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Research Guides
Western Carolina University

Health and Human Sciences (HHS)

https://researchguides.wcu.edu/hhs

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Research methods electronic resources through the library

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: https://www.wcu.edu/learn/office-of-the-provost/research/sponsored-research/Infoed.aspx

  • When you begin working on your IRB submission, please take advantage of templates available on the Forms and Templates page: https://www.wcu.edu/learn/office-of-the-provost/research/sponsored-research/research-compliance/Human-Subjects-Research/IRB-Forms-and-Templates.aspx
     

  • 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: https://www.wcu.edu/_files/provost/RecruitmentofResearchParticipants32323.pdf

    • 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.