IRB Policy Information Sheets

Blood Draws from Healthy Volunteers for Use in Research
Deviation/Violation/Exception Reporting Policy
DFCI IRB Adverse Event Reporting Policy
DFCI IRB Policy on Receipt and Review of IND/IDE Safety Reports
DFCI IRB Two-Year Continuing Review for Qualifying Non-Federally Funded Minimal Risk Studies *NEW
Guidance on Protocol Related Care for Study Subjects at a Non-DF/HCC Facility
Partners Recruitment of Subjects Policy
Requirements to Involve Prisoners as Participants in Research
Single Patient IND and Emergency Use of a Test Article

Consent Form Guidance

General Requirements for Informed Consent
Common Language for Risks and Events
    -  Common Language for Risks and Events Database
Guidance Document: Consent Form for Continued Participation for Young Adults Who Have Reached Age 18 *REVISED
Instructions for Obtaining & Documenting Informed Consent of Non-English Speaking Subjects *REVISED
Legally Authorized Representatives
Procedures for Monitoring Consent Process

OHRS Forms and Submission Guidance

Determining if Project Is Human Subject Research
Guidance on Implementing Dose Escalation Changes in Phase 1 Approved Research  *NEW
Guidance on Completing the Protocol Front Sheet *REVISED
Guidance on Completing Endorsement Forms *REVISED
Guidance on Alert Pages *REVISED
Adverse Event Ranking Scale
Guidelines For Writing A Social/Behavioral Science Research Protocol
Guidelines For Writing A Minimal Risk Research Protocol
Instructions on the Collection and Sharing of Data and Tissue Specimens
Linked and Anonymous Specimens

Law and Regulation Information Sheets

Expedited and Exempt Categories
Additional Protections for Children
How to Contact the FDA
Advertising Information about Clinical Trials
FDA Medical Devices Information
The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
HIPAA Research Guidance Document
Massachusetts Law on Insurance Coverage for Clinical Trials

Miscellaneous OHRS Information Sheets

Overview of the Operations of the DFCI Institutional Review Boards
Common Issues Holding Up Protocol Reviews
Guidelines for Sharing of Protocols
Microsoft Word Tips and Tricks

 

 

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  • Office for Human Research Studies (OHRS)
    • Contacts
    • Information for Sponsors
    • Submitting A New Protocol
    • Single Patient IND/Emergency Use of a Test Article
    • Consent Documents
    • After Activation Forms
    • HIPAA
    • OHRS Information Sheets
    • External Regulatory Guidance
    • OHRS News Updates
    • Oncology Protocol System and OHRS Submit
    • Presentation and Training Materials
    • Partners Policy and Guidance Links
  • Quality Assurance Office for Clinical Trials (QACT)
  • Clinical Investigations Leadership Committee (CLC)
  • Clinical Trials Education Office (CTEO)
  • Clinical Research Unit (CRU)
  • Protocol Review and Monitoring System (PRMS)
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