Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED May 19, 2025
Currently, the study does not have a planned end date. If you no longer visit Renown Health or one of its study partners for your healthcare, your samples and information will remain with Helix and / or Renown Health unless you withdraw from the study or until the study ends. We will not inform you of the details or purpose of specific research studies that will be conducted in the future with your samples, health and genetic information. Helix and / or Renown Health may provide summaries every so often, like a newsletter, with updates on how the study is progressing and any new discoveries.
In general, Renown Health and Helix will not reach out to you for your permission to participate in future studies that will use your samples and / or your health and genetic information unless Renown Health or Helix determines that your additional consent is required. If you do not want your information or samples to be used for future research, you should not participate in this study. In most cases, because the results from future research will not directly affect your health care, we will not share the individual results from these studies with you or your healthcare providers.
What health-related results will I get? You might learn if you have inherited certain risk factors in your DNA that you might not otherwise know about because your family history or standard medical screening tests do not always identify risks for these conditions. Specifically, the genetic sequencing test, called Helix Health CDCT1 Screening Test will tell you about three actionable conditions. Actionable means if you know you have an increased risk based on your DNA, there are steps you and your healthcare providers may take to reduce or address your health risks. However, you may not receive definitive diagnostic information about your condition from the results.
The three conditions are:
● A hereditary form of very high cholesterol that causes heart disease at an earlier age than the general population, known as familial hypercholesterolemia( FH)
● A hereditary form of breast and ovarian cancer syndrome( HBOC), specifically the BRCA1 and BRCA2 genes. Women with HBOC have an increased risk of developing breast, ovarian and certain other cancers. Men with HBOC have an increased risk of developing prostate, pancreatic and male breast cancer
● A hereditary type of colorectal cancer known as Lynch Syndrome. People with Lynch syndrome are more likely to get colorectal cancer at a younger age and are also at an increased risk of developing endometrial, ovarian, upper GI, brain, pancreatic and / or other cancers.
This information may allow you to screen for, prevent, or minimize the impact of these conditions. Only about 1-2 %( 1 or 2 people out of 100) will be found to have a risk for one of these conditions. This means that 98-99 % of people( 98-99 out of 100) will learn that they do not have an increased risk for one of these conditions based on the test. In addition, it is important to note, this is a screening test which means it does not evaluate all genes associated with cancer and heart disease. Also, this test may not identify all DNA variants in the genes that are tested.
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