Frequently Asked Questions
This page contains most frequently asked questions. Please select a topic to see the questions and answers that may apply to your research.
In This Section
Who can I contact if I have questions?
IRB Administration has an email account dedicated to providing support, assistance, and guidance to UC Davis researchers. To speak directly with an experienced IRB administration staff member, please send an email inquiry to [email protected].
IRB review of research conducted at multiple institutions presents a unique set of challenges. If you have questions about IRB review of research involving institutions other than UC Davis, please contact our IRB Reliance group at [email protected].
Does the IRB have any upcoming trainings?
Visit our Upcoming Training Events webpage.
How long does it take to review a project?
Submissions are reviewed on a first come first serve basis. The IRB generally tries to review submissions requiring full board review within 4-8 weeks of submission and submissions requiring non-committee review within 2-6 weeks of submission. However, these timelines depend on the quality of the application and responsiveness to IRB requests. Incomplete submissions, delayed researcher responses, and seasonal workload increases may all contribute to longer review times.
What does the agenda date mean?
IRB Administration uses agenda dates to organize and route applications as part of our internal processing. Your application may be assigned to one or more of the dates listed below during the review process. These dates are placeholders and do not represent the date your application will be reviewed. If your application is assigned to an agenda date not listed below, it will be reviewed on the date and time indicated.
- 01/01 Exempt or Expedited Review Queue (prior to reviewer assignment)
- 02/01 Full Committee Initial Review Queue
- 03/01 Full Committee Response Queue
- 04/01 Reliance Processing
Why is my study unlocked?
The IRBNet lock feature serves as an indicator of when action is needed by the research team. For more information please visit our IRB Review Process webpage.
How do I check project mail?
When an intake analyst or reviewer needs to send requests for additional information, revisions to a submission, or notifications they will be sent to everyone that has access to the project. A copy of the Project Mail will be sent to the email address listed in the user’s profile in IRBNet.
You can also check the project mail on IRBNet.
- Log on to IRBNet
- Click on the project you are working on
- On the left hand side you will see a bell with “Messages and Alerts”
How can I request a rush review?
Use Project Mail to contact “Ask For, IRB Help” and state you are asking for a rush review. Provide the following information:
- Justification for the rush
- Date by which the determination is needed
- Any possible impacts on subjects’ rights or welfare
See Requesting a Rush Review for more information.
How do I find my determination or approval letter?
To find your determination letter, log into IRBNet, click the project title, and click “Reviews.” See IRB Determinations for more information.
When a determination or approval letter is published, does this mean I can start my research?
Not always, sometimes the IRB will request more information, changes or conditions before research can begin. See IRB Determinations for more information.
What is a stamped document? When is it required to use a stamped document?
When a consent document is approved, it will include a stamp on the bottom right-hand corner if it contains all elements of consent. Please note, consent documents for exempt studies are not stamped because they do not include all elements of consent. The IRB does not stamp any other documents.
It is recommended that a stamped consent form (if available) be used to avoid non-compliance issues in using the wrong version.
Does my project need IRB review?
All human subjects research, including exempt research, requires IRB review, regardless of funding. See our Does my Project Need Review by the IRB? for more information.
How do I apply for an exempt study?
For information about exempt studies, visit our Exempt Research webpage.
IRBNet says my study is exempt, does this mean it’s approved?
Exempt studies are issued an Exempt determination instead of an approval. Once a study issued an Exempt determination, you may begin work on the project. For more information on exempt studies please see our Exempt Research webpage.
Which signatures do I need for a new project?
See our New Projects webpage for more information about signature requirements.
Which protocol do I submit to the IRB?
Each project requires one research protocol. The IRB will accept a sponsor’s protocol or an investigator’s protocol. The IRB provides HRP-503 Protocol Templates for your use. For guidance template to use for a specific study visit our New Projects webpage.
To access the protocol templates visit our IRB Forms page.
Please note, a research abstract or funding proposal is not an adequate substitution for a research protocol.
Is a Principal Investigator, Department Chair, Dean, or Faculty Advisor automatically notified when they need to sign a package?
No, IRBNet does not automatically send notifications for required signatures. You will need to send them a message requesting a signature on IRBNet. Some research teams also find it helpful to use the IRBNet Tags to alert others of required signatures.
How do I use the Post-Approval Submission Form?
Use the following tools to aid in using the Post Approval Submission Form:
- Transitioning to the Post Approval Submission Form (PDF)
- Post Approval Submissions (eLearning)
- IRBNet Electronic Signatures (video)
- Adding Your Electronic Signature (PDF)
How do I edit the Initial Review Application?
To edit and add the Initial Review Application please visit our Modifications webpage for step-by step instructions.
What is the difference between a package and the initial submission?
When you create a project in IRBNet the system will assign a project number. At the initial submission, the number will be followed by a dash and 1 (XXXXXX-1). The “1” represents the package number. After review of the initial submission, the package will be locked. The next time you submit to the IRB for the project you will create a new package and the project number will stay the same but the number after the dash will increase by one (XXXXXX-2). Each package represents a single submission to the IRB and cannot be unlocked after the IRB review is complete. You can see a list of all packages and actions by clicking the “Project History” button in IRBNet.
How do I know which package I am working on?
The package number can be found at the top of the “Designer” page just above the package description or notes field. From here, you can also use the drop down arrow to navigate to other packages.
How do I submit a Continuing Review Progress Report?
You will be able to find detailed information on our Continuing Review/Study Closure webpage.
Why do I need to provide a summary of all Reportable New Information when I submit a Continuing Review?
The events summary table will allow reviewers to assess the risks of the study and that the study continues to meet Criteria for Approval (HRP-314). The Project Events Summary Table should list only new information that occurred during the current approval period. A blank Project Events Summary Table can be downloaded from our IRB Forms webpage.
If at continuing review there is a new RNI, should it be submitted with the Continuing Review or as a new package?
Please submit the RNI as a new package. The RNIs may be reviewed by either an IRB in-house reviewer or at a convened meeting if there are new risks.
How do I submit an Amendment/Modification if my project is locked?
After IRB review is complete the package is locked and will not be unlocked. You must create a new package to submit an Amendment/Modification to the IRB. Please visit our Modifications webpage for more information.
Do I need to submit a modification if I am only updating personnel?
No, updates to research personnel do not need to be submitted as an Amendment/Modification, unless it is a change of PI, Co-PI, or Faculty Advisor. Personnel updates should be submitted at the time of continuing review.
Do I need to submit a modification if the project is changing the PI?
Yes, if a change in PI, Co-PI, or Faculty Advisor occurs you will need to submit a modification. Please visit our Modifications webpage for more information.
Do I need to submit a modification if I received new funding?
Yes, changes in funding are considered a change to research and you submit an Amendment/Modification. Please visit our Modifications webpage for more information.
Do I need to close my study?
Yes, all studies which have been approved by the IRB should be closed once all research activities are complete and there is no longer a need to access identifiable information. For more information please visit our Continuing Review/Study Closure webpage.
When is the next committee meeting?
IRB meeting dates and other general information about UC Davis IRB can be found on the About IRB webpage.
How do I know if my study is on the next agenda?
Review How are Studies Assigned to a Full Committee Agenda? To see the agenda a particular package is scheduled for, open the project in IRBNet and click on the “Project Overview” button.
Why am I getting comments before the meeting if my submission is scheduled for a board meeting?
The IRB administration conducts an administrative review prior to sending the agenda and submission to the board members. During this review an IRB analyst may identify important information that may be missing or requires revisions. These comments will be sent through a project mail message.
Additionally, the Full Committee agendas are finalized and agenda item assignments are sent to our board members 1 week prior to the convened meeting. Our members conduct their reviews during this week time period. Committee Analysts gather these comments and try to send these comments out through project mail when they are received. You may receive multiple messages requesting revisions based on this.
Do I need to include both marked and clean documents when responding to reviewer comments?
Yes, marked and clean documents should be provided anytime documents are being updated. This allows for the reviewers and analysts to quickly identify the changes.
Why was my submission not approved at the meeting if I responded to all the reviewer comments before a meeting?
Though the IRB and the board tries very hard to reconcile clarifications and concerns prior to the meeting this does not always happen. Several reviewers are assigned to each submission. Comments and concerns may not be available prior to the meeting or concerns may be brought up at the meeting. Each submission must meet the criteria for approval in order to be approved. Please visit our webpage Full Committee Review Information to find out more about how reviewers evaluate a study.
What does "deferred" mean?
The IRB cannot approve the research as submitted and describes reasons or modifications that might make the research approvable; the IRB requests additional information from the researcher via “LETTER: HRP-516-Deferral of Protocol” which is published in IRBNet. See IRB IRB Determinations for additional information.
How do I respond to a Modifications Required or Deferred determination?
Please submit a new package, not a new study, in IRBNet. Please visit our webpage Response to a Letter of Action for detailed information.
Where do I find the determination letter which identifies the list of recommendations or requirements?
Please visit How do I access IRB correspondence? for information about how to access any correspondence with the IRB.
How much time should I allow for my letter to be published?
You should expect to receive your determination letter within two weeks of the convened meeting. Please visit the following links to find out more details about the status of your project and where to find the determination letters.
What is an IRB reliance?
Sites and personnel who are not part of UC Davis are not covered by UC Davis’ IRB review unless certain agreements are in place. If your project or study involves collaboration with any sites and/or personnel outside of UC Davis, you will need to work with the UC Davis IRB and the other individual/institution to ensure that all reliance issues are addressed. Please see our Single IRB and Reliances webpage for more information.
I am an external investigator recruiting UCD students for my research study. No UC Davis personnel will be part of the study team. Do I need UC Davis IRB approval?
No, IRB approval is not required if UC Davis personnel (faculty, staff, or students) will not be engaged in the research; however, approval may be required from other entities on campus. For more information on “engagement” see our guidance on engagement determinations.
Which IRBs does UC Davis have reliance agreements in place with?
Advarra IRB, WCG IRB, and University of California IRBs. In addition, we can use the SMART IRB agreement with any participating institution that agrees to its use.
When am I required to submit to UC Davis IRB after UC Davis has ceded review to another IRB?
Please see the Single IRB and Reliances webpage.
Does UC Davis charge for reliance reviews?
Please visit our IRB Fees webpage.
My collaborator received IRB approval. Does that cover the UC Davis site too?
To rely on another IRB, the UC Davis IRB must enter into a reliance agreement with that IRB. If the UC Davis IRB has an existing agreement with that IRB, an acknowledgement that the agreement is being used for a specific study must be made. Either way, the UC Davis PI must submit to the UC Davis IRB following the instructions found on our Single IRB and Reliances webpage.