University of Virginia IRB for Health Sciences Research
Continuation Reviewer’s Checklist: Full Board
IRB-HSR#
PI:
Reviewer:
Meeting Date:
Study Status:
Actively Accruing Subjects
Closed to Accrual (subjects currently in treatment)
Instructions: COMPLETION OF THIS ENTIRE FORM IS REQIRED TO DOCUMENT REVIEW.
Review Notes:
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University of Virginia IRB for Health Sciences Research
Continuation Reviewer’s Checklist: Full Board
Review the Status Form, Event and AE reports. Have any of the following occurred Yes
No
NA
since the last IRB continuation approval?
a. Adverse events, untoward events, or outcomes experienced by participants
b. Unanticipated problems involving risks to participants or others
c. Participant withdrawals and the reasons for withdrawals
d. Complaints about the research
e. Amendments or modifications
f. Hold Notifications (FDA)
g. Audits (FDA, PAM)
h. Major Protocol violations or deviations
i. Change in FDA labeling or withdrawal from marketing of drug or device
If you answered YES to any item above, do any negatively affect the risk/benefit ratio so that the study should be
modified or stopped?
YES
NO
Were any of the following submitted since the last IRB continuation approval?
a.
b.
c.
d.
e.
Yes
No
NA
Interim Findings
Recent Relevant Literature
DSMB Reports
Any Relevant multi-center reports
Adverse event reports, protocol deviations, unanticipated problems
If you answered YES to any item above, do you feel the information affects any of the following such that the
study should be modified or stopped?
YES
NO
 Equipoise of study (still not sure which intervention is better than the other)
 Risks associated with the research (increase or decrease)
 Risk-benefit analysis
 Alternative to participation or
 Participant’s willingness to continue participating in the research.
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University of Virginia IRB for Health Sciences Research
Full Board Continuation Reviewer’s Checklist
Additional considerations for continuing review:
1. Have requirements stated in the protocol designed to provide additional protection
to subjects and monitor the safety of the protocol been implemented? (e.g.
DSMB oversight, consent observation, advocate for subject who is ward of state,
two parent signatures, surrogate consent etc.This information may be found in the
new protocol receipt or initial approval event. )
If yes, specify which ones have been implemented:
Comment:
2. Does the consent form contain the most accurate, up to date information?
If NO, describe how the consent form(s) should be revised”:
3. Has the study team exceeded the number of subject they were approved to enroll?
Yes
No
If yes, explain:
 Does this protocol have the potential for benefit? Yes
No
 Is this protocol sponsored by a commercial sponsor? Yes
No
If both questions above are answered NO- answer the question below:
4. Do you have any concerns regarding the ability of the study team to meet
enrollment goals?
Comment:
Note to staff : If YES,
 Enter the following in main comment field: The IRB had enrollment concerns
with (enter year) continuation.
 Enter the following on the assurance form: The board expressed concerns
regarding enrollment with the review of this continuation. Enrollment will be
reviewed again at your next continuation review
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Yes
No
NA
University of Virginia IRB for Health Sciences Research
Full Board Continuation Reviewer’s Checklist
Check the applicable boxes below and complete the text boxes, as necessary. In order to approve this
continuation, the IRB shall determine that all of the following requirements are satisfied.
Under Federal Regulations, the IRB is responsible for a continuing review of research at intervals
appropriate to the degree of risk, but at least once each year. [45CFR 46.109(e)].
Does the
protocol continue to meet the following approval criteria?
Yes No
NA
1. Risks to participants continue to be minimized by using procedures which are
consistent with sound research design and do not unnecessarily expose participants
to risk.
2. Risks to participants continue to be minimized by using procedures, whenever
appropriate, that are already being performed on the participants for diagnostic or
treatment procedures.
3. Risks to participants continue to be reasonable in relation to anticipated benefits, if
any, to participants, and the importance of the knowledge that may reasonably be
expected to result.
4. Selection of subjects remains equitable taking into account the purposes of the
research, the setting in which the research will be conducted, the special problems
of research involving vulnerable populations, the selection criteria and the
recruitment process.
5. Informed consent continues to be sought from each prospective subject or the
subject’s legally authorized representative, in accordance with, and to the extent
required by the regulations.
6. When appropriate, the research plan continues to make adequate provision for
monitoring the data collected to ensure the safety of participants.
7. When appropriate, there are continued adequate provisions to protect the privacy of
participants and to maintain the confidentiality of data.
8. When some or all of the participants are likely to be vulnerable to coercion or undue
influence, such as children, prisoners, pregnant women, mentally disabled
persons, or economically or educationally disadvantaged persons, additional
safeguards continue to be included in the study to protect the rights and welfare of
these participants.
Closed
to
enrollment
REVIEWER: If you select NO to any of the above, the continuing review cannot be approved.
Summarize any other major concerns: [e.g. Study design will not yield useful information; compensation not
acceptable; ethical issues; consenting process issues; inadequate monitoring; specific inappropriate
inclusion/exclusion criteria]
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University of Virginia IRB for Health Sciences Research
Full Board Continuation Reviewer’s Checklist
Documentation of Reviewer Recommendation
Approve Protocol Continuation as submitted for one year
Approve Protocol Continuation for period of less than 1 year
(Designate time frame: 3 months/ 6 months/ other)
Approve Continuation Pending Minor Modifications and review by IRB-HSR Staff and Chair or
designee
Changes include (bullet):
PI will need to resubmit revised protocol and revised consent (if applicable), final approval will
be given by IRB-HSR Chair or Designee after modifications have been made. Examples of items
which are considered minor: grammatical, spelling errors, template issues, providing
investigator specific wording to insert.
List required modifications:
Withhold approval pending major modifications
Additional information is needed from the PI in order to approve continuation. The PI will then
need to re-submit the revised protocol and revised consent (if applicable) at a future IRB-HSR
meeting and may be asked to attend. The study team will be granted 60 days to complete the
request and submit to the IRB-HSR for review. The protocol approval will not expire during this
time period. The protocol will be reviewed at a subsequent full board meeting.
List major concerns:
_____________________________________________
____________
Reviewer Name
Date
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