IRB Submission Forms and Accessing PACS

PACS is the human subjects research database. This system allows users to submit and manage their research studies. Use PACS to submit studies for initial review, modifications, continuing reviews, study closures, and more.

If you are already registered in PACS: Click the PACS button above to login with your ºÚÁÏÊÓƵ UserID and password.

If you need to register for a PACS account: Please click  to Request an Account. When registering please enter IRB in the "Reason for Request" field.

NOTE: This is only a request for an account. The request requires processing before you can access PACS. Your request  will be processed within 24 hours Monday through Friday from 8:00 a.m. to 5:00 p.m. If you cannot after 24 hours, please contact the IRB Office. 

IRB SUBMISSION FORMS (Updated May 2023)

If you are not sure if you are conducting human subjects research, please use  to assist you and/or contact the IRB directly.

NOTE: Do not create a PACS submission until ALL required documents are complete and ready for upload.  We require a Recruitment Script (the email, flyer,etc., you intend to use to solicit participation), as well as supporting documents such as a copy of a survey, interivew questions, etc.  If you are a student you must also submit a completed/signed Faculty Statement.  Ensure that you are uploading documents in the designated areas of your PACS submission.  

For all studies (excluding secondary data analysis), the following templates are required in your PACS submission:

NOTE: If participants are under 18, or cognitively impaired, you must secure the consent of parents and the assent of children/cognitively impaired.

 Supporting Documents:

  •   (required if Principal Investigator is a student).
  •  (if conducting research at or in collaboration with an institution/agency/organization or in a classroom).
  • Any participant recruitment materials (e.g., email, verbal script, flyer, social media post).
  • Any data collection materials and stimuli (e.g., survey, interview questions, stimuli/videos/images).
  •  (for studies that involve deception of participants).
  • (if applicable).
  •  (if applicable).
  • MRI Safety Screening Checklist
  • Any other documents relevant to your research.

For Secondary Data Analysis (analysis of existing data) you must include the following document in your PACS submission:

The IRB Office Oversees the Following Categories of Research

Exempt
Research deemed ‘no greater than minimal risk’ and falls under one or more of the . Reviewed by the Administrative Coordinator, Michele Lukovich.

Exempt research: You will receive a response within 2-3 business days after the submission of your initial IRB application and 1-2 business days from receipt of any subsequent requests for revisions and/or documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.

Expedited
Research deemed ‘no greater than minimal risk’ and falls under one of more of the . Reviewed by IRB Associate Director, Marissa Barbieri and select IRB members.

Expedited research: You will receive a response within 2-5 business days after the submission of your initial IRB application and 2-3 business days from receipt of any subsequent requests for revisions and/or documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.

Full Board
Research deemed ‘greater than minimal risk’. Reviewed by convened meeting of voting members of the IRB.

Upon initial review of a study submission in PACS, the IRB Office may determine that a full board review is necessary if the research appears to pose elevated risk beyond that which is considered, 'minimal' (i.e., risk beyond what one may   experience in daily life).  If that is the case, the IRB Office will determine an appropriate date for a convened meeting of the full board to review the research, and will also reach out to the Principal Investigator with the information necessary to prepare their research, and themselves, for such a review.  Researchers who believe their study may require full board review are encouraged to reach out to the IRB Office for assistance and clarification, as needed.

Additional Information 

Study Closures

If your research is at a stage where you are analyzing only de-identified data, your project qualifies for closure.  You can close out your study by accessing your PACS submission and selecting 'Modification/CR'.  From there you will select the 'Continuing Review' option, answer the enrollment questions to the best of your ability, and under 'Research Milestones' select at least the first 4 options, or your study will not be closed. 

Education/Training Requirements
All study team members must first complete the appropriate . No initial approvals, modifications, or continuing reviews will be given until all study team members have current CITI certification. More information on the educational requirements can be found here.

If your previously approved study does not exist in PACS yet:
Once logged in, select "Create New Study." In the "Brief Description" area, enter your study protocol number and the date it was initially approved. Upload those documents currently in use (i.e., Informed Consent, Recruitment Materials, Surveys, etc.) where prompted. You do not need to complete a new Protocol narrative. The IRB will approve the study within PACS, which will give you access to submit Modifications/Continuing Reviews.