This section of the Investigator Manual includes additional guidance and scripts.

Recruitment Elements & Scripts

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 IRBs Office with any questions about recruitment letter content.

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 they are 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 they decide 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 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.

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.