Boston Children's Research Guidelines & Policies

Section 1: Ethical Principles, Regulations, and Definitions

• 1.1 Statement of Ethical Principles and Regulatory Requirements for Human Subject Protection
• 1.2 Research and Human Subject Definition
• 1.3 Boston Children's Hospital Innovative Therapy Toolkit
• 1.4 Identifying QI/Education/Competency Evaluations as Clinical Research
• 1.5 Case Studies/Series

Section 2: Lines of Authority, Responsibilities, and Record-keeping

• 2.1 IRB Jurisdiction
• 2.2 IRB Autonomy
• 2.3 Institutional Official: Selection and Responsibilities
• 2.4 IRB Chair: Selection, Responsibilities, and Evaluation
• 2.5 IRB Member: Selection, Responsibilities, and Evaluation
• 2.6 Consultants, Observers, and Guests
• 2.7 Legal Counsel
• 2.8 Principal Investigator Responsibilities
• 2.9 IRB Administrative Office Resources
• 2.10 Records and Files
• 2.11 Convened IRB Meeting Minutes
• 2.12 Storage of Research Data and Informed Consent Documents
• 2.13 Single IRB Review
• 2.14 DF/HCC CCSG Protocol Review and Monitoring Requirements

Section 3: Credentials, Education, and Training

• 3.1 Who May Serve as Principal Investigator
• 3.2 Research Team Members
• 3.3 Education and Training: Investigators and Research Staff
• 3.4 Education and Training: Administrative Staff, IRB Members and Others

Section 4: Research Activity Review

• 4.1 Department/Division Scientific Review of Human Subjects Research
• 4.2 Convened IRB: Operational Review Procedures
• 4.3 Expedited Reviews
• 4.4 Exemptions
• 4.5 Amendments and Revisions
• 4.6 Protocol Exception Requests
• 4.7 Continuing Review and Administrative Update
• 4.8 Activation/Release, Approval, and Expiration Dates
• 4.9 Verification of No Material Changes Since Prior IRB Review
• 4.10 Ancillary Review: Additional Human Subject Protection Review
• 4.11 Disapprovals and Appeal
• 4.12 Data and Safety Monitoring Plans
• 4.13 Multi-Site Research When a Children's Investigator Oversees an Operation's Coordinating or Statistical Center

Section 5: Reporting, Unanticipated Problems, Noncompliance

• 5.1 Internal and External Reporting
• 5.2 Reportable Events: Unanticipated Problems and Adverse Events Involving Risks to Research Subjects and Others
• 5.3 Noncompliance: Investigations and Determinations
• 5.4 Suspensions, Terminations, Administrative Closures, Investigator-Initiated Voluntary Suspension or Termination
• 5.5 Research Related Injury
• 5.6 Managing Research Participant/Family Concerns and Complaints
• 5.7 Coordination Between Program for Patient Safety and Quality and Institutional Review Board Office

Section 6: Informed Consent/Assent

• 6.1 General Information - Informed Consent and Parental Permission
• 6.2 Special Considerations - Assent and Parental Permission
• 6.3 Waivers and Alterations of Informed Consent/Parental Permission/Assent Children
• 6.4 Informed Consent with Non-English Speakers
• 6.5 Informed Consent Decision Monitoring Program
• 6.6 Remote Consent: Process and Documentation
• 6.7 Exception from Informed Consent Requirements for Emergency Research
• 6.8 Collecting Data from Pregnant Partners of Research Subjects
• 6.9 Consent Guidance When Turning the Age of Majority

Section 7: Drugs, Biologics, and Devices

• 7.1 Drugs, Biologics, and Dietary Supplements Regulations
• 7.2 Expanded Access: Investigational Drugs
• 7.3 Patients Hospitalized with Investigational Drug from Another Institution/Investigator or with Supply of Drug Not Approved in the United States
• 7.4 Requirements for Sponsor-Investigators of Investigational Drugs (INDs)
• 7.5 Investigational Devices
• 7.6 Requirements for Sponsor-Investigators of Investigational Devices (IDE)
• 7.7 Humanitarian Use Devices

Section 8: Vulnerable Populations

• 8.1 Children
• 8.2 Incarcerated Youth and Prisoners
• 8.3 Sex Assigned at Birth, Birth Control, and Pregnancy Testing
• 8.4 Pregnant persons, Fetuses, and Neonates
• 8.5 Children in State Custody
• 8.6 International and Cross-cultural Research
• 8.7 Community Based Participatory Research (CBPR)
• 8.8 Guidelines for Review of Research Involving Vulnerable Populations Not Covered by Subparts B, C, and D
• 8.9 Research Involving Adults with Decisional Impairment

Section 9: Guidance for Special Topics/Procedures

• 9.1 Extending Anesthesia and Sedation for Research Purposes
• 9.2 Skin Biopsy Guidelines
• 9.3 Extra Endoscopy Biopsies for Research Guidelines
• 9.4 Research Blood Drawing Guidelines
• 9.5 Secondary Use of Human Biological Specimen Data
• 9.6 Certificates of Confidentiality
• 9.7 Special Confidentiality Issues When Performing Research Related Imaging
• 9.8 Requirements for Mental Health Safety Plans in Research Protocols
• 9.9 Genetic Research Guidance: Non-Paternity with Trios
• 9.10 Investigator Self-Experimentation
• 9.11 Community Consultation and Public Disclosure Guidance for Exception from Informed Consent Research (EFIC)
• 9.12 Data Sharing Requirements for Individual Participant Level Data
• 9.13 Use of Non-secure Email and Texting in Research
• 9.14 IRB Emergency Preparedness and Response Policy/Procedure

Section 10: Recruitment and Remuneration

• 10.1 Recruitment: Responsibilities and Requirements
• 10.2 Recruitment: Methods
• 10.3 Recruitment: Special Circumstances
• 10.4 Research Subject Remuneration

Section 11: Funding Agency Certifications and Requirements

• 11.1 Coordination of Certification of Institutional Review Board Review and Acceptance of Grants and Contracts for Sponsored Research
• 11.2 Research Involving Department of Defense Funding
• 11.3 Research Funded by Department of Education and School Based Research
• 11.4 Research Involving Department of Justice Funding
• 11.5 NIH Genomic Data Sharing

Section 12: Conflict Of Interest

• 12.1 Institutional Review Board Conflict of Interest Policy
• 12.2 Boston Children's Hospital Conflict of Interest and Commitment Policy
• 12.3 Boston Children's Hospital Public Health Service Investigator Conflict of Interest Policy