The following provides a checklist, tips, forms and template documents for PPHS:
Forms and Documents
- 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.
- Investigator Information Sheet: Comparative Review
Information sheet explaining when to use the Comparative Review Form
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):
- HRP-212 Continuing/Final Review Progress Report (9/2/14)
- HRP-213 Modification of Approved Human Research (9/2/14)
- HRP-214 Response to PPHS (9/2/14)
- HRP-215 Comparative Review
Use this form in response to a “approved pending funding” letter from the IRB once the notice of award has been received or when adding a funding source (or changing a funding source) to an already approved project.
- HRP-221 Continuing/Final Review Progress Report for Humanitarian Use Device (HUD) (1/31/19)
- HRP-222 Modification of Approved Humanitarian Use Device (HUD) (1/31/19)
- HRP-223 Response to PPHS Required to Secure Approval of Humanitarian Use Device (HUD) (9/2/14)
- HRP-224 Reportable New Information (12/12/17)
- HRP-231 - FORM - International Research (5/1/5/19}
- HIPAA Forms
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 requried for our site.
When uploading consent documents that will be reviewed and approved by an external IRB, select type Other-Other IRB Correspondence.
- Quorum Coversheet
- WIRB Waiver of Jurisdiction
- Advarra Waiver of IRB Oversight
- Note: Advarra was formed through a merger of Schulman Associates and Chesapeake IRBs.
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
***The new consent template incorporates new elements of consent required under the Revised Common Rule, which goes into effect on January 21, 2019. All new projects must utilize the new template. The new template has been revised and reorganized, so please start from stratch with this document rather than trying to cut and paste whole sections from old templates.***
Additional template versions (additional translations) will be forthcoming. If you need a specific version, or a copy of the old template, please contact the IRB Office directly at firstname.lastname@example.org.
- ***HRP-502a MSHS Template for Adult Subjects (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502a MSHS Template for Adult Subjects - Elmhurst Hospital Center (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502a MSHS Template for Adult Subjects - Queens Hospital Center (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502b MSHS Template for Incapacitated Adults (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502c MSHS Template for Parental Permission (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502a MSHS Template for Adult Subjects - FOR USE WITH STANDALONE HIPAA AUTHORIZATION (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502e - MSHS Template for Adult Subjects - SPANISH (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502e MSHS Template for Adult Subjects - Elmhurst Hospital Center - SPANISH (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502e MSHS Template for Adult Subjects - Queens Hospital Center - SPANISH (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502e MSHS Template for Incapacitated Adults - SPANISH (Revised Common Rule edits, v. 1/16/19)
- ***HRP-502e MSHS Template for Parental Permission - SPANISH (Revised Common Rule edits, v. 1/16/19)
PROJECTS APPROVED PRIOR TO JANUARY 21, 2019 SHOULD NOT TRANSITION THE CONSENT FORMS TO THE NEW TEMPLATE. Because these projects were approved under the old rule and will continue to be reviewed under those regulations, they should remain on the old consent template.