December 2003
At Hopkins, the IRB always has required approval of the research protocol before patient screening and recruitment could begin. However, the Health Insurance Portability and Accountability Act (HIPAA) has changed the ways a treating physician or treatment personnel may refer patients to a researcher for screening and recruitment. The Privacy Regulations under HIPAA regulate 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 this protected health information or “PHI” in research generally is not permitted without an authorization from the subject or an IRB waiver of authorization. Therefore, HIPAA requires either that an authorization from the subject or a full or partial IRB waiver of HIPAA authorization for recruitment be obtained.
Below are two mechanisms for recruitment permitted under HIPAA. Under The Johns Hopkins University School of Medicine policy these mechanisms must be approved by the IRB as “processes for recruitment” under the applicable protocol.
Recruitment by the Clinician or the 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 any IRB approved trials 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 and 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 specified subject identifiers 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. 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 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. A partial waiver of authorization to advertise about the study and screen potential subjects for the study and to keep the screening database for use in screening for future studies.
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