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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
- A physician who has a treatment relationship with the patient (the “clinician”) and who is also the researcher may approach a patient about participation in an IRB-approved trial in which the clinician participates as a researcher. The clinician’s treatment personnel (those who have a “reason to know” identifiable health information by virtue of the treatment relationship) also may approach the patient about this research. The clinician or his/her treatment personnel must note the communication in the patient's medical record.
- A clinician who is not the researcher (and the clinician’s treatment personnel) may approach a patient about participation in another researcher's study. The clinician or his/her staff must note the communication in the patient's medical record. If the patient agrees to a referral to the researcher, suggested language is as follows:
" 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."
- A clinician who is not the researcher (and the clinician’s treatment personnel) may give the patient another researcher's name and contact information, and the patient may contact the researcher.
- A clinician who is not the researcher (and the clinician’s treatment personnel) may discuss possible patient eligibility with the research personnel in a de-identified manner, i.e., with all PHI removed. If the research personnel believe the de-identified patient would be eligible for the trial, the treatment personnel could then obtain the patient's permission to give the research personnel the patient's name or give the patient the researcher's contact information. (See bullets two and three above.)
- A clinician who is not the researcher (and the clinician’s treatment personnel) may send a letter to the patient about how to join an IRB-approved study so long as the content of the letter is approved by the IRB. (Note: unless the IRB approves a waiver of authorization for study recruitment purposes, the letter may NOT be co-signed by the researcher and the researcher may not have a copy of the letter.)
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:
- A partial waiver of authorization for treatment personnel to refer patients to the researcher or share PHI with the researcher without first speaking to the patient about the referral.
- A partial waiver of authorization for the researcher to look at medical records, or schedules, patient lists, etc., and then contact potential subjects.
- A partial waiver of authorization to advertise about the study and screen by phone potential subjects for the study.