Revised October 2009
INFORMED CONSENT INFORMATION & SAMPLE DOCUMENTS
1.
The Elements of Informed Consent
2.
Model Form for a Verbal Script
3.
Model Form for a Cover Letter
4.
Model Form for Information Letter
5.
Model Form for Letter of Consent for Adults
6.
Model Form for Parental Letter of Consent for Minors
7.
Model Form for Samples of Written Child Assent Forms
8.
Model Form for Adult Informed Consent
9.
Model Form for Parental Informed Consent for Minors
10.
Model Confidentiality Statement for Persons Assisting Researcher
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Revised October 2009
THE BASIC 8 ELEMENTS OF INFORMED CONSENT
Eight basic elements are required for the recruitment of subjects in verbal scripts/cover letters,
and in consent letters for activities not exceeding minimal risk:
1.
Who you are
2.
What you are doing
3.
Why you are doing it
4.
What subjects will be asked to do and how long it will take
5.
That participation is voluntary
6.
That there will be no penalty for nonparticipation/withdrawal from study
7.
How confidentiality/anonymity will be handled
8.
Who to call with any questions or concerns regarding the research
ADDITIONAL ELEMENTS IF RISK EXCEEDS A MINIMAL LEVEL
Additional elements may be required when activities exceed minimal risk:
1.
A specific description of possible risks or discomforts
2.
Examples of sensitive material
3.
Post-research debriefing to mitigate risks
4.
Post-research referrals or assistance to mitigate risks
5.
Emergency contact information
6.
Additional requirements as appropriate
MODEL FORM
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Revised October 2009
VERBAL SCRIPT
(Typically used for recruitment of subjects from classrooms, telephone surveys,
and recruitment by personal contact)
I am a professor [a graduate student under the direction of Professor __________ ] in the
Department/Division/College of ___________________________ at the University of Houston
Downtown. I am conducting a research study to (state purpose of study)
subjects to
which will take approximately
. I am recruiting
. I would like to invite you to participate
in my study.
Your participation in this study is voluntary. If you choose not to participate or to
withdraw from the study at any time, there will be no penalty, (it will not affect your grade,
treatment/care, whichever applies - select only one). The results of the research may be
published, but your name will not be used.
If you have any questions concerning the research study, please call me at
.
NOTE: If data collection involves audiotape/videotape of activities, any verbal script, consent
letter/form, assent or information letter must advise subjects that the activities will be
audiotaped/videotaped and the disposition of the tapes (such as "the tapes will be erased
upon completion of the study" or "the tapes will be kept indefinitely for archival
purposes").
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Revised October 2009
MODEL FORM
COVER LETTER
(Typically accompanies a questionnaire)
Dear
:
I am a professor [or a graduate student under the direction of Professor __________] in the
Department/Division/ College of
at the University of Houston Downtown. I am
conducting a research study to (state purpose of study)
I am requesting your participation, which will involve
(Include the expected duration of
the subject's participation). Your participation in this study is voluntary. If you choose not to
participate or to withdraw from the study at any time, there will be no penalty, (it will not affect
your grade, treatment/care, whichever applies - select only one). The results of the research
study may be published, but your name will not be used. [If anonymous questionnaire is
completed, include a statement that "The questionnaire is anonymous. The results of the study
may be published but your name will not be known."].
If you have any questions concerning the research study, please call me [or Dr. _____] at ( )
___-_____.
Return of the questionnaire will be considered your consent to participate.
Sincerely,
(Researcher’s name)
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Revised October 2009
MODEL FORM
INFORMATION LETTER
(Typically used in lieu of written consent, for interviews when the research could not reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subject's financial
standing, employability, reputation or insurability.)
Dear ______________________:
I am a professor [a graduate student under the direction of Professor __________] in the
Department/Division/ College of _____________________ at the University of Houston
Downtown. I am conducting a research study to
(state purpose of study)
_____________________________________________________________________.
I am requesting your participation, which will involve ________________. (Include the
expected duration of the subject's participation). Your participation in this study is voluntary. If
you choose not to participate or to withdraw from the study at any time, there will be no penalty,
(it will not affect your grade, treatment/care, whichever
applies - select only one). The results of the research study may be published, but your name
will not be used.
If you have any questions concerning the research study, please call me [or Dr. _____] at ( )
___-_____.
Sincerely,
(Researcher’s name)
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Revised October 2009
MODEL FORM
LETTER OF CONSENT FOR ADULTS
(Typically used for studies that will not exceed minimal risk or would
qualify for exempted status except for population)
Dear _______________:
I am a professor [a graduate student under the direction of Professor _____________] in the
Department/Division/College of ______________________________ at University of Houston
Downtown. I am conducting a research study to (state purpose of study)
.
I am requesting your participation, which will involve __________________________. (Include
the expected duration of the subject's participation). Your participation in this study is
voluntary. If you choose not to participate or to withdraw from the study at any time, there will
be no penalty, (it will not affect your grade, treatment/care, whichever applies - select only one).
The results of the research study may be published, but your name will not be used.
The expected risks to participants in this study are ____________________________. Although
there may be no direct benefit to you, the possible benefit of your participation is
______________________________________________.
If you have any questions concerning the research study, please call me [or Dr. ___] at ( ) ________.
Sincerely,
(Researcher’s name)
I give consent to participate in the above study. (Release statement for videotaping or
relinquishing confidentiality must be inserted here if applicable.)
__________________________________
Signature
Date
______________________
Any questions regarding your rights as a research subject may be addressed to the UHD
Committee on Standards for Research Involving Human Subjects through its current chair, Dr.
at
or email at
. All research projects that are carried out at the University of
Houston Downtown are governed by requirements of the University and the Federal
Government.
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Revised October 2009
MODEL FORM
PARENTAL LETTER OF CONSENT FOR MINORS
(Typically used for studies that will not exceed minimal risk)
Dear Parent:
I am a professor [a graduate student under the direction of Professor ________] in the
Department/Division/College of ____________________________ at the University of Houston
Downtown. I am conducting a research study to (state purpose of study)
.
I am requesting your child's participation, which will involve _____________________. (Include the
expected duration of the subject's participation). Your child's participation in this study is voluntary. If
you choose not to have your child participate or to withdraw your child from the study at any time, there
will be no penalty (it will not affect your child's grade, treatment/care, whichever applies - select only
one). Likewise, if your child chooses not to participate or to withdraw from the study at any time, there
will be no penalty. The results of the research study may be published, but your child's name will not be
used.
Although there may be no direct benefit to your child, the possible benefit of your child's participation is
______________________________________________.
If you have any questions concerning the research study or your child's participation in this study, please
call me [or Dr. _________] at ( ) ___-_____.
Sincerely,
(Researcher’s name)
I give consent for my child _______________ to participate in the above study.
(Release statement for videotaping or relinquishing confidentiality must be inserted here if applicable.)
__________________________________
Signature Date
______________________
Any questions regarding your rights as a research subject may be addressed to the UHD
Committee on Standards for Research Involving Human Subjects through its current chair, Dr.
at
or email at
. All research projects that are carried out at the University of
Houston Downtown are governed by requirements of the University and the Federal
Government.
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Revised October 2009
Additional clauses for special circumstances –use if applicable to your study
Abuse: If the nature of the study (sensitive topic or face-to face interviews) makes it likely for
participants to reveal reportable information such as child abuse include a version of the following
statement.
All information you give us will be confidential. Your child will not be personally identified and his/her
name will not be linked with any information given to us. We will not use your child’s identity in any
reports or publications about this research. A code number will identify the information your child
provides. However, this promise of confidentiality is not absolute. The researchers must report intent to
harm oneself or others and cases of current child abuse to the proper authorities.
Student Researcher: Include the following statement if the primary researcher is conducting research
under the supervision of a faculty sponsor.
All information will be confidential. We will not use your child’s identity in any reports or publications
about this research. A code will identify the information your child provides. However, this promise of
confidentiality is not absolute. Authorized persons from the university have the legal right to review your
son or daughter’s research records and will protect the confidentiality of those records to the extent
permitted by law.
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Revised October 2009
SAMPLE OF WRITTEN CHILD ASSENT FORM
Language must be simplified as appropriate for the age group used as subjects:
Principal investigator(s):
Name, degree
Complete mailing address
Contact phone number
Co-investigator(s):
Name, degree
Complete mailing address
Contact phone number
What is a research study?
This should be a simple description of what the child will do written in simple language appropriate to the age
of the youngest child for whom the form is intended.
Why is this study being done?
The purpose of the study should be described.
What will happen to me?
The nature of the child’s participation should be described, including any time commitment. If there will be any
recording it should be described here.
What are the good things about being in the study?
This section should include information about any benefits that might exist for the subject. If there are none,
say there are none.
Will being in the study hurt me?
This should include basic descriptions of the benefits a participant could expect. If there are no benefits, state
“You will not benefit from being in this study.” This section should also include basic descriptions of the risks
of the study that may include changes of stress, distress, fear, anxiety, or pain. If risks are only minimal state
“we don’t think you will be hurt by helping with this study.”
How long will I be in the study?
The time commitment should be described.
Do I have other choices?
It should be clear that the child can leave the study or not participate.
Will people know that I am in the study?
This should describe who will know that the child is in the study. Also included a statement such as, “Anything
you tell us or do for us might be found out by someone else, but we will do everything we can to keep it secret.”
Whom should I ask if I have questions?
This should provide children with information about who to contact. This should always remind children they
can ask their parent or guardian questions.
Is it OK if I say “No, I don’t want to be in the study”?
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Revised October 2009
This should state that “You do not have to be a part of this study if you don’t want to. No one will be mad or
upset. If you change your mind, you can decide during the study to stop being in the study.”
Do you understand and do you want to be in the study?
I understand. All my questions were answered.
 I want to be in the study.
 I don’t want to be in the study.
__________________________________________
Your name
____________________________________
Your signature
Date
_________
____________________________________
Signature of person explaining the study
_________
Date
For children unable to understand written assent forms, a verbal script for assent should be submitted
in lieu of the above.
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Revised October 2009
MODEL FORM
TITLE OF RESEARCH STUDY
INFORMED CONSENT FORM (FOR ADULTS)
(Typically used for studies exceeding minimal risk)
The consent form must be typewritten and written in lay language. The language must be further
simplified to meet the needs of a specific population. Please add additional statements when
appropriate.
I HAVE BEEN INFORMED THAT:
1. Investigator's name, who is title/position, has requested my participation in a research study
at this institution. [Place title of project at top of all pages of consent form.]
2
The purpose of the research is to...
[Describe the justification for the research. If appropriate, indicate the number of subjects
involved and why the subject is included.]
3. My participation will involve... [Describe the subject's participation and identify those
aspects of participation, which are experimental. Indicate the expected duration of the
subject's participation. If the subjects are students, patients, clients or employees, advise that
nonparticipation or withdrawal from the study will not affect their grade, treatment, care,
employment status, as appropriate.]
4. There are foreseeable risks or discomforts to me if I agree to participate in the study. The
possible risks are... Possible discomforts include... [Any foreseeable risks or discomforts are
to be explained/described.]
OR:
If there are no foreseeable risks or discomforts, see page 6 - letter consent.
5. There are alternative procedures available. Alternative procedures include... [Describe any
alternative procedures to be included in language the subject can understand.]
OR:
There are no feasible alternative procedures available for this study. If the study includes no
intervention, you may delete #5 entirely.
6. The possible benefits of my participation in the research are... [Describe the benefits of
participants, or lack of benefits, to the individual subject as well as to society.]
OR:
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Revised October 2009
Although there may be no direct benefits to me, the possible benefits of my participation in
the research are...
7. The results of the research study may be published but that my name or identity will not be
revealed. In order to maintain confidentiality of my records, name of investigator will...
[Indicate specifically how the investigator will keep the names of the subjects confidential,
the use of subject codes, how this information will be secured, and who will have access to
the confidential information. "Confidentiality will be maintained" is not adequate.]
8.
In case of injury I can expect to receive the following treatment or care which will be
provided at my expense: [If more than minimal risk of foreseeable injury is anticipated,
describe the facilities, medical treatment or services which will be made available in the
event of injury or illness to a subject. Description may include on and off-campus services.]
OR:
If #4 indicated no foreseeable risks or discomforts, see page 6 - letter consent.
9.
I will be paid for my participation as follows: [If payment is to be provided to subject,
include amount of payment, method of payment, and schedule for payment including
whether payment will be made in increments or in one lump sum.]
OR:
I will not be paid for my participation.
10. Any questions I have concerning the research study or my participation in it, before or after
my consent, will be answered by name of individual, address, and telephone number. [This
refers to the principal investigator. In the event the investigator is a student, the name of the
doctoral or thesis advisor (responsible faculty member) must be included.]
11. (In case of injury, or) If I have questions about my rights as a subject/participant in this
research, or if I feel I have been placed at risk, I can contact the Human Subjects
Institutional Review Board, through _______________, at (
) ___-_____. [This
information must be included in all consent forms. If #4 has indicated "no foreseeable risk,
or discomfort"; then first phrase (in parenthesis) should be omitted.]
12. The nature, demands, benefits and any risk of the project have been explained to me. I
knowingly assume any risks involved. I understand that I may withdraw my consent and
discontinue participation at any time without penalty or loss of benefit to myself. In signing
this consent form, I am not waiving any legal claims, rights or remedies. A copy of this
consent form will be given (offered) to me. [If #4 has indicated "no foreseeable risk or
discomfort", then omit this paragraph].
I have read the above informed consent form. (Release statement for videotaping or
relinquishing confidentiality must be inserted here if applicable.)
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Revised October 2009
Subject's
Signature___________________________________________Date___________________
13. "I certify that I have explained to the above individual the nature and purpose, the potential
benefits and possible risks associated with participation in this research study, have
answered any questions that have been raised, and have witnessed the above signature."
14. "I have provided (offered) the subject/participant a copy of this signed consent document."
Signature
Investigator______________________________________Date___________________
of
Any questions regarding your rights as a research subject may be addressed to the UHD
Committee on Standards for Research Involving Human Subjects through its current chair, Dr.
at
or email at
. All research projects that are carried out at the University of
Houston Downtown are governed by requirements of the University and the Federal
Government.
13
Revised October 2009
MODEL FORM
TITLE OF RESEARCH STUDY
PARENTAL INFORMED CONSENT FORM (FOR MINORS)
(Typically used for studies exceeding minimal risk)
The elements of the Informed Consent Form for Adults are used with the following variations:
I HAVE BEEN INFORMED THAT:
1.
Investigator's name, who is title/position, at University of Houston Downtown has requested my minor
child's (ward's) participation in a research study at this institution.
2.
[same as adult]
3
My child's (ward's) participation will involve….
4.
There are foreseeable risks or discomforts to my child (ward) if I agree for them to participate in the
study.
5.
6.
[same as adult]
The possible benefits of my child's (ward's) participation in the research are….
OR:
Although there may be no direct benefits to my child (ward), the possible benefits of their participation….
7.
The results of the research study may be published but that my child's (ward's) name or identity will not be
revealed. In order to maintain confidentiality of my child's (ward's) records, name of investigator will....
8.
In case of injury I can expect my child (ward) to receive….
9.
Payment for my child's (ward's) participation is as follows:
OR:
I will not be paid for my child's (ward's) participation.
10.
Any questions I or my child (ward) have concerning the research study or my child’s (ward’s)
participation…
11. (In case of injury) If I have questions about my child’s (ward’s) rights as a subject/participant in this
research, or if I feel my child (ward) has been placed at risk….
12. [same as adult]
(Release statement for videotaping or relinquishing confidentiality must be inserted here if applicable.)
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Revised October 2009
Signature____________________________________________Date____________
(Father, Mother, Legal Guardian, or Legally Authorized Official)
13. [same as adult]
14.
[same as adult]
Any questions regarding your rights as a research subject may be addressed to the UHD Committee on
Standards for Research Involving Human Subjects through its current chair, Dr.
at
or
email at
. All research projects that are carried out at the University of Houston Downtown are
governed by requirements of the University and the Federal Government.
(Persons assisting the researcher should complete this document.
If the study includes sensitive information, it must also be utilized by the researcher.)
[NAME OF STUDY]
CONFIDENTIALITY STATEMENT
As a researcher working on the above research study at University of Houston, I understand that I must
maintain the confidentiality of all information concerning research participants. This information includes, but
is not limited to, all identifying information and research data of participants and all information accruing from
any direct or indirect contact I may have with said participants. In order to maintain confidentiality, I hereby
agree to refrain from discussing or disclosing any information regarding research participants, including
information described without identifying information, to any individual who is not part of the above research
study and in need of the information for the expressed purposes on the research program.
_______________________________________________ ___________________________
Signature of Researcher
Date
15