CHECK LIST FOR ELEMENTS OF INFORMED CONSENT
YES
NO
1.
We are asking you to take part in a research study of (state what is being studied).
2.
We want to learn (state what the study is designed to discover or establish).
3.
We are asking you to take part in this study because (state why the subject was invited).
4.
(Describe total time over which the subject will be studied).
5.
If you decide to take part, we will (describe in lay language all procedures, their purposes, how long they will take, and their frequency, indicating
which are being done for research only, which are experimental and which are part of standard management,.
6.
Total number of subjects that will be involved in the study overall.
7.
(Describe the discomforts, inconveniences, and other risks to be reasonably expected and indicate incidence of occurrence.)
8.
(Describe any benefits reasonably expected or indicate subject will not benefit. When benefits are mentioned, add:) We do not guarantee you
will benefit from taking part in this study.
9.
(If applicable, add a description of alternative procedures that might be advantageous and disclose any standard treatment being withheld.)
10.
(Describe the possibility of costs to the subject because of participation. VA consent forms must include the following, no exceptions:) If you are
a veteran, your only cost for treatment as a subject in a research study at any South Texas Veterans Healthcare System facility would be the
copayment that may be required based on your category of eligibility for medical care.
11.
(If the subject will receive compensation, describe the amount & nature, when it will be paid and how it will be pro-rated if the subject does not
complete the study. Also add:) The compensation you receive may be taxable. When the total compensation paid to someone participating in
one or more studies is $600 or more in one calendar year, the institution must report the amount to the IRS. The IRS considers it earned income
and treats it like any other income. ( If being paid by a check issued by UTHSCSA, add): Please note that if you are on record as owing money
to the State of Texas, such as for back child support or a delinquent student loan, the compensation will be applied to that debt and you will not
receive a check.)
12.
(Injury/compensation statement): If you are injured as a result of the research procedures, your injury will be treated. You will be responsible for
any charges. We have no plans to give you money if you are injured. (VA consent forms must include different wording. See VA template.)
13.
(Confidentiality statement): (If Protected Health Information [PHI] is being used, a valid authorization must be in the consent. Guidance is found
at: www.uthscsa.edu/irb/hipaa.html ) (If no PHI is involved, include:) Everything we learn about you in the study will be confidential. If we
publish the results of the study in a scientific journal or book, we will not identify you in any way. The Institutional Review Board and other
groups that have the responsibility of monitoring research, may want to see your records which identify you as a subject in this study.
14.
(Right to withdraw): (A valid authorization covers this element, however if no authorization to use PHI will be included, add:) Your decision to
take part in the study is voluntary. You are free to choose not to take part in the study or to stop taking part at any time.
15.
(Without prejudice statement): (A valid authorization covers this element, however if no authorization to use PHI will be included, add:) If you
choose not to take part or to stop at any time, it will not affect your future medical care at the University of Texas Health Science Center at San
Antonio or (name of institution/s at which study is being conducted).
16.
(Principal investigator's full name and phone number [and after-hours phone number - if digital pager give instructions how to use]; full names of
co-investigators who will enroll/perform procedures): If you have questions now, feel free to ask us. If you have additional questions later or you
wish to report a medical problem which may be related to this study, (full name and degrees) can be reached at (work and home phone/afterhours numbers with area code). (note: If >minimal risk, provide names & number of at least 2 MDs or otherwise clinically appropriate people.)
17.
The University of Texas Health Science Center committee that reviews research on human subjects (Institutional Review Board) will answer any
questions about your rights as a research subject (210-567-2351).
18.
We will give you a signed copy of this form to keep. You do not waive any of your legal rights by signing this form.
19.
(Statement of understanding and agreement to participate): (A valid authorization covers this element, however if no authorization to use PHI will
be included, add:) YOUR SIGNATURE INDICATES THAT YOU HAVE VOLUNTARILY DECIDED TO TAKE PART IN THIS RESEARCH
STUDY AND THAT YOU HAVE READ AND YOU UNDERSTAND THE INFORMATION GIVEN ABOVE AND EXPLAINED TO YOU.
POSSIBLE ADDITIONAL ELEMENTS, WHERE APPLICABLE:
20.
Information about issues like lactation, pregnancy, any potential for unforeseeable risks to the subject or fetus, contraception and concerns about
fathering a child (contact IRB for samples of language)
21.
If minors involved: a. The form must address parent throughout: We are asking you to allow your child to take part... b. Include lines for
Signature of Parent/Guardian; person’s authority to give consent and minor's assent (if age 7 or older)
22.
If the study is sponsored (private, public or industry) by a grant or contract, disclose the information (contact IRB office for wording).
23.
Persons obtaining consent must sign and print name & title. (persons obtaining consent must be designated in protocol)
24.
We will tell you about any significant new findings which develop during the course of this research that may relate to your willingness to
continue taking part.
25.
Anticipated circumstances when study may be terminated by sponsor or principal investigator, even if subject does not concur; any potential
consequences to subject from early study withdrawal, and procedures to be followed for early termination, if applicable.
26.
If the study involves GENETICS, USE OF DNA, ESTABLISHMENT OF PERMANENT CELL LINES, BANKING OF SAMPLES FOR FUTURE STUDY, HIV
TESTING, OR DEVELOPMENT OF MARKETABLE PRODUCTS MADE FROM HUMAN SAMPLES, contact the IRB office for additional guidelines and
sample consent form wording.
FORMAT REQUIREMENTS
27. Title of study on top of all pages (must be same, word-for-word, as protocol), UTHSCSA and study sites listed under the title on p. 1 (except VA),
page numbers on all pages (page 1 of 2, page 2 of 2), except p. 1 of VA consent. VA uses form 10-1086.
28.
Lines for the signatures of the subject, a witness, the person obtaining consent, printed name & title of person obtaining consent and for each to
record the date & time signed. (If surrogate consent involved, contact IRB office.)
Rev: 08/06