Improves efficiency through a streamlined IRB submission and review process
- Provides electronic support for the full life cycle of the research study, which includes initial submissions, modifications, reportable new information, and continuing reviews.
- Automated reminders will notify researchers, reviewers and administrators of important milestones and when actions are needed in the review process.
- UGA-specific guidance via integrated “help” menus will guide researchers through the process.
Increases transparency, easy access to protocols, and enhances communications
- Investigators will have easy access to their entire project records in one location 24/7; this includes the approved protocol, recruitment materials, questionnaires, amendments, and the current consent forms.
- Investigators will be able to see where the project is in the submission and review process, view IRB decision and approval letters, and view their entire study project history.
- All communications between the researchers and the IRB/HSO will be contained within the system.
- By eliminating virtually all paper, the new system will be environmentally friendly.
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.
Only the basic information for all previously approved protocols were migrated to the IRB portal (i.e., IRB protocol number, PI and co-PI, project title, and approval period). If you have an active project that you need to modify, please contact the Human Subjects Office at firstname.lastname@example.org or 706.542.3199. The HSO staff will scan and upload the study documents when a request for is received by our office. The researcher will be notified as soon as this step has been completed and the system is ready for the modification submission process. The HSO staff will also help you add any missing information to the project record.
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 email@example.com.
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 firstname.lastname@example.org to determine how to proceed.
Research is defined as a systematic investigation that contributes to the larger body of knowledge of any given discipline. This includes collection of scholarly materials for theses and dissertations done by students, and investigations carried out by faculty and staff for publication and/or presentation.
Training records from CITI are uploaded to the IRB portal at regular intervals. Depending on when 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 night’s 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.
The IRB has requested a revised consent document. How do I submit the revised document?
- 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.
- 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.
- 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.)
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 the IRB portal, 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 Modification.
- If your study will expire in the next 30 days, you can request for Continuing Review to have the IRB grant a new approval period.
- If your study will expire in the next 30 days AND you want to propose a modification (amendment) to the approved protocol and/or materials, choose Modification and Continuing Review.
- If your study is complete and meets the criteria for closure (see notes), choose Continuing Review or Close Study.
If you propose a Modification, you will need to indicate the scope of the change:
- If you are only modifying the list of UGA research personnel (except for the PI), 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, including 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 email@example.com or 706.542.3199.
A new version of the IRB portal will be rolled out for university-wide use in Spring, 2015
Improvements based on users’ feedback and experience during the past two years include:
- New look and user interface
- New forms for developmental review, reliance on an external IRB, and human research determination
- Automated validation of CITI training for human subjects research
- Streamlined application and revised form questions
- Additional Help menus