Research and Sponsored Programs

Institutional Review Boards (IRBs) review research studies that involve human participants to ensure that studies: a) follow applicable regulations, b) enact commonly accepted ethical standards, c) meet institutional policies, d) treat participants ethically, and e) appropriately protect research participants from research-related risk. The IRB members include faculty and community members from varying backgrounds who have experience in research, meeting federal regulations for IRB composition. WCU’s IRB includes members who represent the perspectives of scientists, non-scientists, community members not affiliated with the institution, and a prisoner advocate. WCU’s IRB includes members from various colleges and disciplines to offer diverse experiences and perspectives when reviewing IRB applications. (Content adapted from: https://www.hhs.gov/ohrp)

Do I need IRB?

1. Attend office hours to meet with IRB Co-Chairs or IRB Members
   Fall/spring weekly office hours: Listed on the IRB website.
   Summer/winter: Please email co-chairs to meet
2. Contact co-chairs for 1:1 meetings or to attend/present during a class session. mreed3@wcupa.edu or hleaman@wcupa.edu
3. Students-work directly with your faculty sponsor through all stages of IRB application development.
4. Questions re: Cayuse or IRB application status can be directed to the IRB office at: IRB@wcupa.edu

IRB Applications will be reviewed according to submission date, and typically take 3-4 weeks for review. Investigators should plan 6 weeks to allow time for revisions, if needed.

Application Steps:

1. All investigators complete required CITI training and request Cayuse accounts (must use WCU email address when completing Caysue account form).
2. Investigator(s) complete the IRB application, including all required materials (application, recruitment messaging, data collection instruments, informed consent and assent documents, letters of support, etc…).
3. Student investigators work with their faculty sponsor to review/revise IRB applications before submission.
4. Investigator(s) submit and certify the IRB application.
   Note: Submission/certification confirms investigators and faculty sponsors have thoroughly reviewed/revised the IRB application.
   Note: All investigators must certify the application for it to be received for review.
5. Applications are received by the IRB Office and assigned to reviewers.
   Note: Exempt applications are assigned to one reviewer. Expedited applications are assigned to two reviewers.
6. Reviewers receive the IRB application via the Cayuse system.
7. Reviewers complete an initial review of the application, returning the application to the Primary Investigator(s) within 3 to 4 weeks, if revisions are necessary.
8. Investigators address required changes, and submit/certify the application to be returned to the initial reviewers.
9. Once all revisions have been accepted, the IRB application will be approved.
10. Investigators will be notified of requests for revisions, and approvals, via automated email from Cayuse to their WCU email.

Notes:

1. Certification of applications by investigator(s) and/or faculty sponsors confirms that they have reviewed the application in detail prior to submission to the IRB.
2. Investigators may check the status of their IRB application after 4 weeks by emailing IRB@wcupa.edu
3. Investigators may request to communicate with their IRB reviewers by emailing IRB@wcupa.edu
4. Full board applications will require convening of the IRB and timelines for approval may be different than exempt and expedited applications.
5. Application status as listed in Cayuse:
   Under pre-review (with the IRB office; not yet distributed to reviewers)
   Under post-review (with the IRB office; not yet returned to investigators or approved)
   Under review (with reviewers)
   Unsubmitted (with investigators)

Common Application Problems:

1. Application has not been proofread for consistency.
   Investigators should ensure risks/benefits/time commitment/data collection, etc… is consistent throughout application and informed consent.
2. Informed Consent does not follow federal requirements.
   Investigators should use the Informed Consent Creator to ensure all required elements are included in the consent form. Note: The Consent document generated by the Consent Creator must be proofread and edited.
3. Informed Consent or Recruitment Materials are too lengthy, unclear, the reading level is above 8th grade.
   Investigators are encouraged to check reading levels via online tools and to ensure content is appropriate and accessible for laypersons.
4. The IRB Application does not follow instructions listed in each section.
   Investigators should double check the specific instructions listed above each box in Cayuse.

Faculty Sponsor Reminders:

1. Faculty sponsors assume responsibility for their students’ research.
2. When certifying an application, modification, or incident report, faculty sponsors are insuring they have reviewed the application in its entirety and are in support of the content submitted by the student.
3. Faculty sponsors are responsible for accessing required materials (as per IRB application) in case of federal audit.

Consent Form Sample

Assent Form Sample

IRB Members Spring 2024

Non-WCU Community Members: