Fillable FULLBOARDCONTINUINGREVIEWEXPEDITEDCHECKLIST IRB COMMITTEE

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FULLBOARDCONTINUINGREVIEWEXPEDITEDCHECKLIST IRB COMMITTEE

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Page 1 of 2 January 21, 2013
Institutional Review Board
Office of Research Compliance
Continuing Review Checklist
V.1
CONTINUING REVIEW FULL BOARD CHECKLIST
Directions: The purpose of this checklist is to provide documentation of determining whether a project meets the
criteria for continuation at a convened full board meeting. Please contact the IRB staff if you are unable to review this
study or have a conflict of interest related to this research or review.
I. GENERAL
Project Title:
Principal Investigator:
MU IRB#: HR-
Reviewer:
For Meeting Date:
II. REVIEW CRITERIA:
1.
All appropriate documents are included for review.
☐
YES
☐
NO
☐
NA
2.
Risks to participants are minimized by using procedures which are consistent
with sound research design and do not unnecessarily expose participants to risk.
☐ YES
☐ NO ☐ NA
3.
Risks to participants are minimized whenever appropriate, by using procedures
already being performed on the participants for diagnostic or treatment
purposes.
☐
YES
☐
NO
☐
NA
4.
Risks to participants are reasonable in relation to anticipated benefits, if any, to
participants, and the importance of the knowledge that may reasonably be
expected to result.
☐
YES
☐
NO
☐
NA
5.
Selection of participants is 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 procedures.
☐ YES
☐ NO
☐ NA
6.
Informed consent will be sought and appropriately documented from each
prospective subject or the subject’s legally authorized representative. If a waiver
to obtain, document or alter the requirements of informed consent is being
requested, there is adequate justification to do so.
☐
YES
☐
NO
☐
NA
7.
When appropriate, the research plan makes adequate provision for monitoring
the data collected to ensure the safety of participants.
☐
YES
☐
NO
☐
NA
8.
When appropriate, there are adequate provisions to protect the privacy of
participants and to maintain the confidentiality of data.
☐
YES
☐
NO
☐
NA
9.
Are adequate safeguard still in place for participants who are likely to be
vulnerable to coercion or undue influence?
☐
YES
☐
NO
☐
NA
10.
Are there significant new findings concerning this research that might affect the
willingness of participants to continue to take part in the research. If there are
☐
YES
☐
NO
☐
NA
Page 2 of 2 January 21, 2013
significant new findings, are they adequately conveyed to the participants?
11.
Do any reports of non-compliance or participant complaints represent
unanticipated events or problems involving risks to participants or others or
serious or continuing non-compliance?
☐
YES
☐
NO
☐
NA
III. EXPEDITED CATEGORY 9 RECOMMENDATION
1.
Research previously reviewed and approved by the full board may be approved
for future continuing reviews under expedited category 9 if conditions a, b, and c
are met:
(a) The research is not conducted under an investigational new drug application
(IND) or investigational device exemption (IDE); and
(b) No additional risks have been identified since IRB review at a convened
meeting; and
(c) The IRB has determined and documented at a convened meeting that the
research involves no greater than minimal risk.
Based on (a) and (b), would you recommend the study for expedited under
category 9? If so, the committee will be recommended to vote on this for (c).
☐
YES
☐
NO
☐
NA
IV. DETERMINATION
☐
Recommend approval with no changes or stipulations
☐
Recommend disapprove
☐
Recommend approval with changes or stipulations (use comment box below)
COMMENTS
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Completed 11 February 2020

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