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Ways to Explain Subject Selection and Recruitment

Subject recruitment for research cannot begin until written approval from the IRB is obtained. However, researchers can describe how and when they intend to select and recruit their subjects in their IRB protocol.

IRB reviewers will often ask that researchers answer the following questions regarding subject selection and recruitment:

  • How will the researcher access the participant group?
  • Has the researcher clearly explained the process for recruiting participants?
  • Did the researcher create materials to contact people and introduce them to the study (e.g., recruitment script or flyer)?

Below are some suggestions to help answer these common IRB questions:

  • Research Purpose
    • Start by describing the purpose of the research. Provide relevant background information and scientific justification for the study. Cite previous studies and their past participants.
  • Subject Selection
    • Justify the selection of subjects. IRB reviewers are adhering to guidelines that state research cannot exclude any classes of subjects without scientific justification.
  • Subject Selection and Data Collection
    • Outline the specific data planned for the study and explain how data and the subjects chosen will help to answer the proposed research questions.
  • Subject Recruitment
    • Explain how (e.g., flyer, word-of-mouth, etc.) and where (e.g., conference, online, etc.) subjects will be recruited. Researchers should write out their recruitment materials and submit them with their IRB applications. This includes announcements, online information, or email correspondence.
  • Number of Subjects
    • Researchers should include the projected numbers of participants they expect to recruit for their research. Researchers can recruit up to their projected number, but they should not exceed that number during recruitment.

There are resources to optimize subject recruitment and describe the challenges associated with recruitment, especially for random controlled trials.

Providing information to IRB reviewers about the recruitment process is important because they will not be present when the investigator(s) interacts with potential subjects. As such, IRB reviewers need to understand the recruitment setting, context, and process to ensure that it is adhering to federal, state, and local guidelines.

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