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Table 2 Qualitative spectrum of criteria and procedures in data use and access governance in CDW

From: Implementation of data access and use procedures in clinical data warehouses. A systematic review of literature and publicly available policies

MAIN CATEGORY SUBCATEGORY SUBCATEGORY SUBCATEGORY SUBCATEGORY
REQUIREMENTS
  Recipient Recipient categorization Roles
Status Authorized vs. non-authorized
Internal vs. external
Recipient background Professional background Academic staff
Healthcare professionals
Office staff
Researchers
Other background Organizations
Patients
Students
Recipient qualifications Human-subjects training
Recipient relation to CDW Affiliation
Reciprocity
Reuse Reuse purpose Research purposes General research
Clinical trials
Epidemiological studies
Feasibility check for research
Health services research
(Non-)human subject research
Observational studies
Personalized treatments
Health care purposes Audit
Care management
Clinical care coordination
Clinical quality improvement
Facilitating organ, eye or tissue donation and transplantation
Public health reporting
Other reuse purposes Grant application support
Marketing
Reuse setup Clear documentation provided
Dissemination plan provided
Feasibility assessment provided
Funding provided
Process details provided
Reuse risk mitigation Data protection
HIPAA compliance
IRB authorization
No contacting data subjects
No reidentification
No resharing without approval
Reuse values Ethical soundness Responsibleness Compliance
Privacy
Responsible reuse
Patient-centricity Clinical relevance
Patients first
Non-competitiveness Business issues
Collaboration principles
Non-profit
Scientific soundness Good research conduct
Innovation
Merits
Appropriateness Appropriateness of requests
Appropriateness of results
Mission consistent with CDW
Reputation
Formal requirements Data reuse documents Data access/ sharing/ use agreement
Data collaboration agreement
Ethical agreements
Honorary/ substantive contract
Participation agreement
Term license agreement
General policies and regulations Ethics Consent
IRB approval
Laws General laws
Specific laws
Other general policies and regulations FAIR principles
Statewide policy guidance
Local policies and regulations Information governance
Data access policies
Data identifying/ access/ sharing/ publishing protocols
Data management policies
Privacy/ security policies
Protocol review guidelines
Research policy
SOPs
Fees
STRUCTURES AND PROCEDURES
  Review bodies Governance bodies Board of directors
Clinical committee
Department head
Director of professional services
Executive board
IRB
Project review committee
Privacy board
Privacy and security committee
Policy advisory groups
Use and access committee
Working groups
Scientific review bodies Academic staff
Data analysts
Health information research unit
Research committee
Scientific peer-review
Patient review bodies Patient-led oversight committee
Review values General values Appropriate competency
Fine-grained control
Holistic governance
Reducing bias Empirical evaluation
No conflict of interest
Objective review
Transparent review
Reducing investment Effective review
Timely review
Managing competitiveness Collaboration
Community before individual
ACCESS
  Access limitations Limited data Aggregated data set
De-identified data set
Limited data set
Limited location Remote access
View only
Virtual access
Limited time