Institutional Review Board
Continuing Review Checklist for the Primary Reviewer
IRB Number
IRB Meeting Date
Primary Reviewer
PI Name
Protocol Title:
INSTRUCTIONS
Please complete this checklist as you review your protocol. Provide your stipulations on the last page under
“Stipulations”. Please be advised every section must have a response.
Please log into InfoEd at https://rdhs.utmb.edu/ to complete review.
§46.111 Criteria for IRB approval of research
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are
satisfied:
(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.
(4) 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 the regulators.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by the regulators..
(6) When appropriate, the research plan makes adequate provision for monitoring the
data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality
of data.
(b) When some or all of the subjects 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 have been included in the study to protect the rights and welfare of these subjects.
Last Revised 10/20/08
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CONTINUING REVIEW SUBMISSION
Has the continuing review report been submitted in a timely fashion?
YES
NO
YES
NO
Has the form been completed to its entirety?
YES
NO
YES
NO
YES
NO
Check
Appropriate
box
Check
Appropriate
box
YES
NO**
YES*
NO
YES
NO**
YES*
NO
YES
NO
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
Is the information provided (and attachments) in the report adequate?
Has an adequate protocol summary been provided?
Has there been a change in the financial relationship with the sponsor and the PI and/or study personnel
listed on this project?
Points for Discussion:
SUBJECT ENROLLMENT
Open to Enrollment of New Subjects
Closed to enrollment of new subjects
(Skip item a)
(Please answer item a)
a.
Subjects are still receiving study interventions
Subjects have completed all study interventions, study remains open for long-term follow-up
Subjects have completed all study interventions, data analysis only
Is the selection of subjects equitable?
**If “NO”, specify in stipulations.
Is enrollment into this study, to date, less than 20% of the projected enrollment?
*If “YES”, was a rationale for this low enrollment and a justification as to why the study should be
continued provided?
**If “NO”, specify in stipulations.
Have any subjects been withdrawn or discontinued from the project?
How many?
Reasons:
Points for Discussion:
PROTOCOL DEVIATIONS
Has there been any protocol deviations reported and reviewed by the IRB?
Do the deviations alter the risk/benefit ratio?
Were protocol changes required or recommended to prevent similar incidents in the future?
Were these changes submitted for IRB review and approved?
Points for Discussion:
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NON-WRITTEN CONSENT - WRITTEN CONSENT/PERMISSION
YES*
NO**
Is this project approved for non-written consent?
YES*
NO**
YES
NO
YES
NO
*If “YES”, was assent obtained from each subject?
**If “NO”, specify in stipulations.
YES
NO*
If this project is approved for children, were copies of the parental permission forms provided?
*If “NO”, specify in stipulations.
Note: Permission means the agreement of parent(s) or guardian to the participation of the child in the research or clinical
investigation.
Is the consent/permission form still adequate and written in a language easily understandable to the subject, and/or
guardian? **If “NO”, specify in stipulations.
YES
NO**
YES*
NO
YES
NO**
YES
NO
Is this project approved for written consent?
Were copies of the consent forms provided?
If “NO”, specify in stipulations.
Will genetic/DNA analysis be performed and/or will DNA be store for future use?
*If “YES”, are the procedures adequately described in the consent/permission form?
**If “NO”, specify in stipulations.
Are all of the elements included and accurate? (Please check below)
If “NO”, please specify in stipulations.
Required Elements
A statement that the study involves research
A statement that participation is voluntary
An explanation of the purpose of the study
A description of procedures to be followed (coincides with protocol)
Identification of any procedures which are experimental
A description of any reasonably foreseeable risks or discomforts to the subject (coincides with protocol)
The anticipated number of subjects to be enrolled
The duration of participation
A description of benefits to the subjects (if any) (coincides with protocol)
A description of benefits to society (if any)
A disclosure of appropriate alternative treatment/procedures, if any, that might be advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained (HIPAA
language)
A statement that notes the possibility that the Food and Drug Administration may inspect the records
The amount of reimbursement (if any) and a schedule of the reimbursement
An explanation as to whether any compensation is available if injury occurs
If compensation is available, what it consists of, or where further information may be obtained
An explanation as to whether any medical treatments are available if injury occurs
If medical treatments are available if injury occurs, what it consist of, or where further information may be obtained
Any additional costs to the subjects that may result from participation in the research
Anticipated circumstances under the PI may terminate the subject’s participation without the subject’s consent
The procedures for orderly termination of participation of a subject (if applicable)
The consequences of a subjects decision to withdraw from the research (if applicable)
An explanation of whom to contact for answers to pertinent questions about the research
An explanation of whom to contact for answers to pertinent questions about the research participant’s rights
An explanation of whom to contact in the event of a research-related injury to the participant
Contact information for the research team for questions, concerns, or complaints
Contact information for someone independent of the research team for problems, concerns, questions, information or input
A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled
A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the
participant is otherwise entitled
Last Revised 10/20/08
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YES
NO**
N/A
YES
NO**
N/A
YES
NO**
N/A
YES
NO**
N/A
WRITTEN CONSENT/PERMISSION
Additional Elements (if appropriate)
A statement that specific treatment or procedures may involve risks to the subject (or to the embryo or fetus,
if the subject is or may become pregnant), which are currently foreseeable.
**If “NO”, specify in stipulations.
A statement that significant new findings developed during the course of the research, which may relate to
the subject’s willingness to continue participating will be provided to the subject.
**If “NO”, specify in stipulations.
A statement if the PI or his/her collaborators have a financial COI or have received a management plan from
the COI committee.
**If “NO”, specify in stipulations.
Is the consent/permission form still accurate and complete?
If “NO”, specify in stipulations.
Points for Discussion:
YES*
NO
N/A
YES
NO**
N/A
CHILD ASSENT
Is child assent required (for subjects ages 7-17)?
Note: Assent means the child's affirmative agreement to participate in research or clinical investigation. Mere failure to
object may not, absent affirmative agreement, be construed as assent.
*If “YES”, is the assent form appropriate and written in a language easily understandable to the subject?
**If “NO”, specify in stipulations.
Points for Discussion:
ADVERSE EVENTS/UNANTICIPATED PROBLEMS/SUBJECT COMPLAINTS
Have any adverse events and/or unanticipated problems been reported to the IRB?
YES
NO
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES*
NO
N/A
YES*
NO
N/A
a.
Do any of these events/problems alter the risk/benefit ratio?
b.
Was it required that currently enrolled subjects be informed of the events/problems?
c.
Did the consent/permission/assent form(s) require modification to include new information?
Have any subject complaints been reported to the IRB?
a.
Do any of the complaints raise concern and need to be discussed?
*If “YES”, specify in Points for Discussion and/or stipulations.
Points for Discussion:
Last Revised 10/20/08
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YES*
NO
YES
NO**
N/A
DATA & SAFETY MONITORING PLAN (DSMP)
Does this study have a DSMP?
Note: All clinical research trials including drugs, biologics or interventions of any kind, requires submission of a Data and
Safety Monitoring Plan (DSMP). A DSMP is a general plan contained in the research protocol to ensure the safety of
subjects and to ensure the validity of the data.
*If “YES”, were copies of safety monitoring reports submitted (local and Multicenter)?
**If “NO”, specify in stipulations.
Points for Discussion:
YES*
NO
YES
NO
N/A
YES
NO
N/A
PROTOCOL AMENDMENTS/MODIFICATIONS
Have there been any protocol amendments/modifications since the last review?
Note: PI not required to list administrative changes (i.e., change of study personnel, typographical errors, etc.)
*Do any of the changes alter the risk/benefit ratio?
Have there been any amendments to the Investigator’s Drug Brochure (IDB)?
Points for Discussion:
YES*
NO
YES
NO
N/A
YES
NO
N/A
AUDITS/SITE VISITS
Has this study been audited (internal or external)?
*If “YES”, were there any findings of non-compliance?
If so, state the findings in Points for Discussion.
*Were these reports previously reviewed by the IRB?
If “NO”, specify in stipulations.
Points for Discussion:
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YES*
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES
NO
YES
NO
OTHER CONSIDERATIONS
Have there been any new significant findings?
If “YES”, could this information influence the willingness of current and/or future subject participation?
If so, has the consent form been modified to include this information? Yes
No
If so, should current subjects be notified? Yes
No
Re-Consented? Yes
No
Do the risks to subjects continue to be minimized and reasonable in relation to anticipated benefits?
Are vulnerable populations included? If so, please check the appropriate boxes below:
Pregnant Women
Fetuses/Neonates
Prisoners
Children
Mentally Incapacitated
If vulnerable populations are included, do the study procedures ensuring safeguards for the vulnerable
population continue to be adequate?
If vulnerable populations are included, does is still meet the requirements under the approved subparts?
If “NO”, specify in stipulations.
Does the research plan make adequate provisions for monitoring the data collected to ensure safety of the
subjects?
Are there adequate provisions to protect the privacy of subjects and maintain confidentiality of data?
Is a certificate of confidentiality required?
Note: Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research
information from forced disclosure. They allow the investigator and others who have access to research records to refuse
to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other
proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies
collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial
standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to
disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research
objectives and promote participation in studies by assuring confidentiality and privacy to participants.
Points for Discussion:
Last Revised 10/20/08
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Check
Appropriate
box
YES
NO
YES*
NO
YES
NO
Check
Appropriate
box
REVIEW PERIOD
Level of Risks:
Minimal
Moderate
High
Note: Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests. Clinical investigations are usually more than minimal risk.
Does the research still meet the criteria for approval under 45 CFR 46.111?
Note: See page 1 for checklist.
Does the protocol need verification from sources other than the principal investigator that no material changes
have occurred since the last IRB review? If “Yes”, please explain in stipulations.
In view of the risks, is the review of research activities on an annual basis appropriate?
If “NO”, review should occur at:
3 MONTHS
6 MONTHS
RECOMMENDATIONS
APPROVAL
APPROVAL WITH STIPULATIONS
DEFERRAL
Stipulations:
IRB Reviewer Signature: _______________________________________________
Last Revised 10/20/08
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Date: _____________________