Office of Human Subjects Protection INSTITUTIONAL REVIEW BOARD The mission of the Institutional Review Board (IRB) is to ensure that Shaw University complies with all federal and university mandated criteria for human subjects' protection and to ensure that the rights, welfare, and safety of volunteer participants are protected at all times. The IRB will approve, disapprove, or ask for modifications to planned research by principal investigators conducting research at Shaw. Research participants will not be exposed to unreasonable risks and will be ensured that a properly informed consent process has occurred. The IRB will continue to review protocols for the duration of each study and will terminate any research activities that are in violation of University or Federal regulations.NOTE: IRB REVIEW AND APPROVAL IS REQUIRED PRIOR TO INITIATING ANY RESEARCH INVOLVING HUMAN PARTICIPANTS! Review Process All investigators who wish to submit an application to the IRB must familiarize themselves with the policy and procedure manual prior to submission.If you are collaborating with another institution, email the IRB office for additional information prior to initiating the application process.All research involving human subjects must be submitted to the IRB for review prior to initiation. In order to determine if your proposed work must be submitted for review please read the following: Is my work considered research? The federal definition of research is "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."What is a systematic investigation? A systematic investigation usually attempts to answer a question or attempts to prove or disprove a hypothesis.What is "contributing to generalizable knowledge"?The statement applies to sharing the information/data/results that you obtain in your investigation with others in the classroom setting, at a poster presentation, in a publication, or at a conference. If you are unsure about your plans to share your results at a time in the future you should submit an IRB application for review.What is a human subject?A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.The IRB meets on the first Thursday of each month, with some exceptions for holidays. IRB applications that require full IRB review should be submitted by the 15th of the prior month for review at the next IRB meeting.Please note that the IRB office accepts applications throughout the month. If you suspect that your application may be exempt from review or requires expedited review, please submit the application at any time during the month. IRB Office Contacts: Tori Willis, IRB Administrator Yancy, Room 330 919-719-1890 IRB@shawu.edu Required Education All personnel who will work on research projects are required to complete training in the responsible conduct of research involving human subjects. Personnel must be retrained every two years. Shaw University requires all research personnel to successfully complete one of the following before submitting a new IRB application for review:U.S. National Institutes of Health, National Cancer Institute, Human Participant Protections Education for Research Teams online training module.Collaborative Institutional Training Initiative (CITI Program) - The program provides training for IRB and other required compliance topics. Contact IRB@shawu.edu to register for training. Attendance at a seminar where the main purpose is to discuss the responsible conduct of research involving human subjects.A certificate of completion for any of the above should be submitted with your IRB application.