You are being asked to participate in a research study. The purpose of the study is to . . . (state what the study is designed to discover. Be succinct - 2-4 sentences usually suffice).
If you decide to participate, we will (describe in simple language the procedures to be followed, including their purposes, duration, frequency, and recovery time, if applicable. In a separate paragraph under this heading, include time commitment for the subject, the total duration of the study, and the approximate number of subjects involved.)
(Describe alternative procedures or treatments that might be considered by the subject. If the study does not involve therapeutic or diagnostic procedures, this section may be omitted).
(Describe the risks, discomforts and/or inconveniences that the subject may reasonably expect.)
(Describe any benefits to the subject and/or to others/society reasonably to be expected. Make clear that no benefit is guaranteed. If no direct benefit to the individual is anticipated, this must be stated): There is no direct benefit to you anticipated from your participation in this study.
(State the persons or agencies to whom information from the study will be furnished, the nature of the information to be furnished, and the purpose of the disclosure. The following language must be included in all studies. Absolute confidentiality cannot be guaranteed, since research documents are not protected from subpoena. (If you are collecting unidentifiable data, you may substitute) "The data we collect will not be linked to your identity in any way."):
(If the subject will receive payment, describe the amount and method of payment. Payment must be pro-rated, per Federal regulations, as the subject may withdraw before completion of the study and is entitled to receive partial compensation appropriate for what he/she has undergone.)
(Include the following standard language): If you are injured as a direct result of research procedures, you will receive reasonably necessary medical treatment at no cost. The University of California does not provide any other form of compensation for injury.
You may refuse to participate and still receive the care you would receive if you were not in the study. You may change your mind about being in the study and quit after the study has started. (If sudden withdrawal constitutes a health hazard, indicate conditions necessary for withdrawal from the study. Also indicate that the investigator may withdraw subjects from the study at his/her discretion.)
(If the investigator has a financial interest in the research study, include the following language): The study investigator has a financial interest in this research and may benefit monetarily from this study. You may ask your investigator for more information on his or her interest. (For medical research, if samples will be taken for research and development purposes not related to the subjectÕs treatment or condition, include the following standard language): Samples taken during this study may be used for research and development purposes not related to your treatment or condition. You will not have any property rights or ownership interest in products or data which may be derived from your samples.
If you have any questions about this research project or if you think you may have been injured as a result of your participation, please contact (give the name of the principal investigator or his/her co-investigators) who will answer them at (give a phone number and address).
If you have any questions regarding your rights and participation as a research subject, please contact the Human Subjects Committee at (805) 893-3807 or hsc@research.ucsb.edu. Or write to the University of California, Human Subjects Committee, Office of Research, Santa Barbara, CA 93106-2050
Signature of Participant or Legal Representative: Date: Time: