The below information and processes are taken directly from or guided by the regulatory requirements, state laws, and institutional polices. If you do not find the answer to your question below, please contact an IRB Coordinator.
NUgrant to NuRamp Transition
As a general note, all information, files, records, comments, or any documentation associated with a project that was started in NUgrant will be automatically transferred or “copied” to the NuRamp IRB module. This includes projects in all stages of the IRB review process including preparation, routing, revisions requested, submitted to reviewer, submitted to an IRB meeting, etc. Investigators will have access to each of their projects (irrespective of the status) that were available in NUgrant. The following questions and answers are those that are most anticipated by the Research Compliance Services staff during the transition. This listing will be updated as we begin campus training sessions and learn of or answer any additional questions during implementation that we believe are relevant for the broader UNL human subjects research community.
Q: How will I refer to my project? Will my project ID(s) be the same, or will it/they change?
All project IDs will remain the same in terms of the base number. However, now that the IRB module will be used by more than one campus, ID numbers will identify which campus the project or application is associated with. For example, a project that was originally given the project ID #12345 in NUgrant will now be given the project ID #UNL-00012345 in NuRamp.
Q: I have been drafting an application in NUgrant prior to the NuRamp transition. Will that application still be available for me to work on in NuRamp?
Yes, all records and information will be copied from NUgrant to NuRamp, allowing you to continue to work on your project with no interruptions.
Q: I noticed that the IRB New Project Form application in NuRamp has changed from the last NUgrant version. What if I am still working on the old NUgrant version application?
The project will remain on whichever version of the new project form you originally started the form on. Any new project forms started in NUgrant will be transitioned to NuRamp.
Q: How do I submit a new form (e.g., change request form, annual update, continuing review, reportable new information form) on a project that was approved via NUgrant?
The process of adding a new form is completed the same as it was in NUgrant. Navigate to your project via NuRamp and click on the button labeled “Add a New Form.” You will be able to select the appropriate form to submit on the subsequent page and complete it as you did in NUgrant.
Navigating Change Request Forms
Q: The NuRamp change request form now includes all of the sections of the new project form. When I submit a change request, do I need to update all of these fields, or do I only fill out the proposed changes and justifications?
The project application should now be considered a “living document,” and any changes that are requested should be incorporated into the new project form sections at the time of a change request form submission along with the brief description of the change and the justification in the “Project Information” section. This applies for both newly submitted projects as well as projects approved via NUgrant.
Q: I have previous change request forms that were approved but not included in the New Project Form. Should I add that information to the protocol as well?
Generally, yes, all previously approved changes should be included in the living protocol.
Q: When should I add all the previously requested changes to the new living protocol?
You can incorporate them while submitting a new change request form. If the modifications in the change request form have a specific time restriction, you may choose to add these details later, but be aware, at some point in time you will be required to update the protocol with all changes previously approved.
Q: Do I need to submit all previous modifications to the project when I submit a new change request?
No, you don’t need to submit all previous modifications when you submit a new change request form. However, all previous modifications which are applicable to the current project must be included in the living protocol at some point during its duration. If you have specific time constraints, you can address those modifications later.
Q: I am going to submit a change request form, and I happen to be done with some of the procedures just simply based on the timing of when the procedures are completed as part of the research, should I remove the procedure from the application?
No, procedures that are still part of the research design and approved protocol should continue to be described in the new project form portion of the change request form. While we understand that the particular procedure may no longer be active because data collection is complete for that portion, it still needs to remain as part of the documentation of the approved protocol.
Q: How will I know which changes I need to make in the application?
The IRB coordinator assigned to your project will provide you with a revisions requested letter and an Excel sheet that summarizes all the changes you’ve requested throughout the life of the protocol. This Excel sheet will include a list of all modifications needed, along with the specific sections where changes are required.
Q: How does the IRB Coordinator decide if the project needs to update previous change requests?
The IRB Coordinator considers several factors, including the submitted forms, project statuses, time constraints, complexities involved, the nature of previous revisions, and the current stage of the project (such as recruitment, data collection, or data analysis) to make this determination.
Q: Is this process project-specific, or will I have to follow it for every project I submit?
Each project is reviewed individually, and decisions are made on a project-by-project basis. The coordinator determines when updates to the application are necessary based on their understanding of the specific project.
Q: After a Change Request Form I submitted was approved, my project title now includes “FPCU.” What does this mean?
“FPCU” (Full Protocol Change Update) signals the decision the coordinator made specific to requiring updates to your protocol based on previously submitted change forms. If your project title includes FPCU, when the next Change Request Form is submitted for this protocol, you will be required to update the protocol to reflect all previously approved changes following the same process described above. This information will be noted as part of your approval on NuRamp.
Q: Do I need to update the files when submitting a change request?
Yes, all files that were modified as part of the change request must be updated, and any files that are no longer in use due to old versions or other updates should be removed from the most current living protocol. Please ensure that only the most recently revised documents are available.
Q: I used to be able to request changes as part of the continuing review. Can I no longer do that?
The questions related to protocol changes have been removed from the continuing review form. All changes will instead need to be submitted through the change request form. This will allow the IRB application to be a comprehensive record through the life of the project.
Getting Started with Institutional Review Board (IRB) Approval
Q: What are the current requirements when working with human subjects as they relate to the COVID-19 pandemic?
Please see the guidance available via the R&I COVID-19 webpage.
Q. What types of projects require IRB approval?
In order for a project to require oversight by the IRB it must meet the regulatory definitions of research AND human subjects. Policy #3.001, “Investigational Activities Requiring IRB Review and Approval” defines activities that must be reviewed and approved by the IRB before the project begins (including recruitment). For more information, see our Review, Approval, and Post-Approval Requirements page.
Q. Who can make the decision of whether I need to get IRB approval?
The decision of whether or not you are conducting human subjects research can be made by the Principal Investigator and whether or not an application for IRB review must be submitted. According to Policy #3.001 titled, “Investigational Activities Requiring IRB Review and Approval,” Section 3.3 specifies, “Any individual who is unsure whether or not a proposed activity constitutes ’research involving human subjects’ should contact the HRPP office for guidance.”
Q. What happens if I make the wrong decision?
If the wrong decision is made and IRB approval is required, it may not be granted if the research has already started or been conducted and the determination of IRB applicability was made incorrectly by the investigator.
Q. When am I required to submit an IRB application?
All proposed research projects involving the use of human participants through either interaction or intervention or the use of identifiable data/biospecimens conducted under the auspices of the University of Nebraska-Lincoln are to be submitted for IRB review BEFORE the research begins. This includes recruitment of study subjects, and/or access or sharing of identifiable data/biospecimens.
Q. I am just doing a simple survey; do I need to submit to the IRB?
Yes, if the survey meets the definitions discussed above. UNL’s Assurance with the Department of Health and Human Services says all research conducted under the auspices of this institution will undergo the IRB review and approval process.
Q. I believe my protocol is exempt. Does it need to be reviewed?
Yes. “Exempt” does not mean that it is exempt from the IRB review process. Rather “exempt” per IRB terminology is a form of a review type or process. It is the policy of the UNL IRB that all proposed exempt research is reviewed by the Human Research Protection Program (HRPP) staff for final determination.
Q. I am not collecting any identifying information from a human subject; do I need to file for approval?
Yes. Federal regulations and UNL regulations require that ALL research obtaining information from human subjects either through interaction and/or intervention regardless of it being identifiable be submitted for review and approval.
Q. What is considered identifiable?
Please review our Data Identifiability Definitions A-Z Guidance page.
Q. I am only working with previously collected data; do I need to file for approval?
It depends. Federal regulations require that if the study will use either existing or to-be-collected data, documents, records, pathological specimens or diagnostic specimens from human subjects, the study must be submitted for review.
Q. My research is based on de-identified tissue samples; do I need to file for approval?
It depends. Research involving the study of existing pathological specimens from participants who cannot be identified, directly or through identifiers linked to the participants, may qualify for an exemption determination or may not be considered human subjects research. For it qualify for an exemption determination, all of the de-identified specimens must exist prior to the start of the research project for this to apply. These determinations can be complex, so we encourage you to contact an IRB Coordinator at the earliest possibility to discuss your project.
Q. I will be collaborating with a researcher at another institution. Do I need to file for IRB approval at both UNL and the other institution?
Investigators should contact the IRB reliance coordinator whenever collaborative or multi-institutional research is planned. Separate applications may be necessary, or an IRB Authorization Agreement may be reached with the other institution. However, this is the decision of the UNL Institutional Official. The Principal Investigator or study staff do not have the authority to enter into agreements or pledge IRB resources (including review) on behalf of the IRB with other institutions or collaborating researchers. For more information, please review our Single IRB (sIRB) | Reliance Agreement webpage.
Q. I will be working with another institution on a project reviewed as Exempt. Do I need to do anything?
The UNL IRB generally does not enter into reliance agreements for exempt research. In this case, you will likely need to submit a New Project Form if you are conducting human subjects research activities including consenting participants, data collection, or analysis of identifiable data. For more information, please review our Single IRB (sIRB) | Reliance Agreement webpage.
Q. Who do I contact if I have questions about Single IRB or the reliance process?
Contact the reliance coordinator at unlreliance@unl.edu.
Q. Should I wait until my research proposal has been funded to submit a protocol for IRB approval?
You can wait, but it is best to submit your IRB application soon after your research proposal is submitted to the sponsor. Some sponsors provide only a small window of opportunity to provide the IRB approval materials, and you will want to be as prepared as possible when your proposal is funded.
Before/During the Review Process
Q. How do I submit my application for IRB approval?
All IRB protocols should be submitted through NuRamp. The NuRamp system is easy to use and leads you through the application process step-by-step. You may be asked to upload certain files to accompany your application, such as measures used in the study (surveys, questionnaires, interview questions, etc.), recruitment materials (flyers, emails, letters, scripts, etc.), informed consent/assent forms, grant proposals, approval letters, follow-up materials, etc.
Q. How long does it take to review an application for IRB approval?
Review times vary. The length of time depends on the quality of the IRB application upon submission, the investigator response times, and the review level or complexity of the project. At certain times of the year, a large volume of protocols appear in the reviewing queue. All forms are reviewed on a first-come-first-serve basis. More complex protocols often take more time and could involve multiple offices outside of Research Compliance Services, increasing the time for final approval to occur. Our current review time metrics are available in the “IRB Protocol Review Times” tab on our website.
Q. How can I tell what the review status of my project is?
Please review our Review, Approval and Post-Approval page, specifically section 4, for a link to our Form Status definitions sheet.
Q. Who is required to complete the human participants training?
Please review our Required Human Subjects Training webpage.
After Approval is Granted
Q. How do I add new forms to my IRB application?
All forms are submitted as part of your project on the NuRamp system. For help in navigation in adding the form including a Reportable New Information Form, a Change Request form, a Continuing Review Form, an Annual Update, or a Final Report, please see the IRB NuRamp navigation videos, specifically, the “Adding a New Form” video.
Q. What do I have to do if I need to amend my approved protocol?
Depending on the review category, changes to an approved protocol must be reviewed by the IRB prior to implementation. Policy 12.001 entitled, “Request for Change” delineates when a change request is necessary. These change requests must be made through NuRamp via submission of a change request application.
Q. If I submit a change request form for review and my study is registered with ClinicalTrials.gov, do I need to update my ClinicalTrials.gov registration?
Maybe. The current ClinicalTrials.gov guidance on updating a registered study tell us that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration with 30 days after IRB approval of the modification.
Q. Does approval of a modification or a change request form extend the next update required date?
No. The expiration date of the original approval is not changed by the review and approval of a modification.
Q. How do I renew my project for continued approval?
The principal investigator is responsible for ensuring the continued approval of research projects involving human participants. To remind you of this obligation, approximately two months before the approval expires, you will begin receiving notices via e-mail requesting that you submit a Continuing Review Form (for projects reviewed using the Pre-2018 guidelines or for projects reviewed at the Full Board level) or an Annual Update (for projects reviewed at the expedited level under the 2018 requirements, also known as the Common Rule) that you need to file if you plan to continue this research beyond the one-year approval period.
Q. In the case of an adverse event, unanticipated problem or non-compliance, when am I expected to report this occurrence to the IRB?
The Principal Investigator should report any adverse events, unanticipated problems, or non-compliance within 48 hours of when any of the research team members become aware of the incident. A comprehensive list of examples and definitions can be found in Policy #13.001 titled, “Unanticipated Problems Involving Risk and Adverse Events” and Policy #14.001 titled, “Non-compliance.”
Q. Can the IRB temporarily or permanently discontinue a research project as result of an adverse event, unanticipated problem or noncompliance?
Yes. If an adverse event, unanticipated problem, or non-compliance poses an unexpected risk to the participants, or creates an unmanageable issue related to human subjects protection, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Depending on the results of the investigation, the IRB may request changes to a research project or permanently discontinue the research project.
Pre-2018 vs. 2018 Requirements
Q. I have an Exempt research project approved under the Pre-2018 Requirements. Does this update affect me?
Nothing will change for the project. The project will remain under the Pre-2018 regulations. Once the project reaches the 5-year approval period, a new project application will need to be submitted.
Q. An ongoing research project approved under the Pre-2018 regulations has progressed to the point that it only involves data analysis, including analysis of identifiable private information or identifiable biospecimens; and/or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. Does this update affect me?
A continuing review will still be required to be submitted, but while processing the continuing review, IRB staff will ensure the project will be transitioned to the 2018 regulations and documented under the appropriate 2018 category.
Q. My project has transitioned from the Pre-2018 Requirements to the 2018 Requirements. Can I continue to collect additional data once it has transitioned?
Generally, the project won’t be allowed to transition if continued data collection is planned. The UNL IRB has decided that all projects with ongoing data collection will remain under the Pre-2018 Requirements given the ambiguity in the regulatory transition requirements specific to consent of subjects.
Q. I have a project that was approved on or after the revised Common Rule effective date using the Expedited review method. Is a continuing review required?
In most cases, no. An annual update will be required where the IRB can track the status of the project only.
Q. My project involves deception. How will this be reviewed?
Depending on the project complexity and when participants are informed regarding the deception, projects involving deception could be reviewed at the exempt or expedited level. For projects involving more than minimal risk, a review by the full board would be required. For more information, please visit our A-Z Guidance entry titled, “Deception in Research.”
Q. I have a currently approved Expedited project that will transition to the revised Common Rule requirements. Do I need to worry about consent/re-consent of subjects?
If the institution chooses to apply the new regulations to research that was approved prior to the revised Common Rule effective date, which is closed to enrollment and follow-up, the 2018 Requirements for informed consent and waiver of informed consent would NOT need to be implemented retrospectively. In other words, subjects would not need to be re-consented with a revised consent form, and the waiver of consent would not need to be reconsidered under the new criteria. This is only applicable to those projects that have no plans for future data collection or ongoing contact with subjects including follow-up or observation.
Q. I have a currently approved Exempt project and I want to pay my participants $10 instead of $5. Do I need to submit a change request?
No, you would not be required to submit this change request if your project was certified as Exempt. However, please note certain changes to exempt protocols still require IRB review and approval. Please reference our A-Z guidance titled, “Exempt Research” for further information.
Q. My project is currently approved to include participants 19 years and older, but I want to make a change to include participants 18 years old now. Do I need to submit a change request form?
This would potentially change the project category and the type of participants (minors) involved (consent/assent/waiver impact). You would be required to submit a change request form and receive approval prior to implementing this change regardless of the review level (e.g., Exempt, Expedited or Full Board).
