ABSTRACT

The real ethical difficulties arise in the consideration of how studies in volunteers should be organised and executed. Ethics are a reasoned analysis of moral duty. Beneficence requires that our actions should, when possible, benefit others. Ethics are a reasoned analysis of moral duty. Beneficence imposes upon us a most powerful ethical obligation to maintain the highest standards in the design and execution of research. A badly designed study is unethical because it must fail to yield as much useful data as a well-designed one. Balancing non-maleficence against beneficence in volunteer studies is by no means the same thing as balancing risks and benefits in the treatment of patients. Respect for autonomy is almost tangibly expressed in the universal requirement that a person must give his consent to participate as a volunteer in a research project. The obtaining of consent is one area in which ethical obligations coincide with legal requirements.