Protocol Review Form [rev March 2014]
“Third Party Access to Existing Data Protocol”
Protocol Number:
Investigator:
Title:
Reviewer:
A. Are the potential benefits of the study shown?
B. Informed Consent/Authorization
For the original data collection, was informed consent obtained for:
1. data use for program evaluation?:
2. data use for research purposes?:
Yes*
Yes*
No
No
C. Is it clear what data are to be collected? Will personal identifiers be included?
D. Could the research be practicably conducted without access to the data? [must be “no” for
authorization]
E. Could the research be practicably conducted without the waiver of authorization? [must be “no” for
authorization]
F. Is the research of no more than minimal risk? [must be “yes” for authorization]
1. If informed consent for use of the data for program evaluation purposes has not been
established [section C1, above], researcher must show that the individuals, even if personal
identifiers are absent, will not be placed at greater than minimal risk by the research [for
example by substantial risk of loss of benefits depending upon the results obtained].
CSUB IRB, Third-Party Protocol Review Form, Rev March 2014
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2. If personal identifiers are present, establish that each of the following is present:
a. An adequate plan to protect identifiers from misuse;
b. An adequate plan to destroy the identifiers at the earliest opportunity consistent with
the research and law;
c. Adequate assurances that the data will not be disclosed to any other person or entity
except as required by law;
d. Adequate oversight of the research project.
Recommended Action:
Full Approval
Conditional Approval
Conditions:
Disapproval
Signature:
Date:
CSUB IRB, Third-Party Protocol Review Form, Rev March 2014
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