Not in use_Policies and Standard Operating Procedures
Guidance and instructions regarding the policies and procedures related to conduct of human subjects research that are specific to this Institution are contained within the Investigator’s Manual. It is important that all Investigators and professional staff read this manual thoroughly and make sure that study personnel are familiar with it. This manual describes procedures ranging from how to submit research to the IRB to the Principal Investigator’s responsibilities following IRB approval. It references the policies and procedures on this page and the Investigator Guidance page. Additional help is always available at the IRB office by calling (508) 856-4261 or e-mailing IRB@umassmed.edu
Policies
- HRP-001 POLICY: Definitions
- HRP-003 POLICY: Designations - Doc-003 POLICY: Designations UMass
- HRP-010 POLICY: Human Research Protection Program
- HRP-021 POLICY: Legally Authorized Representatives, Children, and Guardians
Standard Operating Procedures
- HRP-101 SOP: Pre-Review
- HRP-111 SOP: Post Review
- HRP-112 SOP: New Information
- HRP-122 SOP: Undue Influence of the HRPP
- HRP-142 SOP: Human Research Protection Program Quality Assurance/Quality Improvement Program
- HRP-180 SOP: Emergency and Compassionate Uses
- HRP-190 SOP: Investigations
Checklists and Worksheets
These documents provide support regarding determinations that the IRB must make before a project may be approved. These documents may be used as additional guidance in preparing your submission to the IRB. Not all checklists/worksheets apply to all research. You may use, as a guide, those which are applicable to your research. Additional help is always available at the IRB office by calling (508) 856-4261 or e-mailing IRB@umassmed.edu
Please Note: The following Checklists and Worksheets are form fillable, and are compatible with the most up-to-date version of Adobe Reader. Should you experience trouble opening a PDF in your internet browser, please download the document (we recommend saving it to your desktop), and try opening it with Adobe Reader from the saved location on your computer. Should you experience further difficulty, please contact the IRB office for assistance.
Checklists
- HRP-300 CHECKLIST: Waiver of Consent HHS
- HRP-301 CHECKLIST: Waiver of Consent Emergency Research
- HRP-302 CHECKLIST: Waiver of Consent Leftover Specimens
- HRP-303 CHECKLIST: Waiver of Documentation of Consent
- HRP-305 CHECKLIST: Pregnant Women
- HRP-306 CHECKLIST: Neonates of Uncertain Viability
- HRP-307 CHECKLIST: Nonviable Neonates
- HRP-308 CHECKLIST: Prisoners
- HRP-309 CHECKLIST: Unexpected Incarceration
- HRP-310 CHECKLIST: Children
- HRP-311 CHECKLIST: Wards
- HRP-313 CHECKLIST: Non-Significant Risk Device
- HRP-320 CHECKLIST: HIPAA Waiver of Authorization
Worksheets
- HRP-400 WORKSHEET: Criteria for Approval
- HRP-402 WORKSHEET: Advertisements
- HRP-403 WORKSHEET: Payments
- HRP-404 WORKSHEET: Short Form
- HRP-411 WORKSHEET: New Information
- HRP-414 WORKSHEET: Adults Lacking Capacity
- HRP-420 WORKSHEET: Pre-Review
- HRP-421 WORKSHEET: Human Research
- HRP-422 WORKSHEET: Engagement
- HRP-423 WORKSHEET: Exemptions
- HRP-424 WORKSHEET: Expedited Review
- HRP-425 WORKSHEET: Drugs
- HRP-426 WORKSHEET: Devices
- HRP-427 WORKSHEET: HIPAA Authorization
- HRP-450 WORKSHEET: Criteria for Approval HUD
- HRP-451 WORKSHEET: Emergency Use Drugs and Biologics
- HRP-452 WORKSHEET: Emergency Use Devices
- HRP-453 WORKSHEET: Compassionate Use Devices