INDIANA UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)
Expedited Reviewer Checklist – FYI: VA Prompt Report
IRB Study #:
Principal Investigator:
General Information #:
This form is for expedited review. If IRB reviewer determines reviewed by the convened IRB is necessary, please copy
comments from Section II below into Full Board RVC on SharePoint or provide a copy of this form to reviewer.
Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO):
In general, includes any incident, experience, or outcome that meets all of the following criteria:
1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the
protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the
characteristics of the subject population being studied;
2. related or possibly related to participation in the research (in this guidance document, possibly related means there is a
reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in
the research); and
3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological,
economic, or social harm) than was previously known or recognized.
IRB Staff:
1. Is this study FDA- or VA-regulated?
No. Study may be electronically signed.
Yes. Study may NOT be electronically signed.
Staff Comments:
Staff Initials:
Qualified IRB Reviewer:
1.
Was the event serious (i.e., resulted in a life-threatening experience, inpatient hospitalization, prolongation of hospitalization,
persistent or significant disability or incapacity, congenital anomaly, or birth defect)
Yes
No
2.
Was the event unanticipated (unforeseen in terms of nature, severity, or frequency of occurrence)?
Yes
No
3.
This event was:
related to the research.
possibly related to the research.
probably not related to the research.
4.
Is immediate action needed to prevent an immediate harm to subjects?
Yes. Please explain:
No.
5.
Is an informed consent modification warranted?
Yes. Please explain:
No.
Expedited RVC – FYI: VA Prompt Report v07/21/2015
Page 1 of 3
6.
Is review by the convened IRB necessary?
Yes
No
7.
Based on the information provided by the investigator, do you believe the study continues to meet the criteria for approval
under 45 CFR 46.111 (see below)?
Yes.
No. Please explain.
Full-Board Reviewer:
8.
Does the information provided in this report affect the study’s risk/benefit ratio?
No.
Yes. Please explain:
9.
This report:
represents an unanticipated problem involving risks to subjects or others.
does NOT represent an unanticipated problem involving risks to subjects or others.
10. Based on the information provided by the investigator, do you believe the study continues to meet the criteria for approval
under 45 CFR 46.111 (see below)?
Yes.
No. Please explain.
11. Reviewer recommendation: Based on the information provided by the investigator, the IRB should take the following
action:
Accept report. Sign report and return to investigator.
Accept with provisions. Additional information is required. Please indicate requested information below. Report will
be signed at time of final acceptance.
12. Please include the following information during your report/discussion of the item.
a. Findings in the report:
b. Any unexpected change to the risks or benefits to the research:
c. Corrective measures taken (if any):
Corrective measures are appropriate.
Corrective measures are not appropriate and additional measures should be recommended. Please explain:
d. Any further action required:
Reviewer comments/revisions:
Criteria for approval under 45 CFR 46.111:
1. Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not
unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the
subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge
that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and
benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive
even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge
gained in the research (for example, the possible effects of the research on public policy) as among those research risks that
fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research
and the setting in which the research will be conducted and should be particularly cognizant of the special problems of
research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or
economically or educationally disadvantaged persons.
Expedited RVC – FYI: VA Prompt Report v07/21/2015
Page 2 of 3
4.
5.
6.
7.
Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in
accordance with, and to the extent required by §46.116.
Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of
subjects.
When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of
data.
Expedited RVC – FYI: VA Prompt Report v07/21/2015
Page 3 of 3