Ethics of evaluation of new drugs in human volunteers.

Experiments in human volunteers are a vital part of the evaluation of most new drugs. Are such experiments ethical? This question is discussed in the light of four ethical principles: justice, beneficence, non-maleficence and respect for autonomy. Problem areas include recruitment of volunteers, obtaining consent, payment for participation and special groups such as students and staff of research institutions, the poor, women of child-bearing potential, children and elderly volunteers. Drug evaluation in volunteers does present ethical difficulties, but none of these is insurmountable.