• IRB: ETHICS & HUMAN RESEARCH

Moving Beyond Compliance: Measuring Ethical Quality to Enhance the Oversight of Human Subjects Research

A robust measure of whether local oversight of human subjects research is achieving the ethical goals of research oversight (protecting the welfare of subjects, promoting respect, and attending to justice in human research) has never been developed. Assessing whether the local review process is achieving the ethical goals of research oversight will allow institutions to monitor their own human subjects protection programs and guide the investment of funds to improve performance. Without a measure of ethical quality, institutions, institutional review boards, regulators, and the public have no way of knowing if the intent of regulations is being realized.

Key words/concepts: ethics review, research oversight, goals, quality assessment