IRB review of psychiatric medication discontinuation and symptom-provoking studies.

Abstract:

:Federal regulations governing human subjects research call for additional protections for the "mentally disabled." However, there is currently no consensus definition of mental disability or guidelines for how these research subjects should be protected. This ambiguity complicates the work of institutional review boards (IRBs) charged with the review and approval of protocols involving psychiatric medication discontinuation and symptom provocation. It is particularly important for these studies to be reviewed within the larger context of the research program in which they are conducted. The author 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 clinical investigators in issues related to research bioethics.

journal_name

Biol Psychiatry

journal_title

Biological psychiatry

authors

Rosenstein DL

doi

10.1016/s0006-3223(99)00168-7

subject

Has Abstract

pub_date

1999-10-15 00:00:00

pages

1039-43

issue

8

eissn

0006-3223

issn

1873-2402

pii

S0006322399001687

journal_volume

46

pub_type

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