial that included access to primary care, periodic measurement of CD4 cell counts and viral load counts, referral to secondary clinical care, and psychological support. Because collaboration was established with a nongovernmental organization, community network support also was provided. Procedures were reviewed and approved by the appropriate local and international review boards and all patients provided written informed consent.

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