Request to Start a New Study

There are essentially three processes involved in submitting a new application for human subjects review. This page provides an overview and links to details of the process. Currently, all projects must have a Grants and Contracts Office GCO submission which requires:

  1. Conflict of interest disclosure in Sinai Central
  2. GCO forms completed on Proposal Development in InfoEd
  3. For the Human subjects submission, you will need to make a submission to the PPHS/IRB office.

Education requirements must be met by all members of research personnel prior to submission to the PPHS. These requirements are completed through CITIProgram.org and are outlined under the Training and Education tab.

All initial project submissions are now made through Ideate, including all initial exempt determination requests and requests to rely on an external Institutional Review Board (IRB). Modifications, continuations, new information, and final reports made for projects not approved through Ideate continue to be submitted to the PPHS via IRB@mssm.edu.

For submissions to IRB@mssm.edu, follow the submission checklist on the PPHS Documents and Forms Kiosk for additional information on requirements.

To submit an advertisement (flyer, web post, etc.), confirm that you already have IRB approval to use the specific recruitment method for which you are now submitting an ad. (Verify the mention of this recruitment method is present in the most recently IRB-approved protocol or new protocol template #5a), then submit electronically via e-mail to the PPHS office at IRB@mssm.edu as a Word document.

Complete HRP-213 Modification of Approved Research Section B, which should indicate that you are submitting an ad for approval, and attach the ad you want to use. If you need to update your protocol template to add a specific method of advertising as a recruitment method, attach the updated protocol template and identify this change in the HRP-213 Section B as well.

The HRP-224 Reportable New Information Form is used to submit new information to the IRB. Page 2 of this form indicates the information items that must be reported to the IRB. Use this form to determine if an information item is reportable to the IRB.

All information must be reported to the IRB within five business days of the date the PI became aware of the information. This form is to be used to report any information listed on page two of the form.

Only information that falls under the categories on page 2 must be reported to the IRB.

If any changes to the protocol or consent are required based on the information being reported, HRP-213 (Modification Form) must also be submitted.

If you believe your project may fit into a category for exemption from IRB review, review HRP-320-Worksheet: Exempt Determination. If your project seems to meet the criteria, submit your request for an exempt determination through IDEATE under "application type" select request for IRB exemption.  If your project involves surveys or other interactions with subjects, you will need to upload an "exempt research subject information sheet." A template can be found under "consent templates" on the PPHS Forms & Document Kiosk.