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Submission Requirements

The Prisma Health IRB has created a Read-Me-First Document, as well as a Required Elements Guide – New Submission Tool to assist researchers in completing their IRB submissions.

These documents are also available in IRBNet. Below is an outline of various requirements that are helpful in addition to the Read-Me-First Document and the Required Elements Guide-New Submission Tool. There are additional submission resources specific to IRBNet located on our IRBNet Help page, including step-by-step instructions.  

IRBNet registration

The Prisma Health IRB utilizes an electronic submission process through IRBNet for all protocol submissions. All study related documents requiring review must be attached electronically to the protocol application. Each study team member will need to register on IRBNet at www.IRBNet.org.

The following required documentation should be uploaded into each study team member’s User Profile within IRBNet as applicable:

  • CITI training (everyone).
  • Signed and dated CV (Investigators).
  • Assurance Form (Investigator or Coordinator – whichever applicable).

Please see IRBNet Help for specific instructions on accessing IRBNet.

Protocol development

All researchers will be required to submit a protocol for an IRB review. For assistance drafting a protocol, templates are provided below. Depending on the study, elements of the protocol may or may not be required. Should the protocol require consenting participants, please review the Elements of Consent Disclosure guidance document for required elements.

Please note: If your project involves a data chart review that involves an EPIC data pull, you will need to submit your project to the Data Support Core prior to IRB submission. The DSC will provide you with a Data Clearance Letter that is a required attachment to your IRB submission.

Prospective Design Research Protocol Template
Retrospective Design Research Protocol Template 
Not sure which basic design to select? Click here for a descriptive overview

CITI training

All researchers (principal investigators, co-investigators, other research staff and students) involved in human subjects research must complete Human Subjects Protection CITI training before a requested study protocol is approved and/or before research is conducted.

For help with registering for CITI training, click here! 

For help linking your CITI account to your IRBNet account, click here! 

COI disclosure

All study personnel involved in human subjects research must comply with relevant institutional and regulatory criteria. This includes identifying and reporting any known or potential conflicts of interest. Institutional Review Board committee also must fulfill this requirement. NOTE: Prisma Health Team Members (including providers) will be assigned a Conflict of Interest module through Learning Hub that includes educational components and the completion of the Conflict of Interest Disclosure. 

Prisma Health Conflict of Interest Disclosure

AVC signature 

Each project must obtain Academic Vice Chair Approval prior to IRB Review. To obtain their signature, please grant the applicable AVC “read” access on your project and email them requesting a signature. Once they have signed your new study package, remove their access. The IRB can see the signature once obtained. You may locate the appropriate AVC for your departmental review on the Research Leadership webpage. 

IRB application

The IRB Application is required for each submission and can only be accessed on IRBNet. To access the application, navigate to the Designer page within your project. Select “Start a Wizard” and click on the Prisma Health IRB Application. Complete the questions as applicable to your project. Once complete, the application will generate a list of required attachments to your project that are required at the time of submission. This list can be accessed on the Form Complete page of the IRB application. See our IRBNet Help page for more assistance as needed. 

Ready to submit?

Please ensure your project is ready for review at the time of IRB submission by utilizing the above resources.  Submissions made to the Prisma Health IRB that are incomplete and have requested changes identified during the administrative pre-review process have 30 days to complete the changes requested. After 30 days, the submission will be deferred and will require a new package submission for review. If the project has not been resubmitted with the requested changes incorporated after 6 months, the project will be withdrawn. 

Subsequent package submissions

All subsequent package submissions (amendments, continuing reviews, status changes, reportable events, etc.) require a new package to be submitted for a project within IRBNet. The IRBNet number reflects the number of packages within a project via the number following the dash, for example [1234567-4] is the 4th package of study ID #1234567.

To submit subsequent packages for a project:

  • Navigate to the project within IRBNet from your "My projects" page. 
  • Click "Create New Package" within the left-hand side menu once inside the applicable project. 
  • Complete all required components of the package. Begin with the relevant Cover Sheet.
    • For amendments, be sure to include both tracked changes and clean versions of all documents being modified. 
  • Link any required trainings or obtain any additional signatures (see the Signing and Linking Submission Packages in IRBNet Guidance document on the Policies and Guidance page). 
  • Obtain PI signature.
  • Submit the package, being sure to select the most relevant package type and submit to the correct reviewing committee. 

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