Institutional Review Board
[Combined Neuroscience IRB] (http://irb.ninds.nih.gov)
The Combined Neuroscience (CNS) (NEI, NIAAA, NINDS, NICDC, NIMH) IRB reviews all protocols to ensure human subjects protection and ethical conduct of research. Your Branch Chief and the senior staff of your Branch are important resources for protocol submission. The Chair of the IRB is Dr. Barbara Karp (301-496-0150). Dr. Maryland Pao (301-435-5770) is the Deputy Chair and is available to NIMH Principal Investigators for questions. The NIMH Associate Director for Protocol Management is Ms. Jeanne Radcliffe (301-594-7732). The Protocol and Credentialing Coordinator is Ms. Donna Howard (301-496-4588). To schedule a visit to an IRB meeting, please call Ms. Howard. All required IRB forms are on the website (http://irb.ninds.nih.gov/). You must get forms here to get the most current versions.
All protocols are submitted to the Committee for the Scientific Review of Protocols (CSRP) prior to review by the IRB. The CSRP, through an outside peer review process, assesses scientific quality and appropriateness of the study to the goals and mission of the NIMH IRP. A letter of CSRP approval must accompany submission of the protocol to the IRB. Once received by the IRB, the protocol is prereviewed by a committee in the Office of the Clinical Director, whose focus is human subject protection. Use the Initial Protocol Review Checklist (in word form) and the Initial Review Consent Form Checklist (in word form) as guides to the prereview process.
A guide to preparing and conducting a clinical research study called Protomechanics, is available at the website: http://www.cc.nih.gov/ccc/protomechanics/. The Office of Human Subjects Research (OHSR) guidelines for writing research protocols and informed consent documents are found in the http://ohsr.od.nih.gov/.
Serious Adverse Events:
The PI is responsible for summarizing all adverse events (serious and non-serious, expected and unexpected) in the continuing review of the protocol. Most serious adverse events also require reporting in the Clinical Center ORS system.
In addition, the occurrence of any of the following should be directly reported to the office of the clinical director by a member of the physician or nursing staff:
- suicide attempts
- prolonged hospitalization
- death
- AWOL
- Negative clinical outcome
- Medication errors
- Patient injuries
Guidelines for Reporting Adverse Events and the Serious Adverse Event Reporting Form may be found
by selecting the Documents & Forms button in the right margin of this page.
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