Definition of Human-Subjects Research
Case 'Reporting' and Research Related to Medical Records
Innovative Therapy and Diagnosis
Quality Measurement Initiatives
Principal Investigator (PI) Responsibilities
PI Delegation of Responsibilities
Human-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)
Study Staff Information Sheet
Recordkeeping 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
PI Transfer Out (Research) for the Brigham
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 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, Regulatory Agencies and Accrediting Organizations
Requirements for Ancillary Committee Approval of Human-Subjects Research
See also Human Research Committee (HRC) Webpage: Instructions & Forms for submission requirements
Vulnerable Populations: includes children, wards of the State, nonviable neonates and neonates of uncertain viability, and pregnant women and/or fetuses.
Informed Consent of Research Subjects
Individuals Who Can Obtain Consent in Human Subject Research
Consent 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
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 Log
Remuneration for Research Subjects
Bonus Payments in Clinical Trial Agreements
Payments to Subjects for Participation in Research
Cash Control and Accountability for Payments to Human Subjects for Participation in Research
Human Tissues: Brief Primer on Research Use and Requirement for Mass General Brigham 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 Non-Identifiable Tissue
Guidance on Genomic Data Sharing
Flowchart for Depositing Human Genomic Data Into NIH Controlled-Access Repositories
Genomic Data Sharing Consent Checklist
Return of Research Results in Genetic Research Points to Consider
Genetics Research Advisory Panel (GAP) Report
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)
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