HRPP SOP 104
- Policy Title: Determining Which Projects Require Review More Often Than Annually
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Responsible Office: Office of Research Administration
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Responsible Official: Associate Provost for Research Administration
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Effective Date: March 9, 2018
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Revision Date: Feb. 8, 2019
I. Purpose of This SOP
The purpose of this SOP is to set forth the procedures to be followed by the Brandeis University Institutional Review Board in determining at what interval approved human subjects research being conducted under the auspices of Brandeis University should be reviewed.
II. Scope of This SOP
This SOP applies to human subjects research projects conducted under the auspices of Brandeis University.
III. Statement of SOP
It is the standard operating procedure of Brandeis University that when determining the appropriate interval for continuing review of human subjects research conducted under its auspices and reviewed by the fully convened Institutional Review Board, IRB members consider such things as the degree of risk to subjects, the vulnerability of the subject population and the nature and novelty of the intervention.
IV. Procedures
Full-committee reviewed research may be determined to require annual or more frequent than annual review. The determination to review a study more often than annually can be made at any time and as a response to such things as modifications in the research, noncompliance by the researcher(s) or an occurrence of an unanticipated problem or adverse event.