OHRS Information Sheet Library

Info Sheet - Policy

Adverse Event Reporting Policy
Blood Draws From Healthy Volunteers Policy
Consenting Blind and Illiterate Participants Policy
Continued Participation Policy
Determining if a Project is Human Subjects Research Policy
Deviation Violation Exception and Other Event Reporting Policy
DFCI IRB Requirements Relating to the Honest Broker in Biobanking Policy
Expiration of IRB Approval and Administrative Closures Policy
HIPAA Requirements Policy
Implementing Dose Escalation Policy
Institutional Conflicts of Interest Policy
IRB Policies and Procedures Policy
Legally Authorized Representatives Policy
Linked and Anonymous Specimens Policy
Non English Speaking Subjects Policy
Outside Interest Disclosure Policy
Pregnant Partner Consent and Data Collection Policy
Prisoners in Research Policy
Sharing and Transfer of Data or Specimens Policy
Sharing Protocols Policy
Short Form Translation Procedure Policy
Single Patient IND and Emergency Use of a Test Article Policy
Sponsor Requests for PHI Related to Adverse or Severe Adverse Events Policy
Subject Injury Language Policy
Two Year Continuing Review Policy
Updating Consent Forms to Align with Genomic Data Requirements Policy
Use of Alert Pages Policy

Info Sheet - Guidance

Adobe Sign for Electronic Consent Guidance
Approvable and Not-Approvable Language in Consent Forms Guidance
Audio recording in Human Subjects Research Guidance
CLIA in the Research Context Guidance
Consent forms for Gene Transfer Studies Guidance
Data Safety Monitoring Plans Guidance
DFCI IRB Approved Standard Drug Risk Language Guidance
DF/HCC Consortium Guidance Guidance
DFHCC Specimens and Data - External Sites Checklist Guidance
Drug Shortages Guidance
European Union General Data Protection Regulation (GDPR) Guidance
FAQs on Using Adobe Sign Resource
Institutional Certification Process for Genomic Data Sharing Guidance
Guidance on Medical Devices Guidance
Institutional Engagement Guidance
MA State Law Involving Human Research Guidance
Patient Case Reports and When IRB and HIPAA Regulations Apply Guidance
Procedures for Monitoring the Consent Process Guidance
Reconsent Process and Notifying Participants of New Risks Guidance
Remote and Electronic Consent Guidance
Research Funded or Supported by the Department of Defense Guidance
Research Limited to the Use of Data and Specimens Guidance
Research Procedures at External Sites Guidance
Return of Individual Research Results Guidance
Scientific Progress Review Guidance
Statistical Guidelines for Non-Clinical Research Guidance
The Use of Social Media in Recruitment to Research Guidance
Withdrawal of Consent to Continue in Research Form Guidance

Info Sheet - Resource

Additional Protections for Children Resource
Criteria for IRB Approval of Research Resource
Exempt and Expedited Review Categories Resource
Massachusetts Law on Insurance Coverage Resource
Partners Recruitment of Subjects Resource
Requirements for Informed Consent Resource
Required Elements of Consent Resource
Successful Research Participation Communication Resource
Guidance - Adobe Sign Consent Message Language Guidance
Research Participant Adobe Sign Instructions Resource

Worksheets and Checklists

HRP-306 - WORKSHEET - Drugs Resource
HRP-307 - WORKSHEET - Devices Resource
HRP-310 - WORKSHEET - Human Research Determination Resource
HRP-311 - WORKSHEET - Engagement Determination Resource
HRP-312 - WORKSHEET - Exemption Resource
HRP-313 - WORKSHEET - Expedited Review Resource
HRP-314 - WORKSHEET - Criteria for Approval Resource
HRP-317 - WORKSHEET - Short Form of Consent Documentation Resource
HRP-321 - WORKSHEET - Reportable New Information Resource
HRP-322 - WORKSHEET - Emergency Use Resource
HRP-323 - WORKSHEET - Criteria for Approval HUD Resource
HRP-325 - WORKSHEET - Device Compassionate Use Resource
HRP-330 - WORKSHEET - HIPAA Authorization Resource
HRP-332 - WORKSHEET - NIH GDS Institutional Certfication Resource
HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process Resource
HRP-411 - CHECKLIST - Waiver of Written Documentation of Consent Resource
HRP-412 - CHECKLIST - Pregnant Women Resource
HRP-415 - CHECKLIST - Prisoners Resource
HRP-416 - CHECKLIST - Children Resource
HRP-417 - CHECKLIST - Cognitively Impaired Adults Resource
HRP-419 - CHECKLIST - Waiver of Consent Process for Emergency Research Resource
HRP-430 - CHECKLIST - Investigator Quality Improvement Assessment Resource
HRP-441 - CHECKLIST - HIPAA Waiver of Authorization Resource