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.
- Apply via electronic and hard copy. For all Application Documents, please refer to the panel to the right. Researchers from all departments will need to submit their applications on paper or via email to the Compliance Officer in the Office of Sponsored Programs.
Email your complete application to firstname.lastname@example.org for a pre-review. The Compliance Officer will email the results of the preview generally 5 to 7 business days after submission. Once the pre-review is complete, deliver or mail your completed application and a signed and dated cover application to the Compliance Officer in C117B Anderson. If a scanner is available, you may send your completed application by fax to OSP 336-750-2412.
- Once the Compliance Officer receives the completed application with all appropriate signatures and supporting documents, the IRB will review the submission and Compliance Officer will email the results of the IRB review generally 7 business days after the review. The official IRB letter of approval, conditions of approval, and informed consent will follow.
- Use the WSSU IRB Amendment Form to submit any modifications to the approved protocol (see below).
- Approvals are usually valid for 1 year. Before the approval term expires, submit an IRB Continuing Review or Closure Document (see below).
- Retain IRB records and accompanying documentation for as long as they are scientifically useful.
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.
- September 17, 2017
- October 17, 2017
- November 21, 2017
- December 12, 2017
- January 16, 2018
- February 20, 2018
- March 20, 2018
- April 17, 2018
- May 15, 2018
** non-affiliated members
- Naomi Hall-Byers, Chair
- Monica Guillory, Chair
- Dionne Roberts
- Calvert Jeffers**
- Erby Oglesby **
- Robert Herring
- Cynthia Williams-Brown
- Judy Foxworth
- S. Maxwell Hines
- Doris Molina-Henry
- Amber DeBono
- Rebecca Caldwell
- Paul McAuley
- Keya Glover
- Jill Keith
- Stephanie Evans, Administrator
- Becky Mussat-Whitlow, Ad Hoc
- Application for IRB Approval: Application for IRB protocol approval for the 1st time. Send a signed and dated cover application and your completed application by campus mail, email or fax to Stephanie Evans, Compliance Officer.
- IRB Continuing Review/IRB Closure Form: Includes the appropriate forms for continuing review and approval of on-going projects. Forms must be submitted prior to the expiration of the original approval date. If you original approval date has past, please contact the Compliance Officer.
- Informed Consent Templates : Writing an informed consent document is not straightforward, so we have prepared templates to follow when preparing your informed consent document, along with examples of informed consent document that meet the requirements of WSSU’s policy and Federal regulations. For more information, refer to the discussion of the informed consent process in the link above. An Informed Consent Checklist is available to help you make certain that you have covered all required areas of the consent process.
- IRB Amendment Form