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Clinical Research Support

Office for Human Research Studies (OHRS)

Information Sheets

Information Sheets

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fold faq IRB-Related Guidance

DFCI IRB Requirements Relating to the Honest Broker in Biobanking
Blood Draws from Healthy Volunteers for Use in Research
Criteria for IRB Approval of 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
Drug Shortage and Substitution during Research Studies
Partners Recruitment of Subjects Policy
Requirements to Involve Prisoners as Participants in Research
Single Patient IND and Emergency Use of a Test Article
DFCI IRB Visitor Policy

fold faq Consent Form Guidance

Database for Drug Risk and Common Language for Risk & Events
  - Common Language for Risks and Events
  - Common Language for Drug Risks
Guidance Document: Consent Form for Continued Participation for Young Adults Who Have Reached Age 18
Instructions for Obtaining & Documenting Informed Consent of Non-English Speaking Subjects
Legally Authorized Representatives
Procedures for Monitoring Consent Process
Requirements for Informed Consent
Short Form Translational Procedure
Withdrawal of Consent to Continue in Research
Use of Informed Consent Documents Posted to OncPro
Discussing Enrollment in a Clinical or Non-Clinical Trial with Prospective Participants

fold faq OHRS Forms and Submission Guidance

Frequently Asked Questions
Non-Clinical Frequently Asked Questions
Guidance on Completing Nursing & Pharmacy Screening Form
Determining if Project Is Human Subject Research
Guidance on Dose Escalation Changes
Guidance on Completing the Protocol Front Sheet
Guidance on Completing Endorsement Forms
Guidance on PDF Files and Electronic Signatures
Guidance on Alert Pages
Adverse Event Ranking Scale
Guidelines For Writing A Social/Behavioral Science Research Protocol
Guidelines For Writing a Specimen/Data Collection and Banking Research Protocol
Instructions on the Collection and Sharing of Data and Tissue Specimens
Linked and Anonymous Specimens
OHRS Submit Guidance
Change of PI for Leave of Absence
Guidance on Priority List
Guidance on Completing Radiation Safety Screening Form
New Protocol Submission Requirement Chart
Quick Reference for New Protocol Submissions
Statistical Guidelines for Non-Clinical Research Protocols
Pregnant Partner Consent and Data Collection
Protocol Review Path Flowchart

fold faq 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

fold faq Miscellaneous OHRS Information Sheets

DF/HCC Research Administration Contacts
System Generated Study Closures Reopen Procedures
Sponsor Requests for PHI related to Adverse or Severe Adverse Events
Overview of the Operations of the DFCI Institutional Review Boards
Common Issues Holding Up Protocol Reviews
Guidelines for Sharing of Protocols
Microsoft Word Tips & Tricks