Responsible conduct of radiology research: part I. The regulatory framework for human research.

Abstract

The purpose of the articles in this series is to explain the ethical and legal basis for responsible conduct of radiology research. In the current article, the regulatory framework of human research is explained. There is no overall regulatory process for protecting the rights and welfare of humans participating in research. Instead, legal protections in the United States are an amalgam of regulations from multiple federal and state agencies. The key regulations are from the Department of Health and Human Services, the Food and Drug Administration, and the Federal Privacy Rule of the Health Insurance Portability and Accountability Act. Which of these apply in any situation depends on many factors, including the funding source of the research, the site of the research, and the items being tested. Radiologists conducting human research need to know which regulations apply and how to comply with them. The regulations represent a set of rules based on the ethical principles of respect for persons, beneficence, and justice. Radiologists should understand these ethical principles for situations when the regulations are silent, ambiguous, or incomplete. (c) RSNA, 2005.