When you are done completing your study-related documents, i.e. detailed protocol, protocol summary, consent form, etc, initiate a submission using Insight/eIRB, and attach all documents in the Attachments section of the submission. See Insight/eIRB reference guides for more information. If you do not have access to Insight, contact the Insight Help Desk at 617-424-4175

Instructions and checklist for human research protocol submissions

New Protocol Submission Instructions and Checklist
4/09

Continuing Review Submission Instructions
3/09

FAQS and Troubleshooting Insight/eIRB
7/09

Insight/eIRB Submission Tips
5/09

PHS Insight/eIRB Important Reminders
03/09

• Adverse Events
• Amendments
  • Study Staff
  • Protocol
• Continuing Review
• Electronic Signature Inside Partners
• Electronic Signature Outside Partners
• New Protocol Submissions
• Other Events
• Responding to a review
• User Manual

Principal investigators and co-investigators must complete this form and submit to the IRB in conjunction with the a new protocol submission or study staff amendment 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 should be faxed (617-424-4199) separately to the PHRC, and for privacy, should NOT be attached in Insight/eIRB.

Investigator Disclosure Form
12/08

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

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

The forms below are only to be used when amending a protocol that was submitted prior to the implementation of eIRB. To amend the legacy protocol, initiate an amendment in eIRB and complete the appropriate form(s) from below and attach in the Attachments section of the eIRB submission and submit.

Children

Devices

• Ancillary Medical Device
• Medical Device

Drug/Biologic/Dietary Supplement

Individuals with Impaired Decision-making

Neonates of Uncertain Viability and Nonviable Neonates

Nursing Implementation and Planning

Pregnant Woman or Human Fetuses

Principal Investigator Certification

Principal Investigator and Dept/Unit Chief/Chair Certification

Radiation Exposure - Ionizing

Radiation Exposure- Non Ionizing

Site Responsible Investigator Certification

Wards of the State

External adverse events are those adverse events experienced by subjects enrolled at sites that are not relying on the PHRC for IRB review. These are typically sponsor safety reports. Investigators must report to the PHRC any adverse event described in a sponsor safety report that is unexpected and related or possibly related to participation in the research. For more information, refer to the PHRC Adverse Event Reporting Policy.

External Adverse Event Report
10/08

Form for reporting the emergency use of an investigational drug, device or procedure in a life-threatening situation. Refer to Emergency Use of Drugs or Biologics.

Emergency Use of
Drugs/Devices/Procedures
05/04

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)