Revised NCI Best Practices 11-10-11 · PDF fileCollecting Clinical Data ... common principles...
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NCI Best Practices for Biospecimen Resources Office of Biorepositories and Biospecimen Research National Cancer Institute National Institutes of Health U.S. Department of Health and Human Services
Transcript of Revised NCI Best Practices 11-10-11 · PDF fileCollecting Clinical Data ... common principles...
NCI Best Practices for Biospecimen Resources
Office of Biorepositories and Biospecimen Research
National Cancer Institute
National Institutes of Health
U.S. Department of Health and Human Services
National Cancer Institute Best Practices for Biospecimen Resources
Table of Contents INTRODUCTION .......................................................................................................................... 1
A. SCOPE, APPLICABILITY, AND IMPLEMENTATION........................................................ 3
A.1. SCOPE................................................................................................................................... 3
A.2. APPLICABILITY AND IMPLEMENTATION................................................................................ 3
A.3. FORMAT OF THE NCI BEST PRACTICES ................................................................................ 3
B. TECHNICAL AND OPERATIONAL BEST PRACTICES ..................................................... 3
B.1. BIOSPECIMEN RESOURCE MANAGEMENT AND OPERATIONS ................................................ 4
B.1.1. Organizational Overview of the Biospecimen Resource ............................................. 4
B.1.2. Biospecimen Resource Personnel ................................................................................ 4
B.1.3. Considerations Related to Planning and Development ................................................ 6
B.1.4. Biospecimen Resource Infrastructure and Space Planning .......................................... 7
B.1.5. Overall Operational Considerations ............................................................................. 8
B.1.6. Biospecimen Resource Evaluation and Assessment .................................................... 9
B.2. BIOSPECIMEN COLLECTION, PROCESSING, STORAGE, RETRIEVAL, AND DISSEMINATION ... 10
B.2.1. Pre-Analytic and Analytic Variables.......................................................................... 10
B.2.2. Determining Which Biospecimens to Collect ............................................................ 11
B.2.3. Defining References Ranges ...................................................................................... 12
B.2.4. Requirement for Evidence-Based Standard Operating Procedures ............................ 12
B.2.5. Methods Research ...................................................................................................... 12
B.2.6. Biospecimen Storage .................................................................................................. 12
B.2.7. Biospecimen Retrieval ............................................................................................... 14 B.2.8. Shipping Samples ....................................................................................................... 14
B.3. QUALITY MANAGEMENT .................................................................................................... 16
B.3.1. Quality Management System ..................................................................................... 16
B.3.2. Quality Assurance/Quality Control............................................................................ 17
B.3.3. Standard Operating Procedures Manual..................................................................... 18
B.4. BIOSAFETY ......................................................................................................................... 21
B.4.1. Biohazard Precautions................................................................................................ 21
B.4.2. Biosafety Best Practices ............................................................................................. 22
B.4.3. General Laboratory Safety ......................................................................................... 22
B.5. COLLECTING AND MANAGING CLINICAL DATA.................................................................. 22
B.5.1. Regulatory Compliance .............................................................................................. 23
B.5.2. Collecting Clinical Data ............................................................................................. 23
B.5.3. Longitudinal Clinical Data ......................................................................................... 23
B.5.4. Informatics to Support the Tracking of Data.............................................................. 24
B.6. BIOSPECIMEN RESOURCE INFORMATICS: DATA MANAGEMENT AND INVENTORY
CONTROL AND TRACKING ........................................................................................................ 24
B.6.1. FunctionalityGeneral .............................................................................................. 25
B.6.2. FunctionalityIdentification and Tracking of Biospecimens ................................... 26
B.6.3. Interoperability ........................................................................................................... 27
B.6.4. Development of Biospecimen Resource Informatics Management Systems............. 28
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National Cancer Institute Best Practices for Biospecimen Resources
B.6.5. Selection of Biospecimen Resource Informatics Management Systems ................... 28
B.6.6. Validation and Operation of Biospecimen Resource Informatics Systems ............... 29
B.6.7. Regulatory Issues Pertaining to Informatics Systems ................................................ 29
C. ETHICAL, LEGAL, AND POLICY BEST PRACTICES ...................................................... 30
C.1. PRINCIPLES FOR RESPONSIBLE CUSTODIANSHIP ................................................................. 31
C.1.1. Governance................................................................................................................. 32
C.1.2. Legacy or Contingency Plans..................................................................................... 32
C.1.3. Policies on Retention.................................................................................................. 32
C.1.4. Conflicts of Interest .................................................................................................... 33
C.1.5. Confidentiality and Security ....................................................................................... 33
C.1.6. Public Communication ............................................................................................... 33
C.2. INFORMED CONSENT .......................................................................................................... 33
C.2.1. Federal Regulations and Guidelines Pertaining to Informed Consent ....................... 34
C.2.2. General NCI Recommendations Pertaining to Informed Consent ............................. 35
C.2.3. NCI Recommendations on Key Informed Consent Elements and Supplementary
Materials ............................................................................................................................. 36
C.2.4. Issues Pertaining to Discontinuation of Participation in Research ............................ 39
C.2.5. Considerations for Use of Pediatric Biospecimens .................................................... 40
C.3. PRIVACY AND CONFIDENTIALITY PROTECTIONS ................................................................ 41
C.3.1. Federal Regulations Pertaining to Privacy ................................................................. 41
C.3.2. NCI Recommendations Pertaining to Privacy and Confidentiality ........................... 42
C.4. ACCESS TO BIOSPECIMENS AND DATA ............................................................................... 43
C.4.1. General Principles for Access Decisions ................................................................... 44
C.4.2. Research Plan ............................................................................................................. 44
C.4.3. Access Policies........................................................................................................... 45
C.4.4. Models of Sustainability............................................................................................. 45 C.4.5. Availability of Biospecimens ..................................................................................... 45
C.5. INTELLECTUAL PROPERTY AND RESOURCE SHARING ......................................................... 45
C.5.1. Material Transfer Agreements ................................................................................... 46
C.5.2. Inventorship................................................................................................................ 47
C.5.3. IP Rights..................................................................................................................... 47
C.5.4. Licensing .................................................................................................................... 47
C.5.5. Data and Resource Sharing ........................................................................................ 47
C.6. CONFLICTS OF INTEREST .................................................................................................... 47
C.6.1. Investigator Financial COIs ....................................................................................... 48
C.6.2. Institutional Financial COIs ....
