Human Research Protection Program Policy and Guidance
- 第一节: Mass General Brigham Human Research Protection Program Plan
- Section 2: Institutional Review Board (IRB) Governance and Operating Procedures
- Section 3: Human-Subjects Research
- Section 4: Investigator and Study Staff Responsibilities, Training, and Documentation (Recordkeeping)
Principal Investigator (PI) Responsibilities
PI Delegation of Responsibilities
See also,QI Program Staff Signature/Delegation of Responsibility LogHuman-Subjects Protection Education and Training Requirements for Investigators and Study Staff
Required GCP Training: New NIH Policy (effective 1/17/17 Memo # 2)
Instructions for Adding CITI GCP Course to CITI Course List
See also,Human Research Committee (HRC) Webpage, Education & Training (CITI Program - Internal Navigator Link)Non-Brigham and Women's Hospital (BWH)/Non-Massachusetts General Hospital (MGH) Employees As Co-Investigators/Study Staff
See also,Multi-Site Investigator-Initiated Collaborative ResearchRecordkeeping and Record Retention Requirements
Electronic Storage of Research Documents
QI Program Study Checklists, Study Logs, Annotated Case Report Forms, Tools and Guidance Documents
PI Leave of Absence, Sabbatical, or Moving to Another Institution
- Section 5: 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 HRC Approval
See also,QI Program, Study Close Out GuidanceProposed 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, Regulatory Agencies and Accrediting Organizations
Requirements for Ancillary Committee Approval of Human-Subjects Research
See Human Research Committee (HRC) 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 LogQuestions, Concerns, or Complaints from Subjects or Family Members
Reporting Unapproved Deviations in PHRC-Approved Research
See also,QI Program Minor Deviation/Violation Tracking Log - Section 8: Drug and Biologic Research
- Section 9: Device Research
- 第一节0: Vulnerable Populations
Vulnerable Populations,including children, wards of the State, nonviable neonates and neonates of uncertain viability, and pregnant women and/or fetuses.
- 第一节1: Informed Consent
Informed Consent of Research Subjects
Individuals Who Can Obtain Consent in Human Subject Research
See also,NIH Policy on Certificates of Confidentiality (CoC)
See also,QI Program Informed Consent Compliance ChecklistConsent Form Reviewer Worksheet and Checklist
Fact/Information Sheet Outline and Examples
Fact/Information Sheet Outline
Sample Fact/Information Sheet (1)
Sample Fact/Information Sheet (2)
Sample Fact/Information Sheet (3)
Informed Consent in Online Research
Obtaining and Documenting Informed Consent of Non-English Speakers
Frequently Asked Questions - Enrolling Non-English Speakers
'Short Forms' for Non-English Speakers
Translation Services & Resources
Exception from Informed Consent Requirements for Emergency Research
- 第一节2: Recruitment and Remuneration (Payments to Research Subjects)
Recruitment of Research Subjects
Guidelines for Advertisements for Research Subjects
MGN IRB-369205 Procedure: Request to Receive Unencrypted Email
FAQs: Email Communication with Research Participants and Potential Research Participants
Pre-Screening of Research Subjects During Recruitment
See also,QI Program Pre-Screening LogRemuneration for Research Subjects
Bonus Payments in Clinical Trial Agreements
Payments to Subjects for Participation in Research
- 第一节3: Data and Safety Monitoring Plans
- 第一节4: Off-Site Research and Multi-Site Research
- 第一节5: Tissue Banks and Repositories
Human Tissues: Brief Primer on Research Use and Requirement for Partners IRB Review
Research Tissue Banks/Repositories
See alsoQI Program Tissue LogTissue 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 Non-Identifiable Tissue
- 第一节6: Genetics/Genomics
- 第一节7: Sponsored Research and Agreements
- 第一节8: NIH Supported Research
NIH Good Clinical Practice (GCP) Training Requirements
Instructions for Adding CITI GCP Course to CITI Course List
NIH Policy Regarding Large-Scale Genomic Research
NIH Genomic Data Sharing (GDS) Policy Guidance Memo #2
NIH Policy on Certificates of Confidentiality (CoC)
- 第一节9: Additional Guidance
Community-Based Participatory Research (CBPR)
Deception and Incomplete Disclosure in Research
Information Security Guidelines on Zoom
Internet Research: Survey Research Using Web-Based Survey Tools
Patient Centered Outcome Research (PCOR) and IRB Points to Consider
Portable Device Security Handbook
Pregnancy Testing in Research Studies Involving Ionizing and Non-Ionizing Radiation
TWIN IRB Review Process Guidance for Mass General Brigham Investigators