6th International AIDS Conference San Francisco, California, USA — June 20-23, 1990

Int Conf AIDS 1990 Jun 20-23; 6:336 (abstract no. Th.D.843)
Novick A; Yale University, New Haven, Connecticut, USA

OBJECTIVE: Unorthodox clinical trials, in the HIV setting, have been implemented beyond federal regulations, omitting many elements of research with human subjects. Subjects have been asked to waive their rights to be treated as human subjects. Is that ethically acceptable?

METHODS: 1) to analyze the components of clinical trials utilizing human subjects and to identify those components that express our respect for persons and our duties of non-maleficence; 2) to analyze autonomy and the limits to its expression.

RESULTS: Components that express our respect for persons include peer review for scientific soundness (adequate laboratory data on safety and efficacy, appropriate investigator credentials, appropriate inclusion and exclusion criteria, appropriate commitment to follow up, data collection and evaluation), appropriate informed consent negotiations, and institutional review board (IRB) evaluation and oversight. For efficacy trials, earlier data deriving from sound human safety trials would also be expected. Personal autonomy becomes limited in the framework of an organized clinical trial by the duty of the investigator to do no harm.

CONCLUSION: Escape from the protections we believe are due human subjects cannot be based on their willingness to waive their rights. The investigators are bound by the principles of respect for persons and non-maleficence to protect human beings from the abuse and exploitation of subjection to poorly designed or disrespectful experiments. Waiver of rights is inappropriate. Properly structured clinical trials serve subjects, investigators, and society.

900620
ThD843

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