PPHS Form and Document Kiosk

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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)

Investigator Tips: Submission Process [PDF]

E-submission Checklist 

PPHS Submission Tips

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.

Forms

Exempt Determination Form (10/10/12)

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-212 Continuing/Final Review Progress Report (12/18/12)

HRP-213 Modification of Approved Human Research (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-220 Application for Humanitarian Use Device (HUD) (12/29/11)

HRP-221 Continuing/Final Review Progress Report for Humanitarian Use Device (HUD) (8/16/10)

HRP-222 Modification of Approved Humanitarian Use Device (HUD) (8/16/10)

HRP-223 Response to PPHS Required to Secure Approval of Humanitarian Use Device (HUD) (8/16/10)

HRP-224 Reportable New Information (2/1/11)

HRP-229A Request to Rely on an External IRB- Other than BRANY (9/28/11)

HRP-229B Request to Rely on an External IRB- BRANY ONLY (9/28/11)

HRP-229C Request to Utilize NCI CIRB
This form is ONLY for use by investigators conducting NCI Cooperative Group research at MSSM. 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.

HIPAA Forms

Protocol Templates

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)

Consent Templates

HRP-502a Consent/Authorization Template for Adult Subjects (3/26/13)

HRP-502b Consent (Permission)/Authorization Template for Incapacitated Adult Subjects (3/26/13)

HRP-502c Consent (Permission) for Child Subjects (3/26/13)

HRP-502d Standalone (No HIPAA) Consent Template for Adult Subjects (3/26/13)

HRP-502e Spanish Consent/Authorization Template for Adult Subjects (3/26/13)

HRP-502f Spanish Consent (Permission)/Authorization Template for Incapacitated Adult Subjects (3/26/13)

HRP-502g Spanish Consent (Permission)/Authorization Template Child Subjects (3/26/13)

HRP-502h Spanish Standalone (No HIPAA) Consent Template for Adult Subjects (3/26/13)

HRP-502x Consent to Volunteer in a Research Study (3/26/13)

HRP-507a Consent for HIV Testing in Research (2/1/11)

HRP-507b Spanish Consent for HIV Testing in Research (2/1/11)

Institutional Standard Operating Procedures (Selection)

HRP-001 - SOP - Definitions

HRP-012 - SOP - Observation of the Consent Process

HRP-013 - SOP - Legally Authorized Representatives, Children, and Guardians

HRP-023 - SOP - Emergency Use of a Test Article Review

HRP-090 - SOP - Informed Consent Process for Research

HRP-091 - SOP - Written Documentation of Consent

PPHS Worksheets [Criteria IRB Uses to Make Determinations]

HRP-307 - WORKSHEET - Scientific or Scholarly Review

HRP-309 - WORKSHEET - Human Research Determination

HRP-310 - WORKSHEET - Engagement Determination

HRP-311 - WORKSHEET - Criteria for Approval and Additional Considerations (7/2/12)

HRP-312 - WORKSHEET - Advertisements

HRP-313 - WORKSHEET - Payments

HRP-314 - WORKSHEET - Criteria for Approval and Additional Considerations for Humanitarian Use Device (HUD)

HRP-315 - WORKSHEET - Drugs

HRP-316 - WORKSHEET - Devices

HRP-317 - WORKSHEET - Emergency Use of a Test Article

HRP-318 - WORKSHEET - Short Form of Consent Documentation

HRP-321 - WORKSHEET - Contract Review

HRP-330 - WORKSHEET - FERPA Compliance

PPHS Checklists [Criteria IRB Uses to Make Determinations]

HRP-402 - CHECKLIST - Non-Committee Review

HRP-412 - CHECKLIST - Exemption Determination

HRP-413 - CHECKLIST - Eligibility for Review Using the Expedited Review Procedure

HRP-415 - CHECKLIST - Waiver of Alterations of the Consent Process

HRP-416 - CHECKLIST - Waiver of Written Documentation of the Consent Process

HRP-417 - CHECKLIST - Research Involving Prisoners

HRP-418 - CHECKLIST - Research Involving Pregnant Women

HRP-419 - CHECKLIST - Research Involving Non-Viable Neonates

HRP-420 - CHECKLIST - Research Involving Neonates of Uncertain viability

HRP-421 - CHECKLIST - Research Involving Children

HRP-422 - CHECKLIST - Research Involving Cognitively Impaired Adults (7/20/12)

HRP-423 - CHECKLIST - Non-Significant Risk Device

HRP-424 - CHECKLIST - Waiver of Consent Process for Planned Emergency Research