Office of Research Frequently Asked Questions - Office of Research

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:


New Projects Questions

 

  • What are the steps to start a first-time submission to the UC Davis IRB?

All applications to the UC Davis IRB must be submitted using our electronic submission system, IRBNet. Visit New Projects and IRBNet Guidance for more information.

 

  • Which signatures do I need for a new project?

Each new project requires PI and Administrative Approval signatures. See New Project Submission Requirements for more information.

 

  • 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. To see example of which template to use for a specific study visit our New Projects page.

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.

 

  • How do I check if my department Chair has an IRBNet account?

To check who has an IRBNet account use the PDF titled, “Verify IRBNet Users” which is available at the top of our IRBNet page.

 

  • What are the steps for a Principal Investigator, Department Chair, Dean, or Faculty Advisor to sign a package?

Signatures Accepted on IRB Applications on the IRBNet Guidance  or watch the IRBNet Demonstration Video: How Do I Electronically Sign an Application?

 

  • 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.

 


Post Approval Submissions Questions

 

  • How do I use the Post Approval Submission Form?

Use the following tools to aid in using the Post Approval Submission Form:

 

  • How do I edit the Initial Review Application?

To edit and add the Initial Review Application please visit our Modification page 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 page.

 

  • 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 website here.

 

  • 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 can create a new package to submit an Amendment/Modification to the IRB. For more information please visit our Post- Approval Submissions page.

 

  • 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 Modification page 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 Modification 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  Continuing Review/ Closure.

 


IRB Administration Questions

 

  • Who can I contact if I have questions?

IRB Administration has a phone line and email account dedicated to providing support, assistance, and guidance to UC Davis Researchers. To speak directly with an experienced IRB Administration staff member please call 916-703-9158 or send an email inquiry to hs-irbeducation@ucdavis.edu

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 hs-irbreliance@ucdavis.edu.

 


Full Board Questions

 

  • When is the next Full Board Meeting?

IRB meeting dates and other general information about UC Davis IRB can be found on the About IRB page.

 

  • 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 Actions and Correspondence 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?  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.


General Questions

 

  • Does the IRB have trainings coming up?

Visit our Upcoming Training Events page.

 

  • 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 Non-committee Queue
      • 02/01 Full Committee Initial Review Queue
      • 03/01 Full Committee Response Queue
      • 04/01 Reliance Processing
      • 12/31 Non-committee Review

 

  • 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 a screener 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.

      1. Log on to IRBNet
      2. Click on the project you are working on
      3. 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/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/ 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.

 

  • Can you please explain the stamping of documents and when it is required to use a stamped document?

When the consent form is approved their will be a stamp on the right bottom corner. It is recommended that the stamped consent form be used to avoid non-compliance issues in using the wrong version. The IRB does not stamp any other documents.

 


Study Specific Questions

 

  • How do I apply for an exempt study?

For information about exempt studies, visit our Exempt webpage.

 

  • It says my study is exempt, does this mean it’s approved?

Although the category is called “exempt,” this type of research does require IRB review and registration. Once the Exempt determination letter is published in IRBNet, you may begin work on the project. For more information on exempt studies please see our Exempt webpage.

  • If I am conducting an online survey, how do I get consent for someone?

When providing consent online, there are a number of ways in which an e-signature might be documented. See Consent Documentation for more information.

 

  • Does my project need IRB Review?

All human subjects research projects require IRB review, regardless of funding. To determine if a project requires submission to the IRB, you must assess two criteria:

See Does my Project Need Review by the IRB? for more information.

 


Reliance Questions

 

  • 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 Reliance webpage for more information.

 

  • I am an external investigator recruiting UCD students for my research study. No UCD personnel will be part of the study team. Do I need UCD IRB approval?

No, IRB approval is not required if UCD 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 webpage on Engagement Determinations.

 

  • Which IRBs does UCD 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 UCD IRB after UCD has ceded review to another IRB?

Please see the Single IRB and Reliance webpage subsection “UCD is relying on an External IRB.”

 

  • Does UCD charge for reliance reviews?

Please visit our IRB Fees webpage subsection “Reliance.”

 

  • My collaborator received IRB approval. Does that cover the UCD site too?

To rely on another IRB, the UCD IRB must enter into a reliance agreement with that IRB. If UCD 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 UCD PI must submit to the UCD IRB following the instructions found here.