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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.1-3 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.

Our estimates of the short-term impact of the termination of the clinical trial include the following: 84% (95% confidence interval [CI], 79%-89%) of patients will have no periodic measurements of CD4 cell counts in the short term, 84% (95% CI, 79%-89%) will not have easy access to primary health care, 93% (95% CI, 90%-96%) will not have psychological support, 40% (95% CI, 34%-46%) will not have access to community support, and 84% (95% CI, 79%-89%) will have difficulties obtaining secondary or tertiary health care in the short term. These percentages are not just numbers but represent human beings living with HIV/AIDS.

Existing guidelines regulate ethical aspects of research in human subjects during the course of clinical trials. However, it is unclear what ethical responsibilities remain after clinical trials end. Among the questions that investigators should ask are: Is there a mechanism that ensures that patients (who may have received their diagnosis as a result of their participation) continue receiving the benefits that they received during the trial? What happens when these benefits are not economically feasible and are not included in the local "standard of care?" Should changes in host country health policies emerge from the results of clinical trials?

We propose the establishment of international guidelines for moral and ethical obligations that must be considered after clinical trials end.

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