Research Involving Human Subjects (IRB)
Winston-Salem State University’s Institutional Review Board (IRB) is the committee responsible for ensuring the protection of human subjects partnering in research studies at Winston-Salem State University. The IRB is charged with this task while facilitating research that is consistent with long-standing ethical principles and federal, state and university regulations. All research that involves human subjects must be reviewed and approved by the IRB prior to initiation.
- Review the WSSU IRB Manual and the Guide to the IRB Process.
- Complete required CITI training and upload your certificate in IRBIS.
- Apply via electronic submission in IRBIS the electronic IRB submission system. Please expect a 7-10 business days to complete the review process.
- Approvals are usually valid for 1 year. Before the approval term expires, IRBIS will send out a notice.
- Retain IRB records and accompanying documentation for as long as they are scientifically useful.
- How can I log into IRBIS?
Faculty and student researchers need to be in the IRBIS system in order to access the application. WSSU students need to fill out a Student Accesss form and email it to the Compliance Officer at firstname.lastname@example.org to register in RAMSeS. To get to the IRBIS application go to the Research Compliance page of the Sponsored Programs website and click on “IRB application” the right section of the page. Use your WSSU credentials and password to log into the application.
- How can I complete the IRB application in IRBIS?
The training guides are available in IRBIS on the upper right corner of the page when you first log into IRBIS (The information is provided by UNC-Chapel Hill but it is still valid for WSSU).
- Whom should I contact if I have questions?
For log in issues (user name and password) please contact the helpdesk at 336-334-7195 the Compliance Officer @ 336-750-2982. For IRB assistance please email the Compliance Officer email@example.com or call at 336-750-2982.
- 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.
- Where can I find the required attachments and consent form templates?
You can get them both in IRBIS and on the Sponsored Programs website. 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.
- 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 IRBIS 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:
Meetings for the Fall semester are every 2nd Thursday of the month in Anderson C016. All IRB applications requiring a FULL BOARD review are due in the Compliance Office Anderson C125 2 weeks prior to meeting date.
- August 28, 2018
- September 25, 2018
- October 23, 2018
- November 27, 2018
- January 22, 2019
- February 26, 2019
- March 26, 2019
- April 23, 2019
Monica D. Guillory
Management, Marketing and MIS
RJ Reynolds Center 127C
** non-affiliated members
- Monica Guillory, Chair
- Doris Molina-Henry, Chair
- Naomi Hall-Byers
- Dionne Roberts
- Calvert Jeffers**
- Erby Oglesby **
- Robert Herring
- Cynthia Williams-Brown
- Judy Foxworth
- S. Maxwell Hines
- Amber DeBono
- Rebecca Caldwell
- Paul McAuley
- Keya Glover
- Jill Keith
- Stephanie Evans, Administrator
- Becky Mussat-Whitlow, Ad Hoc