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Hunter Library
Research Guides
Western Carolina University

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The IRB process

  • The Research Compliance Office does a pre-review of IRB submissions before they go to an IRB reviewer.  This pre-review allows them to be able to make sure that protocols meet all federal regulations while also getting clarification on any items they think might cause a submission to be returned for changes. 
  • IRB approval is required prior to any study activity, per federal regulations (this includes recruitment as well).  All of these steps are covered on the InfoEd Training page:
  • When you begin working on your IRB submission, please take advantage of templates available on the Forms and Templates page:
  • For information on recruiting for a study, please view the recruitment standard operating procedure document as well as the important items it highlights that would need to be included:
    • Items include:
      • ​​​​​​​A statement that the recruitment is for research purposes
      • The name and contact information for the Principal Investigator
      • The purpose of the research
      • A summary of the criteria that will determine participant eligibility (inclusion/exclusion criteria)
      • The time or other commitment required of participants
      • A brief list of participation benefits, if any
    • Payment should not be listed as a benefit of participating
    • Advertisements may state that participants will be paid, but they should not emphasize the payment by using larger or bold type
    • Recruitment materials directed at minors should not include payment information
    • For research that may involve sensitive topics, a description of why the individual is receiving recruitment material and/or how the investigators got their contact information
  • If any of the elements are unclear or missing, the research compliance office will instruct the investigator of necessary modifications or clarifications.
  • Recruitment cannot begin until the study has been reviewed and the research team has received an approval letter from the research compliance office.