Consent, HIPAA & Other privacy documents
Consent
Before you participate in the 10,000 Families Study (10KFS), we ask that you complete a consent form. The consent form provides the information you will need to make an informed decision about participating in the study. It explains the goals of the research study along with the risks and benefits of participation. In addition, the consent form describes how and when the study team will contact you, what information and biological samples you will be asked to provide, and how the samples and information will be used.
What does the consent form contain?
The consent form begins with detailed information about participation, including how we work to protect your privacy and how to provide feedback on your research experience. Please read this information carefully before agreeing to participate in the study. It is also important to know that you can leave the study at any time and no one will be upset with your decision.
The consent form includes nine questions about activities associated with the study.
Some activities are required if you choose to participate in the study. To participate, you must agree to allow study researchers and other scientists to use your de-identified data and samples for current and future research and deposit that data in a database maintained by the National Institutes of Health. You must also agree to allow research staff to contact you in the future to ask questions about your health and where you live. De-identified means that your name, contact, and other identifying information are removed from the data.
Other activities are optional. You can participate in the study even if you choose not to share your health information with family members, healthcare providers, or commercial and for-profit companies.
Only participants who have reached the legal age of consent of 18 years old (age recognized in the USA) can give consent. For young participants between the ages of 8-11 and 12-17, 10,000 Families asks you to sign a form called an assent, which is the agreement of someone not able to give legal consent to participate in a Study. Parents or guardians are asked to sign a parental consent for their child under age 18.
- Adult Consent
- Assent ages 8-11
- Assent ages 12-17
- Parental consent ages 0 to 11
- Parental consent ages 12-17
HIPAA
In addition to the consent the 10KFS ask you to sign a Health Insurance Portability and Accountability Act (HIPAA) privacy form. This form allows your healthcare provider to share your health information with the research team. The research team may also share it with others who support, oversee, or sponsor the research. You can cancel your permission at any time and stop taking part in the study. Your signature and initials on this form show that you understand and agree to this sharing.
Certificate of Confidentiality
10,000 Families has a Certificate of Confidentiality (CoC) that protects the privacy of its participants by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research, except when the participant consents or in a few other specific situations.
The CoC protects information, documents, and/or biospecimens gathered or used by the investigators during research that contains identifiable, sensitive information related to a participant. These protections last in perpetuity.
