Future Dated Data Requests
PHRPC receives requests for use of Personal Health Information (PHI) in clinical trials and other research projects that plan on using data that has not yet been collected.
Key Considerations for PHRPC
- PHRPC scope is limited to situations where the individual’s consent to disclosure has not been obtained (s. 22(1) PHIA).
- It is appropriate for PHRPC to review a request for use of PHI to determine participant eligibility for a study.
- Once identified as eligible, informed consent can typically be obtained for participation in the study including access to PHI collected during the study (e.g. future dated PHI).
- If/once consent is obtained, PHRPC approval is not required.
- Some studies may involve both situations (un-consented access to PHI to determine eligibility and consented access to participate in a study that includes access to PHI to be collected).
- PHRPC’s role is to focus on the request for access to PHI without consent.
- PHIA does not prevent PHRPC from approving use of PHI that has not yet been collected.
PHRPC Approach
- PHPRC will link the scope of the data request to the length of the research project*, thus allowing a project to use PHI during the length of the project, without requiring an amendment each time a new year of data becomes available. *As a safeguard, PHRPC will only approve the use of data for up to a maximum of 5 years, at which time the project must be reviewed by PHRPC.
- Example: a multi-year project that starts in 2022 and is funded until 2025 can request use of PHI up to 2025 without submitting an amendment each time a new year of data become available
- Amendment requests would still be required for any other changes (e.g., personnel and/or co-investigators, databases required, research questions/objectives, location of data storage and/or analysis, funding source and/or sponsor, etc.).