Personalized Medicine (ORBIT)
About the Open-Access Robotic Biorepository and Informatics Technology (ORBIT) Program
Patients 18 years or older capable of making decisions regarding their health care and are being treated at an Aurora Health Care facility will be asked if they wish to participate in the ORBIT program.
If the patient agrees, he or she will sign a consent form giving access to discarded blood and protected health information. The consent form is reviewed by Aurora’s Institutional Review Board (IRB). The biorepository will collect any blood leftover from physician ordered clinical testing and store it for later use. Blood samples and information from health records are only collected from patients who agree to participate in the project. Blood and information will be collected in an ongoing process to enhance our ability to follow disease susceptibility and progression in people.
The blood samples and data will make it possible to study many questions in Aurora’s effort to improve health care. Participating in this project will not affect patient care in any way. There are no costs incurred to the patient for participation in the biorepository project. Also, patients will not receive financial compensation for their participation.
Aurora is using an automated robotic system to handle, catalog and store specimens in the biorepository. This system is expected to reduce errors that could occur in handling, analyzing or tracking specimens manually.
The technology used is Tecan’s Freedom EVO® liquid handling platforms and REMP Small Size Store™.
There is no physical risk to taking part in this project because ORBIT uses only discarded blood samples. Every attempt is made to protect privacy, but it cannot be guaranteed that identity will never become known. It is possible that genetic information could be used to identify patients and even some relatives (parents, brothers, sisters and children) who share some genetic information. Should this occur, it may reveal patient or their relatives are at increased risk for future health problems.
The Genetic Information Nondiscrimination Act (GINA) of 2008 protects Americans from being treated unfairly because of genetic differences that may affect their health. This act became a federal law in May 2008. In May 2009, the law affected health insurers and in November 2009 the law also affected employers. The law does not cover life insurance, disability insurance and members of the military.
Aurora Health Care is dedicated to maintaining patient privacy. Information identifying patients from the blood samples and health data is removed. Researchers will only be able to access samples and health data marked with a unique research number. Only designated employees of Aurora authorized to access medical records will know a patient’s identity for purposes of updating and managing the privacy-protected research database.
Blood samples are stored in a secure facility accessible only by personnel authorized to maintain the biorepository. Samples are marked only by a unique barcode. Two databases will be created and maintained under security measures used by Aurora to protect patient identities. One database will contain identifiers such as patient name and social security number to allow designated Aurora employees to collect appropriate data relevant to this project. Researchers will only be allowed access to the second database containing data that has had the identifying information removed. This database is designed to comply with HIPAA regulations by removing the following identifying information:
All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP code, and their equivalent geographical codes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:
- The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people.
- The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people are changed to 000.
- All elements of dates (except year) directly related to an individual (including birth, admission, discharge and death dates) and all ages older than 89 and elements of dates (including year indicative of such age). Ages and elements may be aggregated into a single category of age 90 or older.
- Telephone numbers.
- Facsimile numbers.
- Email addresses.
- Social security numbers.
- Medical record numbers.
- Health plan beneficiary numbers.
- Account numbers.
- Certificate/license numbers.
- Vehicle identifiers and serial numbers, including license plate numbers.
- Device identifiers and serial numbers.
- Universal resource locators (URLs).
- Internet protocol (IP) address numbers.
- Biometric identifiers, including fingerprints and voiceprints.
- Full-face photographic images and any comparable images.
- Any other unique identifying number, characteristic, or code, unless otherwise permitted by the HIPAA Privacy Rule for re-identification.
We have also obtained a Certificate of Confidentiality from the National Institutes of Health (NIH) to help us protect privacy. The NIH grants Certificates of Confidentiality to protect identifiable research information from forced disclosure. With this certificate, Aurora Health Care personnel who have access to research records through the biorepository project cannot be forced to provide identifying information on research participants in any civil, criminal, administrative, legislative or other proceeding, whether at the federal, state or local level. Identifying characteristics include things such as: name, address, social security or other identifying number, fingerprints, voiceprints, photographs, genetic information or tissue samples, or any other item or combination of data about a research participant which could reasonably lead, directly or indirectly by reference to other information, to identification of that research subject.
The Certificate of Confidentiality protects individuals participating in Aurora Health Care’s biorepository project.
How to Participate or Withdraw
If asked at an Aurora facility to participate:
- Read the consent form and ask questions if something is not clear.
- Participate by signing the consent form.
- Check with website for updates on ORBIT’s progress.
- Call 1-877-266-1660 (toll free).
- Provide patient name, phone number and the best time to return the call during normal business hours (Monday through Friday, 8 a.m. to 4 p.m.).
By withdrawing, blood and data associated with the name given will be removed from the biorepository and prevented from being used in future projects.