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Who owns associated clinical data?

For many types of biomedical research, particularly genomics and proteomics, the biological information in the tissue must be correlated with clinical donor information. Researchers conducting studies on tissue samples are typically interested in knowing how the disease was treated and how it responded. Repositories usually request that tissue samples become linked to medical records data, either retrospectively or longitudinally.

Donors have control over clinical data in their medical records. Donor consent is required to access the record for research or treatment purposes. Linking tissue to a donor's medical chart has a greater level of complexity when a donor has several medical charts located at different medical centers (e.g., surgical facility, general and subspecialty clinics) that are owned and controlled by different entities (e.g., hospital, physician practice groups, etc.).

Private practice groups, for instance, may not be willing to grant medical record access to a commercial repository company with whom they have no relationship, or even to the medical center since the reason for access does not involve patient care. It may take more than a signed HIPAA release from the donor to obtain clinical data associated with the donated tissue sample at clinics and other medical institutions that have no collaborative agreement with the repository.

Which medical records of a donor are linked, then, is a matter of negotiation between the institution and the repository and cosent of the donor. This seems to happen on a site-by-site basis, or even on a case-by-case basis at some sites, given the lack of legal precedent or state and federal regulation in this area.

Key Point: HIPAA and state privacy laws require donor authorization for release of personal medical information.