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
- Who Can Make First Contact: In-Person
- Mailed Recruitment Letter Information Required in ARROW Application
- Telephone Recruitment and Screening Information Required in ARROW Application
- Information to be Provided to Potential Subjects: Telephone Recruitment and Screening Scripts
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:
- 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).
For some of the most common situations when recruitment letters will be used by a study team, the IRB recommends the following:
- Recruitment of patients from a clinic population: Letter should come from someone who, by virtue of his/her position, would have access to the potential subject’s confidential health-related information. See above for examples.
- Recruitment of subjects from a previous study for a follow-up or other related study: Letter should refer to the study in which the individual has already participated and state how the new study is related to it.
- Recruitment of children through their school: Letter should be addressed to parents/guardians; it can be provided in a packet that children take home with them.
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
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…Return to top
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.Return to top
Telephone Recruitment and Screening Information Required in ARROW Application
- 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.
- 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)
- 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. 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.
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.
- 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.”
- 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
- 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