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

Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordance with the federal-wide definition adopted by the Office of Science and Technology Policy. The second set of regulations, set forth in the Department of Health and Human Services regulations on the protection of human subjects (known as the “Common Rule”), prescribes a set of ethical and procedural protections for research involving human subjects. These two sets of research regulations are distinguished from each other by having different foci of enforcement, priorities of protection, oversight officials, oversight procedures, seizure of evidence, standards of proof, expectations of privacy, and appeal procedures for researchers who are subject to adverse findings and penalties. These differences are significant and fundamental. They complicate the process of compliance for institutions and researchers, who are expected to adhere to both sets of standards for the same federally funded research activities in research with human subjects. Compliance is especially complicated when suspected violations of both sets of standards must be investigated and resolved concurrently. This document represents an effort to provide institutions and individuals with practical suggestions as they try to comply with both sets of regulations.