• New Protocols
  • New Protocol Submission Instructions and Checklist
  • Oncology/Cancer Research Guidance on Responsible IRB (see Oncology Guidance)
  • Insight/eIRB New Protocol Quick Reference Guide
  • New Protocol Forms/Templates (for submission in eIRB on Attachments page)
    • Protocol Summary
    • Tissue or Sample Repository Protocol Summary
    • Data Repository Operating Policies and Procedures
    • Investigator Disclosure (see Financial Conflicts of Interest policy)
• Consent Forms
  • Consent Form Templates, Tools & Tips and Terminology
• Continuing Reviews
  • Continuing Review Submission Instructions
  • Insight/eIRB Continuing Review Quick Reference Guide
  • Continuing Review Reporting Forms (for submission in eIRB on Attachments page)
    • Minor Deviations Tracking Log
    • Adverse Event Log
• Amendments
  • Insight/eIRB Amendment Quick Reference Guide
• Study Staff Amendments
  • Insight/eIRB Study Staff Amendment Quick Reference Guide
• Adverse Events or Other Events
  • Insight/eIRB Adverse/Other Event Quick Reference Guide

The Principal Investigator, Site Responsible Investigators, Coinvestigators and any other member of the study staff responsible for the design, conduct, or reporting of the research (collectively ‘investigators’) must complete the Investigator Disclosure Form when the research involves ANY of the following: (1) for-profit sponsor or funding source; (2) a marketed drug, device, or other technology, or a drug, device, or other technology in development; or (3) a new technology, software or therapeutic approach. This form can be faxed (617-424-4199) to the PHRC, or attached in Insight/eIRB.

Questions about Conflict of Interest should be directed to Maria Sundquist, Assistant Director, IRB at msundquist@partners.org; 617-424-4101. For more information, refer to the Partners Human Research Committee policy on Financial Conflicts of Interest.

Investigator Disclosure Form
08/12

PROTOCOL SUMMARY

To be included with a PHRC submission unless noted otherwise in submission instructions. Summary document describes protocol and investigator's plan for recruitment and enrollment of subjects. Includes important regulatory information needed for IRB review. Refer to documents Prescreening and Recruitment Guidelines for acceptable methods of recruitment. Sample recruitment letters are available.

Protocol Summary
6/05

Tissue or Sample Repository Protocol Summary
12/05

Data Repository Operating Policies and Procedures
02/07

Instructions for investigators who are writing their own protocol for use when there is no sponsor initiated protocol or cooperative group protocol.

Detailed Protocol Instructions
3/02

To be included with a PHRC submission when the research involves multiple groups, treatment arms, or randomization.

Schema Instructions
3/98

Form for responding point-by-point to IRB concerns or questions. Once complete, attach the document in the Attachments section of the pending application in Insight/eIRB and re-submit. Learn more...

eIRB Response to Review
3/09

To be included with a PHRC submission ONLY when Co-Investigator/study staff do not have a Partners user name to sign electronically in eIRB. If non-BWH/non-MGH employees will perform institutionally designated research activities or exercise institutionally delegated authority or responsibility for research, please see the policy "Non-BWH/MGH Employees As Co-Investigators/Study Staff."

Co-Investigator/ Study Staff Certification
8/07

To be completed and attached in the Attachments section of an eIRB continuing review submission when subjects have been enrolled.

Enrollment Report

For Assistance with Submission Preparation (for help using eIRB, email the Insight Help Desk or Daniel Connor directly) and:

• Study Design
• Utilization of Research Study Coordinators
• Facility to Evaluate Patients, etc, contact:
  
  BWH Center for Clinical Investigation (CCI)
  MGH Clinical Research Program (CRP)