The Intersection of Research Fraud and Human Subjects Research: A Regulatory Review

Editors: Barbara E. Bierer and Mark Barnes

The uncertain relationship between the two sets of federal regulations for research on human subjects has long posed a vexing regulatory problem. One of these sets is the “Common Rule,” which guides the treatment of human subjects. The other is the body of regulations concerning “research misconduct,” which has to do with fraud—plagiarism and fabrication of data, for example. Both sets may govern a study, and when something goes wrong in the study, provisions in each set may be triggered. Figuring out how to meet the various requirements can be bewildering. The goal of this special report is to provide guidance. To order the full report, please contact John Wiley & Sons customer support at 800-835-6770 or


Table of Contents


Research Misconduct Involving Noncompliance in Human Subjects Research Supported by the Public Health Service: Reconciling Separate Regulatory Systems

Barbara E. Bierer and Mark Barnes


Why Guidance Comes from the Research Community

David E. Wright

The Irregular Terrain of Human Subjects Research Regulations

David Forster, Daniel K. Nelson, David Borasky, and Jeffrey R. Botkin

The Third-Party Notification Dilemma

Ann K. Adams

Parallel Processes at the NIH

Sally J. Rockey and Amy P. Patterson

Public Trust and Institutional Culture

Alexander M. Capron, Elisa A. Hurley, and Amy L. Davis