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| Research Services and Sponsored Programs |
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Responsible Conduct in Research: Human Subjects Research |
NEXT ORSSP WORKSHOP (OPTIONAL) Title: How to Comply with the IRB
ONLINE TRAINING FOR RESEARCHERS (REQUIRED) Who needs to complete IRB training? Any person involved in the design and/or conduct of a human subject research project must complete the approved online human subject protections training program offered by the University of Miami's Collaborative Institutional Training Initiative (CITI). The IRB will not review a protocol until training documentation is on file at ORSSP. This requirement includes any faculty, staff, students, or collaborators from other institutions. Submission of IRB Training Completion Certificates: PLEASE NOTE: The new CITI program automatically emails ORSSP when training is completed. You are no longer required to submit hard copies of training certificates to ORSSP if you complete training through CITI and identify the University of North Carolina Wilmington as the participating institution. If you completed CITI training through a different participating institution, or if you completed training through the National Cancer Institute site, please see the second FAQ below for more information. PLEASE READ THE INSTRUCTIONS BELOW TO REGISTER FOR THE CORRECT HUMAN SUBJECTS COURSE. Go to: IRB Training for Human Subject Researchers Instructions: New Learners: If you never registered before on the CITI site, register as a New User. Please choose the University of North Carolina Wilmington as the participating institution and select the Submit button. Make note of your username and password, as it may take you multiple sessions to complete all of the required modules. Submit your name and email address. Choose the appropriate course (Basic Human Subjects Protection). DO NOT SELECT THE REFRESHER COURSE unless you already completed the full course at another time. Select your role on the research project. If you are unsure of your role on the research, please ask the principal investigator of the research or contact the regulatory compliance officer at xt. 7774. Scroll to the CITI Course Enrollment Questions. At Question 1, choose your learner group. Choosing your Learner Group: Choices - - If you are unsure what your learner group should be, please ask the principal investigator of the research or call the regulatory compliance officer at xt. 7774. At Question 2, choose N/A if you are taking the course for the first time. Otherwise, select the appropriate refresher course. You can ignore Question 3 unless you are also conducting research on live, vertebratre animals. The Responsible Conduct of Research Course offered at Question 4 is optional at this time and strongly encouraged. Link to more information about Responsible Conduct of Research at UNCW. Returning Learners: If you are returning to the site to continue working on your modules or if you are returning to change to a different learner group, login with the username and password you already have. The Learner's menu allows you to choose a new learner group or go to the grade book to see which modules you have already completed. Training FAQs How often do I need to renew my training? At this time there is no expiration to your completion certificate. However, since the new training course has refresher courses available, this may change in the future. Some institutions require refresher training after 3 years, so if you conduct research at another institution they may consider your training to be expired. Who do I send my completion certificate to? If you are a research assistant on a project, the principal investigator may ask you to provide him or her with a hard copy of the completion certificate. You are strongly encouraged to keep a hard copy for your own records as well. You are no longer required to submit a hard copy of your completion certificate to ORSSP if you complete the CITI training and identify the University of North Carolina Wilmington as the participating institution. When you complete the course for which you registered, the regulatory compliance officer will receive an email notification directly from CITI. This notification is considered "official" documentation of your training. However, if you completed the CITI training through a participating institution other than the University of North Carolina Wilmington, ORSSP will not be able to access those records. There are several options available for this situation and you should contact the regulatory compliance officer, Leanne Prete, to see what is best for you (962-7774 or pretel@uncw.edu). Also, if you completed training through the National Cancer Institute site you must still provide a hard copy of your completion certificate if it is not already on file with ORSSP, since there is no other way for ORSSP to obtain this documentation. Please send completion certificates to Leanne Prete, Regulatory Compliance Officer, ORSSP, Campus Box 5973. Are Institutional Review Board members required to complete additional training? The IRB Member learner group has more modules than any other group. IRB members must complete all of the required modules. If a new IRB member previously completed the Social & Behavioral Research Investigator learner group, the IRB member only needs to complete the additional modules required for IRB members.
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