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IRB Forms and Templates

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.

IRB Forms are updated regularly to remain current with federal guidelines and/or institutional policies and procedures. To ensure you are using the most up to date version, download the application form in IRBNet. The IRB reserves the right to return applications submitted on outdated forms.

A description of WCU's application forms, which can be downloaded in IRBNet, is listed below:

FORM PURPOSE
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 IRB Review of New Research Project This form is used to request a review of any new human subjects research by the IRB. 
D. Informed Consent Template with Instructions This template contains all the required elements for your consent form.
E. Request for Modification to an Approved Project 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.
F. Request for Continuing Review of an Approved Project Certain projects must be continually renewed at annual interviews. This form is used to request continuing review for an already approved project.
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.
J. Individual Investigator Agreement This form is used for unaffiliated investigators who do not have an institutional IRB at their place of employment.
K. 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

FORM PURPOSE and GUIDANCE
H. Deviation / Violation Event Form Primarily used when study procedures are not followed as indicated in the approved protocol. Click here for further guidance.
I. 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.

 


Informed Consent/Assent 

The Institutional Review Board has several templates and samples to serve as guides when creating your informed consent document.


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 form.


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 irb@wcu.edu.

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