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Office of the Provost

Frequently Asked Questions

Getting Started

I'm new to Villanova. What do I do?

Welcome to Villanova! Please look on the main IRB landing page to find the Quick Start Guide. You can also review the Application Requirements section of this website. There, you will find a list of the IRB required CITI courses you must complete before submitting an IRB application. The CITI Program provides a comprehensive overview of human subjects research. You will also need to complete a financial conflict of interest disclosure form. Contact the COI Office with your username and department to be added to the Conflict of Interest system. On the Application Requirements page you’ll find user guides for CITI, and our online protocol management system, CAYUSE IRB.

In addition, ORP offers an in-person New PI Orientation. Contact ORP to schedule a session and learn about how the IRB works here at Villanova, receive guidance for writing proposals that will have the required elements expected by the IRB members, and personalized consultation about your project.
 

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I'm a student and my professor told me I need IRB approval for my project. What do I need to do?

Please visit the Application Requirements section of this website and view the list of the IRB required CITI courses you must complete before submitting an IRB application. There you will also find a Student Training "cheat sheet". The CITI Program provides a comprehensive overview of human subjects research. You will also need to complete a financial conflict of interest disclosure form. Contact the COI Office  with your username and department to be added to the Conflict of Interest system. On the Application Requirements page you’ll find user guides for CITI, FCOI, and our online protocol management system, CAYUSE IRB.

In addition, ORP offers an in-person New PI Orientation. Contact ORP to schedule a session and learn about how the IRB works here at Villanova, receive guidance for writing proposals that will have the required elements expected by the IRB members, and personalized consultation about your project.

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Do I need IRB Review?

The IRB reviews all research involving human subjects, human subjects’ data, and human cell lines. Research studies reviewed by the IRB could be a survey of your class about pedagogy or course materials, psychological experiments, brain monitoring, behavior testing, or a full-scale clinical trial with devices or drugs.

If your work involves any such activity, you must submit an application for review through CAYUSE IRB, the online protocol management system. There is a user guide for CAYUSE IRB available on the Education and Training section of this website. For additional assistance, contact the Office of Research Protections.
 

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The IRB has told me my research is Not Human Subjects Research. What does that mean?

If the IRB has given your project an “NHSR” determination, then your work does not meet the definition of human subjects research according to regulations. This means that the IRB will not maintain continued oversight of your project. This determination is an official IRB decision, so you can use such a determination letter as proof of IRB review for funding materials or journal submissions if necessary. This does not reflect on the scientific merit of the project or study.

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I'm conducting research internationally. What should I do?

Please see our guidance for international research on the Policies and Procedures section of this website. You can e-mail the Office of Research Protections for more information regarding international research. Please allow plenty of time to complete the IRB process as there are additional considerations and agreements necessary for human subjects research outside of the United States. ORP recommends three to six months advance notice before your travel dates.
 
Consult the CDC "Yellow Book" website for guidance from the government on health concerns when traveling internationally.

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Training and Personnel

How do I check my students' CITI trainings?

CAYUSE now has fully functioning integration with the CITI program. When you list a student on your CAYUSE application you will be able to click on the “view” link under the “training” column to see a list of completed courses. Please note that in order to view CITI records, your student must be added to your protocol using the “Find People” feature, and not by using the open text box. The "Find People" feature will only work if your student has a Cayuse account.

Refer to the Application Requirements page for an up to date list of what trainings are required.

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How do I link CITI and CAYUSE?

As long as you have the same primary e-mail address for your CITI and CAYUSE accounts, you will be able to view your CITI trainings from within the application. If you’re experiencing trouble please email the Office of Research Protections.

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What should I do if I have a collaborator from another institution?

Collaborations on  human subjects research projects are handled one of two ways: reliance agreements (IRB Authorization Agreements) or Independent Investigator Agreements. Contact ORP for help deciding which is right in your situation. 

If your collaborator will be listed on your IRB protocol, he or she may need to complete an FCOI disclosure and all CITI trainings required by the Villanova IRB. In some cases, we also recommend a data sharing agreement.

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Who should I add to my protocol and how do I add them?

Anyone who is engaged in the research (views/analyzes identifiable data, has contact with research participants) must be listed on your IRB protocol and be approved by the reviewer. You should list them in the General Information section of your Cayuse application. If you need to add someone to your protocol after you have already received IRB approval, you must submit a modification with the personnel change.

Be sure to remove any approved personnel if and when they leave the institution by submitting a modification to your protocol (for example, if you have a student research assistant who has graduated from the institution).

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IRB Review Process and Procedures

When will my protocol be reviewed?

As soon as you submit your protocol application in CAYUSE IRB, it will need to be certified by what is called an “organizational approver”. This person has administrative oversight of research and could be your Dean or Designee. Once it is certified, it will be available to the Office of Research Protections, where our analysts complete a brief pre-review of your application to ensure you and your research staff have completed the required trainings and that the study materials are complete. If everything is in place, ORP will assign your protocol to an IRB reviewer. 

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Where can I find submission deadlines for Full Board Review?

For full board review, consult the "Important Deadlines," section of the IRB homepage. These deadlines apply only to studies that will be reviewed by the full board – those with greater than minimal risk or which will sample from vulnerable populations like children or prisoners. All other studies are reviewed on a rolling basis.

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What happens after I submit?

Once you submit your protocol and certify it as PI, the application is routed for “organizational approval.” This is usually your department chair and/or dean who certifies your submission. Only after organizational approval does the protocol come into ORP for pre-review (see below).

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How long will it take to get approval?

For most expedited and exempt protocols, the IRB attempts to complete their initial review within two weeks. Please note the initial decision may be "Return to PI" if the reviewer needs clarification. More information on deadlines can be found on the Application Requirements page. Full board protocols are reviewed at the monthly convened meeting; see “important deadlines” on the IRB homepage for submission dates for full board studies. Inter-institution agreements like reliance or data agreements may extend this timeframe.

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I think my study is exempt. Do I still need IRB review?

Yes! The IRB requires that all projects involving humans, human subjects’ data, or human cell lines be presented to the IRB for review, regardless of whether the research will be granted exempt status. If the independent reviewer determines that your project is exempt, then you will have limited continued oversight.

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I work with human cell lines. Do I need IRB review?

Yes! The IRB requires that all projects involving humans, human subjects’ data, or human cell lines be presented to the IRB for review, regardless of whether the research will be granted exempt status. If the independent reviewer determines that your project is exempt or NHSR, then you will not have continued oversight. The IRB reviewer is the only one authorized to make such determinations about your proposed research

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I have IRB approval. Can I begin my study?

In most cases, yes! However please be aware that there may be other university committees or departments who will need to review and sign off on your study. (For example, if you are working with student athletes, you should contact the athletics department. If you are interviewing participants about sexual violence, you should contact the Title IX coordinator.) It is the PI’s responsibility to ensure that any other university departments and committees are notified about your research project if necessary, as the IRB is only bound to review human subject protections issues.

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I have funding. Do I need IRB review?

Grants and funding decisions and overview are independent functions from IRB review. The factor that determines whether you need IRB review is whether you are working with human subjects, human subjects’ data or human cell lines. If any of that applies to your study, please submit a protocol to the IRB for review.

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Does my study need to be reviewed by the IRB annually?

The federal regulations require an IRB to conduct continuing review of human subjects research that is within the IRB's jurisdiction.  For federally funded research with more than minimal risk (full board review category) or minimal risk (expedited review category), continuing review of human subjects research projects is required at least annually regardless of any amendments previously approved by IRB during this period. For expedited protocols, or for studies which involve no more than minimal risk, Villanova University’s IRB has approved the use of a Status Update Report, which is a short renewal form in Cayuse that the PI submits annually for review. Full board protocols require Continuing Review, which is a more detailed renewal form in Cayuse that the PI submits annually for review. Both of these forms (Status Update Report or Continuing Review) can be completed on Cayuse through the “Renewal” option. Please see the Cayuse User Guide in the Application Requirements section of this website for more details about submitting a renewal.

Your project must be renewed and reviewed annually as long as you maintain any personally identifiable data, even if your data collection is complete. This means that you may need to renew your study even if you are only analyzing data or preparing your manuscript.

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Who should submit a Continuing Review or Status Update Report?

The Principal Investigator (PI) is responsible for submitting a renewal application through CAYUSE prior to the expiration of the current IRB approval with sufficient time for IRB review so that no lapse in study approval occurs.  CAYUSE will send automatic reminder notices beginning 45 days before a study's IRB approval is scheduled to expire.  The average time for the Villanova IRB to process a Continuing Review submission is 2 to 3 weeks (this allows time for any clarifications needed during the review process), so please submit the renewal application through CAYUSE at least three weeks prior to your study's expiration date. 

It is ultimately the investigator's responsibility to submit a Continuing Review application/ Status Update Report and to allow sufficient time for the review and re-approval process to be completed before the current IRB  approval expires.

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When should I close my study?

When all research-related interventions or interactions with human subjects have been completed, and all data collection and/or utilization/analysis of identifiable private information, for any purpose, have been concluded, then the research may be considered as completed and the protocol may be closed. The Principal Investigator should not close an IRB protocol as long as the investigator is utilizing individually identifiable private information collected as part of the research.

A study is ready to be closed via a Closure submission on Cayuse when the criteria below are met:

1. The study is permanently closed to enrollment, AND
2. All subjects have completed research-related interventions or interactions, AND
3. All long-term subject follow-up activities are complete, AND
4. Identifiable data are no longer needed and all data have been de-identified

In most circumstances, investigators may pursue publications and presentations derived from de-identified human subject data in line with their data management plan after study closure without further IRB review.

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The approval period for my IRB study has expired. I want to continue with the study. What should I do next?

If IRB approval expires, all research activities involving human subjects MUST STOP, including subject contact, data collection, and data analysis.  No new subjects may be enrolled after IRB approval lapses.  The only exception to this requirement is for activities that should be continued for reasons of participant safety, for example, the continuation of a medical treatment that would be dangerous if stopped abruptly.  You should contact the IRB as soon as possible if you would like to restart your study activities.

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Data Sharing and Reliance

What is a Data Sharing Agreement?

A Data Sharing Agreement is a formal, written document shared between two or more collaborators and their IRBs to outline the parameters for sharing data collected during and following the course of their research study.

Please email the Office of Research Protections for more information.

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What is a Reliance Agreement?

A Reliance Agreement is a formal, written document that provides a mechanism for two or more institutions collaborating on research to delegate institutional review board (IRB) review to a single IRB or “IRB of record.”  

Email the Office of Research Protections to get started or ask questions about whether this is appropriate in your situation.

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Other Questions

I'm leaving Villanova. What should I do?

If you will be leaving the institution, you should be removed from any protocol where you are listed as a researcher. Please direct the IRB to close any active research studies you have where you are listed as PI by submitting a Closure form through Cayuse IRB. Please also ask any fellow researchers to remove you from their protocols so that their work is not impacted by your separation from Villanova.

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Where can I find the federal regulations or institutional policies?

The Common Rule section on human subjects research protections, 45 CFR 46, can be found on the HHS website.

Villanova’s Human Research Protection Program (HRPP) plan can be found on the  Policies and Procedures section of this website.

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