HRPP SOP 105
- Policy Title: Determination of the Need for Verification That No Material Changes Have Occurred
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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
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 for a determination of the necessity of an audit of human subjects research conducted under the auspices of Brandeis University.
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 the Brandeis University Institutional Review Board may determine at any time that verification from sources other than the principal investigator is necessary to ensure no material changes have occurred since the last review of a human subjects research project being conducted under its auspices.
IV. Procedures
Any member of the Institutional Review Board may request monitoring of approved projects in the form of routine, targeted or random audits. Possible reasons for such audits include, but are not limited to:
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Complaints received from research subjects.
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Concerns raised by a third party.
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Research involves a high risk of harm to subjects.
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An occurrence of an unanticipated problem or adverse event.
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A history of noncompliance by the investigator.
Any member of the IRB may request an audit be conducted. Such an audit may be conducted by one or more members of the IRB and/or an independent person designated by the IRB.
Audit activities may include, but are not limited to, the following:-
Requesting progress reports from investigators.
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Examining research records.
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Contacting research subjects.
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Dispatching observers to the sites where research involving human subjects and/or the informed consent process is being conducted.
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Auditing advertisements and other recruitment materials.
Results of the audit are reported at the next convened IRB meeting. If the auditors believe the subjects are being put at immediate risk due to the occurrence of material changes, a special meeting may be called.
A report of the committee's review of the audit is communicated electronically to the principal investigator, the institutional official and the department or agency head, as appropriate. A copy is placed in the IRB file and a signed hard copy is available upon request.
If the auditors suspect noncompliance by the research team, procedures for the reporting of noncompliance are initiated.