Forms and Documents

The following provides a checklist, tips, forms and template documents for PPHS:

E-Submission Checklist

  • HRP-430 Checklist—Investigator QI Assessment
    The HRP-430 Checklist covers what must be stored in the regulatory (study) binder, study records, PI responsibilities when holding an IND or IDE, and other requirements that must be met for each study.

HRP forms are not required for Ideate submissions.

This form accompanies changes to add personnel or to the Appendices. The Principal Investigator must sign the form. The Department Chair or designee must sign the attestation on modifications that include the addition of study personnel. If personnel are being added from multiple departments, the chairs of each department involved in the research must sign.

Below are standalone sections of Form HRP-211: These can be used if multiple of same sections of the Application for Human Research form are needed (e.g. multiple "drug/biologic" Appendix B):

Commercial IRB Waiver Forms

Requests to Rely on an External IRB are made through Ideate.mssm.edu. Please complete and upload (under the attachments tab in Ideate) the waiver form corresponding to the Commercial IRB you are requesting to use.

Click here to access a guide to the submission process.

All consent documents to be used by Mount Sinai need to include site specific template information. Please click here for the Site specific consent language required for our site.

When uploading consent documents that will be reviewed and approved by an external IRB, select type Other-Other IRB Correspondence.

For additional information, please review Our IRB, Commercial IRBs/BRANY and Other IRBs on the For Researchers page.

All applications submitted to IRB@mssm.edu for IRB review require a Protocol Template. Please refer to the Template Protocol with Instructions (HRP-503) in order to see what information the IRB needs in order to evaluate each section. You can use this for your Template and delete the instructions as you go or use this as a reference document and type directly into HRP-503a, which contains only section headings without detailed instructions.

The template you will use depends on how your submission will be made to the PPHS. Our electronic submission system, Ideate, is in use for all new submissions and requires use of the Ideate template versions below.

Ideate Consent Templates

Use with submissions you are submitting through IDEATE:

Content templates for projects not active in IDEATE

IRB Consent Templates

Use with submissions you are sending to IRB@mssm.edu (submissions not required to use Ideate):

For SOPS, Worksheets & Checklists IRB Uses to Make Determinations

Changes to Documents Made by the PPHS Office: