Internal Use Only
CONSENT PROCESS CHECK LIST
A. Informed Consent Process: Please review and confirm the circumstances of the consent process. Next, confirm the presence of all
applicable elements of informed consent in the consent document (e.g., consent form, information sheet, or verbal telephone script).
List any concerns you would like communicated to the researcher in the IRB Reviewer Checklist.
(Documentation & General Requirements of Consent per 45 CFR 46.116, 45 CFR 46.117, 21 CFR 50.25, 21 CFR 50.27 & UCI policy)
Circumstances of Consent
YES
NO
N/A
YES
NO
N/A
The information presented to the subject or (LAR) will be in a language understandable to the subject or
the representative.
YES
NO
N/A
4
No information will be provided to the subject or subject’s LAR that waives or appears to waive any of
the subject’s legal rights.
YES
NO
N/A
5
No information will be provided to the subject or the subject’s LAR that releases or appears to release
the researcher, the sponsor, the institution, or its agents from liability for negligence.
YES
NO
N/A
6
The subject or the subject’s LAR will sign and date the informed consent form.
YES
NO
N/A
7
A copy of the informed consent document will be given to the person signing the form.
YES
NO
N/A
8
If this study requests the use of short form consent, the use of short form consent is approvable.
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
N/A
YES
NO
N/A
YES
NO
N/A
1
The circumstances of consent provide the subject or LAR sufficient opportunity to consider whether or
not to participate.
2
The circumstances of consent minimize the possibility of coercion or undue influence.
3
General Requirements of Informed Consent
Items listed below with grey shading and blue text are not required elements. They are “additional” elements.
1
Disclose that the study involves research.
2
Include only study team members currently authorized to obtain informed consent as listed in the
protocol narrative.
3
Explain the purpose of the research.
4
The approximate number of subjects involved in the study is not important in making a decision to
participate in research.
Explain the approximate number of subjects involved in the study (# at UCI / total # for all study sites).
5
Explain the expected duration of the subject's participation.
6
Describe the procedures to be followed.
7
Identify any procedures that are experimental.
8
Describe any reasonably foreseeable risks or discomforts to the subject.
9
For studies with scans (e.g., MRI, X-ray, CT), include risk language regarding incidental findings.
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10
The risk profile of all research-related interventions is well known and the research involves no
investigational drugs or devices.
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
N/A
YES
NO
N/A
Disclose that the particular treatment or procedure may involve risks to the subject which are currently
unforeseeable.
The research does not target pregnant women and/or women of child bearing potential. Study not
reviewed under 45 CFR 46 Sub Part B.
The research excludes pregnant women and/or women of child bearing potential.
11
This research includes pregnant women and/or women of child bearing potential. The risk profile of all
research interventions or interactions on embryos and fetuses is well known.
This research includes pregnant women and/or women of child bearing potential. Disclose that the
particular treatment or procedure may involve risks to the embryo or fetus, if the subject is or may
become pregnant, which are currently unforeseeable.
12
Describe any benefits to the subject or to others which may reasonably be expected from the research.
13
Disclose appropriate alternative procedures or courses of treatment, if any that might be advantageous to
the subject.
Disclose study compensation.
14
Compensation is over $600, language regarding tax reporting requirement is included.
Compensation is processed through the UCI Office of Accounting, language regarding releasing
personal information to UCI Accounting is included.
There are no costs to the subject that may result from participation in the research.
15
Disclose additional costs to the subject that may result from participation in the research.
16
Include UCI's compensation for injury statement.
The research involves no more than minimal risk.
There are no anticipated circumstances under which the subject's participation will be terminated by the
researcher without regard to the subject's consent.
17
Disclose anticipated circumstances under which the subject's participation may be terminated by the
investigator without regard to the subject's consent.
There are no adverse consequences (physical, social, economic, legal or psychological) of a subject's
decision to withdraw from the research.
18
Disclose the following information:


The consequences of the subject’s decisions to withdraw from the research.
The orderly termination of participation by the subject.
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19
Include applicable template language that informs subjects of their rights related to data retention.
20
Disclose the extent, if any, to which confidentiality of records identifying the subject will be maintained.
(Include language on Subject Identifiable Data, Data Storage, Data Retention, Who Will Have Access to
Data).
Include the possibility that the FDA may inspect the records.
21
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
N/A
YES
NO
N/A
The research is NOT subject to FDA regulations.
22
For clinical trials approved by the IRB on or after March 7, 2012, include ClinicalTrials.gov language
required by the FDA.
23
For NCI-funded research, include required template on the Clinical Trials Reporting Program.
24
For studies involving a Certificate of Confidentiality, include appropriate template language.
25
When subjects are asked to donate leftover biospecimens or collecting additional biospecimens, include
how the donated biospecimens will be used.
The research does not involve specimen collection.
Disclose that specimens are property of the UCI and that specimens will be discarded or destroyed once
used for this specific study.
26
Disclose that specimens are property of UCI; that subjects will not have access to them; and that
specimens will be retained and used for research where such use may result in inventions or discoveries
that could become the basis for new products or diagnostic or therapeutic agents. The subject will not
receive any compensation derived from any commercial or other products that may be developed from
use of the specimens.
Any specimens obtained for the purposes of this study will be provided to the Sponsor of this study; that
subject will not have access to them; specimens are not directly identifiable; and that specimens will be
retained and used for research where such use may result in inventions or discoveries that could
become the basis for new products or diagnostic or therapeutic agents. The subject will not receive any
compensation derived from any commercial or other products that may be developed from use of the
specimens.
Standard template language for use when the study involves
genetic testing or access to genetic information.
27
Alternate template language for research that involves individuals
who have a diagnosis and/or are being treated for a genetic
disease or disorder.
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The research involves no more than minimal risk and there is not even the appearance of a financial
conflict of interest.
Disclose that that no one on the study team has a significant financial interest in the outcome of this study.
28
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
YES
NO
N/A
Disclose that a member of the study team personal financial interest in either the Sponsor or another
interested entity. The nature of this financial interest and the design of the study have been reviewed by
the UCI Conflict of Interest Oversight Committee, and that this committee has determined that the
investigator's financial interests would not compromise the quality or reliability of the study.
29
Include UCI’s statement explaining whom to contact for answers to pertinent questions about the
research and about the research subjects' rights.
30
Explain whom to contact in the event of a research-related injury to the subject.
31
Disclose that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits
to which the subject is otherwise entitled, and that the subject may discontinue participation at any time
without penalty or loss of benefits, to which the subject is otherwise entitled.
Significant new findings during the course of the research which may relate to the subject's willingness to
continue participation are unlikely.
32
Include a statement that significant new findings developed during the course of the research, which may
relate to the subject's willingness to continue participation will be provided to the subject.
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