All proposed projects must be submitted to the IRB prior to beginning research activities. Completion of the IRBNet Prisma Health IRB Application will determine whether the project constitutes research involving human participants. Final determination about whether IRB review will be required rests with the Prisma Health IRB using criteria under federal regulations 45CFR46.102.
No, Not usually! The only time an amendment for an exempt project would be needed is if the protocol is changing in such a way that the risk determination no longer applies (it cannot be reviewed under one of the exempt categories). Your letter states:
Report significant modifications to the IRB in the form of an amendment if:
There is an increase in risk to participants;
There is additional activity or procedures that would not be eligible for exempt review; or,
There are significant changes altering the study design that present more than minimal risk.
Note! Adding additional staff to assist you in your project does not change the risk so amendments to add study team members are not needed and will be withdrawn. If you have a question about whether an amendment would be needed, please email your question to IRB@prismahealth.org.
Each individual who is engaged in research on a specific project should be listed on the IRB Application. If new study team members join after initial approval of a project, an amendment will need to be submitted to add new study staff. To do this:
Create a new amendment package with the project.
Edit the IRB Application by clicking the pencil icon to the right of the IRB Application. DO NOT create a new IRB application via start a wizard. Modify the original application.
Add new personnel to the IRB application via "add additional personnel".
Share the project with all new staff being added to the project via the "Share this Project" button.
Link the new staff's CITI training, CV, and Assurance forms as applicable via the "link trainings and credentials" button.
If the new staff is functioning as sub-investigators or clinical research coordinators, they will need to sign the amendment package via the "Sign this Package" button within their own individual IRBNet accounts. PI's cannot sign on behalf of sub-investigators.
Once all the above is complete, submit your package to the appropriate board. Amendments that are only study staff changes can be reviewed via expedited process.
Please Note: Amendments to remove study staff are not required. Please remove staff at the time of continuing review for non-exempt research projects. The IRB will withdraw amendments submitted only to remove study staff.
The Academic Vice Chair (AVC) is responsible for overseeing all research with their specific department. As such, each research project submitted at Prisma Health must receive AVC review and approval. This is accomplished by sharing all new research project with the departmental AVC, so that they may review the protocol and sign the package. Once the AVC has signed the package, please un-share the project with them. You may locate the appropriate AVC for your departmental review on the Research Leadership webpage.
Projects are submitted in IRBNet. The “Read Me First” document is a guidance for all new submissions in IRBNet. You can access this document within the Designer page of your new project submission, as well as in the Forms and Templates Library of IRBNet.
If you cannot login to IRBNet becuase you have forgotten your password, you will need to click on "Forgot Your Password?" and go through the steps as prompted. The password reset link will be sent to your secondary email address you entered upon registering for IRBNet.
The Prisma Health IRB office cannot provide much assistance to you in resetting your password. IRBNet is a web-based application and is not an interal Prisma Health System. If you have checked your secondary email address and still are not able to reset your password, please reach out to IRB@prismahealth.org to confirm your username within the IRBNet system.
If your project receives a “Not Research” determination, this means that the IRB has determined that your project does not meet the federal definition of Human Subjects Research. Quality improvement projects and case studies/reports are the most common types of “Not Research” submitted to the Prisma Health IRB.
For projects that are not considered research, no additional IRB oversight is required: meaning, no additional IRB submissions are needed, and you are good to begin your project!
This means that your project is "unlocked" and pending modifications requested by the IRB. During the review process, the IRB may unlock your package submission to allow you to make requested changed to your submission. Once you finish making the requested changes, you will need to lock back your submission by clicking "Mark Revisions Complete". Once you do this, the pad lock will turn green and it will be returned to the IRB office. The IRB will not review a project in a red, unlocked state. The project will need to be locked back to mark completion of the requested changes.
To request archived IRB documents, please complete the Request for Archived Documents form found on the Forms and Templates page and email it to IRB@Prismahealth.org.
If you are an affiliate to Prisma Health, you must register with an affiliation to Prisma Health, Greenville SC. Documents specific to Prisma Health will not appear if you do not affiliate with our institution. To add an affiliation:
Navigate to your User Profile
Select “Add an Additional Affiliation”
Select “Researcher at Prisma Health, Greenville SC"*
*Everyone conducting research at Prisma Health (Upstate and Midlands) should affiliate with Prisma Health, Greenville SC.
As long as you have completed the Biomedical Sciences CITI course that includes Human Subjects Protection, we are able to accept unexpired CITI certificates from other institutions. Please note, you will note be able to link your CITI acount in IRBNet unless the institutional email address in your CITI account is a prismahealth.org email address.
If you completed your CITI training at an external institution, please upload a copy of your completion certificate to your User Profile. Please input correct effective and expiration dates reflected on your certificate. Submit your certificate for review to the appropriate board.
For additional help on how to register for CITI training, please visit the Resources page for more information.
If you were registered with IRBNet through a different institution, but now are conducting research at Prisma Health - DO NOT register for a second account with IRBNet. Instead, login to your original IRBNet account and add the Prisma Health affiliation via the User Profile page, by clicking on the blue "Add an Additional Affiliation" link and then selecting Prisma Health, Greenville SC*. Then, self-deactivate any past affiliations by clicking the yellow "Deactivate" link next to the corresponding affiliation on the User Profile. Once this is done, you will have access to Prisma Health document libraries and can proceed with completing your User Profile set up by uploading relevant documents.
*Everyone conducting research at Prisma Health (Upstate and Midlands) should affiliate with Prisma Health, Greenville SC.
For a visual on when to link trainings and credentials, and to determine who needs to sign and when, please see the Signing and Linking submission package in IRBNet Guidance document on the Policies and Guidance page.
In order for a CV to be accepted and approved for use in IRBNet, it must have a written or verifed electronic signature and date. If your CV is unsigned or undated, it will be rejected. CVs are good for 3 years after the date of signature.
If your CITI was rejected, it is most likely that it was not Biomedical CITI training that includes Human Subjects Protection. The IRB does not need GCP, Information Security, CRC, etc. CITI trainings associated with your IRBNet User Profile.
There is no short cut around uploading required documentation into your User Profile (signed and dated CV, Biomedical CITI training, and an applicable assurance form). As required by Federal Regulations, the IRB uses the documents to verify investigator credentials to conduct research under review. BUT - you only have to upload your documents once! Once approved, you can "link" your trainings and credentials from your User Profile into every project you submit into IRBNet. Upload once, & use multiple times! Taking the time to set up each investigator's User Profile at the start makes it easier to make subsequent submissions to the Prisma Health IRB.
Each investigator conducting research at Prisma Health must complete CITI Human Subjects Protection Training. Your CITI training should be added to your User Profile in IRBNet.
If your CITI training has been completed through Prisma Health, please link your CITI account to IRBNet via the "External Accounts" button. This will allow your CITI trainings to automatically flow into IRBNet going foward.
If you completed your CITI training at an external institution, please upload a copy of your completion certificate to your User Profile. Please input correct effective and expiration dates reflected on your certificate. Submit your certificate for review to the appropriate board.
For help on how to register for CITI training, please visit the Resources page for more information.
Each project requires a protocol – including not human subjects research projects – be submitted in IRBNet.
The package must be complete with:
Protocol
CITI trainings linked for each study team member
Assurance forms complete for each investigator/CRC
Signatures of PI and each sub-investigator
Completion of the Prisma Health IRB Application
For more information and guidance, please see the Not Human Subjects guidance and the Case Report guidance on the Polices and Guidance page.
Every package submission in IRBNet, with the exception of a New Project, requires the completion of a "Cover Sheet." Cover Sheets collect information needed for IRB review of subsequent package submissions. Cover Sheets can be accessed within IRBNet Forms and Templates. Please choose the most relevant cover sheet (amendment, continuing review, status change, SAE, etc), complete it, and include it within your package submission.
Each submission undergoes administration pre-review prior to protocol review. Administrative pre-review confirms that the submission package is complete. Packages are considered complete when all required training and credientials have been linked, required signatures have been obtained, and all documents have been uploaded into the package. For a complete list of all items required upon submisson, check out the Required Elements Guide - New Project Submission Tool on the Policies & Guidance page.
Administrative changes are required to be completed within 60 days of initial submission, or the project will be processed as "requiring modifications" and a new package submission will be necessary.
YES! But you can't have two packages in progress (unsubmitted) at the same time. To submit two packages, you will need to complete and submit the first one, before you'll be able to "create new package" to create and submit the second. You can have multiple packages in a pending review status.
The Investigator Assurance (IA) form is required for each investigator conducting research at Prisma Health. It is an attestation to the knowledge of investigator responsibilities and an assurance of fulfilling those expectations.
To complete the IA form, simply download the form from Forms and Templates and complete the text boxes. Upload the completed form to your User Profile - this is done only once. There is no need to sign the IA form. Your signature is added electronically to each package and the form is assocated with each project/package by linking the form to the project and electronically "signing" the package. This signature is was activates the Investigator Assurance form for each project and must be done for each new project.
and pending modifications requested by the IRB. During the review process, the IRB may unlock your package submission to allow you to make requested changed to your submission. Once you finish making the requested changes, you will need to lock back your submission by clicking "Mark Revisions Complete". Once you do this, the pad lock will turn green 
and it will be returned to the IRB office. The IRB will not review a project in a red, unlocked state. The project will need to be locked back to mark completion of the requested changes.