Using clinical data in research

Overview

A researcher asked the NPC to permit use of stroke-patient data. The NPC said it does not grant access on behalf of a hospital. It suggested requesting data without identifying information, obtaining consent where personal data are needed, and submitting the protocol for ethics review.

Practice implications

Parao Law practice guidance

For physicians

Before a chart review, agree with the hospital on the precise fields needed and whether a truly anonymous extract will answer the study question. Seek the required institutional and ethics approvals. Limit access to the approved dataset and protocol.

For lawyers

Identify whether the proposed extract can reasonably identify a patient, including through combined fields. Document the basis for any identifiable-data processing, the hospital’s authorization, ethics review and data-handling terms. NPC advice alone is not permission to inspect records.