Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research
Covered Entity: Private Practice
Issue: Impermissible Disclosure-Research

A private practice physician who was the principal investigator of a clinical research study disclosed a list of patients and diagnostic codes to a contract research organization to telephone patients for recruitment purposes.  The disclosure was not consistent with documents approved by the Institutional Review Board (IRB). The private practice maintained that the disclosure to the contract research organization was permissible as a review preparatory to research.  Activities considered “preparatory to research” include: preparing a research protocol; developing a research hypothesis; and identifying prospective research participants.  Contacting individuals to participate in a research study is a use or disclosure of protected health information (PHI) for recruitment, as it is part of the research and is not an activity preparatory to research.  To remedy this situation, the private practice revised its policies and procedures regarding the disclosure of PHI and trained all physicians and staff members on the new policies and procedures.  Under the revised policies and procedures, the practice may use and disclose PHI for research purposes, including recruitment, only if a valid authorization is obtained from each individual or if the covered entity obtains documentation that an alteration to or a waiver of the authorization requirement has been approved by an IRB or a Privacy Board.