Welcome to Genetic CSA: 20+ Years of Advocacy & Support!
Empowering Individuals to Live Their Best Lives!
  • About Your Health

    With genetic cancer testing!



  • Fully covered by insurance plans for MANY!

    Your insurance plan may cover a simple, at-home, genetic cancer screening kit at no cost to you.

  • IT'S IMPORTANT TO

    Be Proactive.

    Knowledge Is Power to

    Save Lives!

    Knowing in advance gives you options and can offer you better outcomes. Contact us today to request your kit.

  • Know your Family History.

    Learn Your Health Risk

    With Genetic Cancer Testing.

    Be empowered to help protect the health of YOU

    and YOUR LOVED ONES for generations to come!

  • Results You Can Trust!

    You can have

    Confidence in our

    ACCURACY and QUALITY

    All samples are processed in CLIA certified, CAP accredited labs that meet the American Society of Clinical Oncology (ASCO) recommended requirements, and federal standards for quality, accuracy and reliability of tests.

Genetic Cancer Screen Association Informed Consent
Effective Date: March 29, 2018
Introduction

Thank you for considering participation in our Cancer genomic testing (CGx) and Pharmacogenomics testing (PGx) genetics. We are  grateful about the advances in genomic science and research that are rapidly improving progress for more patients,
as understanding of cancer genetics improves; We are excited by the future and the limitless possibilities in medicine.  This Informed Consent relates to CGx and PGx testing that may be performed by GCSA's lab partners as well as the pre- and post phases of the above-mentioned testing. As to any internal GCSA product development or enhancement work that is not covered by this consent, such development or enhancement is covered by the GCSA Terms and Conditions and Privacy Statements.

Your consent to participate in this testing is completely voluntary and is not required to use any of our resources, information, tools or services. Even if you consent to participate in the testing, you may withdraw your consent at any time, and your information will be removed and biological sample will be properly disposed of. We encourage you to carefully read the full text below before deciding whether to give consent.

 

Full Informed Consent

What am I agreeing to if I consent?

Undergoing testing using our services you are referred to as ("patient"). By having testing performed, the patient acknowledges that they been offered the opportunity to discuss with a healthcare provider the benefits, risks, & limitations of the test (s) to be performed. They have discussed with the Advocate the reliability of positive or negative results and the level of certainty that a positive result for a given disease or condition serves as a predictor of that disease or condition. They have been informed about the availability of genetic counseling.

 

They consent to having this test performed and will discuss results and appropriate medical management with desired healthcare provider. Patient understands and consents that the saliva and/or buccal swab sample submitted, will only be used in a test that provides results for Comprehensive Hereditary Cancer Risk Assessment and/or Pharmacogenomic Screening, and that no tests other than those authorized above will be performed on such sample by GCSA and its lab partners. 

Patient consents to the collection and testing of their specimen. Patient certifies that the specimen is fresh and has not been adulterated in any manner. Patient authorize the laboratory to release the results of the testing to the ordering provider. Patient further authorizes their insurance benefits to be paid directly to our lab partners for services rendered.

GCSA and its lab partners, will make every reasonable effort to obtain reimbursement for the ordered tests. Patient understands that they are responsible for any outstanding balances, deductible/co- payments as required by my plan. Patient consents to having genetic analysis performed and the results and the analysis made available to their physician(s). Patient consents all claims to the samples and genetic information are to be released to GCSA and its affiliates. Patient consents that they authorize GCSA and its affiliates, and its assigns, to utilize the sample(s) for further research following HIPAA - compliant de- identification of sample(s). Patient understand that the test results will be communicated to me through the ordering physician, its affiliates, and/or written summary of my test results.

 

Patient consents that their results may be supplemented by patient education about genetic or medical conditions, testing, test results, or other subjects and may be in the form of videos, secure email, website, print, or other forms of media.

 

Patient understands that they will have an audio interview prior to having the CGx or PGx testing.

By giving consent to participate in the testing, you agree that all information and Biological Samples that you share with us (as further described below) through your use of our websites, mobile applications, and products that exist now, or in the future (our “Services”) will be used in the process of determining medical insightful data from CGx and/or PGx testing. Anyone who has initiated an CGx or PGx test can voluntarily participate in this program, but understands that their insurance carrier will be billed to cover the costs of the testing.

Who conducts the services?

Associates/Advocates of GCSA perform services for the testing by pre-screening patients for preliminary qualification that they meet medical necessity for undergoing testing. We work with scientist and clinicians from other organizations and companies who share our Purpose. This might include academic institutions as well as non-profit and for-profit businesses or government agencies (“Collaborators”).

These Collaborators may also work with other entities to conduct other types of genetic testing (“Collaborator Partners”).

The testing for the Project may be performed solely by us, or by Collaborators with help from GCSA physician partners or Collaborator Partners. All healthcare professionals, whether affiliated with GCSA, our Collaborators, or Collaborator Partners may be referred to in this Informed Consent as “Clinicians.” GCSA will review all research requests for Biological and DNA Samples (as described below).

In some instances, GCSA receives compensation from Collaborators who work on the resulting of the tests in the CAP accredited CLIA certified lab of our lab partners.

What data is used?

When you give consent, clinicians and medical professionals may use all data that you provide to us when you use our Services, including Biological Samples and any data derived from those samples (the “Data”). Data includes:

Biological Samples: means saliva samples (“Saliva Samples”) and the DNA obtained from the saliva samples (“DNA Samples”) that you voluntarily provide to us now or in the future;
Genetic Data: Genetic information derived from processing your DNA Sample through genomic, molecular, and computational analyses using various technologies, such as genotyping and whole or partial genome sequencing. Genetic Data is broader than just the results delivered to you when you use the GCSA CGx and/or PGx test and includes a range of DNA markers such as those associated with your health or other conditions;
Self-Reported Health and Trait Data: Information that you voluntarily share with us about the health, medical conditions, diseases, lifestyle or other traits of you and your family members, for example through the family health history tool or by answering questions on our Services.

We take your privacy seriously and value the trust you put in us when you allow us to use your Data. Our privacy statements describe how we handle your Data and our compliance with applicable laws for cross-border transfers of Data. As part of the Project, Researchers outside the United States may access and use your Data. If this occurs, those further cross-border transfers of Data will be made in compliance with the mechanism described in our privacy statements. For more information, refer to our Privacy Center and the Privacy Statement.

Your name, contact information and other common identifying information are always replaced with a code for your protection.

Data and Biological Samples, are submitted to our lab partners using that code ( without your name, contact information or other common identifying information). Again, when your Biological Sample is sent, it is labelled only with a code.

When we collaborate with government agencies on research, we take all necessary steps to protect the privacy and integrity of your Genetic Data and Biological Samples in accordance with laws and regulations pertaining to government-funded research. In some instances, if we partner with, or our research is funded by, certain U.S. agencies like the National Institutes of Health, we may be required to contribute certain Data to a national database that will be accessible by other researchers. In the event such contribution is required, we will only provide Data that has had identifying information removed in accordance with U.S. federal regulations.

Your Data may also be shared with others who review the quality and safety of the research (for example, the U.S. Food and Drug Administration, other regulatory agencies, and Quorum Review, an institutional review board, which is a group of people who review research studies to protect the rights and welfare of research participants). We will never knowingly disclose or interpret your Data for use by employers or insurers for employment or insurance purposes.

How is my Data protected?

As described in our Privacy Statement, we use multiple layers of physical, technical, and administrative procedures to protect your Data from unauthorized access while conducting our business.  In addition, we require our Collaborators and Collaborator Partners to use similar physical, technical, and administrative procedures to protect the Data and Biological Samples we share with them.

Are there any risks to me?

There are no physical risks involved with providing a DNA Sample and having your Data used for testing. There are some potential risks to participating in the services as follows:

Data about you could become public as the result of a security breach. Although we have strong policies and processes in place designed to minimize the possibility of a security breach (see the controls described above) and we require our Collaborators and Collaborator Partners to have similar controls, we cannot provide a 100% guarantee that a breach will never happen.
When Researchers publish results from the Project, such results may include your Data, but only as part of aggregated results across many people to minimize the chance that your personal information is identified. But it is possible that third parties could identify you from research that is made publicly available, for example if they are able to combine your Genetic Data with other information about you that is available to them that links your Genetic Data to your name or other common identifying information. However, identification of your individual data would be extremely difficult, because it would be published as part of an aggregated summary of information for many people and without any common identifying information.
When Biological Samples are physically transferred from us to Collaborators, there is a potential risk that the samples could be lost or stolen while in transit or storage. We take precautions to reduce the likelihood that this will happen and your Biological Samples are not transferred with your name or contact information.
When we provide you with information about your Genetic Data, you will learn information about you or your genetic relatives that you do not expect or that makes you uncomfortable, such as potential health risks. With this, genetic counseling is made available to anyone to work-through the outcomes of any findings.

If your Data is somehow made public or made available through a security breach, it may be used to identify you, and may negatively impact your ability to obtain certain types of insurance coverage, or used by law enforcement agencies to identify you if they have additional DNA data to compare to your Data. In addition, if you or a family member has Data linked to your name or your family member's name in a public database, someone who has access to your Data might be able to link that data to your name or your family member's name through the publicly available data.

However, in the United States, a federal law called the Genetic Information Non-Discrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to seek your genetic information without your consent, and to discriminate against you based on your genetic information. GINA does not protect you from discrimination with regard to life insurance, disability insurance, long-term care insurance, or military service.

In addition, there are laws in certain states and laws outside the United States that prohibit discrimination against an individual based on genetic data, which further minimize the risk of potential negative impacts to you or a relative through a third party identifying you based on publicly available information and your Data. GCSA will never disclose your Data to insurance providers, employers or law enforcement (unless compelled by valid legal process).

There may be additional risks to participation that are currently unforeseeable.

Are there any costs for testing?

There is no cost to you for testing if you meet the medical necessity and billing requirements indicated by Medicare.

Do I have to consent to the testing?

No, your participation is voluntary. No one is required to participate in testing. It is always best to take the guidance of a physician when making medical decisions. If you choose not to participate in the Project, you can still use the resources, tools and service we offer. No one should influence or pressure you to participate in testing.

We may terminate our services at any time without notice to you. In that event, your Data will continue to be protected as described in this Informed Consent and our applicable privacy policy.

What is my alternative to testing?

Seek guidance and medical management direction from your physician and share personal and family medical history so they can have the information they to provide the best possible care and recommendations for best health outcomes.

Can I withdraw my consent?

Yes, you can withdraw your consent at any time. If you withdraw, we will cease using your Data for the Project within 30 days and the Data will not be used and properly disposed of. However, Data cannot be withdrawn from testing already in progress or completed, or from results and findings already provided to your physician and/or ordering physician. In those cases, information may be accessible by medical professionals on your medical history records indefinitely. There is no negative impact to you for withdrawal of your consent, and you will continue to be able to use the information, resources and tools we provide as before, if you choose to do so.

This Informed Consent does not have an expiration date. If you do not withdraw consent, it will remain in effect until you withdraw in writing by sending an email to Contactus@geneticcancerscreen.org.

Who can I contact about the testing?

Please contact us if you have any concerns, complaints, or questions about the testing. You may reach out to us by calling: 855-543-6837 or emailing us at: Contactus@GeneticCancerScreen.org

In accordance with applicable law, you may have a right to seek access to, rectification of, or object to use of your Data. You may contact us and your local data protection regulator (if you are in the EU) should you wish to lodge a complaint about our handling of your Data.

We encourage you to print a copy for your records, and this Informed Consent is also available on our GCSA website.

Genetic Cancer Screen Association is a leading Health Advocacy group in the fight against cancer! We are comprised of like-minded individuals, with one goal: To offer support, information and resources to Empower and Help Save Lives!

* The information provided is for general informational purposes only and not intended to be nor should be construed as medical or other advice.  You should consult your own doctor and/or an appropriate professional to determine what may be right for you.

Any discussion of medical management options is for general informational purposes only and does not constitute a recommendation. While genetic testing and medical society guidelines provide important and useful information, all medical management decisions should be made based on consultation between each patient and his or her healthcare professional.

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