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FORMS AND POLICIES

IRB/Human Subjects Committee

Home Forms and Policies IRB/Human Subjects Committee
IRB/Human Subjects Committee – protects confidentiality of data for research and projects involving the use of human subjects and ensures protection against physical, psychological, social and legal risks in biomedical and behavioral research. Chair: Dr. Paul I. Musey Phone: 404.880.6829 E-mail: pmusey@cau.edu IRB Policies and Procedures IRB_Policy Manual IRB Application - To obtain an IRB application click on IRB Application Submit one (1) copy of the application packet to Room 1001, Thomas W. Cole, Jr. Research Center for Science and Technology. The Package should include the following items:
  • IRB Application
  • Survey Instrument, if applicable
  • Consent form, if applicable (Consent form template and consent process)
  • Certificate of Completion of Mandatory Training program (see below)
Mandatory Training for Researchers Using Human Subjects – All investigators should read the IRB_Policy Manual. All investigators should take the appropriate mandatory training by accessing the website, www.citiprogram.org, and following the instructions to secure a login account, login, and complete the appropriate training module. Clark Atlanta University is enrolled in the Collaborative Institutional Training Initiative (CITI) Program. This program replaces the previous training program sponsored through NIH. This course is designed for four (4) Learner groups with each consisting of several modules specially prepared for investigators conducting research in that group. All investigators should read the IRB_Policy Manual and Mandatory Training documents prior to accessing the CITI program. To access the CITI program, click on www.citiprogram.org to begin registration. IRB Frequently Asked Questions (FAQ's) - Please read the following.
Who is required to take the training? The training requirement applies to anyone conducting human subjects research activities at Clark Atlanta University. This means all key personnel, including researchers and faculty sponsors, involved in any human subjects research protocol must complete the CITI training. This includes all faculty, staff, assistants and students who are engaged in the planning, conduct, or analysis of the research, regardless of funding of the project. Board members and administrative staff of the IRB are also required to complete human subjects protection training through CITI.***Undergraduate students assisting in research or conducting course-related research are exempt for this training; the faculty instructor assumes responsibility for them. Graduate students conducting applicable thesis/dissertation research must take this training.To view those that have successfully completed the mandatory training you may click the link below. What is a "learner group"? A Learner Group is a designation for all researchers and key personnel to be directed to the appropriate set of training modules. Currently, CAU has elected 4 CITI learner groups:
  • Social & Behavioral Research
  • Biomedical Research
  • Undergraduate Students
  • IRB Members & Staff
The training may be fulfilled for the learner groups by completing required modules. Each module takes approximately 30 minutes to complete. The training modules may be completed in steps by completing a module, logging out, logging in at a later time, and completing more modules. A passing score of 70% or better is needed to meet the CAU IRB training requirement. Which CITI training module should I choose?
  • Biomedical: This learner group is designed for Investigators who are involved in biomedical research, with a focus on normal or abnormal physiology and development. The Biomedical learner group is comprised of 9 modules. Biomedical research is designed to evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention, and may involve any invasive procedures (e.g., collection of tissue, urine or blood samples, dietary manipulation, exercise studies, etc.). There are also optional modules (e.g., research involving minors, prisoners and genetics) you may be required to take if appropriate to your studies.
  • Social & Behavioral: This learner group is designed for social and behavioral research that examines human society and the intrapersonal/interpersonal relationships that take place within that society. Social and behavioral research projects commonly involve surveys, questionnaires, interviews, focus groups, etc., for data collection. The Social and Behavioral Sciences track has 11 required modules. There are also various optional modules (e.g., research involving minors, research in public elementary and secondary schools, and internet research). If your research involves these topics, you will be required to complete the appropriate “optional” modules as well.
  • Undergraduate Student: This learner group contains 3 required modules. It is designed to give undergraduates an introductory overview of research ethics and respect for persons involved in research.
  • IRB Members & Staff: This learner group contains 4 required modules. It is designed for current or newly appointed members of the IRB, in addition to IRB administrative and support staff. "Student researchers and faculty sponsors are not eligible for the IRB Members & Staff group."
If you still have questions or are unsure which learner group to select, please contact the IRB office at (404) 880-6979 or (404) 880-6829. How do I start the Program? If you are a first-time CITI user, please review instructions on getting started. Log on to Collaborative Institutional Training Initiative (CITI). How long will it take to complete the course? According to CITI, the average learner spends 3.5 hours completing the Basic Course training modules. The refresher course takes, on average, 2 hours to complete. Do I have to complete all the modules at once? No. CITI allows for multiple sign-ins, so you can complete the training at your convenience. CITI will keep track of your place each time you log out of the system. Is there a passing score for the training modules? Clark Atlanta University’s IRB office requires a minimal, cumulative passing score of 70%. Please remember that a quiz may be repeated to increase your score, but it must be done in one sitting. For how long is my training certificate valid? The basic course for any training module is valid for 2 years. After that, a refresher course of the appropriate learner group must be completed for recertification every 2 years. I received an e-mail from the IRB office stating that I completed the wrong training modules. How do I change my learner group, and will I have to complete additional modules for the correct learner group? You can change your learner group at any time in the CITI program. Log in to the program; click on "Add a course or Update Learner Groups," then click on the "update group" link. Select the appropriate learner group. The content of the training modules and quizzes are specific to each learner group. If there are any modules that weren't completed as part of the original learner group, you may have to complete additional modules to satisfy training requirements. If the "IRB Members & Staff" training was completed, there are no additional modules required for certification under the "Social & Behavioral" or "Biomedical" Research groups. Your training will be updated automatically and a confirmation e-mail will be sent to you from our office.