History, previous, ADRs

Medical History. Previous medical history and concurrent conditions, known allergies (including ADRs with similar drugs), previous experience with drug. 

Investigators participating in clinical research must obtain from each subject authorization that accurately describes the uses and potential disclosure of PHI. The authorization (2) may be presented as part of the Informed Consent (see p. 565). In any event, authorization for access to PHI generated prior to research must be obtained from the subject (e.g., past medical history, previous treatments, hospitalizations). The authorization will state who will have access to the PHI and detail the specific duration of the use of the PHI the expiration of use can be referred to a specific event, e.g., an FDA approval. If data will be used as a research database, then an expiration of none might be acceptable to the subjects. The authorization must disclose whether there is compensation to the researcher from a third party and the use or disclosure of the PHI, but the amount of compensation is not required. If the subject revokes the PHI authorization, information already obtained under the authorization may still be used to preserve the integrity of the clinical trial such as marketing application or ADR reporting. If this is the case, no new PHI on that subject may be collected or disclosed. 

Patients who have had a previous reaction to drugs are also more likely to experience an ADR. Patients with history of allergic diseases also have an increased risk due to a genetically related ability to form immunoglobulin E. 

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