Repositories and other retention of samples or data
Investigators must indicate in their submissions whether their research involves establishing a repository or retaining samples or data for extra use by the study team or by other investigators. Extra use means any analysis that is in addition to that required for the study endpoints. Studies that involve a repository or retention of samples or data include:
- Establishing a new repository of samples/data; or
- Adding a plan for retaining samples/data to an existing study; or
- At the completion of a research project changing the study to a repository so that the data/samples obtained for the research can be stored for future use; or
- Collecting data/samples as part of the study to be added to a repository elsewhere (e.g. another research site, a national database, another investigator’s repository).
For any study involving repositories or retention of samples/data, the application must describe what information will be required for an individual request that samples/data be released, and how and by whom release requests will be reviewed to ensure that the use is consistent with the consent provided by the subjects and that confidentiality protections are adequate.