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CONTACT US

Human Subjects (IRB)
(209) 946-3903
irb@pacific.edu
Knoles Hall, 2nd Floor, Room 204

Valerie Andeola
IRB Administrator
Gilbert Ojeda
IRB Program Specialist

IRB Frequently Asked Questions

Ask a new question!

1. What do I do if I don’t believe my research project needs IRB review?

- The IRB determines if your research project meets requirements of being considered as "Human Subjects Research". You will have to complete/submit a Human Subjects Research Worksheet to IRB@pacifc.edu.

2. I already know my research project will be working with human subjects, do I still need to complete the Human Subjects Research Worksheet?

- Yes, you will still need to to complete the Human Subjects Research Worksheet

3. What is CITI Training?

- It is an online training program designed to educate students, faculty, or any personnel who will have access to subjects or collect data in a human subject’s research project. CITI training is also known as “Human Subject Research Training”.

4. Who will need to be CITI Trained?

- It is an online training program designed to educate students, faculty, or any personnel who will have access to subjects or collect data in a human subject’s research project. CITI training is also known as “Human Subject Research Training”.

5. How and where do I complete the required CITI training?

  • Go to https://www.Citiprogram.org
  • Click on the Register box in the upper right corner
  • Follow the steps for Learner Registration
  • Select Your Organization Affiliation: University of the Pacific
  • Agree to the Terms of Service and affirm that you are an affiliate of the University of the Pacific and then continue to create your CITI Program username and password
  • Enter your first and last name and email contact
  • Create a username, password and security question
  • Answer CITI Related research questions
  • Enter personal identified information for Pacific
  • Scroll down to question 2
    • Choose the research modules that best fit your subject of research* (Social and Behavior modules or biomedical modules).
    • CAUTION: Do not choose IRB Members unless you are a member of the IRB Committee.
    • Complete registration and start on modules assigned

6. Will my research application be reviewed/processed if I have not completed CITI training?

- No, IRB Research Applications will not be reviewed by the IRB until proof of the principal investigator’s training is confirmed.

7. I am only going to do research with information in an existing database (not involving direct contact with human subjects), what form do I complete and do I still need to complete CITI training?

- Yes, you will still need to complete the CITI training and you will need to complete the Existing Information/Biospecimen Research Application.

8. Can I begin working on my research project before it is approved by the IRB?

- No, you will need approval from Pacific’s IRB prior to commencing research activities with human subjects. If you begin research activities with human subjects prior to IRB approval, it will result in noncompliance and further actions will be taken. As a result, the researcher may be subject to the disciplinary proceedings and sanctions contained in such policies, subject to the oversight and approval of other University officials.

9. I’ve submitted my research application, what now?

- Your research proposal will first have a one week timeframe in which it will be administratively reviewed. Afterward, (depending on the review/risk level) it will be processed accordingly. If your research proposal contained issues of concern, a personnel in the Office of Research and Sponsored programs will contact you and request revisions.

10. My research project falls within the exempt review category (according to Pacific’s IRB manual), how long would the review process approximately take?

- Your exempt category research proposal would take the aforementioned one-week administrative review, plus one additional week for the IRB Co-chair to provide a final review (2 weeks total, with no requested revisions). Note: This timeframe also applies to cooperative agreement research projects (see question #9). If the IRB requests you to make revisions to your proposal, your response time to those requests will impact the time to complete your review.

11. My research project falls within the expedited review category (according to Pacific’s IRB manual), how long would the review process take?

- Your expedited category research proposal would take the aforementioned one-week administrative review, plus two additional weeks for two IRB committee members to perform an evaluation, and another week for the IRB Co-chair to provide a final analysis (4 weeks total, with no requested revisions). If the IRB requests you to make revisions to your proposal, your response time to those requests will impact the time to complete your review.

12. My research project falls within the full review category (according to Pacific’s IRB manual), how long would the review process take?

- Your full review category research would take the take the aforementioned one-week administrative review, plus two additional weeks for two IRB committee members to perform an evaluation, and a full board IRB meeting that will require planning (4+ total weeks.)

13. How will I know when my research project has been approved?

- An official letter of approval will be sent to you via e-mail when your research project has received IRB approval.

14. I want to work on an already approved IRB research project with someone from a different institution, do I have to do anything?

- This requires IRB review and approval. You will need to complete/submit the Cooperative Agreement form. Additionally, you will also need to provide the approval letter, and the originally approved research application from the lead institution. Proof of CITI training is also required.

15. Someone from another institution wants to work on my active research project that was approved by University of the Pacific, do I have to do anything?

- This requires IRB review and approval. You will need to complete/submit the IRB Authorization Agreement Form and provide proof of CITI training for the personnel wanting to join your research team.

16. What is University of the Pacific’s IRB Federal Wide Assurance (FWA)#?

- Pacific’s FWA#A00004103

17. I completed my research project, what now?

- Once you’ve completed research-related interventions with participants, data collection, and data analysis, you will need complete/submit the Active Protocol Status Report Form.

18. What happens if I don’t complete/submit the Active Protocol Status Report form to close my research project with the IRB?

- Your research project will expire and you will not be allowed to begin a new research project until you formally close your expired research project.

19. I want to make amendments to my approved research project (e.g. modify research activities, purposes, add/remove research personnel etc.), how is this processed?

- Yes, you will need to complete/submit the Protocol Revision Form which will need to be reviewed and approved by the IRB.

20. How long will it take for my submitted protocol revision form to be processed?

- Your protocol revision form will be processed in the same timeframe as if you submitted a new research proposal (i.e. the evaluation timeframe of the amendment is based on the risk level of the approved research project). Please see questions 10, 11 & 12 to review the exempt, expedited, and full review processing timeframes.

21. My research project expired and I now realize that I need to access some of the original data. Can I reactivate my original protocol?

- An expired research project cannot be reactivated. You will need to submit a new research proposal to be reviewed and approved by the IRB. Please note, that prior to submitting a new research proposal you will first need to formally close your expired research project by completing/submitting the Active Protocol Status Report Form to IRB@pacific.edu