Policies and Guidance Documents

Partners Human Research Protection Program (HRPP)

• Program Description

Partners Human Research Committee

• Governance and Operating Procedures
• PHRC Member Handbook

 Policy Topics

• Ancillary Committees
• Approval Requirements
• Stem Cell Research: ESCRO (PHS internal only link)
• Conflicts of Interest
  • Financial Conflicts of Interest
  • Harvard Medical School Policy on Conflicts of Interest and Commitment
  • Partners Code of Conduct (including Conflicts of Interest Policy) (PHS internal only link)
• Data and Safety Monitoring Plans
• Drugs and INDs: Investigational New Drug
• Devices and IDEs: Investigational Device Exemption
• Events - Other
  • Adverse Event Reporting Policy
  • Protocol Deviations, Exceptions and Violations
    • Minor Deviation/Violation Tracking Log NEW
  • Unanticipated Problems Involving Risks To Subjects or Others - Prompt Reporting
• Genome-Wide Association Study (GWAS)
• Investigators Leaving the Institution
• Non-BWH/Non-MGH Employees As Co-Investigators/Study Staff
• Noncompliance
• Offsite Research
• Payments
  • Bonus Payments:in Clinical Trial Agreements
  • Taxation and Payments to Subjects
    • Subject Payment Spreadsheet
• Reporting to Institutional Officials and Regulatory Agencies
• Review: Exemptions
• Exemption Determination
• Review: Initial
• Expedited Review UPDATED
• Full Board Convened Meeting Review
• Review: Continuing
  • Continuing Review Notification
  • Expedited Review UPDATED
  • Full Board Convened Meeting Review
• Review: Amendment
  • Expedited Review UPDATED
  • Full Board Convened Meeting Review
  • Reporting of Proposed Changes
• Review: Other Events
  • Unanticipated Problems
• Suspension or Termination of Research
• Sponsor Access to Protected Health Information (PHI) - Onsite
• Tissue Uses and Banking
  • CSRL Checklist:Investigator Checklist for Transfer of Tissue/Data to Academic Institutions/Collaborators
  • Human Tissues: Brief Primer on Research Use and Requirement for Partners IRB Review
  • Letter of Agreement Between Academic Collaborators for Transfer/Receipt of Coded Data/Limited Data Sets
  • Letter of Agreement Between Academic Collaborators for Transfer/Receipt of Non-Identifiable Tissue
  • Tissue Banks / Repositories
  • Tissue Transfers to Third Parties
• Vulnerable Populations
  • Children
  • Neonates
  • Pregnant Women and/or Fetuses
  • Prisoners

 Guidance Topics

• Blood Sampling Guidelines
• "Case Reporting" and Research Related to Medical Records
• Deception and Incomplete Disclosure in Research
• Emergency Use of an Investigational Drug or Biologic
• Genetics Research
  • Guidelines
  • DNA For Dummies
• Genetics Research Advisory Panel (GAP)
  • GAP Report
  • Appendix
• Drugs: Clinical Investigations of New Drugs or Marketed Drugs
• Informed Consent of Research Subjects
• Compliance Reminder (PHS internal only link)
• Consent Process
• Minors
• Non-English Speakers UPDATED
  • Frequently Asked Questions - Enrolling Non-English Speakers NEW
  • Translation Resources (PHS internal only link) NEW
• Surrogate Consent (PHS internal only link)
• Innovative Therapy and Diagnosis
• Investigator Responsibilities
  • Delegation of Responsibilities
  • Leave of Absence, Sabbatical, or Moving To Another Institution
  • Principal Investigator
• Pregnancy Testing in Research Studies Involving Ionizing and Non-Ionizing Radiation
• Prisoners
• Quality Measurement Initiatives
• Recordkeeping and Record Retention Requirements
• Recruitment
  • Advertising
  • Pre-Screening
• Recruiting
• Responsible Conduct of Human Studies
• Remuneration
  • Compensation