Our system of research self-regulation, designed to provide internal checks and balances for those who participate in research involving human subjects, is under considerable stress. Much of this crisis has been caused by what we call mission creep, in which the workload of IRBs has expanded beyond their ability to handle effectively. Mission…

Existing federal government policies and systems to protect against scientific misconduct in government-supported research projects are described, and additional considerations not covered in federal policy are enumerated. Misconduct inquiries and review procedures are outlined. Applicant and institutional responsibility and the role of prevention…