Recruitment methods should ensure that the incursion on individual privacy, necessary to determine a potential subject’s eligibility, is minimized and that all private information collected is kept confidential until destroyed. In most clinical trials, and particularly where involvement could have an effect on the subject’s health, the recruitment of subjects should be through a practicing professional (such as a physician, social worker, other health care provider, or school counselor or administrator) who would normally have access to confidential information on subjects as it relates to the study. Ideally, the investigator will work through the practicing professional to introduce a potential subject to the study, informing them of the availability of the study, and referring them to the researcher, with the subject’s permission. The practicing professional would not obtain consent for participation from the subject. After gaining the practicing professional’s approval, a formal invitation to participate in the study is made, and if the subject is willing to consider participation, the investigator would then initiate the consent process. In some cases the practicing professional and investigator may be the same person.
In other situations it may not be possible to work though a practicing health or school professional, and it may be necessary to identify potential subjects by examining the records of hospitals, physicians, schools, or welfare agencies. In other cases databases such as disease registries, public health records, and pharmacy records, may be used to identify potential subjects. During this record review process, confidential information is often reviewed without the subject’s consent, and depending on the types of records being reviewed and the nature of the institution holding them, the federal HIPAA and Family Educational Rights and Privacy Act (FERPA) regulations may restrict access to them and regulate what can be done with them (See note 1 below). It may not be appropriate for an investigator to approach a potential subject after gaining access to confidential information (which the investigator would not ordinarily have access to), and in some cases this may also violate HIPAA regulations. Investigators planning on identifying potential subjects by using records or databases must understand how the HIPAA regulations impact this recruitment approach. Since potential subjects, when contacted following initial selection by a record review, are often concerned about how they were identified and what information about them has been disclosed, individuals contacting potential subjects must follow a script and be trained to address the concerns a potential subject may raise about the confidentiality of their medical or other information. The preferred approach for recruiting subjects is to work through a practicing professional who would normally have access to confidential information on the potential subjects as it relates to the study.
In still other cases, subjects are invited to contact an investigator or a member of their team to determine if they might be eligible to participate in a study. Potential subjects might become aware of the study through an indirect method such as a website; radio, newspaper, or TV ad; flyer; brochure; poster; or mass mailing. Research personnel receiving calls from potential subjects and screening potential subjects are collecting confidential information and they must be trained in how to collect and maintain this information. Personnel receiving these calls should follow a script and secure the confidential information they are collecting immediately, ideally placing this information directly into a secure database. If paper copies are generated, they should be destroyed after data entry. Information collected from potential subjects who have not been selected for participation in the study should be purged from the database as soon as a decision has been made regarding their participation unless protocols are in place to maintain the security of the database and the investigator has received the subject’s permission (i.e., through signed consent or verbal agreement) to retain the contact information for recruitment in future research studies. While evaluating a potential subject’s eligibility, some individuals will be found to be ineligible for the current study as well as future studies. If a log of these individuals is maintained it must be secured and access to it must be restricted. Identified private information collected on subjects and potential subjects should be purged and destroyed following the study unless the investigator has received the individual’s permission to retain the contact information for recruitment in future research studies.
Additional information on subject recruitment methods is available in module 5.
Note 1 - The HIPAA regulations apply to recruitment of subjects through health care providers, health plans, and others institutions that store or transmit health information (such as medical insurance providers). Access to a potential subject’s health information must be restricted by these entities under HIPAA. In most cases, a potential subject must authorize the review of his/her health information before an investigator can determine his/her eligibility. In special cases the IRB can waive the subject authorization requirement. When a potential subject’s information is reviewed without authorization, the owner of the data must maintain a log of who had access, when, and for what reason (required by the accounting rules of HIPAA). Additional information on the HIPAA regulations can be found in the Applicable Regulations and/or Guidance From Professional Associations section of this module.