Contributing Data or Biospecimens to a Repository
Description
Researchers who collect data or biospecimens that may be used in future research must include a description of this activity in the IRB application. Often, investigators or sponsors would like to keep data or biospecimens that are collected during a research study for further scientific research. Participants may consent to the collection of data or samples for future use when participating in a research study. Before retaining/storing or contributing data and/or biospecimens for future use in a repository, specific information must be provided in the IRB application and in the consent and authorization document.
IRB Application (New Study Application Form)
The IRB application asks investigators if the study involves creating or sending data and/or samples to a repository to be saved for future research uses. If data or biospecimens will be kept or sent to a repository for future use, an additional page must be completed. The questions should be answered from the point of view of the repository, even if the investigator will not be managing the repository.
- What will be stored for future use?
- What type(s) of future research will be allowed on the data/samples?
- Who manages the repository and where will the data/samples be storied?
- Will data/samples be identifiable or de-identified?
Identifiable means that the participant can be identified by the repository using information kept with or linked to the data/sample.- Who will manage and have access to the identifiable data? Where will the data be kept? How will the data be kept confidential?
- Who will de-identify the data/samples? When will the data/samples be de-identified?
- Will participants be able to withdraw data/samples from the repository?
- Will future research results or findings be communicated to participants?
- How will researchers obtain data/samples from the repository for use in future research?
Consent and Authorization*
Informed consent and authorization for the collection of data and/or biospecimens within the covered entity for future use must be accounted for in one of the following ways:
- Full informed consent and authorization (for information or samples collected within the covered entity)
- Waiver of consent plus a method to account for authorization (for example, left-over pathology samples or de-identified samples)
*Authorization refers to permission to use HIPAA-protected data and is not applicable for non-HIPAA-related research