OPRS Newsletter 5/16/2024
Details
Important updates and notes to assist with utilizing the IRBOnline system and submitting IRB applications.
Topics Included
- Required Transition to IRBOnline
- Responding to Revision Requests
- Comment as part of Revisions
- Tracked Change Documents
- IRB Application Questions 1.2 & 1.3 - What to Include
- Participants in Mainland China - Timeline for Review
- Stay Connected with OPRS
1. Required Transition to IRBOnline
Remember - all previously approved human subjects research projects must be submitted in IRBOnline. Projects that were originally approved using the old forms will be closed on November 1, 2024. In order to continue conducting any human subject research projects, the project must be submitted and approved in IRBOnline by October 31, 2024. To ensure there is no lapse in approval, submit your applications as soon as possible. All researchers with active projects according OPRS records received an email with a list of their active projects in early 2024. Any project that has not been approved by October 31, will have to cease all research activities until it has been approved via the IRBOnline system.
Information and assistance can be found here:
Transitioning Projects to IRBOnline
Research Topics and FAQs
Tip Sheet for Transitioning Projects
Note: Non-Human Subjects Research is not required to be transitioned to IRBOnline
2. Responding to Revision Requests
Revisions are now sent and addressed in the system, which is a permanent record of the study. During the Pre-Review process, researchers will receive an email listing any revisions that are required. Once you log into IRBOnline and access your project, you will see your IRB application in the lefthand pane of the browser window ("Current Form") and the revisions requested in the righthand pane ("Revisions"). Revisions should be made directly into the "Current Form" pane - this is your IRB application and is the information that OPRS/IRB will be approving.
Additional training related to responding to revisions requests can be found here: https://mediaspace.illinois.edu/media/t/1_rl9lb4ht
3. Comments as part of Revisions
Although there are boxes for Comments in the "Revisions" pane, comments are generally not needed and most often should be left blank. It is not necessary to enter comments such as "Done", "Completed", etc. as you are completing the requested revisions. IRBOnline documents the changes that have been made so the IRB staff can review and verify they are done. Only information entered into the "Current Form" is considered part of the approved application and IRB protocol, so this pane must provide full information, be clear, and address the revision requests.
The Comments boxes are not part of the approved IRB application; however, they are part of the official study record for your project. This information will be reviewed by OPRS staff and IRB board members as part of future submissions and is also available to be reviewed by auditors, funding agencies, and other entities/departments with oversight responsibilities for human subject research. Keeping the record clear of extraneous notes and comments will avoid future confusion and make it easier for ongoing review of the study.
4. Tracked Change Documents
During the review process, there are often changes to documents, especially to consent documents. When the IRB sends a revision to update a document, please ensure that you attach both a tracked changes version and a clean version of the updated document. The IRB will use the tracked changes version to verify that the requested changes have been made to the document that was last reviewed. This improves the efficiency and speed of the review as the reviewer may only need to review the changes. Prior to approval, OPRS staff will remove the tracked version of the document as part of the review and will stamp the clean version for approval.
For New Study Applications - tracked change documents should be submitted along with clean versions as part of each revision requesting changes to a document.
For Amendment Applications - the original submission of the amendment should include a tracked change version of any document that is being changed as part of the amendment. For example, the study already has an approved consent document, with this amendment you are making a change to the compensation - the amendment application should include a tracked version of the consent document including the new compensation amount and a clean version that includes the new compensation amount. This allows OPRS to stamp the clean version of the updated consent document.
Additional information can be found here: https://oprs.research.illinois.edu/research-topics/submitting-documents-irb-review
5. IRB Application Questions #1.2 & #1.3 - What to Include
When completing your application in IRBOnline, it is important to answer the question asked, without including details that are addressed in other sections of the application. Providing information in more than one location and not where specifically requested in the application can lead to an increased likelihood of non-compliance as changes may be made in one place and missed in another. The first section of the application should be reserved for an overview of the study and broad information about its purpose. When answering Questions 1.2 and 1.3, please keep the following in mind.
Question 1.2) Study Purpose and Objectives - this should be a clear and concise description of the objective and/or aims of the study. This response often includes a bulleted list of the aim(s). The OPRS staff and IRB memebrs use this section as a first step in understanding why the research is being done, and as a basis toe valuate the rest of the application. Including extraneous information such as background, references, lengthy academic writings, etc. can hinder the review. When answering this question, try to state the reason for the study in basic terms understandable to a scientist outside your department. The information in this question will be used as a base to consider and justify the participant population being studied, the research design, procedures, and all other specific aspects of the study.
Question 1.3) Background and Introduction - this should provide additional information about the reason for the study. The IRB must ensure that the risk to participants is justified based on the science and need for this study. This response is needed to help the IRB understand the context and importance of your research. This section should be as detailed as necessary to justify your project and the risks involved. The length of the response may vary depending on how much information is needed to justify those risks. The riskier the research, the more information may be needed to ensure the IRB understands the context of the project.
This section should not include specific details about the current study. Specific information about recruitment, procedures conducted under this protocol, and other details are addressed in other sections of the application. Including those details here does not address the question asked, confuses the information provided, and can lead to inconsistencies if information elsewhere is updated but this section is not.
6. Participants in Mainland China - Timeline for Review
Any research conducted in mainland China must be done in accordance with China's Personal Information Protection Law (PIPL). PIPL is a comprehensive privacy law that protects personal information, which is defined very broadly, and makes it difficult to export any personal information collected from people in mainland China to the United States. Consideration of PIPL is necessary any time the participant is located in mainland Chinda, this means that surveys or interviews where a participant might be located in mainland China are impacted - regardless of the location (or nationality) of the researcher.
Any project that may include participants located in mainland China must first be reviewed for the applicability of PIPL. If PIPL is determined to apply, the research must be designed to be compliant with PIPL before OPRS is able to being the standard review of human subject research.
When a project is submitted to OPRS and PIPL may apply, the researcher will receive information to submit the Privacy Intake Assessment to determine applicability of PIPL. The researcher will need to ensure PIPL is not applicable to the study or that the study has been designed to comply with PIPL. Once this has been confirmed with the Privacy Office and University Compliance, OPRS can begin the standard review process for the project.
Due to the various departments involved in PIPL review in addition to the standard OPRS review, the process from submission to receiving final approval will be considerably longer than that for a standard submission. Those planning any projects in mainland China should keep this in mind when making arrangements to begin their research with participants in China.
Prior to submitting an application that may include participants in mainland China, researchers should review the information provided by the University of Illinois System as well as the applicable online tools: https://oprs.research.illinois.edu/research-topics/pipl-peoples-republic-china-privacy-laws
7. Stay Connected with OPRS and IRB
OPRS Listserv: To be added to the OPRS Listerv, email irb@illinois.edu
Research Topics: https://oprs.research.illinois.edu/forms-guidance-resources/research-topics
Researcher Guidance: https://oprs.research.illinois.edu/forms-guidance-resources/researcher-guidance