HRPP
Protocol ID:
CHK-38m
CIRB
Informed Consent Form Checklist
Stanford University
PD:
1/4
Meeting Date:
Protocol Title:
Checklist completed by (IRB Staff name):
Date:
ICF Element
Text/Language in the ICF
Stanford
University Header
Standard Header, as on templates
Approval and
Expiration Dates
Dates match CIRB approval and Expiration dates
Footers
Participant ID and study barcode, if required by hospital
Participation in
other research
Are you participating in any other research studies? ___ Yes ___No
Enrollment
Stanford University expects to enroll (state number) research study participants.
Samples
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Your samples will be sent outside of Stanford for analysis.
AND/OR
Any of your samples which are used in research may result in new products, tests or discoveries. In
some instances, these may have potential commercial value and may be developed and owned by
the Investigators, Stanford University and/or others. However, donors of samples do not retain
any property rights to the materials. Therefore, you would not share in any financial benefits from
these products, tests or discoveries.
AND/OR
Any samples left over after analysis will be destroyed when the study is completed.
MRI
IF YOU FEEL DISCOMFORT AT ANY TIME, NOTIFY THE OPERATOR AND YOU CAN DISCONTINUE
THE EXAM AT ANY TIME.
Participant
Responsibilities
Follow the instructions of the Protocol Director and study staff.
Benefits
We cannot and do not guarantee or promise that you will receive any benefits from this study.
Participant Rights
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ClinicalTrials.gov
CHK01038 rev2 09/13
You should not feel obligated to agree to participate. Your questions should be answered clearly
and to your satisfaction. If you decide not to participate, tell the Protocol Director.
AND
You will be told of any important new information that is learned during the course of this
research study, which might affect your condition or your willingness to continue participation in
this study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by
U.S. Law. This Web site will not include information that can identify you. At most, the Web site
will include a summary of the results. You can search this Web site at any time.
Research Compliance Office
Stanford University
HRPP
ICF Element
Confidentiality
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HIPAA
Authorization
CIRB
Informed Consent Form Checklist
CHK-38m
2/4
Text/Language in the ICF
Patient information may be provided to Federal and other regulatory agencies as required. The
Food and Drug Administration (FDA), for example, may inspect research records and learn your
identity if this study falls within its jurisdiction.
AND/OR
The purpose of this research study is to obtain data or information on the safety and effectiveness
of (insert name of drug, device, etc.); the results will be provided to the sponsor, the Food and
Drug Administration and other federal and regulatory agencies as required.
If embedding the Authorization, insert before Financial Considerations and/or after Confidentiality
(the authorization should not be the last document in the ICF). HIPAA Authorization requires its
own signature line per California law.
Costs
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Research related
injury
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There is no cost to you for participating in this study.
OR
If you participate in this study, there may be additional costs to you. These include the personal
time it will take to come to all of the study visits.
The study will pay for those services, supplies, procedures, and care associated with this study that
is not a part of your routine medical care.
Participation in this study is not a substitute for health insurance. You and/or your health
insurance must pay for those services, supplies, procedures, and care that you require during this
study for routine medical care. You will be responsible for any co-payments and/or deductibles
as required by your insurance.
All forms of medical diagnosis and treatment – whether routine or experimental – involve some
risk of injury. In spite of all precautions, you might develop medical complications from
participating in this study. If such complications arise, the Protocol Director and the research study
staff will assist you in obtaining appropriate medical treatment. In the event that you have an
injury or illness that is directly caused by your participation in this study, reimbursement for all
related costs of care first will be sought from your insurer, managed care plan, or other benefits
program. You will be responsible for any associated co-payments or deductibles as required by
your insurance.
If costs of care related to such an injury are not covered by your insurer, managed care plan or
other benefits program, you may be responsible for these costs. If you are unable to pay for such
costs, the Protocol Director will assist you in applying for supplemental benefits and explain how
to apply for patient financial assistance from the hospital.
You do not waive any liability rights for personal injury by signing this form.
OR
All forms of medical diagnosis and treatment – whether routine or experimental – involve some
risk of injury. In spite of all precautions, you might develop medical complications from
participating in this study. If such complications arise, the Protocol Director and the research study
staff will assist you in obtaining appropriate medical treatment. In the event that you have an
injury or illness that is directly caused by your participation in this study, care will be provided to
you. You will not be responsible for any of these costs.
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If you receive Medicare benefits, and if the sponsor of this study pays for any study-related
treatment, complications or injuries, personal information about you, your treatment, and your
participation in this study will be provided to the sponsor, who is required by law to provide it to
Medicare.
You do not waive any liability rights for personal injury by signing this form.
CHK01038 rev2 09/13
Research Compliance Office
Stanford University
HRPP
CIRB
Informed Consent Form Checklist
ICF Element
CA Bill of Rights
CHK-38m
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Text/Language in the ICF
As a research participant you have the following rights. These rights include but are not limited to
the participant's right to:
 be informed of the nature and purpose of the experiment;
 be given an explanation of the procedures to be followed in the medical experiment, and
any drug or device to be utilized;
 be given a description of any attendant discomforts and risks reasonably to be expected;
 be given an explanation of any benefits to the subject reasonably to be expected, if
applicable;
 be given a disclosure of any appropriate alternatives, drugs or devices that might be
advantageous to the subject, their relative risks and benefits;
 be informed of the avenues of medical treatment, if any available to the subject after the
experiment if complications should arise;
 be given an opportunity to ask questions concerning the experiment or the procedures
involved;
 be instructed that consent to participate in the medical experiment may be withdrawn at
any time and the subject may discontinue participation without prejudice;
 be given a copy of the signed and dated consent form; and
 be given the opportunity to decide to consent or not to consent to a medical experiment
without the intervention of any element of force, fraud, deceit, duress, coercion or undue
influence on the subject's decision.
Contact information should include the following as appropriate.
Questions, Concerns, or Complaints: If you have any questions, concerns or complaints about this
research study, its procedures, risks and benefits, or alternative courses of treatment, you should
ask the Protocol Director, (name of Protocol Director). You may contact him/her now or later at
(Protocol Director’s phone number).
Injury Notification: If you feel you have been hurt by being a part of this study, please contact the
Protocol Director, (name of Protocol Director) at (Protocol Director’s phone number).
Contact Info
Independent Contact: If you are not satisfied with how this study is being conducted, or if you
have any concerns, complaints, or general questions about the research or your rights as a
participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone
independent of the research team at (650)-723-5244 or toll free at 1-866-680-2906. You can also
write to the Stanford IRB, Stanford University [M/C 5579], 3000 El Camino Real, Five Palo Alto
Square, 4th Floor, Palo Alto, CA 94306.
If applicable:
Appointment Contact: If you need to change your appointment, please contact (name) at (phone
number).
If applicable:
Alternate Contact: If you cannot reach the Protocol Director, please contact (name) at (phone
number and/or pager number).
If the contact person for both the first two paragraphs will be the Protocol Director, you may
combine the two as follows:
Questions, Concerns, or Complaints: If you have any questions, concerns or complaints about this
research study, its procedures, risks and benefits, or alternative courses of treatment, you should
ask the Protocol Director, (name and phone number of Protocol Director). You should also contact
him/her at any time if you feel you have been hurt by being a part of this study.
Future Contact
CHK01038 rev2 09/13
May we contact you about future studies that may be of interest to you? __Yes __ No
Research Compliance Office
Stanford University
HRPP
ICF Element
CIRB
Informed Consent Form Checklist
CHK-38m
4/4
Text/Language in the ICF
Signing your name means you agree to be in this study and that you were given a copy of this
consent form.
_____________________________________
Signature of Adult Participant
____________
Date
When consent is obtained from a legally authorized representative (LAR) or representatives (e.g.,
parent(s), guardian or conservator), include signature lines for representatives and a description of
their authority to act for the participant.
_____________________________________
Signature of LAR (Parent, Guardian or Conservator)
____________
Date
_____________________________________
Authority to act for participant
Signatures
_____________________________________
(If available) Signature of Other Parent or Guardian
____________
Date
_____________________________________
Authority to act for participant
____________________________________
Signature of Person Obtaining Consent
___________
Date
Add the following if you are using the Short Form Consent Process:
The following witness line is to be signed only if the consent is provided as a summary form and
accompanied by a short form foreign language consent.
_____________________________________
___________
Signature of witness
Date
(e.g., staff, translator/interpreter, family member, or other
person who speaks both English and the participant’s language)
CHK01038 rev2 09/13
Research Compliance Office