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) (9/2/14)
- HRP-222 Modification of Approved Humanitarian Use Device (HUD) (9/2/14)
- 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)
- 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
Use with submissions you are submitting through IDEATE:
- IDEATE HRP-502a MSHS Template Consent for Adult Subjects
- IDEATE HRP-502a NYC Health + Hospitals/Elmhurst Consent Adult
- IDEATE HRP-502a NYC Health + Hospitals/Queens Consent Adult
- IDEATE HRP-502b MSHS Template Consent for Incapacitated Adult
- IDEATE HRP-502c MSHS Template Consent for Child Subjects
- IDEATE HRP-502e MSHS Template Consent Adult Spanish
- IDEATE HRP-502e NYC Health + Hospitals/Elmhurst Consent Adult Spanish
- IDEATE HRP-502e NYC Health + Hospitals/Queens Consent Adult Spanish
- IDEATE HRP-502f MSHS Template Consent Incapacitated Adult Spanish
- IDEATE HRP-502g MSHS Template Consent Child Spanish
- IDEATE HRP-502d MSHS Template Consent No HIPAA for Adult Subjects (stand alone)
- IDEATE HRP-507a-HIV Consent
- IDEATE HRP-507b-HIV Consent Spanish
- Exempt Research Subject Information Sheet
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):
- HRP-502a Consent/Authorization Template for Adult Subjects (1/20/16)
- HRP-502a NYC Health + Hospitals/Queens Consent/Authorization Template for Adults Subjects (4/1/17)
- HRP-502e NYC Health + Hospitals/QUEENS Spanish Consent/Authorization Template for Adult Subject (4/1/17)
- HRP-502a NYC Health + Hospitals/ELMHURST Consent/Authorization Template for Adults Subjects (4/1/17)
- HRP-502e NYC Health + Hospitals/ELMHURST Spanish Consent/Authorization Template for Adult Subject (4/1/17)
- HRP-502b Consent /Authorization Template for Incapacitated Adult Subjects (1/20/16/)
- HRP-502c Consent (Permission) for Child Subjects (1/20/16)
- HRP-502d Standalone (No HIPAA) Consent Template for Adult Subjects (1/20/16)
- HRP-502e Spanish Consent/Authorization Template for Adult Subjects (1/20/16)
- HRP-502f Spanish Consent (Permission)/Authorization Template for Incapacitated Adult Subjects (1/20/16)
- HRP-502g Spanish Consent (Permission)/Authorization Template Child Subjects (1/20/16)