The typical sequence of an Institutional Review Board (IRB) research proposal review:
- The Principal Investigator (PI) reviews the IRB website, including reading the IRB manual and reviewing the materials for submitting a proposal to eProtocol (software platform for the automated submission and review of IRB proposals).
- Any individual acting as a researcher in the project must complete CITI training and show evidence of CITI training on the protection of human subjects in research when any proposal is submitted.
- Beginning February 1, 2022, all proposals will be submitted using eProtocol (see below).
- The IRB Chair receives the proposal, verifies completeness, and determines the level of IRB review required.
- Proposals requiring expedited or exempt status are reviewed on a rolling basis, as submitted.
- Proposals requiring full committee review will be reviewed during the monthly IRB meeting (submissions must be received at least 2 weeks prior to the meeting in which they are reviewed).
- After review, the IRB Chair will provide the PI with an approval letter or a list of requests for clarification or modification, if necessary.
- Following approval, research that spans longer than one year (approval to publication) may require annual review and completion of an Extension Request Form for continuation.
- Upon completion of the research (completion of analysis of identifiable data), the Closure Request Form should be submitted, indicating that the research is complete.
UHART’s IRB proposal submission and review software must be used for all submissions of NEW IRB proposals beginning 02/01/2022.
- The PI will access eProtocol using his, her, their University of Hartford email credentials. First time users will need to enable pop-ups. If you are unable to login, please email email@example.com
- Preferred Browser for Windows: Firefox or Chrome
- Preferred Browser for Mac: Safari or Chrome
Creating the Proposal
- Once logged in, click Create Protocol in the upper right to begin a new IRB Proposal electronic submittal form. The PI will enter the Title of the Proposal and complete the required Principal Investigator information and then click Create. Once this initial step is completed, the Proposal will be assigned a protocol ID and appear in your dashboard upon login. Once created, you may view and/or edit this during the preparation of your proposal at any time by clicking on the Protocol ID from your dashboard.
- Next, the PI will provide the date of completed CITI Training (you will be required to upload your certificate later in form), identify any other investigators/researchers and provide date of competed CITI training. If the PI is a student, Faculty Advisor information is required.
- Use the search icon to locate the name of your faculty advisor.
- The faculty advisor is required to sign off on the proposal, enter the required Citi Training information, and upload a current certificate prior to the submission of your proposal. It is the student’s responsibility to notify the faculty member to review the proposal and complete the aforementioned when the proposal is completed.
- The PI will then complete the Subject Checklist indicating the subjects that will be sought for participation in the research, identify the study location, indicate the reason for your study, and share funding information (if applicable).
Faculty Advisor Steps to Approve a Protocol: Login into eProtocol, click on the Protocol ID
- Scroll down to enter the date of your Citi Training, then click on Obligations on the left main menu. Click on the available check box for faculty advisor approval (this should be done only after you have reviewed the full proposal).
- Then, click on Protocol Information on the left menu and select attachments from the top of left menus. You will attach your valid CITI certificate here.
- Once you have completed the approval, the student will need to log back in to submit the completed protocol.
Entering the Protocol Information
- Then identify the type of application (Exempt, Expedited or Full Board-criteria for each can be found by clicking the help button in the top right corner). Once you identify the type of application, you will further identify where within the aforementioned your study falls.
- The form will populate with the information you need to complete based on your application type. You will be asked to write out the Summary, Purpose and Procedures for your research. Background information (summarized literature review and additional subject information will be collected).
- The PI will describe the Recruitment Process as well as the Risk and Benefits associated with the research.
- The PI will then address procedures to maintain confidentiality, consent/assent information, as well as any HIPPA, use of drugs or devices, and conflict of interests.
- Last, the PI will be required to upload all necessary attachments (including but not limited to: recruitment advertisements, assent and/or consent forms, CITI training certificate/s, surveys, questionnaires, etc.)
Once your proposal is complete, you will submit it for review by the IRB.
Supporting Documents for Preparing your Proposal Submission
- IRB Manual for Researchers
- Consent for Participation in a Research Study
- Parental Permission Form for Participation in a Research Study
- Parental Notification Form Regarding Participation in a Research
For all research and studies approved prior to 01/31/22, the following forms will be used to maintain compliance with IRB policies and procedures:
All inquiries and questions about the IRB research review process should be directed to firstname.lastname@example.org or 860.768.5365.