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

Pavlenko, Elena; Strech, Daniel; Langhof, Holger

doi:10.1186/s12911-020-01177-z

BMC Medical Informatics and Decision Making

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
			Status	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
		Recipient relation to CDW	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
			Other reuse purposes	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
				Patient-centricity	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
			Ethics	IRB approval
			Laws	General laws
Specific laws			Laws
Other general policies and regulations			FAIR principles
Other general policies and regulations			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
			Reducing investment		Timely review
			Managing competitiveness		Collaboration
		Community before individual
*ACCESS*
	Access limitations	Limited data	Managing competitiveness	Aggregated data set
			De-identified data set
			Limited data set
		Limited location	Remote access
			View only
			Virtual access
		Limited time

Back to article page

ISSN: 1472-6947

Contact us

General enquiries: journalsubmissions@springernature.com