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 cs-journals@wiley.com.