Health and Human Sciences (HHS)

Research is defined as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Generalizable knowledge is not defined solely as an intent to publish. 

Human subjects are "living individuals about whom an investigator conducting research i) obtains information or biospecimens through intervention or interaction with the individual OR ii) obtains, uses, studies, analyzes or generates identifiable private information or biospecimens."

Projects that meet the criteria of both definitions require review by the Institutional Review Board, or IRB. If you are unsure whether your project involves research with human subjects, please contact IRB@wcu.edu for help making this determination.

• The office of Research Compliance performs 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 (including recruitment).  All of these steps are covered on the InfoEd training page.

  • Creating a new IRB application

  • How to respond when modifications are required

• To begin IRB submission, use the templates available on the IRB Forms and Templates page.

• For information on recruiting for a study, view the recruitment standard operating procedure document.

  • 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.