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 the VA are not allowed to be the PI. Please refer to the VA 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 UCSD 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 UCSD). 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 UCSD). 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 “UCSD/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/UCSD 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 UCSD IRB will be the Reviewing IRB for all eligible studies that involve the UCSD 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 UCSD 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 UCSD, 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 “UCSD/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 UCSD.
          • 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.

 

 

UCSD IRB Process

 

How to Submit an IRB Request at UCSD

All IRB submissions will be prepared and submitted using the UCSD web-based electronic submission process (instructions for submission can be found here). UCSD requires that the PI sign both the Joint Doctoral/Master’s Degree Programs Cover Sheet for Application and the Standard UCSD Application Face Sheet. In this case, the PI is the student as this should be an original project.

 

Step 1: Set Up a UCSD HRPP eIRB Services Account:

  • Contact the HRPP Office at 858-246-HRPP (858-246-4777) for a P-number.
  • Go to the UCSD HRPP website (https://irb.ucsd.edu/Home.FWx) and sign in using the “Sign in to HRPP” link in the upper right-hand corner of the page, following the instructions in the “Note about Registration” section (blue box).
  • Update your information, especially email address and phone number, in the “Edit your Contact Information and Preferences” section.

 

Step 2: Complete Required Trainings

 

Step 3: Determine What Data You Will Collect/Analyze

  • Will your data be obtained from an existing/ongoing study or collected from patient medical records?
  • Are the data pre-existing? Pre-existing means that the data are in place/on the shelf prior to the time you submit your application via eIRB services.
  • Are the data de-identified? De-identified means that there is no way to link the data back to an individual subject/patient. See the HIPAA Fact Sheet of De-identification (https://irb.ucsd.edu/HIPAA_deidentification_factsheet.pdf) to determine if your data will include any identifiers.
  • Are the data coded? Coded means that the data include a code (study ID) that can be used to link them back to subject/patient identifiable information. This is usually done by having the data saved with the study ID, and the study ID linked to the identifiable information (i.e. name, medical record number, date of birth, dates related to treatment) in a separate master code list.
  • How will you protect the confidentiality of the subjects and study data? See UCSD HRPP SOPPs 3.6 (https://irb.ucsd.edu/3.6.pdf) and 3.20, (https://irb.ucsd.edu/3.20.pdf) for detail on required measures.

 

Step 4: Review the SDSU/UCSD JDP/Master’s Degree IRB Review Fact Sheet

 

Step 5: Determine Which Application You Need

  • First, examine all of the links below then discuss the project with your advisor and, if necessary, contact the HRPP Office at 858-246-HRPP (858-246-4777):

 

Step 6: Complete Necessary Forms

  • Complete the appropriate forms listed below and save them locally, i.e. to your computer, then print out those needing signature(s):

 

Step 7: Questions?

  • If needed, contact the HRPP Office at 858-246-HRPP (858-246-4777) to answer any questions you may have or to schedule a One-on-One Advising Session (to go over particular issues/questions).

 

Step 8: Submit IRB Application

  • Submit your project (using the signed versions of required forms) following the instructions on the UCSD HRPP “How to” page (https://irb.ucsd.edu/How-To.shtml).

 

San Diego VA IRB Process

 

How to Submit an IRB Request at the San Diego VA

A trainee’s project may involve human, animal, and/or bench research. For human subject research, the study may involve identifiable or de-identified data as appropriate for the study. In all cases, the work must be conducted under a VA qualified principal investigator (PI) with sufficient experience in the area of interest of the trainee. The VA PI is responsible for ensuring all applicable local, VA, and other federal requirements are met including those related to research, privacy, and data security. The research application should identify that the study is to support the trainee’s thesis/dissertation and identify the school in which the individual is affiliated. If an educational mentor (non-VA employee) will have access to study data the arrangements for this (sharing, transportation, data type) must be described in the application and the individuals should be identified as consultants. All applicable VA research review committees (e.g. institutional review board, institutional animal care and use committee, subcommittee on research safety, research and development committee) must approve the research components. When the trainee leaves VA, the VA investigator is reasonable for ensuring that all research records are retained by the VA.

 

Step 1: Identify PI

  • Work with faculty advisor to identify a VA PI, and contact that individual to ensure they are willing to serve as the PI for the study.

 

Step 2: Obtain a WOC Packet

 

Step 3: Complete IRB Application

  • After the student’s WOC appointment is complete, access to OnRAMP, the VASDHS electronic protocol management system, can be requested.
  • Students should work with their VA PI to complete an IRB application.
  • Questions about the VA IRB process should be directed to Deborah Van Etten (Deborah.Vanetten@va.gov).

 

Step 4: Submit IRB Approval to UCSD

  • After VA IRB approval is completed, the student must then submit the approval notification to UCSD IRB with the UCSD/SDSU Joint Doctoral/Master’s Degree Programs Cover Sheet for Application (http://irb.ucsd.edu/JDP_IRB_Cover_Sheet.pdf) for IRB Application.