IU Precision Health Consent

The IU Precision Health Consent project is a statewide Initiative developed by Indiana University School of Medicine and IU Health in order to expand their capabilities delivering individualized patient care, specifically tailored to an individual based on their DNA.

The IU Precision Health Consent project gives every IU Health patient the opportunity to participate in this effort by donating a biological sample (in this case, blood). The goal of the project is to enroll up to 25,000 IU Health patients in 2020 and up to 300,000 over the next five years.

The purpose of the IU Precision Health Consent project is to find better treatments for dreaded diseases of today and the future, tailored to individuals based on their DNA or genetic information. By providing a biological sample, participants will be adding their information to a larger bank of data which can then be used for studies and research. 

While participants will not receive any individual results back based on the research done on their sample, they are automatically enrolled in All IN for Health, a program that provides access to health blogs and resources for good health. Additionally, they receive the opportunity to participate in more research studies, including clinical studies. Participants will receive the All IN for Health newsletter, which will provide updates regarding additional research projects. Participants can opt out at any time from receiving the newsletter.

To participate in the Precision Health Consent program, patients at IU Health hospitals (including Arnett, Ball, Bloomington, Methodist, North, Saxony, University, and West) are being asked to donate an extra vial of blood as part of a regularly scheduled blood draw. The blood sample is stored at the Indiana Biobank, a repository of blood samples and linked to an individual’s electronic medical record (again, no patient identifying information is relayed to the approved researcher, only de-identified information).

To date, more than 6,000 IU Health patients have participated in the IU Precision Health Consent project by providing blood samples using a new electronic consent process that has been rolled out in clinical settings, particularly IU Health phlebotomy labs. 

Your participation is completely voluntary and you may withdraw your consent any time. Any research data already obtained will remain part of the research that has been conducted. You can contact the Indiana Biobank via email at inbiobnk@iu.edu or 317.278.0880 with questions or to withdraw from this study. 

For questions about your rights as a research participant or to discuss problems, complaints or concerns about the research study, contact the Indiana University Human Subjects Office at 317.278.3458.

The Indiana Biobank, which stores all of the biological samples for the IU Precision Health Consent project, follows the same HIPAA rules as other U.S. healthcare organizations, including IU Health. Participants' basic information is collected (name, address, email, etc.) and stored in a HIPAA compliant database. At the time of consent, no personal health information is collected. Participants are assigned a study ID, and their biological sample and identifying information are stored based on this ID. No one other than specified study personnel have access to this information.

In addition, this information is protected through the National Institute of Health's Certificate of Confidentiality. This certificate protects against forced disclosure of personally identifiable information in any civil, criminal, administrative, legislative, or other proceeding whether at the federal, state or local level. This research also follows the Genetic Information Nondiscrimination Act (GINA), a federal law which generally makes it illegal for health insurance companies, group health plans, and most employers to request the genetic information we get from this research and discriminate against you based on your genetic information. Learn more about Genetic Information Nondiscrimination Act (GINA).