Q: How can participation in GHI help shape the future of healthcare?
A: NorthShore has embarked on the next major step in advancing medicine—individualized healthcare based on an individual’s comprehensive genetic profile. Common diseases, such as diabetes, cancer, stroke, and heart disease, are shaped by many genes and environmental factors. The Genomic Health Initiative (GHI) investigates the relationship between DNA sequence variations in human genes and diseases. The results of our analyses may lead to discoveries about the relationship between DNA sequences and disease, which in turn may lead to insights into new medical treatments and prevention.
Q: What are the goals of the GHI?
A: We are studying how DNA sequence variation influences health, disease, and the effectiveness of treatments. We will conduct research aiming to:
- Identify genetic risk factors for common medical disorders
- Enable early diagnosis and preventive measures
- Tailor treatment options based on patient’s specific genetic makeup
- Return genetic data that is highly significant for your health
Examples of disorders we are studying include cancer, diabetes, high blood pressure, asthma, obesity, abnormal heart rhythms, glaucoma, psoriasis, and many others.
Q: What is required of me to participate?
A: We are inviting all NorthShore patients age 18 or older to participate in this study. Participation requires the donation of less than a tablespoon of blood and allowing NorthShore researchers to access your electronic medical record (EMR). We use these records in order to obtain information about participants including medical history, medications, demographic information, and environmental exposure factors that affect disease. We will extract the DNA from your blood sample and will store it in highly secured facilities within NorthShore. All DNA samples and data obtained from your EMR are de-identified and kept confidential.
Q: I have decided to participate. How can I enroll?
A: There are two methods for enrollment:
1. Electronically via NorthShoreConnect: logon and click on the Genomic Health Initiative enrollment link to read and electronically sign the consent form.
2. Visit one of our Enrollment Packet Locations which are at most outpatient labs, patient service centers, and many medical group locations. There you may obtain a GHI enrollment packet, which contains a cover letter, consent form, brochure, and return mailer. If ready, you can return your completed consent form to the front desk staff then or by using the postage-paid envelope at your convenience.
Q: How will my sample be collected?
A: We will collect a blood sample when you have your next clinically scheduled blood draw at any of NorthShore's hospital outpatient labs or patient service centers. Or if you prefer, you can come in just for this research blood draw. Your participation is voluntary and you may withdraw from the study at any time by contacting us at 224.364.7470.
Q: What happens to my sample?
A: Your DNA will be stored in highly secured facilities within NorthShore. DNA stored at NorthShore and any DNA sent elsewhere for analysis will be de-identified. This means that we will replace your name with a random research number that will be assigned to your study-related information, including your DNA and all biosamples, to ensure confidentiality.
Q: How will my information be kept confidential?
A: To ensure confidentiality, we will replace your name with a randomized research number that will be assigned to your study-related information, your DNA, and all biosamples. Only qualified researchers will access your study-related information. The genetic data generated by our research study will not become part of your EMR. Your name and identifying information will not be used when any findings are published.
Q: How many people will be studied?
A: Our goal is to enroll tens of thousands of individuals in this ongoing study. This large sample size will allow us to study the widest range of genetic variants in DNA to best inform about many different genetic and medical disorders.
Q: Will I be recontacted?
A: The choice to be recontacted is yours. If you allow, we will make reasonable and practicable efforts to contact you if we find significant results affecting your personal health (see below). Researchers may also contact you to ask you to consider volunteering for future studies, although you have no obligation to do so.
Q: How will I benefit from this research?
A: There are two basic ways you can benefit from the study. First, you will be participating in a high-caliber research study that will examine associations between specific DNA sequences and disease. The study results, in the aggregate, may lead to improved methods for prevention of disease, and potentially, to new and improved treatment options. Secondly, our study may uncover data directly relevant to your health, such as high risk for some cancers, cardiovascular disorders that are associated with sudden death, or genetic susceptibilities that may predispose to toxic reactions to some drugs. Although the GHI genetic research results are highly precise, they are primarily for research use and are not required to comply with federal CLIA (Clinical Laboratory Improvement Amendments) standards. Therefore, if such data points to a medically actionable genetic risk for a disease (meaning that there is an existing medical intervention available), and you have indicated on your consent form that you desire to be notified of such findings, a genetics counselor will make reasonable and practicable efforts to contact you to:
- Provide instructions for you to obtain a confirmatory CLIA test
- Provide advice and inform you of available clinical follow-up after CLIA confirmation
If you have further questions, please call the Genomic Health Initiative staff at 224.364.7470 or email firstname.lastname@example.org.