Step 3: How to Submit
Those wishing to conduct human subjects research must submit materials to the IRB for review and approval or determination prior to beginning human research, including recruitment of subjects. Submissions to the IRB are made through the online application system, CATS IRB. This Step will explain in more detail how to complete your submission.
CATS IRB Library
CATS IRB is the web-based application system that Penn State researchers use to create submissions for the use of human participants in research. CATS IRB is where you can access all the information about your submissions as well as the CATS IRB Library. The CATS IRB Library is a series of Standard Operating Procedures (SOPs), worksheets, checklists, and templates, which investigators will need to use or reference to create materials for submission to the IRB. The IRB also uses many of these same documents during their review of submissions. Access the Library by first logging in to CATS IRB; the link to the Library is on the Sidebar Menu on the left side of the screen.
All CATS IRB-related resources are consolidated in the Help Center in CATS IRB. Here you’ll find information on applicable Penn State policies related to human research, the Investigator Manual, the Study Submission Guide, a Quick Start Overview, video tutorials, and more. You can navigate to the Help Center from the sidebar menu in CATS IRB, which is shown below.
Components of an IRB Submission
You must have IRB approval or determination before conducting human research, but you will need to have a plan for your research before submitting to the IRB. You will explain your planned activities in your materials submitted to the IRB.
Components of a submission:
- Study Submission Form: This is the online form you complete within CATS IRB. Through this form, you’ll upload all required documents described below. Access this form in CATS IRB by clicking “Create a New Study.”
- Study Protocol: The central component of your submission to the IRB is the study protocol; this document is a Word document template that you complete to describe your proposed research activities, in detail, to the IRB. Start by downloading the appropriate study protocol template from the CATS IRB Library. The study protocol template you need to use will depend on your research—see the Investigator Manual to determine which study protocol template you should complete. You will upload the study protocol template with your submission to the IRB. You’ll upload the completed study protocol in the online Study Submission Form on the Basic Information Page. Review the following video to learn more about completing the IRB protocol and the more difficult questions.
- Study Team Member Qualifications: Use the Study Team Member Qualifications document template (available in the CATS IRB Library) to describe the role and qualifications of each study team member listed in the Study Submission Form, including education/training, experience conducting assigned procedures, etc.). You’ll upload the completed form in the online Study Submission Form on the Study Team Members page.
- Informed Consent Forms: If applicable, use available templates from the CATS IRB Library to create consent forms; see the Investigator Manual for further guidance related to informed consent. You’ll upload the informed consent form(s) in the online Study Submission Form- Consent Forms and Recruitment Materials Page.
- Grant application: If your research is externally funded, you will need to include any grant application/proposal. You’ll upload the material(s) in the online Study Submission Form on the Funding Sources page.
- Recruitment materials: If prospectively recruiting participants, all recruitment materials, including ads, handouts, scripts, etc., may need to be submitted to the IRB; see the Investigator Manual for further guidance related to recruitment. You’ll upload the recruitment material(s) in the online Study Submission Form on the Consent Forms and Recruitment Materials Page.
- Other supporting documents: As applicable, upload all data collection instruments, including but not limited to screening documents, interview questions, video/audio/written stimuli to be viewed by participants, questionnaires/surveys, etc. Depending on the study, additional documents may be needed to support your IRB submission. You’ll upload the supporting material(s) in the online Study Submission Form on the Supporting Documents Page.
Completing Your Submission
The preliminary work of submission to the IRB is completing all required templates and creating or gathering other necessary documents, as discussed above. Once you’ve collected your materials and completed your templates, you’ll need to fill out the Study Submission Form in CATS IRB. It’s in the Study Submission Form that you’ll upload the study protocol and other materials.
To access the online Study Submission Form, click on “Create a New Study” from “My Inbox” in CATS IRB. After the online Study Submission Form is complete, the “Submit” action must be initiated by the Principal Investigator (PI) or assigned PI Proxy. Note that “Finish” and “Submit” are two separate activities in CATS IRB, and that both actions must be taken to officially submit to the IRB.
For more on completing the online Study Submission Form, see the Study Submission Guide in the Help Center in CATS IRB.
Depending on your research, your activities may require additional internal and external approvals prior to provision of an IRB approval or determination. Others are to be obtained prior to the conduct of human research, but are not required to be provided at the time of IRB review. See “What other approvals are required before initiating research?” in the Investigator Manual for more information.
If you would like to have a study reviewed by an external IRB, you must still submit a request and supporting materials to Penn State’s IRB for review and determination. Please see the Investigator Manual for conditions under which our IRB will rely on an external IRB and contact our office before submitting in CATS IRB to help prepare your submission for success: firstname.lastname@example.org.