PPHS Form and Document Kiosk
Please always download the most current documents from this Website and avoid using versions stored on your computer. The date of the latest version of each will appear after the document title. If you do not see the latest version date in the footer of the document, make sure to clear your browser cache to avoid your browser reverting back to a previous version.
Investigator Manual HRP-103 (2/1/11)
This document contains information on Investigator Responsibilities and basic instructions for completing PPHS forms.
Investigator Information Sheet: Comparative Review [PDF]
Information sheet explaining when to use the Comparative Review Form
Frequently Asked Questions
If your question is not answered in the Investigator Manual, check out these additional questions.
PPHS Forms and Documents Version Revision History [PDF] (3/26/13)
HRP-430- Checklist - Investigator QI Assessment
This 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.
Exempt Determination Form (4/11/13)
HRP-211 Application for Human Research (10/19/12)
This form accompanies all new projects. The Principal Investigator must sign the form. The Department Chair or designee must sign the attestation on initial applications and 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: can be used if multiple of same sections of the Application for Human Research form are needed (e.g. multiple "drug/biologic" Appendix B's)
HRP-211a Standalone Appendix A (8/16/10)
HRP-211b Standalone Appendix B (10/19/12)
HRP-211c Standalone Appendix C (8/16/10)
HRP-211e Standalone Personnel Section
HRP-211h Standalone Chair Signoff Section (8/16/10)
HRP-214 Response to PPHS (2/1/11)
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-224 Reportable New Information (5/1/13)
HRP-229C Request to Utilize NCI CIRB
This form is ONLY for use by investigators conducting NCI Cooperative Group research that has been approved by NCI's Central IRB. Investigators must first be enrolled and have access to the Participants Area of the NCI CIRB website – contact the CCTO or the PPHS office to begin the process.
All applications need a protocol.This form provides a template for the information that is needed; this form may be used and refer to another document, such as a sponsor protocol. Please see the document with instructions for further information.
HRP-503 Template Protocol with Instructions [PDF] (7/20/12)
HRP-503a Template Protocol [PDF] (7/20/12)
Institutional Standard Operating Procedures (Selection)
PPHS Worksheets [Criteria IRB Uses to Make Determinations]
PPHS Checklists [Criteria IRB Uses to Make Determinations]
Program for the Protection of Human Subjects
For submissions and general inquiries send e-mail to: IRB@mssm.edu
345 East 102 Street
(between 1st and 2nd Avenues)
New York, NY 10029
Icahn School of Medicine
One Gustave L. Levy Place
New York, NY 10029-65749