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The JHM IRBs must approve a research protocol with an accompanying recruitment plan before any patient screening and enrollment may begin. This recruitment plan must be detailed by investigators in their eIRB application and must outline a process that is compliant with the Health Insurance Portability and Accountability Act (HIPAA). This law regulates how identifiable health information created or received by a covered entity (such as The Johns Hopkins University School of Medicine) may be used or disclosed in connection with research. Under HIPAA, the use of protected health information (PHI) in research generally is not permitted without written authorization from the subject or an IRB waiver of privacy authorization.
With respect to recruitment, below are methods permitted under HIPAA and accepted by the JHM IRBs:
Recruitment by a Clinician or Treatment Staff
" I discussed the referral of the patient to [team or doctor] for [describe research study]. The patient agreed to the referral, including sharing information about the patient's condition."
As noted in the first bullet in this section, direct recruitment for a study by a clinician/researcher or his/her treatment personnel is not affected by HIPAA. These personnel already have a reason to know the patient's PHI and, assuming the study (and the recruitment process) has been approved by the IRB, these personnel may approach the patient about participating in the trial without a HIPAA authorization or waiver. Also, as noted in the subsequent bullets, these treatment personnel also may discuss the patient's PHI with other research personnel, such as the coordinator, so long as the patient first has given his/her verbal or written consent to wanting to learn more about the study and the proper note has been made in the patient’s record.
Recruitment by the Researcher
The IRB may grant the request of a researcher for a partial waiver of the patient’s authorization for recruitment purposes if the IRB determines that the treating physician's direct approach to the patient or obtaining the patient's prior authorization is impracticable. The request for waiver of privacy authorization may include several possibilities: