Suffolk University
Office of Research and Sponsored Programs
Institutional Review Board
Reviewer Worksheet
Reviewer Name:
Date:
Protocol Number:
Protocol Title:
Principal Investigator:
Co-Investigator:
§46.109(e) CONTINUING REVIEW CHECKLIST
☐The protocol was originally assigned as a Full Board Review
☐The protocol was originally assigned as an Expedited Review
Is the continuing review for data analysis only or will subjects continue to enroll?
If data analysis only, skip to section EVALUATING RESEARCH PROGRESS
If continued enrollment go to next section
INITIAL PROTOCOL REVIEW
Was the research initially reviewed and approved at a convened meeting of the
IRB?
☐Data Analysis
Only
☐Continuing
Review
☐Yes
☐No
Continue if Yes or No
If Yes, the continuing review will need to be discussed at a full board meeting.
RISK ASSESSMENT AND MONITORING -- §46.110 Determination of Risk
Does the research present more than minimal risk to subjects as determined by initial review
of the protocol by the IRB?
☐Yes
☐No
If NO continue.
If YES  STOP continuing review must take place at a convened meeting of the IRB.
Is new information presented by the investigator, such as new procedures or a
modification of procedures that would likely increase risk to subjects?
If NO continue.
If YES STOP continuing review must take place at a convened meeting of the IRB.
☐Yes
☐No
Are risks to subjects 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 subjects for
diagnostic or treatment purposes? - 45CFR46.111(a)(1).
Comments:
☐Yes
☐No
Are risks to subjects reasonable in relation to the anticipated benefits, if any, and the
importance of the knowledge that may be reasonably expected to result?
☐Yes
Reviewer Instructions Version 5.13.15
Suffolk University
Office of Research and Sponsored Programs
Institutional Review Board
Reviewer Worksheet
☐No
Comments:
Does the investigator make adequate provisions in the research plan for monitoring
the data collected to ensure the safety of subjects?
☐Yes
☐No
Comments:
Are adequate provisions in place to protect the privacy of subjects and to maintain
confidentiality of data?
☐Yes
☐No
Comments:
ADEQUACY OF THE INFORMED CONSENT PROCESS
Does the continuing review include a modification to the informed consent process
whereby a waiver of informed consent or waiver of documentation of informed
consent is requested by the investigator?
☐Yes
☐No
If NO continue.
If YES STOP continuing review must take place at a convened meeting of the
IRB.
Is there any new information that should be considered to represent such a
significant new finding that it should be communicated to subjects who have
☐Yes
☐No
comments section below, if the investigator included provisions for
communicating such findings to research participants.
Comments:
Is informed consent sought from each prospective subject or the subject’s legally
authorized representative.
☐Yes
☐No
Comments:
Is the investigator using the most recently approved version of the informed
consent document and does the document contain the most accurate and up-to-date
information about the research?
☐Yes
☐No
Comments:
Does the informed consent document or process provide an accurate and up-todate description of the reasonably foreseeable risks and discomforts.
☐Yes
☐No
Comments:
If applicable, does the informed consent document or process disclose alternative
procedures or courses of treatment that might be advantageous to the subject?
Comments:
Reviewer Worksheets Version 5.13.15
☐Yes
☐No
Suffolk University
Office of Research and Sponsored Programs
Institutional Review Board
Reviewer Worksheet
Is any new information presented by the investigator (or others) that raises
concerns about the circumstances under which informed consent is being obtained
(e.g. conflicts of interest)?
☐Yes
☐No
Comments:
EVALUATING THE INVESTIGATOR AND INSTITUTIONAL ISSUES
Have there been any changes in the investigator’s situation or qualifications?
☐Yes
☐No
Comments:
Have there been any complaints by research subjects or others related to the
investigator’s conduct of the research?
☐Yes
☐No
Comments:
Have there been any changes in the acceptability of the proposed research in terms
of institutional commitments and applicable regulations (State & local law or
standards of professional conduct)?
☐Yes
☐No
Comments:
Have there been any reports received from any third party observations of the
research?
Comments:
EVALUATING RESEARCH PROGRESS
Is the information provided by the investigator consistent with the research
protocol previously approved by the IRB?
Comments:
☐Yes
☐No
☐Yes
☐No
Is enrollment consistent with the planned number of subjects described in the IRBapproved protocol and are enrollment targets being met (make sure to indicate that
enrollment numbers are at or below maximum approved)?
Comments:
☐Yes
☐No
Is enrollment occurring at a rate expected with the ability to provide sufficient data
to answer the scientific question being addressed?
Comments:
☐Yes
☐No
Is the rate of subject withdrawal and the reasons for withdrawal reasonable?
☐Yes
☐No
Comments:
Reviewer Worksheets Version 5.13.15
Suffolk University
Office of Research and Sponsored Programs
Institutional Review Board
Reviewer Worksheet
OTHER CONSIDERATIONS
Selection of subjects is equitable – 45CFR46.111(a)(3)
☐Yes
☐No
Appropriate safeguards are in place to protect subjects that are likely to be
vulnerable to coercion or undue influence and when the research involves pregnant
women, fetuses, or neonates; prisoners; or children, the research satisfies the
additional requirements for IRB approval 45CFR46.111(b) and subparts B,C, an D
respectively.
☐Yes
☐No
Provide Protocol Specific Comments:
☐Approved
☐Referred to Full Board
☐Required Information or Modifications
Reviewer Worksheets Version 5.13.15