Research Involving Human Subjects (IRB)

1. Review the WSSU IRB Manual and the Guide to the IRB Process.
2. Complete required CITI training and upload your certificate in CAYUSE Human Ethics.
3. Apply via electronic submission in CAYUSE Human Ethics. Please expect 7-10 business days to complete the review process.
4. Approvals are usually valid for 1 year. Before the approval term expires, IRBIS will send out a notice. 
5. Retain IRB records and accompanying documentation for as long as they are scientifically useful.
6. Guidance: Examples of Activities that Do and Do Not Require (NHSR. QI, QA) WSSU IRB Review and Approval.

1. How can I log into CAYUSE Human Ethics?
   
   Faculty and student researchers need to be in the CAYUSE system in order to access the application. WSSU students need to fill out a Student Access form and email it to the Compliance Officer at khaniu@wssu.edu  to register in CAYUSE. Navigate to CAYUSE Human Ethics, login using your WSSU credentials, you will be on Cayuse Platform HOME, look for "Products" on the far right on top of the screen beside your Name. Once you are on the Human Ethics page, click on +New Study, and start your application.
2. How can I complete the IRB application in CAYUSE Human Ethics?
   
   The training video is available for Human Ethics module on CAYUSE Resources page.
3. Whom should I contact if I have questions?
   
   For log in issues (user name and password) please contact the Compliance Officer @ 336-750-2982. For IRB assistance please email the Compliance Officer at khaniu@wssu.edu or call at 336-750-2982.
4. Who can certify online submissions for review?
   

   Only a principal investigator and/or a faculty advisor can certify an online submission. Once a study has been certified it will be routed to the Research Compliance Officer and WSSU IRB for review. Currently we don’t need department approval.

5. Where can I find the required attachments and consent form templates?
   
   You can get them on the Sponsored Programs website (Please see the section below “INFORMED CONSENT PROCESS”. You will receive the IRB-approved consent forms and other documents notification by email once your study is approved as well as the completed IRB review and any stipulations that need to be addressed.
6. Will I receive a notification if my protocol is about to expire?
   
   Yes. You will be notified by email of the reminders for expiration sent from CAYUSE 90, 60, and 30 days ahead of the expiration date.

The Office of Sponsored programs associates all WSSU IRB documentation with our designated federal wide assurance number: FWA00000214.

The Federal wide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance. FWAs also are approved by OHRP for federal wide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question. There is a single version of the FWA and the Terms of Assurance for domestic (U.S.) institutions and international (non-U.S.) institutions.

Informed consent is not just a form or a signature, but a process of information exchange that takes place between the prospective subject and the investigator before, during, and sometimes after the study.

The following list of sample documents are provided to assist you in the preparation of consent and assent forms:

• Informed Consent Form
• Assent Form - Example A, Example B 

IRB committee ZOOM meetings for the Fall Semester 2024 are once a month on Fridays at 2:30 PM in Anderson C125. All IRB applications requiring a FULL BOARD review must be completed through CAYUSE Human Ethics at least 14 days prior to the meeting date.

Upcoming Dates:

• August 26, 2024
• September 23, 2024
• October 21, 2024
• November 18, 2024
• December 16, 2024

Charity B. Griffin, PhD
Associate Professor
IRB Chair
Department of Psychological Sciences
305 Coltrane Hall
336-750-8832
griffincb@wssu.edu

Shawn E. Holt, PhD
Compliance Officer
Associate Provost for Research Innovation
Room C131C Anderson Center
(336)750-2369
holtse@wssu.edu

** non-affiliated members

• • Charity Griffin, Chair
  • Megan Edwards Collins
  • Rebecca Caldwell
  • Fenghai Guo
  • Keya Glover
  • Pandora Goode
  • Calvert Jeffers**
  • Kurt Kornatz
  • Eric Greaux
  • Shawn E. Holt

**Community Member