ABSTRACT
Some of the data the FDA uses1 to evaluate the safety of any product to be used on humans or other animals are:
• Toxicity • Observed (demonstrated) lack of adverse side effects • Risks of clinical studies with humans and other animals • Any potential adverse effects, especially carcinogenic and teratogenic • The level of use (dose and duration) that can be approved
Regarding testing on human subjects, the seminal event was the authoring of the Belmont Report, an attempt to summarize the basic ethical principles behind the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, created in 1974 with the signing into law of the National Research Act.2 This report made no attempt to make speci c recommendations for administrative action. Instead, it attempted to provide a framework to resolve any ethical
problems that manifest during research that involves human beings. It is important to note that these guidelines are operative whether it is drugbased research or even sociological or survey-based research. Institutions conducting research and receiving federal funding are expected to form committees to evaluate all research projects that involve human subjects. It is the job of such committees to ensure that every possible safeguard for the participants has been taken. One of the outcomes of this was a basic set of ethical principles:
1. Respect for persons. Individuals must be treated as persons who can make decisions for themselves. Persons with disabilities that make them less autonomous are entitled to some sort of protection. As a result, there are two moral requirements that must be met: acknowledge autonomy and protect those with lower autonomy.
