Brain Health Biobank

Version #5

Brain Health Biobank Consent Form

Jeffrey Burns, MD, MS
4350 Shawnee Mission Parkway
Fairway, KS 66205 University of Kansas Medical Center
913-588-0555

You are being invited to join an optional research study at the University of Kansas Medical Center (KUMC) by Dr. Jeffrey Burns. You can decide not to participate or stop at any time. Regardless of your decision, you will still get the same care from your health care team.

The study is asking your permission to collect and store medical information and extra samples collected during your routine medical care at KUMC. The information and samples will be shared with researchers at KUMC and other institutions for the purpose of advancing research on diagnosing, treating, and preventing cognitive change.

What am I being asked to do?

This study involves no additional visits to our research center.

The following may be collected from past and future standard-of-care medical visits. If you are part of another research study at KUMC, we may also collect the following from already scheduled research visits.   

Medical Information and Imaging: We will collect and store information from your medical records, imaging, and other relevant health data generated as part of your routine medical care. This may include details such as demographics (age, gender), family history, diagnoses, treatments, medications, lab results, and imaging (such as MRI and PET scans). Additionally, as technology evolves, this may extend to other forms of health related data, such as voice, video, or other digital health recordings that may become part of routine care.

Specimen Collection: If you have a sample collected (such as blood, tissue, or other fluids) as part of your routine medical care or any other research studies you are participating in, we may store and use any that remains after necessary clinical testing is completed. We may collect up to 10ml of extra blood or spinal fluid.

Permission to Contact: By participating, you are providing the research team with permission to contact you about ongoing activities and optional research opportunities at KU and the Alzheimer's Disease Research Center. You may decline those opportunities when contacted and opt out of further contact.

What types of research projects will be done?

Your data and samples may be used to advance health-related studies, including research on cognitive aging and other medical conditions, including those outside KUMC and by private companies. Future projects might include genetic testing which examines genes (pieces of DNA) that provide the instructions needed to make our bodies work.  Participants will not be paid if a commercial product is developed. There are no plans to disclose your research results to you.

What are the risks of the study?

Risks about confidentiality: There is a small risk of loss of confidentiality when personal information is used for research. Your information will only be used by study team members and approved researchers. No one's name will be used when this research is published or presented.

Risks of genetic testing: There may be risks to giving your samples for genetic research.  A federal law called the Genetic Information Non-Discrimination Act, or GINA is in effect. This law does not allow insurers or employers to use genetic information to discriminate against you. The law does not cover other types of misuse by life insurance, disability, or long-term care insurance. To learn more about the GINA Law, please go to https://www.eeoc.gov/laws/statutes/gina.cfmj.

How will my privacy be protected?

Your privacy is protected by law, but absolute confidentiality cannot be promised. Your identity won't be disclosed in any publications. The study team labels your data and samples with a research ID to minimize risk of exposure.

Study data includes your medical information, which will be accessed by the research team and others at KUMC. The team may use any and all of your information needed for the study. Your medical records may contain your name, address, phone, date of birth, social security number, or other identifiers.

Your data may be shared within or outside KUMC. If your information is disclosed by your health care providers or the research team to others, federal and state confidentiality laws may not protect it. These groups may include:

• Federal agencies that oversee human research
  
• Study partners, including Medicare
• Your treating clinician
• Experts who inspect the study information to see if the study is being done correctly and if it is still safe to continue
• Other groups that help manage or provide services to support the study
• Ethics committees that review the study for other locations

Consent

By agreeing to participate, you consent to the collection, use, and sharing of your health information. If you do not agree to participate, that excludes you from the study.

Your consent for data use will not expire unless you cancel it by writing to Dr. Jeffrey Burns at the University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160. If you cancel your permission, you will be withdrawn from the study.

If you have questions about the rights of research participants, you may contact the KUMC Institutional Review Board at (913) 588-1240 or IRBhelp@kumc.edu.