Human Rresearch Subjects Protections Program

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In recent years, human subjects research has come under increasing scrutiny. This has resulted in demands for enhanced protection of research subjects and increased oversight of human research. Wake Forest University School of Medicine (WFUSM) is committed to maintaining the highest ethical standards and compliance with federal regulation. To meet this commitment, the WFUSM Institutional Review Board (IRB) is actively engaged in developing procedures and programs to ensure the protection of human research subjects. We propose the following aims to further strengthen the protection of human research subjects at WFUSM and to prepare for national IRB accreditation: 1) technology development to improve IRB infrastructure by allowing electronic submission of new protocols, continuing review, amendments and adverse events, and the ability to make IRB approved consents electronically accessible; 2) enhanced compliance oversight through the addition of a compliance specialist to increase the continuing oversight of IRB approved protocols; and 3) an external audit to identify strengths and weakness and provide recommendations for improvement.