Real-World Data Study
About this study
Adaptive Biotechnologies has developed clinical tests intended to identify an immune response to a given disease. This study aims to provide real-world data to evaluate and improve clinically available T-Detect™ COVID tests based on your and others’ health information, to enable future diagnostic and therapeutic research and development.
What to expect with participation
- When ordering T-Detect COVID, opt-in to contribute to Adaptive’s ongoing T cell-based research.
- Read the consent form and decide whether you want to participate in the study. If you do, complete a quick survey to see if you meet the eligibility requirements for the study.
If you qualify, you’ll take an online questionnaire. This electronic questionnaire will be administered during the study to collect demographic data, information relating to your suspected condition and relevant medical facts such as medication and other health conditions. All information provided will be de-identified in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards. You’ll receive a $50 gift card for completing the questionnaire.
I have additional questions. Who can I contact?
Please email the study staff at firstname.lastname@example.org. Please visit our FAQs to find further contacts, including the study coordinator, the study doctor and the Western Institutional Review Board, an independent research reviewer.
Frequently asked questions
Adaptive has developed clinical tests intended to identify an immune response to a given disease. The goal of this study is to provide real-world data to evaluate and improve clinically available T-DetectTM tests based on your health information, as well as to provide data for future T-Detect tests.
You’re being asked to participate in this study because when you ordered T-Detect COVID you opted-in to contribute to Adaptive’s ongoing T cell-based research. Review the consent form and decide whether you want to participate in the study.
Your participation includes:
- Electronic questionnaire
You’ll take an electronic questionnaire during the study to collect information about your medical history, as well as symptoms and diagnostic tests performed relating to your suspected condition, when you have your blood draw for the T-Detect test. All information provided will be de-identified in accordance with HIPAA standards. You’ll receive a $50 gift card for completing the questionnaire (if all questions are answered).
- Optional portion
You have the option to complete additional questionnaires, over an indefinite period or as long as the study remains open. You’ll be provided a $50 gift card for completing each additional questionnaire (if all questions are answered). Longitudinal questionnaires are adapted to the study’s needs, and will only be sent to participants as applicable.
Adaptive will store, use and share your identifiable information and/or identifiable biospecimens for purposes of this research study, as well as for other medical and scientific research that may be conducted by Adaptive or other researchers, including other biotechnology companies, academic and medical institutions, or drug and device companies, for the indefinite future.
By consenting to participate in this study, you’re agreeing to both the use and sharing of your identifiable information and identifiable biospecimens for research done in the T-Detect™ Real-World Data Study, as well as to the use and sharing of your identifiable information and identifiable biospecimens for other future medical and scientific research, the details of which are not known at this time.
Risks and Benefits
The main risk is that your privacy could be violated. We will do our best to protect your information from going to people who should not have it, including by removing information that could be used easily to identify you. The risk that your identifiable information or identifiable biospecimen will go to someone who should not get it is very small.
You will not receive any direct benefits for being part of this study.
However, research using your identifiable information and identifiable biospecimens may help others by improving our understanding of health and disease, improving health care, making safer or more effective diagnostics, and developing new scientific knowledge.
Neither you nor your insurance company will be billed for your participation in the T-Detect Real-World Data Study.
You’ll be given a $50 gift card for your participation in the T-Detect Real-World Data Study. You must complete the online questionnaire (if all questions are answered) in order to qualify for the gift card.
If you choose to participate in the optional portion of the study after your initial study participation, you’ll be given an additional $50 gift card for completing each additional online questionnaire (if all questions are answered). Longitudinal questionnaires are adapted to the study’s needs, and will only be sent to participants as applicable.
Yes, you may withdraw (revoke) your permission to use and disclose your health information at any time. You can do this by sending written notice to the study doctor at the address shown on page 1. However, if you withdraw your permission for use and disclosure of your health information, you won’t be able to remain a part of this study. Also, although withdrawing your permission will prevent further uses and disclosures of your health information, it will not invalidate uses and disclosures that have already been made at the time the permission is withdrawn. Your original permission will be good until December 31, 2060 if it’s not revoked.
Every effort will be made to ensure confidentiality of Protected Health Information (PHI), in accordance with HIPAA. There’s a small risk that your information will be given to others without your permission.
Total confidentiality cannot be guaranteed, but we will limit disclosures of your health information, as described above. And, as mentioned above, to the extent the results of this research study are presented at meetings or in publications, your identity will not be included in the information that is disclosed. Government agencies or staff sometimes review studies such as this one to make sure they’re being done safely and legally. If a review of this study takes place, your records may be examined. The reviewers will protect your privacy, and the study records will not be used to put you at legal risk.
Your participation in this study is voluntary. If you do change your mind, please notify the study staff in writing. If you withdraw permission to use your samples, no new testing will be done; however, the results of any tests already performed will remain in the study data. Your participation in this study may also be stopped at any time by the study doctor or the sponsor, without requiring your consent, for the following reasons:
- They deem that it is in your best interests; or
- You do not consent to continue in the study after being told of changes in the research that may affect you.
You will be told about any new information that might change your decision to be in this study. You may be asked to sign a new consent form if this occurs.
Every effort will be made to ensure confidentiality of Protected Health Information (PHI), in accordance with HIPAA. There’s a small Please email the study staff at email@example.com.
You can contact the study coordinator:
And/or the study doctor:
Jennifer Dines Phone: 206-279-2486
For any of the following reasons:
- If you have any questions about the study or your part in it;
- If you feel you have had a research-related injury; or
- If you have questions, concerns or complaints about the research.
Western Institutional Review Board® (WIRB®)
1019 39th Ave. SE, Suite 120 Puyallup, WA 98374-2115
Telephone: 1-800-562-4789 or 360-252-2500
WIRB comprises a group of people who independently review research. You may contact WIRB if the research staff cannot be reached, or if you wish to talk to someone other than the research staff.