Human Subjects

FAQs

CITI Training

The Principal Investigator and all personnel engaged in the conduct of research with human subjects are required to complete the training. Basically, an individual who will intervene or interact for research purposes with any human subjects of the research, obtain the informed consent of human subjects for the research, or obtain for research purposes identifiable private information form any source is considered engaged in the conduct of research with human subjects. See information regarding federal guidance to determine when an individual is engaged in human subjects research. It is the principal investigator’s responsibility to ensure that all engaged personnel have satisfied the IRB training requirement.

Researchers should select the track that is most appropriate to the type of research that will be conducted. The Social and Behavioral Research Module (S&BR) relates to studies on sociological, psychological, anthropological, or educational investigations including observational and survey research and work with population and/or epidemiological studies. There are also specific S&BR tracks if your research involves children, foreign countries (international), internet, pregnant women, or prisoners. The Biomedical Research Module would apply for medical, physiological, or pharmacological studies. If your study is an applicable clinical trial regulated by the FDA or sponsored by NIH, key study personnel may also need to take Good Clinical Practices (GCP) training.

Note: Since several courses are available, be sure to select Human Subjects/IRB which is Item #1, and not Responsible Conduct of Research/RCR which is Item #2.

If you are working on a human subject research project with investigators who are not affiliated with UGA, these individuals are still required to complete training. Submit a copy of this researcher’s CITI certificate to verify training completion from another institution.

If the researcher has completed training other than CITI, submit a verification of training. In most cases, the completion of training that meets the requirements of this individual’s home institution will be acceptable.

This individual may take the CITI training through UGA but must contact IRB@uga.edu to request an affiliate username and password.

Yes, but your records need to be associated with UGA. To do this, please go to the UGA CITI Login Portal and use your valid UGA MyID and password. Following the instructions, your UGAID will be associated to your CITI account and your CITI account will be affiliated with UGA. After you have completed this process, you will be able to access the list of modules required by UGA IRB. The list will update to include any that you’ve already completed and show those that will still need to be completed.

There are instances when your research area or subject population may change, and certification in your initial Learner Group is no longer sufficient. For instance, a researcher initially conducted basic behavioral studies (i.e., completed Group 1 – Social and Behavioral Research) and later wishes to conduct a study with children in public elementary schools. Two additional modules – Research with Children and Research in Public Elementary and Secondary Schools – must then be completed.

Each CITI module has text to read and a quiz to complete. The average learner spends approximately 2 to 3 hrs in the Basic Course site. You may use multiple log-ins to complete the course but you should take the quizzes immediately after completing each module.

An aggregate passing score of 80% is required. If you are not satisfied with your score, you can retake the quiz.

The links to the quizzes are at the bottom of each module in the footer of the page. Once you are at the Learners Menu, click on either the Basic Course or the Refresher Course to access your Grade Book. You must complete the first required module before you can access the next module. As you complete modules, the next module in the sequence will become available. After all required modules are completed, the optional modules will become available for you to review.

The software will track your progress through the course. The Grade Book will provide a list of the modules you have completed, and those remaining to be completed in your required course of instruction. When all required modules have been completed with a passing aggregate score, the software will provide you with a link (at the bottom of the Grade Book page) to print or download your course completion report. This report is like a transcript and will provide a detailed record of the completed modules.

Anyone with a valid UGA MyID and password, including active faculty, staff and students, should use the UGA CITI Login Portal to assure that your CITI training records are associated with UGA and your UGAID so that those records can be recognized and used by UGA’s electronic portals. If you are an affiliate user, you should save an electronic copy for your records and this should be submitted with all protocols with which you are associated as an investigator.

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All members of the research team must have completed the CITI training at the time of application submission. The Principal Investigator will only be able to submit a new application if all research team members have satisfied the training requirement.  CITI training may take up to 24 hours to appear in the submission portal.

Yes. As with initial reviews, the Principal Investigator will only be able to submit a continuing review or addition of new research personnel on approved studies if all research team members have satisfied the training requirement and the training is not expired. If the IRB cannot complete the continuing review process because the training requirement has not been satisfied, the protocol will be suspended and subject accrual must cease immediately. Approval of continuing review is generally for one year; if training of key personnel will expire prior to the end of the next approval period, approval can only be granted for as long as the training requirement is satisfied.  When new personnel will be added to a project, this is considered a modification that must first be approved by the IRB and training must be completed by the new personnel before the modification request can be submitted.

Certification will be valid for five (5) years from the date of initial training completion. CITI offers a refresher course which must be completed every 5 years.  GCP training must be refreshed every 3 years.

There is no fee for individual users. The University pays a flat annual fee regardless of the number of users.

Yes. The main CITI website provides links to apply for Continuing Medical Education/Continuing Education Units (CME /CEU) credits through the University of Miami CME office.

For questions or additional information about the training requirements, contact the Human Subjects Office at irb@uga.edu or 706-542-3199. For technical problems with the CITI site or course, contact the CITI Office at citisupport@med.miami.edu or 305.243.7970.

IRB Portal

Look for Help menus to the right of the question in blue shaded areas or by clicking on the question mark icon next to specific questions.

Each Help menu provides important guidance or additional information relevant to the page or section where it appears.  Please take the time to view these, especially when you are submitting in the IRB portal for the first time.

We recommend only using the samples and templates found in the IRB portal and on the Human Subjects Office (HSO) website.  Also, you should download new samples and templates each time you submit as these may be frequently updated to reflect changes in regulations or policies.

Contact the Human Subjects Office (HSO) at 706-542-3199 or irb@uga.edu.

The list of people that appears when you click on Select includes only active UGA employees and students.  Verify your co-investigator’s status; he or she may be retired or a visiting scholar, or not currently enrolled at UGA and, therefore, not active according to UGA authoritative data.  Contact the Human Subjects Office (HSO) at 706.542.3199 or irb@uga.edu to determine how to proceed.

Training records from CITI are uploaded to the IRB portal at regular intervals.  Depending on when the training record is updated, there may be a delay of one day in updating the completion status from CITI to the IRB portal.  Carefully review the Study Team Members CITI Training Records page for all investigators before submitting a request.  If the page shows “There are no items to display” or shows an Expiration Date less than 30 days in the future, but the investigator is sure that the training/refresher course is complete and current, there are two possible causes:  1) the investigator did not associate his/her CITI records with his/her UGA ID, or 2) the training or refresher training was just completed and therefore was not part of the previous system update.

If the former is true, the investigator should login to CITI via the UGA CITI Login Portal to associate his/her CITI training record with his/her UGAID.

If the latter is true, wait a few hours and try to submit the study again.

  1. If there are comments on your form with suggestions, please add supporting language to the form as appropriate. Save the marked-up version to your desktop using a sufficiently descriptive file name.
  2. Click on Edit Submission and use the Jump To menu to go to the Consent Forms and Materials page or the Consent Process and Materials page; upload the revised/updated document where you are prompted on the form to attach the materials by clicking Update next to the current attachment/document name. Any tracked changes will automatically be accepted. Save and Exit the online forms.
  3. Click on “Submit Changes” on the left of the study workspace. (Note: only the PI can submit changes. If you are a co-investigator, click on “Notify PI to Submit Clarifications” in the Study Team Actions section. This will send an e-mail to the PI.)

those that will still need to be completed.

Your office software settings may be blocking this function.  To check/change your settings in 2010 Microsoft Office Professional (for other versions of Microsoft Office, check with your departmental IT assistance):

  • Open Microsoft Word.
  • Go to File: Options: Trust Center: Settings: Protected View.
  • Uncheck all 3 options and click on Enable.

No, any member of the study team can create a submission in Click IRB, but only the Principal Investigator (PI) can submit the request to the IRB.  The person who creates the study will be the Primary Contact by default and both the Primary Contact and the PI will receive system notifications such as review requests for clarifications/revisions. The student co-investigator can create and revise the submission and materials and notify the PI when the request is ready to be submitted to the IRB.  The PI only needs to click on Submit or Submit Changes and to authenticate his/her identity when prompted (by again entering his/her UGA MyID and password) to send the request to the IRB.  The PI can click on Read Submission or Printer View to review the information entered by the co-investigator prior to submission.

Since each item must be reviewed separately and even similar items may require different revisions during review, the IRB recommends for each distinct item to be uploaded separately as a Word document, if possible.  For consent documents, this is especially important as many consent documents are date-stamped with the approval period granted by the IRB and if a particular modification is just to one of the consent documents, the new approval period would only apply to that one document.  Instrument packets that are developed from multiple sources or from a licensed item may be uploaded as a single file, PDF as needed.

  • If you are proposing a modification (amendment) to the approved study protocol and/or materials, choose Create Modification.
  • If your study will expire in the next 30 days, choose Create Continuing Review (you will have the option to choose both modification and continuing review as the purpose of the submission if you also want to propose a modification (amendment) to the approved protocol and/or materials.)
  • If your study is complete and meets the criteria for closure, choose Close Study.

When you propose a modification, you will need to indicate the scope of the change:

  • If you are only modifying the list of UGA co-investigators, choose Study Team Member Information under Modification Scope. You will be presented with an abbreviated form that does not present all of the submission pages.
  • If you are modifying other parts of the study, or if you are changing the PI, choose “Other Parts of the Study” under Modification Scope. You can edit the applicable sections/pages of the submission form and attach revised or new supporting documents.

You will receive automated notices at 90, 60, and 30 days prior to expiration.  You are requested to submit the continuing review in a timely manner to allow the IRB enough time for review.  However, if you submit at time of first or second notice, in order for the IRB to retain last year’s anniversary date for the expiration of annual IRB approval of this study, the IRB will wait to conduct review 30 days or less prior to expiration.

If you have more questions, please contact the Human Subjects Office at irb@uga.edu or 706.542.3199.