Format of Consent Letter

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

1


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

2


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) . I am recruiting

subjects to which will take approximately . 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").

3


MODEL FORM

COVER LETTER

(Typically accompanies a questionnaire)

Dear www.uhd.edu/research/phs/documents/ICandothersampledocsSept05.doc :

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)

4


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,


5


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,


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.

6


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,


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


7


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.

8


SAMPLE OF WRITTEN CHILD ASSENT FORM

Language must be simplified as appropriate for the age group used as subjects:

Principal investigator(s): Co-investigator(s): Name, degree Name, degreeComplete mailing address Complete mailing addressContact phone number 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”?

9


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.

10


MODEL FORM

TITLE OF RESEARCH STUDYINFORMED 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:

11


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.)

12


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 of Investigator______________________________________Date___________________


13


MODEL FORM

TITLE OF RESEARCH STUDYPARENTAL 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. [same as adult]

6. 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.)

14


Signature____________________________________________Date____________(Father, Mother, Legal Guardian, or Legally Authorized Official)

13. [same as adult] 14. [same as adult]


(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

Documents

Format of Consent Letter