⚠️ WARNING This page needs updating
In the meantime please refer to the official IRB roadmap
Any potential projects, research or quality improvement, must be reviewed by the Research Chairs BEFORE starting.
Updated 12/31/2024
### ⚠️ OUTDATED DOCUMENTATION:
* IRB submission consists of 3 parallel processes that are routed through different online systems.
* Financial Conflict of Interest forms (SinaiCentral)
* Institutional Review Board (Ideate)
* Grants and Contracts Office (InfoEd)
* For help, contact irb@mssm.edu and CC the Research Chair and Research Coordinator
* Forms and other information can be found at PPHS
* A helpful powerpoint to help you determine whether your project will be exempt, human research, etc:
### OUTDATED DOCUMENTATION:
* Log into SinaiCentral with your regular Mount Sinai password.
* Click COI > Investigator Forms > New Investigator Form
* Fill in the form as appropriate, including the following values
* Affiliation: Icahn School of Medicine at Mount Sinai
* Principal Investigator: Yasmin Meah (or another faculty member with whom you are working)
* Proposal Type: New or Transfer
* Funding Agency: Internal
* Funding Agency Type: Internal
* Human Subjects: Yes, if applicable
* Add all Investigators including the PI, all co-investigators, and the Research Chair and Research Coordinator
* Click Save
* Remind all other investigators to complete their FCOI forms (they should receive an email link).
* All investigators will need to complete required trainings at CITI Program
### OUTDATED DOCUMENTATION:
- Use the HRP-320 worksheet to determine if your project can be categorized as Exempt. Otherwise, for most EHHOP projects, it will be Expedited. Exempt and Expedited are classifications that you will need to enter later into your application.
- Request a user account for yourself on Ideate. Select Open New Ticket, and Ideate / New User Request from the Help Topic menu.
- For all other personnel on the application, request that they be added as New Personnel to the Ideate system so that they can be selected from within InfoEd. Select Open New Ticket, and Ideate / New Personnel Request from the Help Topic menu.
- Go to Ideate and log into Ideate with your Ideate account.
- Click “Create New” and select “PPHS Protocol” (Program for Protection of Human Subjects)
- Choose to create a New protocol, enter a reasonable title, and select Dr. Meah (or another faculty member you are working with) as the Principal Investigator; click Begin Application.
- Under the Summary tab, fill in the Lay Summary (a brief explanation of the project for a lay person)
- Enter the IF number from SinaiCentral so that Ideate can import your FCOI information.
- Under the Setup sub-tab, state whether your project is funded and the application type
- If your project is Expedited, select “Request to Rely on Mount Sinai IRB” and describe the data and consent situation below.
- If your project is Exempt, select “Request for IRB Exemption”
- If you selected “Request to Rely on Mount Sinai IRB” complete the Objectives, Background and Primary and Secondary Study Endpoints in the Background tab.
- Under Research Personnel, make sure the PI, all co-investigators, and the Research Chair and Research Coordinator are included with appropriate permissions.
- Under Sites, select Icahn School of Medicine at Mount Sinai
- If present, fill in the Consent and Data tabs, which will vary depending on the decisions made earlier.
- When all tabs are complete, select Submit, I Agree, and Send to PI for Review.
### OUTDATED DOCUMENTATION:
- Request a user account for yourself on InfoEd. Go to Support, select Open New Ticket, and InfoEd / New User Request from the Help Topic menu.
- You will have to attend an InfoEd training
- For all other personnel on the application, request that they be added as New Personnel to the InfoEd system so that they can be selected from within InfoEd. Go to osticket.mssm.edu/support, select Open New Ticket, and InfoEd / New Personnel Request from the Help Topic menu.
- Go to eresearch.mssm.edu and log into InfoEd with your InfoEd account.
- Select “My Proposals” > “Create New Proposal”
- Step 0: Change PI to be Dr. Yasmin Meah (or another faculty member with whom you may be working)
- Step 1: Select “Create New Proposal” and “Setup Proposal Manually”
- Step 2: Select “New Proposal”
- Step 3: Select “Icahn School of Medicine” (under “Preferred”) as Sponsor
- Step 5: Enter the title of the proposal
- Step 6: Give reasonable start and end dates for the project
- Step 7: List number of years the project will take (default, based on previous step, is fine)
- Step 8: Setup Questions
- Submission Mechanism: “New (non-S2S, no budget)” (ignore warning)
- Will you be attaching a Cover Letter: No
- Will your proposal be a training grant: No
- Submission title: Can be the same as the previous project title
- Brief Lay Summary: upload a PDF describing your project to a layperson (can copy-paste from Ideate) and check “completed”
- Research or Program Plan: upload a PDF describing your research proposal (can copy-paste from Ideate) and check “completed”
- Personnel: Use “Personnel Wizard” to add all co-investigators, co-PI’s, and the Research Coordinator and Research Chair, and click “completed”
- Classification Codes: click “Manual” and select codes that apply (such as “Clinical Research (not a clinical trial)” or “Nutrition”. Check “completed”
- Internal Documents:
- add “Non-Compete Cont / Supplements / NCEs v1.6” and “New / Competitive Renewals / Resubs v1.6.2”
- complete the above forms by clicking the icons under “Open”
- check “completed” when done
- Finalize:
- Select “Build”
- Email PI (e.g. Dr. Meah) and ask them to finalize the proposal (provide proposal number and CC Research Chair and Research Coordinator)
Updated 9/2023
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