students

SBER IRB Worksheets & Checklists

Manuals, Checklists and Standard Operating Procedures for SBER IRB.

IRB Investigator Manual

The IRB Investigator Manual is designed to guide you through policies and procedures related to the conduct of Human Research that are specific to this institution and the Tufts SBER IRB.

HRP-103 – Investigator Manual
PDF

IRB Review Checklists

These checklists can help you in developing your protocol and IRB applications to ensure compliance with the regulations:

HRP-410 – CHECKLIST – Waiver or Alteration of Consent Process
DOC
HRP-411 – CHECKLIST – Waiver of Written Documentation of Consent
DOC
HRP-412 – CHECKLIST – Pregnant Women
DOC
HRP-413 – CHECKLIST – Non-Viable Neonates
DOC
HRP-414 – CHECKLIST – Neonates of Uncertain Viability
DOC
HRP-415 – CHECKLIST – Prisoners
DOC
HRP-416 – CHECKLIST – Children
DOC
HRP-417 – CHECKLIST – Cognitively Impaired Adults
DOC
HRP-418 – CHECKLIST – Non-Significant Risk Device
DOC

Standard Procedures

These documents can help you develop your procedures for obtaining consent from your participants.

HRP-090 – SOP – Informed Consent Process for Research
PDF
HRP-091 – SOP – Written Documentation of Consent
PDF
HRP-013 – SOP – Legally Authorized Representatives, Children, and Guardians
PDF