Student Affairs

Research Involving Human Subjects (IRB)

Contact
Naomi Hall-Byers, PhD
IRB Chair
Assistant Professor, Psychology

103 East Modular
(336) 750-8800
hallna@wssu.edu


Stephanie Evans

Compliance Officer

Office of Sponsored Programs
Room C117B, Anderson Center
(336) 750-2982 (p)
evansst@wssu.edu



Meetings for the Fall 2014 Semester are every 3rd Thursday of the month in Anderson C016. All IRB applications requiring a FULL BOARD review are due in the Compliance Office Anderson C117 2 weeks prior to meeting date.

September 18, 2014
October 16, 2014
November 13, 2014
*December 5, 2014
*last meeting of the semester

Winston-Salem State University IRB Process

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.

1. Review the WSSU IRB MANUAL and the Guide to the IRB Process.

2. Complete required CITI training.

3. Apply either via hard copy or email. 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 evansst@wssu.edu 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).

4. 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.

5. Use the WSSU IRB Amendment Form to submit any modifications to the approved protocol (located
    under the Application Documents).

6. Approvals are usually valid for 1 year. Before the approval term expires, submit an IRB Continuing
    Review or Closure Document
(located under the Application Documents).

7. Retain IRB records and accompanying documentation for as long as they are scientifically useful.

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

What is a Federal wide Assurance (FWA)?

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.

Winston-Salem State University

601 S. Martin Luther King Jr. Drive

Winston-Salem, NC 27110

Phone: (336) 750-2000



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