Table of Contents
Introduction
A. Scope, Applicability, and Implementation
B. Technical and Operational Best Practices
B.1. Biospecimen Resource Management and Operations
B.1.1. Organizational Overview of the Biospecimen Resource
B.1.2. Biospecimen Resource Personnel
B.1.3. Considerations Related to Planning and Development
B.1.4. Biospecimen Resource Infrastructure and Space Planning
B.1.5. Overall Operational Considerations
B.1.6. Biospecimen Resource Evaluation and Assessment
B.2. Biospecimen Collection, Processing, Storage, Retrieval, and Dissemination
B.2.1. Pre-Analytic and Analytic Variables
B.2.2. Determining Which Biospecimens to Collect
B.2.3. Defining References Ranges
B.2.4. Requirement for Evidence-Based Standard Operating Procedures
B.2.5. Methods Research
B.2.6. Biospecimen Storage
B.2.7. Biospecimen Retrieval
B.2.8. Shipping Samples
B.3. Quality Management
B.3.1. Quality Management System
B.3.2. Quality Assurance/Quality Control
B.3.3. Standard Operating Procedures Manual
B.4. Biosafety
B.5. Collecting and Managing Clinical Data
B.6. Biospecimen Resource Informatics: Data Management and
Inventory Control and Tracking
B.6.1. Functionality — General
B.6.2. Functionality — Identification and Tracking of Biospecimens
B.6.3. Interoperability
B.6.4. Selection of Biospecimen Resource Informatics Management Systems
B.6.5. Validation and Operation of Biospecimen Resource Informatics Systems
B.6.6. Regulatory Issues Pertaining to Informatics Systems
C. Ethical, Legal, and Policy Best Practices
C.1. Principles for Responsible Custodianship
C.1.1. Governance
C.1.2. Legacy or Contingency Plans
C.1.3. Policies on Retention
C.1.4. Conflicts of Interest
C.1.5. Confidentiality and Security
C.1.6. Public Communication
C.2. Informed Consent
C.2.1. Federal Regulations and Guidelines Pertaining to Informed Consent
C.2.2. General NCI Recommendations Pertaining to Informed Consent
C.2.3. NCI Recommendations on Key Informed Consent Elements and Supplementary Materials
C.2.4. Issues Pertaining to Discontinuation of Participation in Research
C.2.5. Considerations for Use of Pediatric Biospecimens
C.3. Privacy and Confidentiality Protections
C.3.1. Federal Regulations Pertaining to Privacy
C.3.2. NCI Recommendations Pertaining to Privacy and Confidentiality
C.4. Access to Biospecimens and Data
C.4.1. General Principles for Access Decisions
C.4.2. Research Plan
C.4.3. Access Policies
C.4.4. Models of Sustainability
C.4.5. Availability of Biospecimens
C.5. Intellectual Property and Resource Sharing
C.5.1. Material Transfer Agreements
C.5.2. Inventorship
C.5.3. IP Rights
C.5.4. Licensing
C.5.5. Data and Resource Sharing