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ACHRE Report Part III Chapter 14 The Federal Policy for Human Subject Protections (The Common Rule) Research Involving Ionizing Radiation Scope of Programs of Research Involving Human Subjects Administravtive Structures and Procedures for Research Oversight Federal Responses to Violations of Human Subjects Protections |
Chapter 14: Federal Responses to Violations of Human Subjects ProtectionsIn the event that the Common Rule is violated in the conduct of federally sponsored research involving human subjects, there are various responses that can affect both investigators and grantee institutions, such as withdrawal or restriction of an institution's or project's assurance and, with that action, of research funding and suspension or termination of IRB approval of the research. In addition, an IRB is authorized by the Common Rule to suspend or terminate its approval of research that fails to comply with the IRB's requirements or when a research subject suffers an adverse event.[37] No federal department or agency may continue to fund a project from which IRB approval has been withdrawn or at an institution whose assurance has been withdrawn.[38]An institution's or investigator's prior performance with respect to human subjects protections may affect future federal funding as well. If human subjects protection regulations are willfully violated, the department secretary or agency head may bar the organization or individual from receiving funding from any federal source.[39] Such debarment must be for a specified length of time and, in some extreme cases, may be permanent. Federal agencies may also take disciplinary action against employees involved in human subjects research for failure to follow human subjects protection rules. For example, DOD sanctions for noncompliance by intramural researchers include loss of investigator privileges. For military personnel, potential sanctions are letters of reprimand, nonjudicial punishment, and sanctions under the Military Code of Justice; for civilian DOD personnel, sanctions include reprimands, suspension, or termination of employment. No requirement of the Common Rule can preempt state and local laws governing the conduct of human subjects research that are stricter or provide additional protections for subjects. Of those states with any laws governing research involving human subjects, only California authorizes sanctions for failure to obtain a subject's informed consent.[40] The California statute authorizes monetary awards for negligent failure to obtain a subject's informed consent (up to $1,000), for willful failure to obtain such consent (up to $5,000) and, if a subject is thereby exposed to "a known substantial risk of serious injury either bodily harm or psychological harm," jail terms of up to one year and/or fines of up to $10,000. |