IRB review of psychiatric medication discontinuation and symptom-provokingstudies

Federal regulations governing human subjects research call for additional p rotections for the "mentally disabled." However, there is currently no cons ensus definition of mental disability or guidelines for how these research subjects should be protected. This ambiguity complicates the work of instit utional review boards (IRBs) charged with the review and approval of protoc ols involving psychiatric medication discontinuation and symptom provocatio n. It is particularly important for these studies to be reviewed within the larger context of the research program in which they are conducted. The au thor proposes a process for IRB review of these studies, which includes the implementation of additional safeguards for subjects determined by the IRB to be vulnerable. Recommendations also are made for training psychiatric c linical investigators in issues related to research bioethics.