CHECKLIST FOR ELEMENTS OF AN INFORMATION SHEET*
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.
If you decide to take part, we will (describe in lay language all procedures, their purposes, how long they will
take, and their frequency. If an instrument is being administered or an interview will be conducted, state the
nature of the information being sought.)
5.
(Describe total time over which the subject will be studied. If an instrument is being administered or an
interview is being conducted, state how long it will take to complete.).
6.
(Describe the discomforts, inconveniences, or any risks to be reasonably expected.)
7.
(Describe any benefits reasonably to be expected. If benefits are mentioned, add:) We do not guarantee that
you will benefit from taking part in this study.
8.
(If the subject will receive any compensation, describe the amount and nature of the compensation, when it
will be paid and how it will be pro-rated if the subject does not complete the study.)
9.
(If applicable, describe the possibility of any costs to the subject because of participation.)
10.
(Confidentiality statement, when no PHI involved): 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. However, 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. (For studies
that involve PHI, the elements of a valid authorization must be added, modifying the final statements “Sign
this form only…”since it will not be signed. Submit an H-4 form to request an alteration in the authorization,
that the signature not be required and a signed copy not be given to subjects.)
11.
(Right to withdraw): 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.
12.
(Without prejudice statement): 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). When students or employees of a study site are subjects, state: ...and it
will not affect your status as a student/employee of the (specify facility/institution).
13.
(Principal investigator's full name and phone number (if digital pager is given, include instructions on how to
use); state 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 wish to report a problem with the study, (full
name, degrees e.g. John Doe, PhD) can be reached at (give phone numbers).
14.
The University of Texas Health Science Center at San Antonio committee that reviews research on human
subjects (Institutional Review Board) will answer any questions about your rights as a research subject (210567-2351).
15.
(Instructions as to what action to take if subject agrees to be in the study): If you want to take part in this
study, please (tell subject what to do, such as complete the questionnaire and return it to the receptionist; or
contact us at 567-xxxx).
16.
This form is yours to keep.
17.
Give the Title of the study at the top of all pages (must be same as protocol) and study sites must be listed
under the title on p. 1.
18.
Page numbers must appear on all pages (page 1 of 2, page 2 of 2) unless the information sheet is only 1 page
or 2 pages using front and back of a single sheet of paper.
* An information sheet is often permitted for studies involving interviews or questionnaires because these involve
minimal risk and no physical procedures that could result in physical injury. If the study involves collection and/or
use of PHI, an alteration must be applied for by submitted an H-4 form requesting that the requirements to have
subjects sign and give a signed copy be altered and verbal authorization be permitted.
Unless the study is EXEMPT, a Form 2E must be submitted to document how the study qualifies for a waiver of
the requirement to document consent. The IRB staff members are available to discuss your study to determine
whether an information sheet would be adequate or if an informed consent document requiring signatures is
needed.
Rev: 04/05