Many of the same principles that apply to recruitment with letters also apply to recruitment by phone. The phone script for recruitment must be submitted to the IRB and must be approved before subjects may be contacted. Furthermore, a HIPAA waiver for recruitment may also be required. 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”. Telephoning potential subjects is not recommended as the first mode of contact. An initial letter obtaining permission to contact the subject is usually the first step. The letter may list a secondary method of contact such as a phone call and advise the subject how to contact the investigator if he/she does not wish to be contacted again. Additional information on privacy during recruitment is available in Module #4.
The phone script should contain the following elements: (1) an introduction of the caller (recruiter) and the caller’s identification of the potential subject, (2) the option to decline to speak to the recruiter, (3) an explanation of how the caller accessed the subject’s name, (4) the option to hear a brief description of the study, and (5) the option to hear about the next step if the potential subject is interested in learning more about the study (i.e., making plans to speak or meet with the investigator). Leaving messages on answering machines is not recommended, since this may prompt family members to ask questions that the potential subject would rather not answer.
An example of a phone script follows:
Caller: Hello, this is Mary Jones from Yale University. Is Mr. Philip Smith at home?
Answer: No.
(Caller thanks the recipient of call and states that she will call back when Mr. Smith is available.)
Caller: Hello, this is Mary Jones from Yale University. Is Mr. Philip Smith at home?
Answer: Yes. This is Philip Smith.
Caller: Hello Mr. Smith. I determined from your medical record at the Immunology Clinic that you may be eligible to participate in a study about a new drug for lyme disease.
— or —
Caller: Thank you for returning the postcard regarding our study of a new drug for lyme disease. Would you like to hear (more) about the study?
If Answer: No. (Caller thanks subject and hangs up.)
If Answer: Yes.
Caller: Would you like to make an appointment to come to the General Clinical Research Center so that the investigator may fully explain the purpose of the study and what participation entails?
Answer: Yes.
(Caller makes appointment with potential subject, confirms date and time, and hangs up.)
If third parties such as calling centers or centralized screening centers will be utilized, this should be specified in the protocol. A phone script of what will be discussed by these third parties should also be presented for IRB review. In addition, techniques such as random-digit dialing for recruitment of normal controls, must be noted in the protocol.