This section of the Investigator Manual outlines recruitment guidelines, including initial contact, email recruitment, clinical recruitment, and social media recruitment.
General Recruitment Guidelines
The IRB reviews study recruitment methods (including advertisements and payments) to evaluate whether they will affect the equitable selection of participants, and to ensure that the proposed methods adequately protect the rights and welfare of participants.
The protocol document or application must include a description of the following: (1) the source of subjects for all study groups (intervention/case and control); (2) when, where, how, and by whom these potential subjects will be recruited; (3) the methods employed to identify potential subjects; and (4) the materials used to recruit subjects, including the use of email and text messaging. If this is a multi-center study in which subjects are recruited by methods not under the control of the local site, e.g., call center or national advertisements, describe those methods.
The IRB must review and approve the content of all recruitment and advertisement materials, including oral communications, before implementation. For guidance on what to include in an advertisement, refer to the “Preparing Recruitment Materials” section as well as HRP 315-WORKSHEET-Advertisements.
These guidelines apply to all research studies that will identify and recruit participants. For guidelines specific to recruiting in a clinical health care setting, refer to the “Clinical Recruitment Guidelines” section.
- Advertising and recruiting procedures must protect potential participants’ confidentiality. In particular, names and contact information for potential participants must be collected and maintained in a confidential manner.
- When obtaining the names of potential participants from third parties, you must consider whether any breach of confidentiality or privacy laws has occurred. For example, doctors must contact their patients for written permission before releasing their names to a third party.
- You are responsible for ensuring that approved procedures are followed by any third parties (e.g., therapists, teachers, or social-service providers) who may be aiding in the recruitment and/or advertising process. Payment to professionals in exchange for referral of potential participants (“finder’s fees”) and payment tied to the rate or timing of enrollment (“bonus payments”) is prohibited.
- If a researcher plans to use snowball sampling to recruit participants, the participant population should be considered. For example, for certain populations, just providing a name or contact information to the researcher could present a risk to the potential participant. In these situations, the researcher could instead provide a business card to a participant with the directive “I am looking for others who may be willing to talk with me. If you know of anyone, please ask them to contact me, using this information.”
- You may not share names of previous research participants with other researchers without permission from the participants.
- The number of times a study team can attempt to contact participants is study dependent and the appropriateness of that number will be assessed by the IRB.
- Email and text messaging, while convenient methods for contacting subjects, are not considered secure methods for communicating sensitive or health related information. The email recruitment guidelines section outlines security measures for communicating with subjects via email. These same principles should also be used when communicating with subjects via text message. Both communication methods and the protections in place to minimize security risks must be described to the IRB as part of the review process.
Initial Contact Guidelines
- Mailed recruitment letters:Letters, whether or not they precede a phone 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.
- Recruitment of subjects from a previous study for a follow-up or other related study:Letters 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:Letters should be addressed to parents/guardians; it can be provided in a packet that children take home with them.
If you plan to recruit or screen potential participants by phone, the IRB requires you to use a script to ensure consistency and completeness in the information that potential participants are given about the study or screening questions. You will need to upload these scripts as part of the IRB application.
For additional guidance on drafting recruitment letters, phone scripts, and eligibility screening scripts, please see Appendix B: Recruitment Elements and Scripts.
Email Recruitment Guidelines
- Only secure, university-issued or approved email accounts should be used, such as @wisc.edu, @medicine.wisc.edu or @uwhealth.org accounts. Personal email accounts, such as @gmail.com, may not be used. Use encrypted email if possible.
- Email addresses must not include references to health information or other potentially sensitive, private information (e.g., email@example.com).
- Protocols or applications must describe how email will be used, including the source of email lists, targeted populations, frequency of emails, and methods for potential participants to remove themselves from the email list.
- The following disclosure language should be included at the end of all email communications with subjects for studies that may collect sensitive or health related information:
- Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately or would prefer not to receive study communication by email, please contact [Name, Title, Phone Number].
- You will need to provide email templates used for recruitment purposes. The subject line and content of these emails should not contain any references to health information or request health information from the subject through email.
- The University of Wisconsin-Madison allows researchers to use email to send its faculty, staff, and students information about research opportunities. Information about the campus mass email service is available at: Mass Email – Getting Started.
Clinical Recruitment Guidelines
In addition to the above general recruitment guidelines, these guidelines apply to research studies that will identify and recruit participants in a clinical health care setting (i.e., patients).
- Initial contact by letter, phone, and email
- “Cold calling” of potential participants by phone is generally not permitted. “Cold calling” is a planned communication with a potential participant by the study team when not known to the potential participant or not expected to have access to their protected health information.
- Phone calls 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 by phone.
- Mailed letters should come from someone who, by virtue of his/her position, would have access to the potential subject’s confidential health-related information.
- Use of patient email addresses in HealthLink for recruitment purposes is not permitted. Use of MyChart for recruitment purposes is also not permitted unless approval from UW Health has been obtained.
- In Person Contact
- How and who initiates contact with patients in a clinical setting 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 or a study team member or administrator who is part of the clinic or department in which the study is being conducted.
- 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. Written permission is required if the research team is not part of the Health Care Component or Affiliated Covered Entity.
- Recruitment of potential participants in waiting areas or other similar space requires permission from the institution or clinic to ensure minimal interruption of workflow.
- Eligibility Screening
- Collection of identifiable private information to determine study eligibility is considered a research procedure. Obtaining oral permission prior to the research screening interview is usually acceptable.
- For HIPAA Privacy Rule purposes, telephone screening generally constitutes a preparatory to research activity. However, 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.
- 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 what information will be retained, and how long, how the information will be stored, how the information will be used, and who will have access to the information. In addition, researchers will need to either obtain informed consent and authorization (for studies that fall under HIPAA regulations) from subjects to retain the identifiable screening data or request waivers of informed consent and authorization from the IRB.
- Retention of sensitive screening information from subjects who are ineligible (e.g., data about illicit or stigmatizing behavior; social security numbers) is discouraged.
- The IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, OR
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
- The research protocol should include information about how potential subjects will be identified and recruited in order for the IRB to be able to determine whether informed consent for these activities is required.
- Contact the IRB Office with additional questions or for further guidance regarding the requirement to obtain HIPAA authorization or a waiver to obtain HIPAA authorization for recruitment purposes