Recruitment letters targeting specific populations, including patients, students, and employees, are another recruitment method. Regardless of the population, the letter should explain how the investigator obtained access to the subject’s name. Recruitment letters must be approved by the IRB. In addition, depending upon the investigator’s relationship with the subject (i.e., if the investigator is not the subject’s treating physician), a HIPAA waiver for recruitment purposes may be necessary. A waiver must be submitted if the researcher wishes to obtain and use protected health information from identifiable individuals (potential subjects) without first obtaining written approval or authorization from the potential subject. For more information regarding a HIPAA waiver, please see the Human Investigation Committee website and the “Request for Waiver of HIPAA Authorization for Research Use/Disclosure of Protected Health Information”. Additional information on privacy during recruitment is available in Module #4.
The contents of the letter should include the following: (1) the purpose of research; (2) a description of the procedures and what participation involves; (3) the major risks and benefits; (4) what payment is offered, as applicable; and (5) the option of voluntary participation and withdrawal. Conversely, if the research study involves sensitive subject material, the investigator may choose to keep the letter vague in order to protect the privacy of the potential subject. Recruitment letters to former, current, or future patients of an investigator should state that the subject’s participation will not affect his/her current or future care and whether any results of the research will be released to the subject. For students participating as subjects in research, it should be made clear in the recruitment letter that their participation will not affect their academic standing. When participation in research includes course credit, students should be offered an alternative means to meet the course requirement. The preferred method of recruiting students is one in which the student takes the initiative to contact the investigator. Investigators should take care to follow their institutional procedures for student participation in research. Guidance is available from the IRB. For occupation-based research or research involving the employees of an establishment, the investigator should consider whether permission of the employer is necessary, and also must ensure the confidentiality of the employee’s data.