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University of Michigan
Central Biorepository Consent

 

 

 

As part of the Providing Mental Health Precision Treatment (PROMPT) study, you will be asked to donate a DNA sample to a research biorepository called the University of Michigan Central Biorepository. Participation is up to you, and if you do decide to take part, you may leave the project any time without penalty. Participation in the biorepository is not a part of your health care.

 

A biorepository contains samples of blood, tissue, and information from many different people.

Researchers can take samples and information from the biorepository and use them in their own studies. The study requires you to contribute to a research biorepository called the University of Michigan Central Biorepository. This document and a separate information sheet have details that you should consider before you decide to join. When this document is signed, it confirms our promises to you and gives us your permission for the project team to obtain and use your samples and your protected health information.

 

Joining the Biorepository.

 

After reading both documents and asking us questions, you should understand that:

  • The biorepository is a research project. It is not part of your health care and will not directly help you.

  • It is designed to help us learn about health and disease for the benefit of all people.

  • Participating in this project is completely up to you.

  • If you decide not to participate in this project, it will not affect your health care treatment or payment, enrollment in your health plan, or your eligibility for health care benefits.

  • You will not receive payment for participating in this project or receive payments from scientific discoveries made using the information or samples you donate.

 

Leaving the Biorepository. Even if you decide to take part now, you may end your permission

and leave this project at any time without penalty. If you do decide to leave the project, contact the Principle Investigators or Study Coordinator at:

 

Principal Investigator: Srijan Sen MD, PhD

Mailing Address: 205 Zina Pitcher Place, Ann Arbor, MI 48109

Telephone: (734) 395-8319

 

Principal Investigator: Amy Bohnert, PhD

Mailing Address: 2800 Plymouth Road, Ann Arbor, MI 48109

Telephone: (734) 845-3638

 

Study Coordinator: Ciddjyne Chery, M.S., C.C.R.P.

Mailing Address: 4250 Plymouth Road, Ann Arbor MI 48109

Telephone: (734) 232-0393

 

Keep in mind that we will not be able to get back samples or your information if they have already been shared with other researchers or if we can no longer identify them as coming from you.

 

Participating in the Biorepository.

 

You should also understand that:

  • Sample donation. You will be asked to provide a sample of cells by saliva sample. The saliva sample can be collected at home and returned to the study team by mail or in person. You may also collect and submit your saliva sample in person with a member of the study team, if desired.

  • Health records. You give the biorepository your permission to collect your protected health information from the University of Michigan and any other past, present, or future sources and link it to your donated sample. Your permission to let this project team do this has no expiration date. See the “Privacy and Confidentiality” section for examples of what information can be used.

  • Sharing. You give the biorepository your permission to share your samples and collected information with researchers anywhere, including those in other countries and those working for companies. The biorepository will follow all regulatory standards before releasing samples or information.

  • Research Uses. You give your permission for researchers to use your samples and health information to study any disease or health condition. The information sheet describes some ways researchers might use your samples and health information.

  • Recontact. Researchers may contact you again to ask for more samples or information or to tell you something they have learned about your sample. You can always say no to the researcher.

 

Risks and protections for you and your information.

 

You should also understand that:

 

  • There are minor physical risks involved with providing your sample. See the information sheet.

  • There is always a risk that you could be identified by your donation and health information.

  • The project team will do its best to keep your information confidential, as required by a law called HIPAA. See the Privacy and Confidentiality section for important details about privacy and confidentiality. But once your information has been shared with others, it may no longer be protected by HIPAA.

 

Privacy and Confidentiality

 

What will researchers be able to see about me?

If you give them permission by signing this form, they will be able to take your health information from:

  • Any health provider’s records. This could include information such as:

    • What illnesses and treatments you have had, and how well the treatments have worked.

    • Results from x-rays or lab tests.

    • Mental health records.

    • Alcohol and substance abuse treatment records.

    • Whether you have HIV or AIDS.

    • Billing information.

    • When needed, identifiers like your name, address, or Social Security Number.

  • Other health information from sources outside of our medical center with appropriate permissions.

  • For more HIPAA information, go to: http://www.uofmhealth.org/patient+and+visitor+guide/hipaa.

 

To make sure this project is conducted safely and properly, University, Food and Drug Administration

(FDA), government officials, and sponsors of the project might need to see your health information.

 

How will my privacy be protected?

  • Whenever possible, donated samples and your health information will be stored with a code instead of identifiers (such as name, date of birth, medical record number, social security number). However, the more information about you that is combined together, the more likely it is you could be identified.

  • All information used by this project will be protected so that it can only be accessed by authorized people. Still, no one can guarantee that computer security will be perfect.

  • No published scientific reports will identify you directly.

 

Can I be discriminated against based on genetic information that people learn about me?

Your biological samples contain genetic information about you. The Genetic Information Nondiscrimination Act (GINA) is a federal law that prohibits certain kinds of discrimination on the basis of genetic information. GINA applies to any genetic information obtained by this project, so you may want to know what protections GINA provides before you decide whether to donate.

 

  • GINA prohibits health insurance companies and health plan administrators from asking for genetic information about you or your family members. It also prohibits them from using genetic information for decisions about coverage, rates, or pre-existing conditions.

  • GINA prohibits employers with 15 or more employees from using genetic information for hiring, firing, or promotion decisions, or for any decisions regarding terms of employment.

  • GINA does not apply to other kinds of insurance, like life, disability, or long-term care insurance.

 

For more information about GINA, go to: http://www.genome.gov/10002328 or ask us for help.

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