By Luis Long,2014-05-07 12:34
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    1) Statements in brackets and italics are instructions or examples, and should not be

    included in the actual consent form.

    2) Required wording (in regular font, not italics) should be used as is (if appropriate).

    3) Suggested wording (in italics) can be revised as needed to provide the simplest and

    clearest description of the study.



Study Title: [Insert study title here]

    [Add SIMPLIFIED TITLE if needed for subjects’ comprehension]

This is a request that you donate specimens for medical research. The researchers, ,[M.D.,]

    and , [Ph.D.,] from the [UCSF Department of . . .], will explain this research to you.

Medical research includes only people who choose to take part. Take your time to make your

    decision about participating. You may discuss your decision with your family and friends and

    with your health care team. If you have any questions, you may ask the researchers.

You are being asked to take part in this study because you are/have [specify prospective

    subjects’ medical condition or other reason for recruitment to study, such as being about to have

    specific tissue removed, some of which will not be needed for clinical care].

Why is this research being done?

The purpose of this study is to…[Limit explanation to why study is being done, explaining in one

    or two sentences. See examples for drug/intervention trials directly below.

[Address sponsorship and financial interests here:

? The CHR requires that all consent forms disclose which agencies or institutions (e.g.,

    National Institutes of Health, Department of Defense, Center for Disease Control, State

    agencies), cooperative groups (CALGB, COG, ACTG), foundations or industry sponsors are

    funding the research or providing study drugs or equipment for the study. If the study is not

    being funded by an external agency, then the internal funding source, i.e., Department funds,

    personal funds, should be identified.

? Investigators must also disclose the nature of any financial or proprietary interests, though

    this disclosure can be in general terms.

    ? For specific examples of suggested wording, see Investigator Conflicts of Interest and CHR

    Review: Recommended Consent Form Language. How many people will take part in this research?

CF-SPECIMEN COLLECTION JULY 2008 Page 1 of 6 [Insert current version date here]

About [state total accrual goal here] people will be asked to donate specimens for this research. [For multi-center studies, it is good to give figures both for the whole study and for local

    enrollment at UCSF.]

What will happen if I agree to donate my specimens?

If you agree to let researchers collect and store your specimens for future research, the following

    will happen:

? After all routine tests required for your care are finished, instead of discarding your leftover

    specimens we will save them 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 specimens or medical record will be used, but they might be used in research about [List

    the types of conditions that the specimens may be used for research on, e.g. cancer, heart

    disease, diabetes, or other diseases.]

? [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.]

? [If the researchers will continue to gather additional information from medical records or

    other sources over a period of time, the collection activities and amount of time they will

    continue should be described here.]

? We may give your specimens and certain medical information about you (for example,

    diagnosis, blood pressure, age if less than 85) to other scientists or companies 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.

    ? Your specimens will be kept for [State how long specimens will remain in the repository. If

    they will become part of a permanent collection, they will be kept indefinitely]. If you decide

    later that you do not want your specimens and information to be used for future research, you

    can tell us, and we will destroy any remaining identifiable specimens and information if they

    CF-SPECIMEN COLLECTION JULY 2008 Page 2 of 6 [Insert current version date here]

     are no longer needed for your care. However, if any research has already been done using What risks are involved with donating specimens for research? portions of your specimens, the data will be kept and analyzed as part of those research studies. ? [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.]

? Confidentiality: Donating specimens 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 from research performed using your specimen. The manager of tissue bank

    [insert name] and select tissue bank staff members will have access to information about you

    but they will not release any identifying information about you to researchers using your

    specimen. The UCSF Committee on Human Research and other University of California

    personnel also may see information about you to check on the tissue bank.

[Include the following section only if extra blood or other tissue will be removed or there are

    other biomedical procedures performed on the subjects for research purposes.]

    What happens if I am injured because I took part in this study? It is important that you tell your study doctor, __________________ [investigator's name(s)], if

    you feel that you have been injured because of taking part in this study. You can tell the doctor

    in person or call him/her at __________________ [telephone number].

    Treatment and Compensation for Injury: If you are injured as a result of being in this

    study, treatment will be available. The costs of the treatment may be covered by the

    University of California or the study sponsor [sponsor 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 sample form for standard wording for the

    VAMC and for other notes].

    What are the benefits of donating specimens for research?

There will be no direct benefit to you from allowing your specimens to be kept and used for

    future research. However, we hope we will learn something that will help in the treatment of

    future patients.

    What financial issues should I consider before donating?

You will not be charged for donating your specimens. You will not be paid for donating your

    specimens. If any new products, tests or discoveries that result from this research have potential

    commercial value, you will not share in any financial benefits. UCSF may receive payment from

    CF-SPECIMEN COLLECTION JULY 2008 Page 3 of 6 [Insert current version date here]

researchers requesting specimens in order to cover the costs of collecting and storing the specimens.

    What alternatives do I have?

If you choose not to donate your specimens, any leftover blood and/or tissue removed during

    your surgery that is not needed for diagnosis will be thrown away [and no additional normal tissue or blood will be removed for research purposes].

    What are my rights if I take part in this study? Taking part in this study is your choice. You may choose either to take part or not to take part in

    the study. No matter what decision you make, there will be no penalty to you and you will not

    lose any of your regular benefits. Leaving the study will not affect your medical care. You can

    still get your medical care from our institution.

    In the case of injury resulting from this study, you do not lose any of your legal rights to seek

    payment by signing this form.

    Who can answer my questions about the study? You can talk with the study researcher about any questions, concerns or complaints you have

    about this study. Contact the study researcher(s) __________________ [name(s)] at

    __________________ [telephone number(s)].

    If you wish to ask questions about the study or your rights as a research participant to someone

    other than the researchers or if you wish to voice any problems or concerns you may have about

    the study, please call the Office of the Committee on Human Research at 415-476-1814. [If

    there are additional informational sources related to the study (e.g., patient representatives or

    individuals at other study sites as appropriate), list here with contact information.]


    Please read each sentence below and think about your choice. After reading each

    sentence, put your initials in the "Yes" or "No" box. If you have any questions about this

    study, please talk to the study doctor or nurse.

    No matter what you decide to do, it will not affect your care.

    1. My specimens may be kept for use in research to learn about, prevent, or treat [list the

    disease the specimens are being collected to study.]

    YES NO

    CF-SPECIMEN COLLECTION JULY 2008 Page 4 of 6 [Insert current version date here]

    2. My specimens may be kept for use in research to learn about, prevent or treat other

    health problems (for example: diabetes, Alzheimer's disease, or heart disease).

    YES NO

    3. Someone may contact me in the future to ask me to take part in more research.

    YES NO [Include if collecting additional specimens:

    4. Additional tissue [and/or blood] may be taken for this research, as described in the

    What Will Happen If I Agree… section above.

    YES NO

You have been given copies of this consent form and the Experimental Subject's Bill of Rights to

    keep. [Delete mention of Bill of Rights if not needed for this study.]

[If Protected Health Information as defined by HIPAA will be accessed, used, created or

    disclosed, add the following: You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you.]

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to

    participate or to withdraw at any point in this study without penalty or loss of benefits to which

    you are otherwise entitled.

If you wish to participate in this study, you should sign below.

Date Subject's Signature for Consent

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.]

CF-SPECIMEN COLLECTION JULY 2008 Page 5 of 6 [Insert current version date here]


Date Legally Authorized Representative

Date Person Obtaining Consent

    CF-SPECIMEN COLLECTION JULY 2008 Page 6 of 6 [Insert current version date here]

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