[AS APPROPRIATE, ADD NAMES OF OTHER SITES AT WHICH THIS STUDY WILL BE CONDUCTED, E.G. Harborview Medical Center, Veteran's Affairs Puget Sound Health Care System, Company X]

Researchers: [INSERT NAMES, TITLES, DEPARTMENTAL AFFILIATIONS, AND TELEPHONE NUMBERS OF PRINCIPAL RESEARCHERS AND THOSE HAVING CONTACT WITH SUBJECTS. ALSO ADD THE NAME OF SPONSOR'S CONTACT PERSON.]

We are asking you to be in a research study. The purpose of this consent form is to give you the information you will need to help you decide whether to be in this study. Please read this form carefully. You may ask questions about what we will ask you to do, the risks, the benefits, your rights as a volunteer, or anything else about the research or this form that is not clear. When all of your questions have been answered, you can decide if you want to be in this study or not. This process is called "informed consent." We will give you a copy of this form for your records. We will keep the original and send a copy to [INSERT NAME OF COMPANY]

As part of the study entitled [INSERT NAME OF TRIAL] we will be taking [SPECIFY: "blood," " tissue," "cells," "urine," etc.] from you.

If you agree, we would like to keep samples of your [SPECIFY: "blood," "tissue," "cells," "urine," etc.]. The samples will be kept [CHOOSE ONE: "here at the University of Washington," "by Company X, the sponsor of this study," or "both at the University of Washington and by Company X, the sponsor of this study."] [CHOOSE ONE: "The University of Washington," "Company X," or "both the University of Washington and Company X"] will use the samples for research about [SPECIFY DISEASE OR CONDITION AND, IN GENERAL, LAY TERMS, STATE THE RESEARCH TO BE CONDUCTED.]

The University of Washington researchers will also send information about you to [Company X]. This information will include things like your age, your ethnic group, if you use alcohol or tobacco, your health history, and what treatments you have received.

The research that is done with your samples will probably not help you. It might help people who have [SPECIFY DISEASE OR CONDITION CATEGORY, E.G., "cancer "] in the future.

The choice to let us keep samples of your [SPECIFY: "blood," "tissue," "cells," "urine," etc.] is up to you. No matter what you decide, it will not affect your regular care. You can still take part in this study. [ALTERNATIVELY, "No matter what you decide, it will not affect your regular care. However, only people who agree to this sample collection may be in this study."]*

We will label your samples and the information about you with a number, not your name. We will keep your name, address, telephone number, and other information that might identify you separate from your sample. The record that links the number with your name will be kept by the UW researchers. [IF RELEVANT, ADD: "sponsoring drug company," "the United States Food and Drug Administration, " "other researchers associated with the University of Washington," and/or "researchers at other educational or non-profit institutes will also have access to your name."] **

One of the risks of allowing us to keep the samples is that information about you might be released accidentally.

Sometimes [SPECIFY: "blood," "tissue," "cells," "urine," etc.] is used for genetic research (about diseases that are passed on in families.) Because these tests will be done in the research context only, we will not be able to give you the results. [OR, IF APPROPRIATE: "If we learn something that is important to your health, we will contact you and give you the results."] ***

The [SPECIFY: "blood," "tissue," "cells," "urine," etc.] samples will be kept until it is used up or destroyed. The samples will be used only for research. This research may be to develop new drugs or tests or treatments. It may also be used to develop new commercial products. Neither the University of Washington nor Company X has plans to share the profits, if there are any, with you.

Even if you decide now that your samples can be used for research, you can change your mind later. Just let us know that you do not want us to use your sample for any new research.

Your name will not be used in any published reports about this study.

We will not put the results of the research in your medical record.

If you have questions about this research or about this study, please contact one of the people listed on this form. If you have questions about your rights as a research donor, please contact the University of Washington Human Subjects Division at (206) 543-0098).

SUBJECT"S STATEMENT

I agree to allow the {CHOOSE ONE: "University of Washington researchers," "Company X," or "the University of Washington researchers and Company X"] to store my [SPECIFY TYPE(S) OF SPECIMENS] for future research about [SPECIFY NATURE OF RESEARCH]. I also agree to allow the University of Washington researchers to provide information about me, as described above, to Company X.

Notes