Recruitment Requirements

Your recruitment process is an important part of your protocol review. It is the beginning of the informed consent process and is the first time a prospective participant receives information about your study. Just as with informed consent documentation, the information must be accurate, and it must contain details that are relevant to the prospective participant’s initial decision about whether to move forward with research involvement. And just as with the informed consent process, the process of recruiting prospective participants into your study must not be unduly influential. All recruitment material and steps must be approved in advance of use.

If you have more questions about the recruitment process, please review our Standard Operating Procedures or Request a consultation with one of our analysts

What must be included in your materials

  • Materials that will be presented in writing must include your protocol number & contact information for the PI. Other contact information should be provided as necessary for the study (e.g. a study scheduling coordinator). verbal scripts do not need to have a protocol number attached.
  • Inclusion (and exclusion, where relevant) criteria must be stated, absent approved use of deception/ misinformation.
  • The purpose of the research must be stated, absent approved use of deception/misinformation.
  • The approximate time commitment must be clear.
  • QR codes are great, but please also share an abbreviated link (like a bit.ly) to help prevent QR code scams and promote participation among participants who might not have a smartphone.
  • If QR codes or other shortcut processes will be used to direct people to another location, that location information must also be provided to the IRB.

What cannot be included in your materials

  • Compensation should be advertised, but it cannot be over-emphasized relative to other information about study participation. Avoiding bots and fraudulent respondents may be a reason not to list compensation in your recruitment materials, but be sure it is then included in either a follow-up communication about recruitment or in your informed consent documentation.
  • No claims about favorable outcomes or benefits beyond those that are described in the approved protocol and informed consent document are permitted.
  • Claims about safety, efficacy, or superiority are not permitted, again, unless they are part of the approved protocol and informed consent process.
  • Research is not treatment. Where there is overlap, the line between treatment and research must be clearly drawn.

Recruitment Process Considerations

Recruitment processes can be as important as the recruitment materials to ensuring an ethical and participant-centered study structure. Recruitment processes must be clearly outlined in your protocol. The IRB must determine that the process prevents any opportunity for undue influence or coercion, and that the recruitment process permits for equitable selection of subjects. All of the following are examples of recruitment steps that must be shared with the USU IRB:

  • Outreach steps (including details like how many emails, calls, or texts prospective participants will receive; how your snowball sampling process will operate; or planned follow-ups) must all be outlined.
  • If you will use third party recruitment processes (i.e. asking a school principal to distribute information to teachers at the school), include the instructions you will provide to that third party to help them avoid (1) crossing the line into becoming an investigator on your protocol; and (2) engaging in a process or adding text that may be unduly influential or coercive.
  • Locations where advertising materials will be shared, as some spaces are considered private, protected, or have separate approval processes even for posting flyers. This includes social media.

Be sure to review the IRB Standard Operating Procedure on Recruitment of Prospective Subjects for full information about recruitment documentation and processes; this page is merely an overview of the most common issues the USU IRB encounters when reviewing recruitment information.

Any Recommendations?

Yes! We find studies are most successful in recruitment efforts when the associated recruitment materials are visually appealing, brief (especially verbal and email recruitment pitches), and avoid technical language. Our office compiles excellent examples from previous study submissions (with permission) that we are happy to share - just ask!

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