IRB Requirements for JDP Students (FAQ’s)

What is an IRB?

An institutional review board (IRB), also known as an ‘independent ethics committee’ (‘IEC’), ‘ethical review board’ (‘ERB’), or ‘research ethics board’ (‘REB’), is a type of committee used in research in the United States that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be completed. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study (Wikipedia 2017, https://en.wikipedia.org/wiki/Institutional_review_board).

Do I Need to Submit an IRB Proposal for my Second Year Project and Dissertation?

YES! ALL students are required to submit an IRB proposal (as the PI*) for their Second Year Project and for their Dissertation even if they have been listed on their mentor’s IRB already. [*Note: Students submitting an IRB at UC San Diego and the VA are not allowed to be the PI. Please refer to the UCSD IRB Process below for more information.] A student must receive IRB approval BEFORE data collection/analysis begins. The IRB proposal is considered to have been approved only once the proposal has either been determined to not meet IRB criteria for involving human subjects OR has been reviewed and signed by both SDSU and UC San Diego and the student has received an approval letter.

You should submit your proposal to the IRB at your mentor’s primary institution (either SDSU or UC San Diego). The IRB will decide if your research does not meet IRB criteria for involving human subjects or falls under the exempt, expedited, or full review categories. If your project does not meet IRB criteria for involving human subjects, you will receive notification as such (via email at SDSU, or via a letter at UC San Diego). If your project falls under any of the three categories listed above (exempt, expedited, or full review), you will need to submit a proposal for review and must complete the “UC San Diego/SDSU Joint Doctoral/Master’s Degree Programs Cover Sheet for Application” form. This form will provide for automatic approval by the secondary institution, after the proposal is approved by the primary institution.

For more information about the SDSU/UC San Diego Agreement for JDP/Master’s Degree IRB Review process, you can visit: https://newscenter.sdsu.edu/researchaffairs/sdsu-ucsd_jointreviewstudents.aspx.

How long will the IRB process take?

If you are using de-identified existing data, it is likely that you will be considered to be not involving human subjects, and approval will be very quick.  In any other circumstance, proposals will require review, and you should plan for a potentially lengthy process.  It is strongly recommended that you consult with your faculty mentor and the IRB office at your mentor’s institution to get a sense of the timeline required. If you are conducting research at the VA, this process will take much longer. Please plan accordingly.

IRB Approval must be obtained before data collection/analysis begins.

Where do I submit my IRB Proposal?

The Reviewing IRB is determined by the primary institutional affiliation of the faculty mentor responsible for oversight of the proposed research with one exception: the UC San Diego IRB will be the Reviewing IRB for all eligible studies that involve the UC San Diego MRI facility, Moore’s Cancer Center, and/or Rady Children’s Hospital. If the study does not involve actual imaging (e.g. it’s a retrospective data review), then the study does not need to be reviewed by the UC San Diego IRB unless that is where the primary faculty mentor for the research is located.

  • NOTE: In the rare instance that your primary JDP mentor is located at SDSU or UC San Diego, but for some reason the primary mentor for the research that you will be conducting for your Second Year Project or Dissertation is located at the other institution, your IRB proposal submission should start at the institution associated with the faculty member overseeing the research.

What if my research is conducted at the VA?

For students whose primary mentor for their research project is located at the VA, IRB approval must be first obtained through the VA. Please refer to the VA IRB Process section posted below.

SDSU IRB Process

How to Submit an IRB Proposal at SDSU

All IRB applications will be prepared and submitted using the SDSU vIRB web-based system. All students will be required to complete the “Joint Doctoral/Master’s Degree Programs Cover Sheet for Application” form unless the IRB determines that the project does not meet IRB criteria for involvement of human subjects.

There is a NEW SDSU IRB Website for the Human Research Protection Program (HRPP): https://newscenter.sdsu.edu/researchaffairs/hrpp.aspx. Some helpful resources for JDP students on this website are as follows:

Step 1: Create an Account

  • Located on the HRPP homepage, under “Start Here”, click on the new support page link: https://sdsuhrpp.freshdesk.com/support/home.
  • Click on the “New support ticket” option located to the right of the search box.
  • Complete the form fields and submit
  • You will receive your account information usually within 24 hours

NOTE: There are “walkthroughs” offered on this support website that you may find helpful including a “create a New IRB Record Submission” tutorial.

Step 2: Logon to your InfoEd Account to Create an IRB Request

  • Once you receive your account information, click on the InfoEd link located on the HRPP homepage, under “Start Here”: http://infoed.sdsu.edu/.
  • Enter your Username and Password
  • Under the Human Protocol option, select “Create New Protocol”
  • Once you’ve entered your study title and selected yourself as the PI, you will be taken to the main submission page for your study. Within the submission page, you will see the HRPP Initial Application. When you are ready to begin the application, you can open it by clicking on the title.
  • Answer the questions accordingly based on YOUR research project (i.e. Second Year Project or Dissertation). NOTE: It is recommended that you save your application often by selecting the Save feature at the top of your application. Once it has been saved, you can go back and change anything until you press complete.
    • Helpful hints/recommendations for some of the questions:
      • Q1: HS or NHSR? (Does your project use human subjects or is it non-human subject research)
        • You should always answer yes to this question since you are conducting research
      • Q2: Does your research involve living individuals through interaction with them or through an intervention?
      • Q3: Existing Data: Whether you will be working with existing data that has one or more of the 18 identifiers listed (the identifier are accessible via the website).
        • If you have a fully de-identified dataset provided by your mentor, with none of the 18 identifiers listed, and no way for you to link that dataset back to any identifiable information on the participants, then you answer NO to Q3.
        • NOTE:
          • If you answer “No” to Q2 and Q3, you will be directed to stop and submit your application at this point because based on your responses it will be automatically determined that you do not require IRB approval – you are, by federal definition, not conducting research involving human subjects. You will receive an email stating as such for your records. The “UC San Diego/SDSU Joint Doctoral/Master’s Degree Programs Cover Sheet for Application” does not apply here – you only need this email from SDSU; you do not need this determination from UC San Diego.
          • If you answer “No” to one question but “Yes” to the other, complete the remaining fields as directed.
          • If you are collecting your own data, you should answer “Yes” to both Q2 and Q3.

If you are determined to be involving human subjects in your research, you will need to submit a proposal.  Directions will be provided via the system; your proposal will be determined to be either considered as exempt, or to require expedited or full review.  Exempt means that, while you are involving human subjects in some way (for ex, you have identifiers available to you, but will strip them from your dataset before analysis), what you are doing is exempt from needing formal IRB review and approval.  If your study appears to present minimal risk, you will typically be considered under expedited review.  If your study appears to present more than minimal risk, you will typically be considered to require full review.

Below are tips that we have summarized for you based on IRB training provided by SDSU:

Study Personnel

  • You are not required to have an end date for your research project
  • Add your primary research mentor here

CITI Training Requirements

Is your study funded

  • You should read this as, “Is your second year project or dissertation funded.” This is NOT asking if the study your mentor has is funded. For example: If you have an NRSA (dissertation award), then you would answer “Yes” to this question.

Investigator Experience

  • Briefly describe your experience and how you are qualified to conduct this research project
  • Briefly describe your mentor’s experience with this research

Study Abstract

  • Be brief and to the point
  • Potential Benefits: Usually none (at least directly)
  • Risk Management:
    • Example response: The data is located behind a firewall on a password protected computer within a password protected document. The key code to access the document is stored separately.

Research Design & Methods

  • Procedures: This should be a bullet point list. It does not have to be written like a paper.

Primary Data Information

  • Source of data: Your research project mentor (as example)
  • How was permission obtained: Upload an authorization letter from the owner of the data (unless it is a publicly available dataset).
    • NOTE: Students should ALWAYS get this. Students should draft the letter for the data owner’s signature (typically your mentor, but may be a collaborator). The letter should state which specific data you are using and that the owner has granted you permission to use it for your specific research project.

Data Storage

  • How long will the database be stored: This is after the data analysis is complete (which should be at least 3 years).
  • How long will identifiers be stored with the data: Data identifiers should be deleted as soon as possible.
    • Example response: The identifiers will be removed as soon as I verify my data.

Step 3: Upload Supporting Documents

  • Some sections of the Initial Application will instruct you to upload documents. This can be done from the Submission page. To upload supporting documents for review, select the blue “Add” link next to the “Document/Form” header above the “HRPP Initial Application” form.
  • Some required documents may include:

Step 4: Complete & Submit Proposal to SDSU IRB

  • Once you have completed the IRB proposal and have uploaded all required documents, click the “Complete” feature at the top and submit.
  • Your IRB proposal will automatically route to your primary research mentor listed within your proposal for approval BEFORE it even goes to the SDSU IRB.
    • NOTE: If you have not heard from the SDSU IRB within 10 days of submitting your proposal, they probably never received it. Check with your research mentor to make sure they approved it.

Step 5: Close Your SDSU IRB

  • You must close out your IRB study once the research project has been completed/before graduating.

UC San Diego IRB Process

UC San Diego IRB has transferred to their new submission portal, Kuali IRB.

Please note that a major change to the UC San Diego IRB process is that students are no longer allowed to be the PI. However, students are allowed to submit their IRB application on behalf of the PI.

Step 1: Set Up a UC San Diego Kuali Account. Follow the instructions listed on the following website: Kuali IRB Access Requests – UC San Diego Students.

Note: For non-employee students, please contact the UC San Diego Graduate Coordinator to request a “Sponsored Affiliates” account and include the following information:

  1. First Name
  2. Last Name
  3. Email Address
  4. Request for: Sponsored Affiliates account with Business Systems SSO
  5. Justification for needing access to Kuali IRB (e.g., “I am a Student researcher / Student study contact for Dr. [insert PI’s name] and need to submit applications to the UCSD IRB Committees”)

More instructions and details to follow soon once the new UC San Diego IRB website goes live!

Last updated 4/15/2022