Is there template language for the consent form and/or protocol to be added to the IRB application that will convey how we will share data with entities and that data will be accessible for secondary use?
Please see sample language below:
“The data collected from you may be used for research that is not yet defined. If that occurs, your information will not be connected to your identity. We call that ‘de-identified. De-identified, individual-level, personal health data will be shared with the UC San Diego Data Coordinating Center. Since this information about you and other study participants will be de-identified before sharing, your identity will not be known by those who access study data in the future. Our research team at [name your site] will certify that any data collected from you is not identifiable prior to placing in the UC San Diego data repository. These de-identified data will also be shared with the National Institutes of Health to advance scientific knowledge.
To help other researchers studying COVID-19, your data will be shared with the RADx NIH Data Hub. Researchers from other institutions may be able to access de-identified data to help with their research. To do this, a “Unique Study ID” will be created. This Unique Study ID is created by entering three types of identifiable information into a secure program/”tool” that is only accessed by the Study-Site research team. The information includes patient name, gender, and date of birth (DOB). The tool then creates a confidential, de-identified Unique Study ID that is not linked to you. However, if you are in a separate study that uses this tool, your Unique Study ID would be the same in both studies. It is possible that data using the same Unique Study ID could be linked.”
This would be a language for adults.
An additional resource is the “Consent Language Template for RADx-rad DCC Unique Study Participant ID” which can be located under Resources>Data Sharing or here: https://www.radxrad.org/wp-content/uploads/2021/07/Consent-Language-Template-for-RADx-rad-DCC-Unique-Study-Participant-ID.docx.