UIC Research IRB FAQs
UIC Research IRB FAQs
UIC Research Introductory, Search, Navigation, and General Questions
Q. Do I need training to be able to use the UIC Research system?
A. You do not need UIC Research specific training; however, it is encouraged. You will still need to meet the Investigator Training requirements as described on the OPRS Investigator Training website.
Q. Where do I get my login and password?
A. You will use your UIC NetID and password to log into UIC Research.
Q. I am lost on what to do. Where can I get help?
A. You can review text and video by clicking on the “?” icon/button next to “Help” on the right side of the main Dashboard. You can also review various Guides under the IRB Help Center menu for step-by-step instructions on how to navigate the system based on your role.
Q. How do I search for my non-exempt study and what can I search by?
A. UIC Research will utilize the current numbering system of YYYY-XXXX; however, the protocol number (now called Study ID) will also include the term “STUDY” in front of the numbers.
You can search for your study by various data elements (i.e., ID, name, state, etc.). Utilize the wild card “%” to assist your search if you cannot remember the exact name or Study ID. For example, if you search for 2022-0001 your study will not appear as the term “STUDY” was not included in front of your Study ID. However, if you use search %2022-0001, then your study would be filtered appropriately.
Q. Where are the forms, templates, and appendices located?
A. The forms, templates, policies, and other documents are now located in the UIC Research IRB Library.
Q. Is the Library in UIC Research IRB system searchable?
A. Unfortunately, the Library is not searchable. If you need assistance finding the appropriate document(s), contact OPRS via UICIRB@uic.edu
Q. Do I need to continue to submit track change versions of documents?
A. You are not required to submit track change versions of Word documents. You are asked to track or mark your PDF and Excel documents.
Q. Is UIC Research 21 CFR Part 11 compliant?
A. Yes
Transfer of Research Studies from OPRS Live to UIC Research
Q. Will my non-exempt research, reviewed by the convened IRB or under expedited review procedures, be transferred from OPRS Live to UIC Research, or will I need to resubmit my studies in UIC Research?
- If your study was approved and did not have any submissions (i.e., modifications/conditions required, modification/amendment, continuing review, etc.) pending approval, or processing of an approval, as of June 16, 2022, then your study was transferred to UIC Research with the first data transfer.
- If your approved study had a pending submissions as of June 16, 2022 and:
- the pending submission was approved and the approval was processed before July 15th, your study and the approved submission will be transferred to UIC Research with the second data transfer on July 22nd.
- the pending submission is not approved before July 15th, your study without the submission will be transferred to UIC Research with the second data transfer on July 22nd.
- If your study was not approved by June 16th, and:
- Is approved and the approval processed by July 15th, then your study will be transferred to UIC Research with the second data transfer on July 22nd.
- Is not approved by July 15th, you will be required to re-submit the study in UIC Research.
- Please note that exempt research and determinations of not human subjects research were not transferred to UIC Research; however, the documents can still be accessed via OPRS Live.
- Exempt studies will remain active and, if the study requires a modification (amendment), then the exemption should be submitted as a new study in UIC Research. OPRS will accept the most recent version of the Claim of Exemption application as the protocol document for such studies.
Q. If my studies are transferred, how do I find them?
A. The protocol number (now Study ID) will continue to be utilized; however, it will now contain the term “STUDY” in front of the protocol number (e.g., STUDY 2022-0001). It is recommended that you use the wild card “%” when conducting a search (e.g., %2022-0001).
Q. Will my 30 research personnel and their roles be transferred to UIC Research?
A. All active and approved personnel should be transferred from OPRS Live to UIC Research. Please email UICIRB@uic.edu if there are errors or omissions.
Q. Will I still have access to OPRS Live?
A. OPRS Live will remain open for historical references only. You will still be able to access documents in OPRS Live
Submitting a New Study in UIC Research
Q. When do I get an IRB protocol number as other committees will not review my study without one?
A. As soon as you complete the first page of the smart form and upload your protocol, you will receive a Study ID (protocol number).
Q. What is the different between single-site and multi-site studies and why do I need to pick one?
A. Single-site studies are studies in which UIC will be the only site. Multi-site studies are studies that will include UIC + other sites regardless of their level of involvement. You are asked to pick single or multi- site as there are different pathways within the system based on the response. For instance, when there are multiple sites who rely on UIC to be the IRB of record, there are numerous documents and information in which needs to be included in the system that is not required for single-site studies.
Q. How do I know which IRB to select on the Basic Information page?
- If your research could be considered to be not human research or meets the criteria of a Claim of Exemption, then you should select “Claim of Exemption/Not Human Subjects Determination”.
- When writing your protocol, consider whether the research aim. If it more from a biomedical or biological science mindset, select “Biomedical/Health Sciences (IRB 1)”. If it is more from a social behavioral, or educational sciences mindset, select “Social/Behavioral/Educational (IRB 2)”
- Select “CHAIRb” only if instructed to do so by OPRS staff and/or the CAPriCORN Steering Committee.
- If your research is being reviewed by WCG WIRB, NCI CIRB, or involves the single IRB (sIRB), you should discuss your protocol with OPRS staff prior to starting your submission, and then select “Request for External Reliance (NCI CIRB, WCG WIRB, sIRB)”.
- Please note that the OPRS staff may change the IRB based on the research proposal.
Q. Do I really need a protocol document, even if my research will qualify for a not human subjects determination or exempt determination?
A. UIC Research is a protocol-based submission system; therefore, a protocol is required. Protocol templates (including Determination and Exempt templates) are provided for investigators who do not have a sponsor protocol (located in the UIC Research IRB Library).
Q. I submitted my study for a Claim of Exemption review, but it might be reviewed at the expedited level. Do I need to submit a different form like in OPRS Live?
A. The same information is collected in the smart form regardless of the level of review. However, you may be asked to provide additional information in the protocol.
Q. Can I print a copy of my submission?
A. You can use the “Printer Version” to print the smart form; however, you will need to print each document separately.
UIC Research Submission Types and Instructions
Q. What are the different types of submissions in UIC Research, or are they the same submission types as OPRS Live?
A. The following submission types available in UIC Research:
- Create New Study (Initial Review)
- Create Modification/CR
- Continuing Review/Study Closure
- Modification/Update (Amendment)
- Modification and Continuing Review
- Report New Information (Prompt Report)
Q. I am submitting a Continuing Review. Do I need to upload any documents? If so, how do I do it?
A. You will need to submit a Modification and Continuing Review (MOD/CR) and select “Other parts of the study” as the modification request, as there is not a mechanism for investigators to upload clean copies of the research documents with the Continuing Review. Clean copies of the documents are required for stamping.
If you submit a Continuing Review without the Modification, you will be asked to submit a Modification so that we can stamp your documents.
Q. How do I submit a Modification (amendment) to my study that was reviewed in OPRS Live?
A. Select the study in which you want to revise and select “Create Modification/CR”. Then select the most applicable answer for the “Modification scope”.
- “Study team member information” is limited to personnel changes only.
- All other revisions must be processed through the option “Other parts of the study”.
If any documents (i.e., protocol, consent, recruitment materials, etc.) will be updated with a personnel change, you must select both “Study team member information” and “Other parts of the study” to update the applicable documents. If “Other parts of the study” is not selected, the system will not allow you to update any documents within that specific submission.
Q. Why does the “state” of my submission say pre-submission when I hit the “Finish” button on the last page?
A. The principal investigator must hit the “Submit” option on the left-hand side of screen or the study will not be submitted to the IRB.
Q. What happened to Prompt Reports and Protocol Exceptions?
A. All items that would require a Prompt Report will now be processed via Report New Information. Any item that would require a Protocol Exception will now be processed via a Modification
Responding to the IRB in UIC Research
Q. I received a “Clarification Requested” email. What does this mean, and do I have to do anything?
A. A “Clarification Requested” is sent to investigators when there are items within the submission that are missing, need to be corrected, and/or clarified prior to sending the submission to an IRB reviewer. You will respond by uploading any new/revised documents directly into the smart form, as you did when you created the submission, then hit “Submit Response” on the left-hand side under “Next Steps”. You must respond to the Clarification Requested or the submission will not move forward in the review process.
Q. How do I respond to a Modifications Required?
A. Create a response letter by responding to each item within a letter to the IRB. You will then respond by uploading any new/revised documents directly into the smart form, then hit “Submit Response” on the left-hand side under “Next Steps”.
Q. Who can respond to Clarification Required and/or Modifications Required?
A. A member of the research team can prepare the response; however, only the PI or PI Proxy can submit the response.
Q. Do I need to submit a track changes version of my documents?
A. You are not required to submit track change versions of Word documents. You are asked to track or mark your PDF and Excel documents.
UIC Research Roles and Views
Q. Who will be able to look at my research studies and what will they see?
A. Everyone who is listed as a study team member will have access to the research file. Any member of the study team can start a submission and/or response; however, the PI/PI Proxy is required to submit the submission and/or response.
In addition, persons listed on the Guest List and Ancillary Reviewers will have read-only access.
Q. Do the PI and PI proxy have the same access to the UIC Research dashboard and research files and documents?
A. Everyone involved in the research will have access to the same information; however, only the PI or PI Proxy can submit submissions and/or responses to the IRB.
Q. What is the difference between a PI Proxy and Primary Contact on the left-hand side?
A. A PI Proxy has the same privileges as the PI. The Primary Contact is the main person who will be notified if there are concerns with the research and/or receive research correspondence.
Q. What is the Guest List and who should be listed?
A. The Guest List is a list of persons who the investigator grants read-only access for their research. Examples of persons who may be on the Guest List include Department Heads, Business Managers, Regulatory Offices, etc..
Q. Who is listed in the Local Study Team Member drop-down list?
A. Persons who have a UIC NetID are included in the drop-down list.
Q. I am trying to add someone with a NetID as a study team member, but they are not in the drop-down list. What should I do?
A. Send an email to UICIRB@uic.edu with the person’s name and UIC NetID and we will investigate the issue.
Ancillary Reviews
Q. What is an ancillary review and why do I need one?
A. An ancillary review is a review by a person or committee that is required prior to an IRB approval letter being processed. Reviews by your Faculty Sponsor and Department Head, the Cancer Center Protocol Review Committee (CC-PRC), and Investigational Drug Service (IDS) are examples of ancillary reviews
Q. How do I know if I need an ancillary review?
A. The questions in the “Additional Information” section will assist you in determining whether any ancillary reviews are required. The exception is if drugs are involved in the research as the “Drugs” section includes a reminder to include the IDS as an ancillary review.
If you believe your research does not meet the definition of human subjects research or fulfills the criteria for an exempt review, the Department Head review is not required. Please note that if the research requires expedited or convened review, OPRS staff may add or request that you add the Department Head review to the list of ancillary reviews.
Q. Who assigns the ancillary reviews?
A. The investigator will assign the ancillary reviews via the “Manage Ancillary Reviews” button on the left-hand side of the screen prior to submitting the study. If you forget to assign an ancillary review, you can add the required review after submission.
Q. How are the ancillary reviewers notified of my study, and how do I know if they completed the review?
A. The person or committee that has been assigned an ancillary review will receive an email notification that a review is required for your study.
Q. Will my study be approved if there are pending ancillary reviews?
A. All ancillary reviews are required to be approved/acknowledged prior to the IRB processing an approval.
Q. Will I receive a notification when the ancillary review has bee completed?
A. You should receive an email notification when the ancillary review has been completed.
Multi-site Studies
Q. How do I submit a multi-site study?
A. You would begin the initial review in the same manner as you would a single-site study. However, you would indicate that it is a multi-site or collaborative study, whether another IRB or UIC IRB is the IRB of record, and the name of the lead investigator if UIC is relying on another IRB for review.
Refer to the IRB Multi-Site Study Guide within the Help Center menu in the UIC Research IRB Library for a full explanation of how to submit multi-site studies.