Please review this Consent Agreeement carefully. Let the attendant know if you have any questions. When you have completed your review, select "Next" to advance to the signature page.
Introduction
This consent form authorizes Enable Biosciences, Inc. to conduct islet autoantibody testing, which identifies biomarkers linked to Type 1 Diabetes (T1D) using a blood spot sample. This authorization applies to either:
- The individual signing this consent form, or
- The dependent minor child of the individual signing this consent form.
If signing this consent form for a dependent, I confirm that I am the parent or legal guardian of the minor and have the legal authority to consent to their medical testing.
Please read this form carefully and consult a healthcare provider or their designee if you have any questions before signing.
Purpose of Testing
The islet autoantibody test helps assess whether the test recipient may be at risk for developing T1D. It detects specific autoantibodies that target insulin-producing cells in the pancreas, indicating an autoimmune process that may lead to T1D. A positive result may indicate an increased risk of developing T1D but does not guarantee the onset of the disease. This test is solely for detecting autoantibodies related to T1D and does not serve as a diagnostic test for diabetes. A licensed healthcare provider must order this test, and they or their designee have explained the purpose, potential benefits, risks, and limitations of the islet autoantibody test.
Sample Collection Procedure
The blood sample will be collected by puncturing the finger using a sterile lancet, which may cause minor bleeding and discomfort. This is a standard procedure for collecting dried blood spot samples.
Confidentiality, Privacy, and Data Use
I understand that the test results will remain confidential and will be shared only as needed for testing, in compliance with applicable laws. I consent to the use of de-identified, aggregated data for public health, research, and quality improvement, with the assurance that no personal health information (PHI) will be disclosed without my authorization unless required by law. Depending on the location and setup for the event, I acknowledge that full privacy may not be available during the sample collection process.
Financial Responsibility and Compliance with Healthcare Laws
This test is being provided at no cost by Sanofi as part of an educational and public health initiative. The free test is not being offered as an inducement to use Enable Biosciences' services in the future, nor as an incentive for referrals, purchases, or any business arrangement. No provider, participant, or third party is obligated to refer, prescribe, or order any additional services from Enable Biosciences in exchange for this free test. Enable Biosciences complies with all applicable healthcare laws, including the Anti-Kickback Statute (42 U.S.C. § 1320a-7b) and Stark Law (42 U.S.C. § 1395nn), ensuring that the provision of free testing does not influence clinical decision-making or future business relationships.
Voluntary Participation
Participation in this test is completely voluntary. I confirm that I have had the opportunity to ask questions, which have been answered to my satisfaction. I acknowledge receipt of this consent form and fully understand the purpose, benefits, risks, and procedures involved in T1D islet autoantibody testing. I understand that choosing to participate or decline will not affect my access to healthcare services.
Transparency Disclosure for Healthcare Professionals Participating in Screenings Provided by Sanofi
Sanofi is committed to transparency in its interactions with healthcare professionals consistent with applicable laws in countries in which Sanofi has Affiliates. Please be advised that the in-kind value of this screening may be considered a transfer of value under applicable transparency disclosure and reporting laws and regulations. If required by the laws or regulations of your country, Sanofi will collect and report the value of this screening to the appropriate government authorities or websites for subsequent public disclosure where applicable. This may include sharing your name, relevant details, and the nature of the screening, as mandated by these laws and regulations. If applicable, a separate consent for this individual publication will be collected. The in-kind value of this screening is $169.00 USD.
By signing, I agree that:
I authorize Enable Biosciences, Inc. to conduct islet autoantibody testing for myself or my dependent as indicated.