Telephone Recruitment and Screening Guidance
Recruitment procedures for research studies often involve phone contact with potential participants to provide an overview of the study and an invitation to schedule an initial study visit. Research studies that recruit potential participants by advertisement, letter or website listing may also employ telephone interview/phone screening procedures to determine basic eligibility. This document provides guidance on the information required by the Health Sciences (HS) IRBs for studies that use telephone recruitment and/or screening, as well as the information that must be provided to potential subjects when telephone recruitment is used.
Version Date: November 15, 2017
Who Can Make First ContactIf a study team is recruiting potential subjects through a clinical setting, whether in-person or via telephone or letter, the initial contact should come from someone who, by virtue of his/her position, would have access to the potential subject’s confidential health-related information. Based on this principle, the following list of individuals who may be the first to contact potential subjects is provided for example purposes only and is not meant to be exhaustive:
- A member of the potential subject’s clinical team, and those individuals working on behalf of members of the clinical team (e.g., nurses, PAs, pharmacists);
- An administrator from the clinic, department or center where the potential subject receives care;
- An individual, such as a study nurse, investigator, or research coordinator, acting as an agent of a clinical researcher involved in the potential subjects’ care;
- An individual, such as a study nurse, investigator, or research coordinator, who works within a clinic, department or center where a potential subject has or will receive care (e.g., from the Department of Surgery for a potential subject who has an upcoming surgery scheduled);
- The administrator of a database housed within a clinic, department or center where a potential subject has or will receive care (e.g., from a recruitment database or registry within the department or clinic where the potential subject has been seen for clinical care).
Telephone Recruitment and Screening Information Required in ARROW Application
Contact via Telephone
When researchers plan to contact potential subjects via telephone, the Health Sciences IRBs generally require telephone calls be preceded by a letter that alerts potential subjects they will be called about the study. The letter also provides information about the research and contact information for the individual to opt-out if they do not want to receive a phone call or further contact. The letter should be signed by someone who meets the criteria outlined above regarding who can make first contact with potential subjects. Telephone recruitment for studies that fall under VA purview must be preceded by a recruitment letter because VA regulations do not permit cold calling. If the study team is within a program or department that does not provide direct care to patients, the Health Sciences IRBs would expect that someone from a department or clinic where the patients receive care co-sign any communication to the potential subjects. Please review the FAQ for additional guidance. Descriptions of subject identification and recruitment methods in the ARROW application and protocol should include:
- how phone contact will be initiated (e.g., response to recruitment flyers, recruitment letter followed by call from study team, contact via a recruitment database)
- how contact information is being obtained and how the study team has access to it
- who will make the telephone call
- how the study team will follow up if the initial call is not completed, such as:
- how many additional call attempts will be made
- whether alternatives such as mailed letters be used if the person cannot be reached by phone
- what message will be left if the intended contact does not answer the phone (e.g., as a voice mail or if someone other than the potential subject answers the call)
- what will be done with telephone contact information in the event that an individual does not enroll in the study.
Eligibility Screening by Telephone
Collection of identifiable private information to determine study eligibility is considered a research procedure under federal regulations governing human subjects research and requires informed consent. Obtaining oral consent prior to the research screening interview is usually acceptable. For an IRB to approve an oral consent process, the screening questionnaire must pose no more than minimal risk of harm to the subjects and must not request information for which written consent is normally required outside of the research context. Consequently, detailed questions about stigmatizing or illicit behavior are not typically allowed in screening conducted by phone. For HIPAA Privacy Rule purposes, the HS IRBs consider telephone screening to constitute a preparatory to research activity. Anyone conducting telephone screening who is part of the Health Care Component, or collaborating with someone who is part of the Health Care Component, must have a Preparatory to Research Certification form on file with the University of Wisconsin-Madison HIPAA Privacy Officer prior to engaging in such screening activities. When the telephone conversation includes questions to determine eligibility for the study, in addition to the information above, the ARROW application and protocol should include:
- protections for privacy and confidentiality of screening information
- what will be done with screening information from individuals who do not enroll in the research study
- a telephone script for obtaining oral consent (see the Script for Eligibility Screening section for details)
- a request in the informed consent section of the ARROW application for an alteration of elements of informed consent (to allow use of a brief consent script)
- a request in the informed consent section of the ARROW application for waiver of written documentation of informed consent.
Retaining Identifiable Telephone Screening Data
In most cases, screening information from individuals who take part in the study is kept as part of study records, while screening information from individuals who are not eligible or choose not to participate is destroyed. Researchers proposing to retain contact information and/or identifiable data collected during telephone screening for future recruitment or other purposes outside the scope of the research study should specify in the ARROW application and study protocol:
- what information will be retained, and how long
- how the information will be stored
- how the information will be used
- who will have access to the information.
- Informed consent must be obtained for retention of contact information or other identifiable information collected as a result of telephone screening. See Script for Retaining Identifiable Information for Future Uses for details.
- Retaining screening data is not a preparatory to research activity. If the information being retained is identifiable and associated with medical information (e.g. medical history, or the type of study for which the person was screened), and if the researchers are within the Health Care Component or collaborating with someone in the Health Care Component, then HIPAA authorization is required in order to store the information for future purposes. To obtain oral authorization for the use and disclosure of protected health information (PHI), the investigator must request an altered authorization in the ARROW application for the study.
- Retaining screening data for the purpose of future recruitment may constitute a recruitment database, if subject contact information is associated with health information (including the type of study for which the person was screened). Recruitment databases must be reviewed and approved by the IRB.
Information to be Provided to Potential Subjects: Telephone Recruitment and Screening ScriptsWhether a study involves contacting potential subjects via telephone about the study or also conducts eligibility screening by telephone, a script is generally required to ensure consistency and completeness in the information that potential subjects are given about the study. The scripts described here are intended for situations in which the study team calls the potential subject, but can be adapted to situations in which the potential subject makes the call, e.g. in response to a flyer.
Basic Introductory Telephone Script
Basic telephone scripts to introduce a study should include the following:
- An introduction that gives the name and affiliation of the person calling, e.g. John Smith from the Department of Medicine at UW-Madison.
- The reason for the call: to invite the person to take part in a research study being conducted by [PI's name]. The study team member should state why s/he is calling that particular individual about the study, e.g. “You’re being invited to participate because you recently had surgery on X condition.”
- A brief description of the purpose of the study and what the potential subject would need to do if s/he decides to participate. This must also include a statement that participation is voluntary.
- An opportunity for the potential subject to ask questions. Simply asking "Do you have any questions about the study?" is sufficient.
- After all questions have been answered, the study team member may ask if the potential subject is interested in proceeding to the next step in recruitment for the study (e.g. scheduling a visit to learn more and go through the consent process, or answering some screening questions).
- Language that will be used if the potential subject does not answer the telephone and a) the research team plans to leave a message on an answering machine or voice mail; or b) someone other than the potential subject answers the telephone. Please note that protected health information should not be disclosed in either of these cases. An example message could be “Hello, I am calling to talk to X about a research study. My name is X and I am from the University of Wisconsin-Madison.”
Script for Eligibility Screening
In addition to the basic telephone script described above, a script requesting oral consent is required when the call includes eligibility screening questions. The oral consent script should include the following information:
- That screening data are being collected to find out if the person meets basic eligibility requirements for the research study
- Whether any sensitive information will be collected
- What will be done with the person’s information, including:
- How long the data will kept
- Who will receive any identifiable data
- How information collected in the screening questionnaire will be kept confidential
- How any risks of breach of confidentially will be minimized
- What will happen to the person’s information if the person chooses not to take part in or is not eligible for the study
Script for Retaining Identifiable Information for Future Uses
If the researcher plans to store contact information or other identifiable information collected during the telephone interviews for future purposes, the telephone script must describe this plan, including a description of:
- what information will be retained
- the purpose of retaining the information
- who will have access to the information
- the confidentiality and security protections for preventing unauthorized use of the information