Informed Consent Form (for Adults)

Title of Research Study

(studies exceeding minimal risk)

Read and address each numbered element of this Model Form in developing an informed consent form for the proposed human research study. 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 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

There are no foreseeable risks or discomforts if I agree to participate in this study.

5. The possible benefits of my participation in this research study are . . . [Describe the benefits of participants, or lack of benefits, to the individual subjects as well as to society.]

Or

Although there may be no direct benefits to me, the possible benefits of my participation in the research are . . .

6. The results of this research study may be published but my name or identity will not be revealed. The researcher will do the following to maintain confidentiality of my records, (name of researcher) will [Indicate specifically how you will keep the names of 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 acceptable. Additionally, confidentiality can only be given to subjects if researcher destroys any master list kept. It is a good idea to explain to subjects that their confidentiality will be maintained because you will destroy any master list containing identifiying information after you have assigned subject codes.)

7. In case of injury I 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.]

8. 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.

9. 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 (and e-mail address, if available). [This refers to the researcher or principal investigator. In the event researcher is a student, the name of the doctoral or thesis advisor (i.e., major professor or responsible faculty member) must be included.]

10. (In case of injury,) 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 Chair of the Human Subjects Committee, Institutional Review Board, through the Office of the Vice President for Research, at (850) 644-8633. [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.]

11. The nature, demands, benefits and any risk of the project have been explained to me. I knowingly assume any risks involved. [If #4 has indicated "no foreseeable risk or discomfort", then omit this paragraph]

I have read the above informed consent form. (Release statement for audiotaping/videotaping or relinquishing confidentiality must be inserted here if applicable). I understand that I may withdraw my consent and discontinue participation at any time without penalty or loss of benefits to which I may otherwise be entitled. 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.

Subject's Signature ___________________________________ (Date) _________________

Other Signature (if appropriate)__________________________ (Date) _________________