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Patient access compliance

Compliance Monitor, December 15, 2006

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Q: Do research participants have any right to see research records or results? How about clinical patients who are also research subjects?

A: Research subjects have neither no more nor no less rights than clinical care patients to see records. In particular, they might not see research-specific documents depending on the study. Under HIPAA, a patient is allowed to see information in the "designated record set." Information in a research record typically is often a duplication of a designated record set and therefore would be accessible in most cases. They typically would not see the randomization of a treatment in a blinded study, as that would compromise the integrity of the study and is also not part of the designated record set.

Commercial sponsors of research would be quite alarmed if patients/subjects could look at proprietary information, thus the limits on the "right to see." For example, study-related laboratory tests are frequently not recognized by the hospital because they are conducted by an outside lab. Because they are not recognized, they don't usually make it into the designated record set and therefore covered entities are not required to allow patients to see this information.

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