Boston College Institutional Review Board
Office for Research Protections
140 Commonwealth Avenue, Waul House
Chestnut Hill, MA 02467
Tel: (617) 552-4778, Fax: (617) 552-0498
E-mail: irb@bc.edu
IRB Member Checklist
Continuing Review
Reviewer
Review
Date
Protocol
Number
Principal
Investigator
Comments
1.
Is the number of subjects accrued consistent with the IRB approved number?
Yes No
2.
Do the subject withdrawals indicate a problem with the protocol that needs correction?
Yes No
3.
Does the protocol summary include study amendments and new information on
adverse events? Yes No
4.
Are the actual risks and benefits as anticipated in the initial review?
Yes No
5.
Have any subjects been seriously harmed?
6.
7.
Have any unforeseen problems or accidents occurred? Yes
If so, has the BC IRB been properly informed? Yes No
8.
Since the last BC IRB review is there new risk, benefit, or alternative
treatment information that might affect subjects willingness to participate in the
research? Yes No
9.
Are there any new findings, knowledge or adverse events that should be
communicated to subjects? Yes No
10.
Does the progress of the research together with any new information indicate that the
BC IRB should impose any new restrictions or relax any restrictions that were
previously imposed? Yes No
11.
Does the consent form require revision?
12.
Are the procedures agreed upon at the beginning of the research still being used?
Yes No
13.
Does the protocol adequately provide for continuing assessment of the balance
between risk and benefits Yes No
14.
Are the procedures for data monitoring adequate?
15.
If a study did not have a DSMB, should one be established?
BC IRB
Continuing Review Checklist – IRB Members
Rev. 1/19/10
Yes
Yes
No
No
No
N/A
Yes
No
Yes
No
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16.
Does the IRB need to request verification from other sources that no material changes
have occurred since the previous IRB review? (i.e. if there is a history of investigator
non-compliance or current indications that material changes have occurred without
IRB approval or unusual types or levels of risk to subjects exist in the study.)
Yes No
17.
What is the risk level of the project at this point?
Minimal More Than Minimal
Comments:
Indicate how risks are minimized:
Qualified investigators
Appropriate inclusion/exclusion criteria
Close monitoring of participants
DSMB
Withdrawal criteria/Informed consent
Informed Consent
18.
19.
If children under age 18 are involved what is the risk level of the project?
a.
Research involving no greater than minimal risk.
b.
Research involving greater than minimal risk but presenting the prospect of
direct benefit to the individual subjects
c.
Research involving greater than minimal risk and not prospect of direct benefit
to individual subjects, but likely to yield generalizable knowledge about the
subject’s disorder or condition.
d.
Research not otherwise approvable which presents an opportunity to
understand, prevent or alleviate a serious problem affecting the health or
welfare of children.
Complicated procedures, PIs with limited experience, higher degrees of risk may
warrant review more often than annually. When should the BC IRB next review the
project?
12mos
Other
ADDITIONAL REVIEWER COMMENTS
Application:
Advertisements:
Questionnaires or
Research Instruments:
Consent Form:
BC IRB
Continuing Review Checklist – IRB Members
Rev. 1/19/10
Page 2
Other Comments:
Reviewer
Recommendation:
Approve.
Approve with Scripted Changes
Return to Reviewer When Changes are Made.
Defer to Full Board.
Please specify Changes or revisions:
BC IRB
Continuing Review Checklist – IRB Members
Rev. 1/19/10
Page 3