Background: The peer review of clinical research projects is an essential step in project preparation. While some projects undergo rigorous review by grant-giving organizations, this does not apply to all clinical research. In many cases, peer review, if undertaken at all, is not rigorous, fully independent, or timely. Depending on their…

This paper presents findings from interviews with US Research Integrity Officers (RIOs) on their overall responsibilities as well as perspectives on Data Management Plans (DMPs). DMPs are formal documents describing the roles and activities for managing data during and after research. DMPs are now a required research criterion by many funding…

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act…