Health and Human Sciences (HHS)

This Flowchart may help guide you.

Additional FAQs can be found on the Human Subjects Research Frequently Asked Questions page: https://www.wcu.edu/learn/office-of-the-provost/research/sponsored-research/research-compliance/Human-Subjects-Research/IRB-faq.aspx

All research personnel, including faculty, staff, subcontractors, students, research supervisors, and unaffiliated investigators, must successfully complete training prior to conducting human subjects research at Western Carolina University. WCU's training is offered through the CITI Program, which may be accessed at www.citiprogram.org.

• Detailed instructions for registering, affiliating with WCU, and selecting the correct course

• Downloading a CITI course completion report

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

• Creating a new IRB application : https://www.wcu.edu/_files/provost/NewIRBApplicationInstructions.pdf

• How to respond when modifications are required: https://www.wcu.edu/_files/provost/ORA-ModifyingDocuments.pdf
   

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.