Putting the "Ethics" Back into Research Ethics: A Process for Ethical Reflection for Human Research Protection

Regulations for protecting human subjects contain practical applications of ethical principles such as respect for persons, beneficence, and justice. Nevertheless, I contend that research ethics-from the perspective of Institutional Review Boards (IRBs), sponsors of research, and others involved in protecting human subjects-focuses more on "compliance with the regulations" and less on the ethical principles themselves. Compliance is important, but it can be too narrowly focused on "checking off boxes" and the bureaucracy of documentation. Without training in how to enliven the ethical principles governing research, it is little wonder that those involved in human subject protections spend the majority of their efforts on ensuring that protocols and informed consent documents contain regulatory required elements. The goal of this paper is to supply IRB members and others involved in human subject protections a framework for engaging in ethical reflection using their own ethical intuitions and in ethical dialogue with others who must protect human subjects.