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. Additional help is always available at the IRB office by calling (508) 856-4261 or e-mailing IRB@umassmed.edu

Investigator’s Manual

Standard Operating Procedures

HRP-001 Definitions
HRP-013 Legally Authorized Representatives, Children and Guardians
HRP-021 Pre-Review
HRP-022 Modifications Required to Secure Approval
HRP-052 Post-Review
HRP-090 Informed Consent Process for Research
HRP-091 Written Documentation of Consent
HRP-101 Human Research Protection Program Plan
HRP-214 Reportable New Information

Checklists/Worksheets:

These documents provide support regarding determinations that must be made 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

Checklists

HPR-401 Pre-Review
HRP-402 Non-Committee Review
HRP-410 Waiver or Alteration of the Consent Process
HRP-411 Waiver of Written Documentation of the Consent Process
HRP-412 Research Involving Pregnant Women
HRP-413 Research Involving Non-Viable Neonates
HRP-414 Research Involving Neonates of Uncertain Viability
HRP-415 Research Involving Prisoners
HRP-416 Research Involving Children
HRP-417 Research involving Cognitively Impaired Adults
HRP-418 Non-Significant Risk Device
HRP-419 Waiver of the Consent Process for Emergency Research
HRP-441 HIPAA Waiver of Authorization

Worksheets

HRP-306 Drugs
HRP-307 Devices
HRP-308 Pre-Review
HRP-309 Reportable New Information
HRP-310 Human Research Determination
HRP-311 Engagement Determination
HRP-312 Exemption Determination
HRP-313 Eligibility for Review Using the Expedited Procedure
HRP-314 Criteria for Approval and Additional Considerations
HRP-315 Advertisements
HRP-316 Payments
HRP-317 Short Form of Consent Documentation
HRP-318 Additional Federal Agency Criteria
HRP-322 Emergency Use of a Test Article
HRP-323 Criteria for Approval and Additional Considerations HUD
HRP-330 HIPAA Authorization
HRP-331 FERPA Compliance