At HHC, the approval process is more than just IRB approval. Your project will move through multiple layers of review to assure that it is ready to start and it will be successful.
Keep in mind that if there is a problem with your project submission at any point in this process, you will be notified and you may need to make the necessary corrections. Don’t be discouraged! We will be happy to provide guidance to be sure you know exactly what to do in order to move ahead swiftly.
Submission Review
The first stop is to make sure that everything that needs to be included with your application is there. This includes all required attachments, such as budgets and informed consent documents.
Scientific Review
Once you have submitted your application and attached all the study related materials, our senior scientists check to see if the design of your project is scientifically sound. If there are any issues or revisions needed to the protocol, the scientific reviewer will send you an e-mail to clarify these issues and return the submission to you for revision.
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Human Research Protection Program (HRPP)
The Human Research Protection Program (HRPP) office will receive your submission. An IRB administrator will conduct an in-depth pre-review of what has been submitted to ensure that everything has been completed clearly and thoroughly. At this time, the IRB/HRPP will determine what level of review the study requires. If there are any issues or concerns that are discovered during the pre-review, the IRB administrator will return the submission to you for correction.
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Institutional Review Board (IRB)
Expedited
If your study is determined to be no more than minimal risk to potential participants, then it will be assigned to a designated expedited reviewer for final review and approval. Once the designated expedited reviewer has approved the study, you will be sent an IRB approval letter as well as any stamped approved materials.
Full Board
If your study is deemed to be more than minimal risk to potential participants, your submission will be assigned to the next available agenda for review by the Full Board for review. The outcome of this meeting may result in one of the following:
- Your project being approved
- Your project being approved with revisions
- Your project being tabled for the next Full Review Board (for projects requiring more information or clarification)
If the IRB committee requests any revisions, you will then be sent a revision letter along with a request for responses to stipulations via iRIS. Once you have addressed the IRB requests, your project will be reviewed by the IRB Chair or the Full Committee. Once the IRB has approved the study, you will be sent an IRB approval letter as well as any stamped approved materials.
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Financial Review
The Grants and Contracts section of Research Administration is available to help with any financial questions you may have related to your research project.
Budget Review
Developing a budget is an important part of the proposal process, and your budget must conform to established federal, Hartford Hospital, and other sponsor requirements. An effective proposal budget outlines the proposed project in fiscal terms and helps reviewers to determine how the project will be conducted. Budget details usually reveal whether a proposed project has been carefully planned and may ultimately be feasible. We provide one-on-one assistance with budget development. Contacting us early and often will smooth the budget development process for you.
Contracts/Agreement Review
When funds for sponsored programs are awarded to Hartford Hospital via a contract (i.e., any contract or agreement), Grants and Contracts will coordinate the contract review and negotiation process. The purpose of contract review is to ensure that terms and conditions of the agreement are acceptable to Hartford Hospital and that sponsor requirements can be met. Contracts may only be signed by authorized officials of the Hospital. Grants and Contracts will coordinate this process.
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Final Approval
After this final step, you will receive a letter stating that you are ready to go ahead with your project. You cannot start your study until you receive this notification from Grants & Contracts.
For final approval, the project must have IRB/IACUC approval, budget and a fully signed agreement. Once documents are received, a grant ID will be assigned to the project and an award letter will be distributed to the PI.
UCONN Health Center (UCHC) Residents
If you are a UCHC resident, you will also need to submit to UCHC for approval.
Even though this research is taking place at Hartford Hospital, if you are a UCHC resident, your involvement engages UCHC in research and they need to be aware of the study. It is UCHC policy that before a UCHC employee, student, or agent can begin a research activity that engages another institution in research, either UCHC must have officially accepted another institution as the IRB of record and that institution has approved the study and agreed to be the IRB of record, or UCHC has agreed to serve as the IRB of record, granted approval for the study, and the other institution has accepted UCHC as the IRB of record.
To do this you will need to invoke the cooperative agreement between Hartford Hospital and UCHC. Hartford Hospital will serve as the IRB of Record for this study.