Introduction

Over 300 000 Americans die each year from catastrophic medical and surgical emergencies. New interventions, based on sound research, could save lives. These research studies must be done in an ethical framework that traditionally includes obtaining prospective informed consent from the research subject. The ethical framework for the conduct of Human Research began with the development of the Nuremberg Code in 1949. This code states that (1) informed consent of volunteers must be obtained without coercion of any form, (2) human experiments should be based on prior animal experiments, (3) the anticipated scientific results should justify the experiment, (4) only qualified scientists should conduct medical research, (5) physical and mental suffering should be avoided, and (6) no death or disabling injury should be expected from the research study.

The Declaration of Helsinki was issued in 1964 and defines rules for clinical research. It repeats the ethical concerns stated in the Nuremberg Code, but also gives a provision for enrolling certain patients in clinical research without their consent, by using either proxy consent, or waiver of consent in minimal risk studies.

The subsequent Belmont Report, which was published in 1979, is the cornerstone of ethical principles upon which current federal regulations for the protection of subjects are based. The Report conveys the three major premises of ethical conduct of studies: respect for persons, beneficence, and justice. The Report also provides elements used by Institutional Review Boards for evaluating the ethical standards for individual research proposals.