IRB Forms and Templates
Proposal Review Guidance
Does my study need IRB approval?
Use the above flowchart to determine if your study needs 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.
The Office of Research Administration develops guidance and templates for WCU researchers utilizing human subjects. Any form required for submission to InfoEd, may be found below.
| DOCUMENT | PURPOSE |
|---|---|
| Informed Consent Template with Instructions | This template contains all the required elements for your consent form. |
| Individual Investigator Agreement | This form is used for unaffiliated investigators who do not have an institutional IRB at their place of employment. |
| Debriefing and Permission to Use Data Form | This form can be used to debrief research participants when deception is utilized. |
| Letter of Support Template | This form is used to provide the IRB with documentation that the site is aware of the study activities and has agreed to the plan for carrying out those activities. |
| HIPAA Authorization Template | This form is used when investigators will be conducting research involving protected health information (PHI). |
| WCU Application for Waiver or Alteration of HIPAA Authorization | This form is used when investigators are requesting to waive or alter the elements of the HIPAA Authorization for research involving protected health information (PHI) (must be approved by IRB). |
Protocol Deviation/Violation and Adverse Event Reporting
| EVENT | PURPOSE and GUIDANCE |
|---|---|
| Deviation / Violation | A deviation is when study procedures are not followed as indicated in the approved protocol. Deviation Guidance |
| Adverse Event | When a problem or event is both unanticipated and indicates the research may place subjects or others at an increased risk of harm. Adverse Event Guidance. |
Informed Consent/Assent
The Institutional Review Board offers templates to serve as guides when creating your informed consent document.
- Consent Form Template with Instructions
- Consent Form Template for Anonymous Data Collection
- Age 6-11 (Verbal) Assent Template
- Age 12-17 (Written) Assent Template
- Parental Consent Template
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.
Human Subject Information
Contact Us
110 Cordelia Camp
69 East University Way
Cullowhee, NC 28723
828.227.7212 tel