The Office of Research and Innovation supports Appalachian State University's scholarly and creative activities by expanding access to and facilitating the management of research opportunities. The Office enhances the research enterprise by building capacity through research development and methodological and statistical consultation, providing support for externally funded projects, ensuring compliance for regulatory programs, and facilitating the protection, management, and translation of intellectual property. The Office of Research and Innovation also collaborates with Special Funds Accounting on the fiscal management of awarded projects. The Units within the Office of Research and Innovation include Research Protections, Sponsored Programs, Grants Resources and Services, and Research Design and Analysis.
involving human participants, animals, and recombinant DNA. In addition, we are responsible for campus administration of export control regulations and the conflicts of interest policy. In support of the University's mission of transmitting and applying knowledge to address the needs of society, we facilitate the protection of intellectual property. The Office of Research Protections includes the following functional areas: the Institutional Review Board (IRB), Responsible Conduct for Research (RCR), Conflict of interest and Commitment (COI), Export Controls (EC), Institutional Biosafety Council (IBC), the Institutional Care and use Committee (IACUC), and Intellectual Property (IP).
Essential Duties and Responsibilities of the Associate Director of Research Protections:
- Provide leadership for the development of the IRB office at App State including supervision of two mid level IRB Coordinators.
- Develop and maintain IRB office unit standards and all subsequent procedures to promote compliance with federal regulations and current best practices.
- Review and approve any research that meets the federal criteria for Exemption or Expedited review including initial reviews, amendments, continuing reviews, and "Just in Time" reviews.
- Manage the IRB review process for Full Board protocols, FDA regulated protocols, large or complex protocols, and funded protocols.
- Manage and facilitate the Post-Approval monitoring processes as appropriate.
- Identify, manage, and resolve instances of non-compliance in accordance with federal regulations and University policy in cooperation with the IRB Chair and/or IRB Full Board.
- Receive and reconcile reported issues of Unanticipated Problems and Adverse Events.
- Receive reconcile complaints from human subjects and resolve in accordance with University's policies and federal regulations.
- Facilitate "for cause" and random audits in accordance with App State IRB unit standards.
- Serve as the IO's signatory designee for Reliance agreements and Individual Authorization Agreements. In conjunction with the IRB Coordinator for Administration, determine when Institutional Authorization Agreements are appropriate.
- Recruit, assist in selection of, and train all IRB Full Board Members including the IRB Chair.
- Work closely with the IRB Chair regarding any issues related to human subjects' research.
- Attend IRB committee meetings to provide guidance for all reviews including advising board members on the criteria for approval and any FDA regulatory requirements.
- Serve as primary voting member on the App State IRB Full Board.
- Participate in the hiring, training, and supervision of IRB personnel.
- Lead assessment efforts for IRB office effectiveness using a variety of metrics.
- Perform outreach and education activities with the research community at App State in conjunction with the IRB Coordinator for Ed and Outreach.
- Advise staff on the development and maintenance of web content and other electronic media content.
- Serve as lecturer, provide presentations, and serve on appropriate panels geared toward education and outreach regarding research.
- Engage App State and local partners in educational and outreach endeavors.
- Serve as liaison between App State and research related federal agencies, regulators, organization, or sponsoring agencies.
- Serve on University committees as an IRB representative for research related University level committees.
- Consult with related units at the University to facilitate compliant research at App State including but not limited to the Office of General Counsel, Sponsored Programs, and the COI office.
- Act as liaison between the IRB Office and University personnel, helping researchers understand and fulfill federal requirements.
- Manage Federal Wide Assurance and IRB Registration documentation.
- This position is also expected to perform job functions of all IRB staff should the need arise.
------------------------------
Shante' Mathes
Director, Research Protections
Appalachian State University
------------------------------