Telephone Recruitment and Screening Guidance

Version Date: February 12, 2015

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.

Information required in the ARROW IRB application about telephone recruitment and screening

Telephone Recruitment

If a study team is recruiting potential subjects directly (rather than inviting them to contact the study team), initial contact should come from someone potential subjects recognize as having legitimate access to their private information, such as a clinical team involved in a patient’s care, or the administrator of a recruitment database. NOTE: Telephone recruitment for studies that fall under VA purview must be preceded by a recruitment letter because VA regulations do not permit cold calling.

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
  • the general content of the telephone call
  • 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.

A script for the telephone call should also be provided with the ARROW application, to ensure that the information provided to potential subjects is consistent. See Basic Introductory Telephone Script for more information.

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:

  • how and by whom the screening will be conducted
  • 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.

Retention of sensitive information (e.g., data about illicit or stigmatizing behavior; social security numbers) is strongly discouraged.

Researchers should also be aware of the following issues and include information about them in the application and protocol:

  • 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 Scripts

Whether a study involves contact 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).
  • A closing section: For those not interested in the study, the closing should include a thank you for the person’s time. For those who say they are interested, the closing section should include instructions for the next step, e.g. setting an appointment for a clinic visit, returning a signed consent form, etc.
  • 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
  • That the person can stop answering questions at any time and that refusal to answer questions will not negatively affect any relationship he/she may have with the University of Wisconsin-Madison or its affiliates.

Note that screening scripts and questionnaires should be structured so that identifying information is recorded only from individuals who meet the basic eligibility criteria and continue to be interested in participation.

 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

Retention of sensitive information (e.g., data about illicit or stigmatizing behavior; social security numbers) is strongly discouraged.

Keywords:template telephone script, elements telephone script, waiver of written documentation of consent, altered authorization, recruitment database, retention of screening data   Doc ID:18626
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-05-23 19:00 CDTUpdated:2015-10-13 15:14 CDT
Sites:Health Sciences IRBs
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