Tackling the IRB

So you’ve made it past your quals…congrats! Now you should prepare your IRB application. Here are the forms and steps that you’ll need to follow.

Step 1: CITI Training

Register for a CITI Program account and complete (and successfully pass!) human subjects training:

Collaborative Institutional Training Initiative (CITI) Program

Step 2: Carefully read the Investigator Manual:

http://research.ucdavis.edu/wp-content/uploads/HRP-103-INVESTIGATOR-MANUAL.pdf

Step 3: Prepare your IRB Protocol

Follow the IRBNet Registration Instructions:

http://research.ucdavis.edu/policiescompliance/irb-admin/researchers/irbnet/

Pay careful attention to the sections “Registration” and “Linking CITI Credentials to IRBNet Account”

Prepare your IRB forms. The IRB forms that you will need to include will vary and depend on the type of data you are collecting. See “Sample New Project Submissions and Required Documents”

http://research.ucdavis.edu/policiescompliance/irb-admin/researchers/how-to-submit/initial-review/

  • Survey/Interviews/Focus Group Review
  • Retrospective Record/Data/Specimen Review: (Record/Data/Specimen existing at time of initial IRB submission)
  • Prospective Record/Data/Specimen Review: (Record/Data/Specimen not existing at time of IRB submission)

**Note: Expect comments and requests for additional information and clarification!

**Important guidance on additional documents that you should include:

  1. Letter(s) of support (Permission to Conduct Research) from the sites that you’ll be using
  2. Quantitative studies of existing data: list of variables
  3. If you are using de-identified data, indicate on HRP 226 that informed consent is not applicable

UC Davis School of Education Internal Four Step Process:

  1. The Principal Investigator (PI) completes the IRB application on the IRBNet website and uploads any other required forms (Application, HRP-503, HRP-226 at a minimum).
  2. The PI gives “FULL” access to your advisor and the Associate Dean of the SOE for signatures.
  3. You need to ensure the accuracy of the substantive content of your protocol. You should speak with your advisor if you have questions about the details of your IRB protocol.
  4. The PI is responsible for then submitting the application via the IRBNet system and retaining all IRB research materials during and after the study (see link for guide on closing out study http://research.ucdavis.edu/wp-content/uploads/HRP-103-INVESTIGATOR-MANU…)