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Samples Linked to Participant

ORI

As part of this study, we would like to store ____ (type of specimen - blood, urine, tissue, etc.) specimens collected from you for future research on ____ (condition). This future research may be conducted by ____ (PI’s name) or by other researchers who obtain IRB approval for their research. This research may/ will not (choose which is correct) involve genetic studies. There are several things you should know before allowing your (tissues, cells, urine, and/or blood) to be studied or to be stored.

  1. The specimens will be labeled with a code that only study personnel can link back to you. Researchers outside of this study will not be given a link between the code number and your name or any other identifying information. While we hope this will prevent any potential loss of privacy or confidentiality, we cannot make any guarantees.
  2. In addition to your name, other information about you might be connected to your sample. For instance, information about race, ethnicity, sex, your medical history, and so forth might be available to investigators studying your specimen. Such information might be important for research or public health. It is possible that this information (including genetic information) might come to be associated with your racial or ethnic group.
  3. The specimens obtained from you in this research may help in the development of a future commercial product. There are no plans to provide financial compensation to you should this occur.

If no re-contact is planned:

  1. In this study, investigators will not tell you what they find out about you, nor will they contact you if a test becomes available to diagnose a condition you might have or later develop.

Or, if potential re-contact is planned:

  1. Investigators in this study may try to re-contact you in the future to find out about your health. If you are contacted and want to know what the investigators have learned about your samples, you should understand that the following are the kinds of things the investigators or your health team might tell you:

    1. Information is too preliminary to give you particular details, but you will receive a newsletter informing you about the results of the project.
    2. For any future research, we may contact you with a new consent form giving you additional information.

      If including genetic testing also add the info below:
    3. You carry a gene for a particular disease that can be treated.
    4. You carry a gene for a particular disease for which there is no current treatment. This news might cause severe anxiety or other psychological distress, depending on the severity of the disease.
    5. You carry a gene for a disease and might consider informing relatives that they, too, might carry the gene. It can be very difficult to decide whether to share such information with relatives. Genetic counselors can help sort out the various options in such a case.

You may request at any time that your research samples be removed from storage and not be used for future research. If you decide you want your samples removed, you may contact _____ (PI’s name) via written communication at the following address: _____________. Once the request is received, and if your samples have not already been used for other research, they will be destroyed. If you do not make such a request, your specimens will be stored indefinitely or until completely used.

If storage of specimens is an optional part of the study, include the following, as well as initial lines to document participants’ choice: You do not have to agree to allow your blood and urine specimens to be stored in order to be part of this study.

Initial your choice below:

___ Yes, I agree to allow my samples to be kept and used for future research.

___ No, I do not agree to allow my samples to be kept and used for future research.