Proposal Review Forms
Does my study need IRB approval?
If you have additional questions about whether your proposed study requires IRB review
or which form to submit, please contact us by emailing IRB@wcu.edu or calling 828.227.7212.
IMPORTANT: IRB Forms are updated regularly to remain current with federal guidelines and/or institutional
policies and procedures. The IRB reserves the right to return applications submitted on outdated forms. New application form versions were released on June 27, 2016. These forms can be downloaded
directly from IRBNet by selecting the "Forms and Templates" tab. Previous form versions
will no longer be accepted.
A description of WCU's application forms, which can be downloaded in IRBNet, is listed
|A. IRBNet Submission Process Overview
||This is a text-based step by step overview of the submission process in IRBNet.
|B. IRBNet User Guide for WCU Researchers
||This is an in depth users guide to IRBNet including example pictures
|C. Request for Initial Review of NonExempt Research
||This form is used to request a review of your proposed human subjects research by
the IRB. Most researchers will choose this form.
|D. Request for Initial Review of Exempt Research
||This form is used to request a review of your proposed EXEMPT human subjects research.How do I know if my research is exempt?Note that researchers may request exempt status but the final determination is made
by the IRB.
|E. Request for Continuing Review
||Non-exempt protocols expire one year after the approval date. Use this form to renew
or extend your approval.
|F. Request for Modification of Addendum
||This form is used to request the review and approval of changes to previously approved
research. This must be completed PRIOR to implementing any changes to the protocol.
|G. Project Closure Form
||This form used when you have completed all interventions and/or interactions with
enrolled subjects. The data collected no longer contains private/identifiable information.
|H. Consent Form Template
||This template contains all the required elements for your consent form.
|K. Individual Investigator Agreement
||This form is used for unaffiliated investigators who do not have an institutional IRB at their place of employment.
|L. Additional Investigator(s) Form
||This form is used when the number of researchers exceeds the space available on the
initial request form.
Protocol Deviation/Violation and Adverse Event Reporting
Forms may be downloaded from IRBNet
||PURPOSE and GUIDANCE
|I. Deviation / Violation Event Form
||Primarily used when study procedures are not followed as indicated in the approved
protocol. Click here for further guidance.
|J. Adverse Event Form
||Used when a problem or event is both unanticipated and indicates the research may
place subjects or others at an increased risk of harm. Click here for further guidance.
The Institutional Review Board has several templates and samples to serve as guides
when creating your informed consent document.
Assent Form Sample
Audio/Video/Photographic Recording of Human Subjects
Recording the voice or image of a research participant is a valid and useful data
collection method. Participants must be informed that a recording will occur and what
will be done with the resulting tape or image. If it is necessary to record human
subjects for your study, please review the following procedure and addendum to consent
Participant Complaint Form
As a participant in research conducted at WCU or by a researcher affiliated with WCU,
you have the right to report any concerns you have about the way the research was
conducted or possible misconduct by the researcher. The IRB takes all feedback seriously
and will conduct a confidential investigation if necessary. Complaints can be made
anonymously by completing the form below and mailing to 110 Cordelia Camp Building,
or the form can be confidentially emailed to firstname.lastname@example.org.