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Guidelines & Policies | Overview

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 and Functions
2.3 Institutional Official: Selection and Responsibilities
2.4 IRB Chairperson: 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

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/Gender Inclusion, Birth Control, and Pregnancy Testing
8.4 Pregnant Women, Human 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

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