Informed Consent to Support Quality Control, Research, & Banking Initiatives
Preamble
Thank you for choosing SageMedic Corp (SAGE) for your cancer diagnostic needs. We are a physician and patient advocacy-driven company, with the mission to help oncologists and patients make the most informed decisions to significantly improve patient outcomes.
Our SAGE Oncotest™ is performed in a California registered and CLIA accredited clinical laboratory and as such our test fulfills all state and federal requirements to be used for clinical decision making. That said, insurance companies may classify our test as experimental so that they don’t have to pay for it.
To provide the best possible results and guidance we have several quality assurance, quality control, general research, and tissue banking initiatives and we are requesting your consent to our terms and conditions regarding the use of your data and tissue specimen.
Benefits and Risks
Benefits: We appreciate you consenting to our terms and conditions regarding the use of your data and tissue specimen and are therefore providing you and your healthcare provider with the SAGE Oncotest™ results at a partially or fully discounted rate.
Risks: Agreeing to SAGE using your data and tissue specimen internally is not associated with a medical risk for you. Furthermore, we take your privacy and confidentiality very seriously and as a CLIA accredited clinical laboratory, we are complying with all HIPAA requirements. However, irrespective of whether you are requesting and consenting health information to be sent via email, because a data breach may occur at any level, there is always a risk for loss of privacy. Thus, with your signature you also agree to hold SAGE harmless should such an event occur.
Use of Data and Tissue Specimen
The main terms and conditions regarding the use of your data and tissue specimen are as follows:
1. We may use your protected health information (PHI) and your SAGE Oncotest™ results for quality assurance, quality control, general research, commercial, or any other purposes.
2. We may follow up with you or your healthcare provider in the future and use your PHI for further research, e.g., to correlate our test results with the clinical outcome to the therapy you have received.
3. The provided data and tissue specimen will become sole property of SAGE and may be stored indefinitely.
4. Any potential commercial benefit, including, but not limited to, research findings, intellectual property such as trade secrets or patents, will also become the sole property of SAGE.
Voluntary Participation
Your consent and authorization for us to use your data and tissue specimen is voluntary and you may withdraw your consent at any time. However, if you withdraw your consent after we have provided you and your oncologist with the SAGE Oncotest™ results, we will no longer contact you or obtain PHI from your healthcare provider for research purposes, but may still use your data and tissue specimen as outlined in the terms and conditions above.
2 SageMedic Corp. is a CLIA accredited lab, CLIA ID: 05D2236809, Lab. Director: Gerald Weiss, MD, FCAP
3 HIPAA stands for the Health Insurance Portability and Accountability Act of 1996.