Ethical Principles for the Conduct of Human Subject Research: Population-Based Research and Ethics

Abstract

Ethical principles for the protection of human subjects in clinical research are now well recognized, and rooted in the inherent worth and dignity of the individual. Respect for persons recognizes people as autonomous agents and requires that their choices be observed. For persons who are not fully autonomous, the principle of respect for persons requires that they are protected from risks and adverse consequences of research, even sometimes excluded from research. Beneficence (do good) and non-maleficence (do no harm) are complementary ethical principles that impose affirmative duties on researchers to maximize any benefits for subjects and minimize any risks. Thus, researchers must go beyond mere respect for a person's choices. The researcher must be vigilant to ensure that the subject receives all possible benefits and avoids all possible harms from participating in the research.