Initial Recruitment Contact and Screening Guidance

Version Date: May 22, 2019

This guidance covers 1) key issues related to contacting and screening research participants, whether they occur in person or remotely (e.g., via telephone, advertisement or a mailed letter), 2) information that must be provided to potential subjects for the different recruitment approaches, and 3) tips for addressing recruitment and screening in the ARROW IRB application. Please note that recruitment via email is covered in a separate guidance document due to the additional, specific requirements for this mode of communication under institutional policy and the HIPAA Privacy Rule.

Who Can Make First Contact: Telephone or Via Mailed Letter

If a study team is recruiting potential subjects and they will be identified based on information within their electronic health care record, 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, either by telephone or written communication, is provided for example purposes only and is not meant to be exhaustive:

For some of the most common situations when recruitment letters will be used by a study team, the IRB recommends the following:

Who Can Make First Contact: In-Person

If a study team is recruiting potential subjects in a clinical setting, whether inpatient or at a clinical appointment, how and who initiates contact depends on the circumstance. Any patients in private clinic rooms or hospital rooms should first be approached by someone who is part of their care team. Unless a member of the care team is also a member of the study team, potential patient-subjects should provide permission to be approached by researchers in this private setting. If the research team is not part of the Health Care Component or Affiliated Covered Entity, the IRB may require that written permission be obtained from the potential patient-subject to be contacted by the research team.

If a study team plans on recruiting research subjects in waiting areas or other similar space, the researchers should obtain appropriate permissions from the institution or specific clinic to approach potential subjects and to ensure minimal interruption of workflow. The IRB would likely require the study team to post IRB-approved signage (including electronic postings) in the waiting area to alert patients that they may be approached about a research study. In addition, the IRB recommends the study team develop and provide for review a script that describes how potential subjects will be approached. Any further conversations about the research after the initial approach should occur in private space.

Mailed Recruitment Letter Information Required in ARROW Application

Contact via Mailed Letter

Because mailed letters are considered a secure form of communication (as opposed to, for example, recruitment emails), limited Protected Health Information (PHI) can be included in the recruitment letter. Of note, however, study teams should avoid using postcards because that format does not adequately protect confidentiality.

Mailed recruitment letters, whether or not they precede a telephone call, should be clear regarding why the potential subjects are being contacted and how the individual(s) sending the letter have identified the potential subjects. The Health Sciences IRBs recommend including the following template language in letters to potential subjects to help clarify why patients are being contacted:

The University of Wisconsin-Madison and UW Health collaborate on research studies and provide research opportunities as part of their core missions. You are receiving this letter because you [are/were] a patient at a UW Health Clinic [NAME OF CLINIC] and we think you might qualify for a research study [I am conducting/conducted by NAME OF RESEARCHER]. The purpose of this study is to…

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Basic Elements to Include in Recruitment Letters

All recruitment letters also should include the following basic information:

  • An introduction that gives the title of the study, the name and affiliation of the Principal Investigator and study team, and a clear statement that it is about a research study. The introduction should also state why that particular individual is receiving a letter about the study.
  • A brief description of the purpose of the study and what the potential subject would need to do if s/he decides to participate.
  • A statement that participation is voluntary.
  • If the study team intends to follow up with recipients of the letters (e.g. with a phone call) the letter must include that information. The IRB typically expects the letter to include instructions on how to opt out of this follow-up, usually by providing a name and contact information or enclosing a self-addressed stamped envelope that allows them to opt-out. NOTE: An opt-out postcard could be used if it does not include details that would suggest the presence of a health condition or other information generally thought of as private. For example, the postcard should not have the title of the study.
  • A closing section. This should include instructions for the next step, e.g. contacting the study team to indicate interest, returning a signed consent form.

In addition to the above information, recruitment letters may need to include other specific details depending on the recruitment process for a particular study. Study teams should contact the Health Sciences IRBs Office with any questions about recruitment letter content.

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Telephone Recruitment and Screening Information Required in ARROW Application

Contact via Telephone

Recruitment procedures for research studies often involve telephone contact with potential participants to provide an overview of the study and an invitation to schedule an initial study visit. 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 (see above guidance regarding letter content). 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 unless there is prior written documentation that the potential subject is willing to be contacted via telephone about the study question or the type of research outlined in the study for which the subject is being recruited. In addition, the VA requires research teams to provide potential subjects with a telephone number or other means for the potential subject to verify that the study constitutes VA research.

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.

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.

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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. Obtaining oral consent prior to the research screening interview is usually acceptable.

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. Note: The VA interprets preparatory to research differently than the UW-Madison. Telephone screening for VA research studies requires a partial waiver or alteration of authorization.

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)

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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. Note: The VA considers retention of information to re-contact subjects in future to constitute a research database and requires a separate IRB application and approval to cover this activity. Additional requirements apply to VA research databases.

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Information to be Provided to Potential Subjects: Telephone Recruitment and Screening Scripts

Whether 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.”

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Script for Eligibility Screening

In addition to the basic telephone script described above, a script briefly describing the eligibility screening requirement should be provided. The 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

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.

Consent and HIPAA authorization requirements will also apply if screening results will be retained in identifiable format from ineligible subjects. In that case a request for waiver of signed consent and alteration of elements of informed consent should be requested in the ARROW application including a rationale for retaining the data in identifiable format. A request for altered HIPAA alteration should also be requested, if applicable. The retention of screen fail data that cannot be linked to identifiers does not require consent or authorization.

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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.

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