Model Informed Consent Agreement (Appendix)

This document lists all required elements of an informed consent form.  For your particular project, you may copy or edit the bolded statements and fill in the information requested in italics.  The following format should be followed in designing your informed consent form.

 The University of North Carolina at Asheville (UNCA)
CONSENT TO PARTICIPATE IN A RESEARCH STUDY

The following information describes the research study in which you are (your child is) being asked to participate.  Please read the information carefully. At the end, you will be asked to sign if you agree to participate (and/or to allow your child to participate).

1. INVESTIGATOR(S): (Principal Investigator's name), a (give title, e.g., student, professor, staff member) in (of) the (department name) at UNCA, will conduct this research project. (If the principal investigator is a student, the research advisor's name, title, and department affiliation should also be included.  If applicable, include same information for co-investigators, including students. Note if any co-investigators are associated with another institution and provide the same descriptive information.)

2. PURPOSE OF STUDY: The purpose if this research study is to (describe the purpose of the study in lay language that will be understandable to the research subject/parent/guardian). 

3. WHAT WILL HAPPEN DURING THE STUDY: (Describe the step-by-step activities [i.e., procedures] in which the subject will be involved. You may wish to number the steps for added clarity.) The length of time you are (your child is) expected to participate in the study is (estimate total duration of the subject's participation, either as a one-time activity or as a repeated activity over a period of time).

4. POSSIBLE RISKS AND/OR DISCOMFORTS: We do not know of any personal risk or discomfort you (your child) will experience from taking part in this study.

or This study may involve some risks or discomfort to participants.  Past experience indicates that the most common discomforts include…  Risks of participation might include...  (Note any discomforts participants may encounter, explaining their significance. Outline risks, physical or psychological, that could be greater than those encountered in everyday life.  Describe provisions you have made to address such risks.)

5. POSSIBLE BENEFITS: It is possible that you (your child) will benefit from this study by... (Describe potential benefits to the individual research subject.  Note that compensation for participation is NOT considered a benefit.)

or Although we do not expect that you (your child) will benefit directly by taking part in this study, the study is expected to benefit (define the larger population, e.g., science or society) by (describe potential benefits to the larger population). 

6. ALTERNATIVE PROCEDURES: (Describe any alternative procedures or courses of treatment that might be advantageous to the subject; this information is usually only relevant if medical/psychological interventions are part of the study.  If not applicable, you may omit this subheading/subsection.)

7. PRIVACY: (Describe the extent to which confidentiality of research records identifying the subject will be maintained. As appropriate, discuss privacy concerns during collection of the data, identifiers that will be recorded which may link the subject to the data, persons who will have access to the data, measures that will be followed to ensure security of the data, how data will be reported, and ultimate disposition of records.  Note that anonymity [no identifying information is collected so privacy is assured] is different than confidentiality [the researcher has a record of participants but will keep the information private]).

8. COSTS OR COMPENSATION: There are no costs or compensation associated with your (your child's) participation in this study.

or (Describe any costs and/or compensation to the subject for participation in the research project.  If neither is applicable, you may omit this subheading/subsection.  [Compensation may include cash payments or reimbursements to the subject, free services that the subject would not otherwise receive, or extra credit in academic courses.].)

If the study places the participant at some risk of injury, even if minimal, include the following statement: UNCA will not provide compensation or medical (and/or psychological) treatment of any kind to you (your child) for an injury which occurs as a direct result of your (your child's) participation in this study.

9. YOUR RIGHTS: The decision to (allow your child to) participate in this study is completely up to you.  You will not be punished or treated any differently if you decide (your child decides) not to be in the study.  If you decide to be in the study, you have (your child has) the right to stop being in the study at any time.

10. CONTACT INFORMATION: (Principal Investigator's name) (phone number; if the principal investigator is a student, also give contact information for the student's research advisor) will gladly answer any questions you may have concerning the purpose, procedures, and outcome of this project. You may also contact the Chair of UNCA’s Institutional Review Board (IRB), Dr. Bryan Schaffer (828-251-6849), to discuss any questions or concerns you may have about the rights of study participants. (The IRB is a college committee concerned with the protection of human subjects in research.)

SUMMARY: I have read the information in this consent form and agree (to allow my child) to participate in this study.  I have had the chance to ask any questions I have about this study, and they have been answered for me.

Although the investigator will make every effort to maintain confidentiality, I understand that research records must be made available to UNCA's IRB, if they are requested.   I will receive a copy of this form after it has been read and signed.

I would like to receive a copy of the results of this study:        _____ Yes      _____ No

Mailing Address: _____________________________________________________________________________

_____________________________________________________________________________________
Signature of Person Obtaining Consent                                                              Date

Child(ren)'s Name(s) & Date(s) of Birth:

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