PARTNERS HUMAN RESEARCH COMMITTEE
116 Huntington Ave, Suite 1002. Boston, MA 02116
Tel: 617-424-4100, Fax: 617-424-4199

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Policy and Guidance

Partners Human Research Committee policy and guidance documents have been organized in sections by topic. Within each section you will find links to relevant Quality Improvement (QI) Program checklists, study logs, tools and guidance documents. If you wish to provide comments or suggestions on PHRC policy and guidance documents, organization of materials on this website, or other human subject protection issues, please contact Rosalyn Gray.

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

Stem Cell Research: ESCRO

 

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

PI Responsibilities

PI Delegation of Responsibilities

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

Study Staff Information Sheet

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

Recordkeeping and Record Retention Requirements

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

 

SECTION 5: Conflicts of Interest

Financial Conflicts of Interest in Human-Subjects Research

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

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

 

SECTION 7: Reporting Unanticipated Problems (including Adverse Events)

Reporting Unanticipated Problems in Human-Subjects Research including Adverse Events

Questions, Concerns, or Complaints from Subjects or Family Members

Needlesticks in Research

Reporting Unapproved Deviations in PHRC-Approved Research

 

SECTION 8: Drug and Biologic Research

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

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

 

SECTION 9: Device Research

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

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

Informed Consent in Online Research

Surrogate Consent (PHS internal only link)

Obtaining and Documenting Informed Consent of Non-English Speakers

Exception from Informed Consent Requirements for Emergency Research

 

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

Recruitment of Research Subjects

Remuneration for Research Subjects

Payments to Subjects for Participation in Research

 

SECTION 13: Data and Safety Monitoring Plans

Data and Safety Monitoring Plans in Human-Subjects Research

 

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

Tissue Transfer to Third Parties

 

SECTION 16: Genetics/Genomics

Genetics Research Guidelines

DNA For Dummies

Genetics Research Advisory Panel (GAP) Report

Genome Wide Association Studies (GWAS)

 

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)