STANDARD CONSENT FORM FORMAT #4
(TISSUE COLLECTION—HIPAA-compliant)
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO BE A RESEARCH SUBJECT
[STUDY TITLE]
**NOTE: Italicized statements are examples of CHR standard wording. These statements should be printed in regular type on the actual consent form. Bracketed statements ([....]) are notes and/or optional wording.

[SIMPLIFIED TITLE (if needed for subjects’ comprehension)]
A. PURPOSE AND BACKGROUND
Dean Dougherty, M.D., and Dolores Dennis, Ph.D., from the Department of . . . , are collecting tissue from patients undergoing surgery for. . . . If you let us, we would like to store some of your leftover specimens and review your medical record for future research. [If collecting additional samples for research purposes: We would also like to obtain additional samples of your . . . .] This research is being funded by . . . .
You are being asked to participate in this research because you [are scheduled for] [have] . . . .
B. WHAT WILL HAPPEN
If you agree to be in this research, the following will happen: **
1. After all routine tests required for your care are finished, instead of discarding your leftover specimen we will save it in what is called a “tissue bank” for possible future research. We also will collect and save information from your medical record, including things like [List all types of information to be recorded for study purposes, including results of physical examinations, diagnostic tests, medical questionnaires and histories, diagnoses, treatments, etc. Be complete; this listing is required by HIPAA regulations.] We do not know for sure if your specimen or medical record will be used, but they might be used in research about cancer, heart disease, diabetes, or other diseases.
2. [If any additional tissue (including blood) will be taken for research purposes, describe the procedures, including how the sample will be taken and how much will be taken. For example: We will also collect a sliver of normal muscle or skin (the size of a grain of rice) from the same place we make a cut for your surgery. We will draw extra blood (2 tablespoons) through tubes already in place for your surgery. We will not collect the extra muscle and blood if we think it will cause any additional risk, discomfort, or pain beyond what we normally expect from your surgery.]
3. We may give or sell the specimen and certain medical information about you (for example, diagnosis, blood pressure, age if less than 85) to other scientists not at UCSF. but we will not give them your name, address, phone number, or any other information that would identify you. Reports about any research will not be given to you or your doctor. Sometimes specimens are used for genetic research (about diseases that are passed on in families). Even if we use the specimen for genetic research, we will not put the results in your medical record. The research will not change the care you receive. Your specimen and any information about you will be kept until it is used up or destroyed. It may be used to develop new drugs, tests, treatments or products. In some instances these may have potential commercial value. Your personal health information cannot be used for additional research without additional approval from either you or a review committee.
4. If you decide later that you do not want your sample and information to be used for future research, you can tell us, and we will destroy any remaining identifiable sample and information if it is no longer needed for your care.
C. RISKS
**NOTE: Italicized statements are examples of CHR standard wording. These statements should be printed in regular type on the actual consent form. Bracketed statements ([....]) are notes and/or optional wording.

1. [Describe any risks of any additional sampling. For example: Any extra tissue or blood we take from you will come through cuts or tubes needed for your surgery, and should not cause you any risk, discomfort, or pain beyond what we normally expect from your surgery.]
2. Confidentiality: Participation in research may involve a loss of privacy, but information about you will be handled as confidentially as possible . Your name will not be used in any published reports about this study .
The researcher [PI name] and his/her research associates and team members will have access to information about you.
[Use this sentence only when appropriate: Representatives from the sponsoring company ([insert company name in parentheses]) and the Food and Drug Administration, [Insert names of all other persons, companies, or institutions to whom you may release health information that identifies the subjects. For multisite studies, say “other sites associated with this study” rather than naming sites; otherwise subjects must sign a revised consent form whenever sites are added. (HIPAA requirement)], the UCSF Committee on Human
Research and other University of California personnel also may review or receive information about you to check on the study. Once your health information is disclosed to the research team it is not protected under the
Health Information Portability and Accountability Act (HIPAA). The research team will continue to protect your personally identifiable health information as described in this consent form. The University of California complies with the requirements of HIPAA and its privacy regulations, and with all other applicable laws that protect the confidentiality of your health information.
[ Treatment and Compensation for Injury: [Include this section only if extra blood or other tissue will be removed or there are other biomedical procedures performed on the subjects for research purposes.]
If you are injured as a result of being in this study, treatment will be available. The costs of such treatment may be covered by the University of California or the study sponsor, [company name], depending on a number of factors.
The University and the study sponsor do not normally provide any other form of compensation for injury. For further information about this, you may call the office of the Committee on Human Research at (415) 476-1814 . **
[NOTE: This statement must be used without changes. See the last page of this form for the standard wording for the VAMC and for other notes.]
D. BENEFITS
There will be no direct benefit to you from allowing your tissue to be used for research. However, we hope we will learn something that will help in the treatment of future patients .**
E. FINANCIAL CONSIDERATIONS
You will not be charged for being in this research. You will not be paid for being in this research. If any new products, tests or discoveries that result from this research have potential commercial value, you will not share in any financial benefits.
F. ALTERNATIVES
If you choose not to participate in this study, tissue removed during your surgery that is not needed for diagnosis will be thrown out [and no additional normal muscle or blood will be removed for research purposes].
G. WHERE TO GO WITH QUESTIONS
**NOTE: Italicized statements are examples of CHR standard wording. These statements should be printed in regular type on the actual consent form. Bracketed statements ([....]) are notes and/or optional wording.

This research has been explained to you by Dr. Dougherty or by the person who signed below. You should ask them any questions you have. If you have other questions later, you may call Dr. Dougherty at (415) 476-xxxx, or the person named below at (415) 476-xxxx.
[The following paragraph is not needed if subjects will be given the Experimental Subject’s Bill of Rights, which includes contact information for the CHR. The Bill of Rights must be given if additional samples are taken for study purposes, but not if only leftover samples will be used:
If you have any comments or concerns about participation in this study, you should first talk with the researchers.
If for some reason you do not wish to do this, you may contact the Committee on Human Research, which is concerned with the protection of volunteers in research projects. You may reach the committee office between
8:00 and 5:00, Monday through Friday, by calling (415) 476-1814, or by writing: Committee on Human
Research, Box 0962, University of California, San Francisco/San Francisco, CA 94143.**]
H. CONSENT
You have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep.** [Delete mention of the Bill of Rights if not needed for this study.]
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw from this study without penalty or loss of benefits to which you are otherwise entitled.**
If you wish to participate in this research, please sign below.**
Date Subject's Signature for Consent
If you wish to authorize access, use, creation, and disclosure of protected health information about you as discussed in sections B and C of this form, you should sign below . If you do not sign this form, the researchers will not collect identifiable information about you.
**
Date Subject's Signature for Authorization
Date Person Obtaining Consent
[STOP! Do not use the following signature lines unless third party consent is being requested and has been addressed in detail in the protocol.]
AND/OR:
Date Legally Authorized Representative
**NOTE: Italicized statements are examples of CHR standard wording. These statements should be printed in regular type on the actual consent form. Bracketed statements ([....]) are notes and/or optional wording.

Date Person Obtaining Consent
**NOTE: Italicized statements are examples of CHR standard wording. These statements should be printed in regular type on the actual consent form. Bracketed statements ([....]) are notes and/or optional wording.