Update on human rights issues in clinical research

The concept of protection of the human rights of patients involved in clinical research studies by the use of informed consent and institutional review of test protocols is not new to these pages. We have, in the past, presented editorial opinion and policy, as well as a review of the subject in our Current Concepts Review section. The process of protection of the human rights of experimental subjects continues to evolve through the mechanism of the Declaration of Helsinki as adopted by the World Medical Association. This international group met in October 2000 to clarify some issues concerning the allowable structure of experimental protocols when human research is combined with medical care. At issue was the acceptability of a classic study protocol that involves use of a placebo as a control in an experiment that is being performed to determine the safety and efficacy of an experimental treatment. Often such a test protocol is used to examine new drugs that are the subject of review by the United States Food and Drug Administration. That agency has been charged by Congress with the responsibility of determining the safety and efficacy of a drug before granting the drug manufacturer permission to market the drug. At the October 2000 meeting of the participants of the Helsinki World Congress, the use of a placebo as a control was severely restricted, as is evident in paragraph 29 of the agreement, which states: The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.