Policy and Guidance

SECTIONS
1.  Partners Human Research Protection Program Plan
2.  PHRC Governance and Operating Procedures
3.  Human-Subjects Research
4.  Investigator and Study Staff Responsibilities, Training, and Documentation
    (Recordkeeping)
5.  Conflicts of Interest
6.  Review of Human-Subjects Research Activities
7.  Reporting Unanticipated Problems (including Adverse Events)
8.  Drug and Biologic Research
9.  Device Research
10. Vulnerable Populations
11. Informed Consent
12. Recruitment and Remuneration (Payments to Research Subjects)
13. Data and Safety Monitoring Plans
14. Off-Site Research and Multi-Site Research
15. Tissue Banks and Repositories
16. Genetics/Genomics
17. Sponsored Research and Agreements
18. Additional Guidance on Various Topics

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SECTION 1: Partners Human Research Protection Program Plan

Human Research Protection Program Plan

SECTION 2: PHRC Governance and Operating Procedures

PHRC Governance and Operating Procedures

Article I      Name, Purpose, and Responsibilities
Article II     Ethical Principles
Article III    Authority and Independence
Article IV    Scope of Responsibility
Article V     Specific Functions of The Partners HRC
Article VI    Membership
Article VII   Member Orientation, Education, Training and Evaluation
Article VIII  Responsibilities of Members
Article IX    Conflicts of Interest
Article X     Chairpersons
Article XI    Review of Research
Article XII   Convened Meetings
Article XIII  Records of Review Activities
Article XIV  Confidentiality
Article XV   Incident Reporting
Article XVI  Policies and Procedures

SECTION 3: Human-Subjects Research

Definition of Human-Subjects Research

Case 'Reporting' and Research Related to Medical Records

Innovative Therapy and Diagnosis

Quality Measurement Initiatives

• See also, Clinical QI Checklist

Stem Cell Research: ESCRO

SECTION 4: Investigator and Study Staff Responsibilities, Training, and Documentation (Recordkeeping)

PI Responsibilities

PI Delegation of Responsibilities

• See also, QI Program Staff Signature/Delegation of Responsibility Log

Human-Subjects Protection Education and Training Requirements for Investigators and Study Staff

• See also, PHRC Webpage, Education & Training (CITI Program)

Study Staff Information Sheet

Non-BWH/Non-MGH Employees As Co-Investigators/Study Staff

• See also, Multi-Site Investigator-Initiated Collaborative Research

Recordkeeping and Record Retention Requirements

• QI Program Study Checklists, Study Logs, Annotated Case Report Forms, Tools and Guidance Documents

PI Leave of Absence, Sabbatical, or Moving to Another Institution

• PI Transfer Out (Research) BWH
• PI Transfer Out (Research) MGH

SECTION 5: Conflicts of Interest

Financial Conflicts of Interest in Human-Subjects Research

• See also, Investigator Disclosure Form
• See also, eCOI FAQs

Bonus Payments in Clinical Trial Agreements

Harvard Medical School Faculty Policy on Conflicts of Interest and Commitment

Partners Code of Conduct (including Conflicts of Interest Policy) (PHS internal only link)

IRB Member Conflicts of Interest

SECTION 6: Review of Human-Subjects Research Activities

Exempt Human-Subjects Research

Expedited Review (Initial, Continuing and Amendment)

Full Board Convened Meeting Review (Initial, Continuing and Amendment)

Continuing Review and Expiration of PHRC Approval

• See also QI Program, Study Close Out Guidance

Proposed Changes in Approved Human-Subjects Research and Exceptions

Unanticipated Problems in Human-Subjects Research

Noncompliance in Human-Subjects Research

Suspension or Termination of Human-Subjects Research

Reporting to Institutional Officials and Regulatory Agencies

Requirements for Ancillary Committee Approval of Human-Subjects Research

• See PHRC Webpage, Instructions & Forms for submission requirements

SECTION 7: Reporting Unanticipated Problems (including Adverse Events)

Reporting Unanticipated Problems in Human-Subjects Research including Adverse Events

• See also, QI Program Adverse Events Tracking Log

Questions, Concerns, or Complaints from Subjects or Family Members

Needlesticks in Research

Reporting Unapproved Deviations in PHRC-Approved Research

• See also, QI Program Minor Deviation/Violation Tracking Log

SECTION 8: Drug and Biologic Research

Requirement for Investigational New Drug (IND) for Human-Subject Research

• See also, QI Program Drug Accountability Log

Emergency Use of an Investigational Drug or Biological Product, or Unapproved Medical Device

• See also, guidance and instructions 'Emergency Use of Drugs or Biologics' webpage

SECTION 9: Device Research

Requirement for Investigational Device Exemption (IDE) for Human-Subject Research

• See also, QI Program Device Accountability Log

Humanitarian Use Device (HUD): Responsibilities & Checklists

Emergency Use of an Investigational Drug or Biological Product, or Unapproved Medical Device

SECTION 10: Vulnerable Populations

Vulnerable Populations

• Children
• Wards of the State
• Nonviable Neonates and Neonates of Uncertain Viability
• Pregnant Women and/or Fetuses
• Prisoners

Guidance on Research Involving Prisoners

SECTION 11: Informed Consent

Informed Consent of Research Subjects

• See also, QI Program Informed Consent Compliance Checklist


• Consent Form Reviewer Worksheet and Checklist


• Compliance Reminder (PHS internal only link)

Informed Consent in Online Research

Surrogate Consent (PHS internal only link)

Obtaining and Documenting Informed Consent of Non-English Speakers

• Frequently Asked Questions - Enrolling Non-English Speakers


• 'Short Forms' for Non-English Speakers


• Translation Services and Resources (PHS internal only link)

Exception from Informed Consent Requirements for Emergency Research

• See also, PHRC Webpage, Consent Forms for Research Consent Form Templates and Instructions

SECTION 12: Recruitment and Remuneration (Payments to Research Subjects)

Recruitment of Research Subjects

• Sample Recruitment Letters


• Guidelines for Advertisements for Research Subjects


• Pre-Screening of Research Subjects During Recruitment
  
  

• See also, QI Program Pre-Screening Log

Remuneration for Research Subjects

Payments to Subjects for Participation in Research

• Cash Control and Accountability for Payments to Human Subjects for Participation in Research


• Subject Payment Spreadsheet

SECTION 13: Data and Safety Monitoring Plans

Data and Safety Monitoring Plans in Human-Subjects Research

• See also QI Program Monitoring Plan Template and Monitoring Log

SECTION 14: Off-Site Research and Multi-Site Research

Review of Human-Subjects Research Conducted Offsite (US & International)

Review of Multi-Site Human-Subjects Research: Investigator-Initiated Collaborative Research

Review of Operations Centers or Coordinating Centers for Multi-Site Research

SECTION 15: Tissue Banks and Repositories

Human Tissues: Brief Primer on Research Use and Requirement for Partners IRB Review

Research Tissue Banks/Repositories

• See also QI Program, Tissue Log.

Tissue Transfer to Third Parties

• Investigator Checklist for Transfer of Tissue/Data to Academic Institutions/Collaborators


• 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

SECTION 16: Genetics/Genomics

Genetics Research Guidelines

DNA For Dummies

Genetics Research Advisory Panel (GAP) Report

• Appendix

Genome Wide Association Studies (GWAS)

Return of Research Results in Genetic Research Points to Consider

SECTION 17: Sponsored Research and Agreements

Bonus Payments in Clinical Trial Agreements

Human-Subjects Research Supported by the Department of Defense

Sponsor Access to Protected Health Information (PHI) Onsite

SECTION 18: Additional Guidance on Various Topics

Blood Sampling Guidelines

Community-Based Participatory Research (CBPR)

Deception and Incomplete Disclosure in Research

Internet Research: Survey Research Using Web-Based Survey Tools

PHS Portable Device Security HandBook

Pregnancy Testing in Research Studies Involving Ionizing and Non-Ionizing Radiation

Research Study Monitor Access: Confidentiality Protections for On-site Sponsor Access to/Audit of Protected Health Information in IRB Reviewed Research Studies (PHS internal only link)