Key Guidelines

The ResearchStudyConsent profile is designed to conform to the same guidelines as found in the DbGaP/NIH Consent model and is intended to be a singular resource that represents the consent signed by a group of participants in a research study.

Added Profile Restrictions

• The consent’s category MUST be set to the code, research from the system, http://terminology.hl7.org/CodeSystem/consentcategorycodes.
• ​All distinct consent restrictions should be added to the consent’s provision.purpose as a separate coding from the NIH Consent CodeSystem.
• For disease specific restrictions, the code DS must be present in the purpose described above along with appropriate code(s) added via the Research Disease Use Limitation Extension.

Recommended Practice

This should go within the regular page content, but I want to wait until I have Katie’s verbiage before working it in.

​In this model, the consent’s category contains an array of codes for each of the restrictions specified in the given consent. For instance, HMB-NPU Consent, there would be two codes added to the provision’s purpose property: One for the HBM restriction and one for the NPU. Those restrictions must be selected from the CodeSystem, NIH Consent. For more disease specific restrictions, the code DS is to be used along with a corresponding disease code(s) added via the Research Disease Use Limitation.

Each ResearchStudyConsent resource is intended to be a singular resource that is used by all participants that were enrolled into the study under the particular consent agreement. As such, the model differs somewhat from the R4 Consent model. In this model, for each distinct consent agreement present in the study will be represented by a (ResearchStudySubject)(StructureDefinition-research-study-subject.html) which contains a single Study Group that may contain references to each participant consented by the relevant agreement. This ResearchStudySubject will contain a reference to the corresponding ResearchStudyConsent resource via the Research Disease Use Limitation.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Consent

Name	Flags	Card.	Type	Description & Constraints
Consent	C	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
category		1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
display		1..1	string	Representation defined by the system Fixed Value: Research Information Access
provision
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
diseaseUseLimitation		0..1	CodeableConcept	Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation Binding: MeSH Terms (example)
purpose		0..*	Coding	Context of activities covered by this rule Binding: NIH Consent Code ValueSet (extensible)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Consent.provision.purpose	extensible	NihConsentCodes (a valid code from NIH Consent Codes) https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
completed-consent-code	error	Consent	If category is DS then there must be a ResearchConsentDiseaseAbbreviation : provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()

Name	Flags	Card.	Type	Description & Constraints
Consent	C	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time ppc-1: Either a Policy or PolicyRule ppc-2: IF Scope=privacy, there must be a patient ppc-3: IF Scope=research, there must be a patient ppc-4: IF Scope=adr, there must be a patient ppc-5: IF Scope=treatment, there must be a patient completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
category	Σ	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
display		1..1	string	Representation defined by the system Fixed Value: Research Information Access
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Consent.status	required	ConsentState http://hl7.org/fhir/ValueSet/consent-state-codes|4.3.0 from the FHIR Standard
Consent.scope	extensible	ConsentScopeCodes http://hl7.org/fhir/ValueSet/consent-scope from the FHIR Standard
Consent.category	extensible	Pattern: research("Research Information Access") http://hl7.org/fhir/ValueSet/consent-category from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
completed-consent-code	error	Consent	If category is DS then there must be a ResearchConsentDiseaseAbbreviation : provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Consent	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Consent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Consent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Consent	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ppc-1	error	Consent	Either a Policy or PolicyRule : policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Name	Flags	Card.	Type	Description & Constraints
Consent	C	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time ppc-1: Either a Policy or PolicyRule ppc-2: IF Scope=privacy, there must be a patient ppc-3: IF Scope=research, there must be a patient ppc-4: IF Scope=adr, there must be a patient ppc-5: IF Scope=treatment, there must be a patient completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Identifier for this record (external references)
status	?!Σ	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
category	Σ	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
display		1..1	string	Representation defined by the system Fixed Value: Research Information Access
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
patient	Σ	0..1	Reference(Patient)	Who the consent applies to
dateTime	Σ	0..1	dateTime	When this Consent was created or indexed
performer	Σ	0..*	Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Who is agreeing to the policy and rules
organization	Σ	0..*	Reference(Organization)	Custodian of the consent
source[x]	Σ	0..1		Source from which this consent is taken
sourceAttachment			Attachment
sourceReference			Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
policy		0..*	BackboneElement	Policies covered by this consent
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
authority	C	0..1	uri	Enforcement source for policy
uri	C	0..1	uri	Specific policy covered by this consent
policyRule	ΣC	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
verification	Σ	0..*	BackboneElement	Consent Verified by patient or family
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
verified	Σ	1..1	boolean	Has been verified
verifiedWith		0..1	Reference(Patient | RelatedPerson)	Person who verified
verificationDate		0..1	dateTime	When consent verified
provision	Σ	0..1	BackboneElement	Constraints to the base Consent.policyRule
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
diseaseUseLimitation		0..1	CodeableConcept	Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation Binding: MeSH Terms (example)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	Σ	0..1	Period	Timeframe for this rule
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
action	Σ	0..*	CodeableConcept	Actions controlled by this rule Binding: ConsentActionCodes (example): Detailed codes for the consent action.
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: NIH Consent Code ValueSet (extensible)
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
code	Σ	0..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: ConsentContentCodes (example): If this code is found in an instance, then the exception applies.
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
provision		0..*	See provision (Consent)	Nested Exception Rules
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Consent.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Consent.status	required	ConsentState http://hl7.org/fhir/ValueSet/consent-state-codes|4.3.0 from the FHIR Standard
Consent.scope	extensible	ConsentScopeCodes http://hl7.org/fhir/ValueSet/consent-scope from the FHIR Standard
Consent.category	extensible	Pattern: research("Research Information Access") http://hl7.org/fhir/ValueSet/consent-category from the FHIR Standard
Consent.policyRule	extensible	ConsentPolicyRuleCodes http://hl7.org/fhir/ValueSet/consent-policy from the FHIR Standard
Consent.provision.type	required	ConsentProvisionType http://hl7.org/fhir/ValueSet/consent-provision-type|4.3.0 from the FHIR Standard
Consent.provision.actor.role	extensible	SecurityRoleType http://hl7.org/fhir/ValueSet/security-role-type from the FHIR Standard
Consent.provision.action	example	ConsentActionCodes http://hl7.org/fhir/ValueSet/consent-action from the FHIR Standard
Consent.provision.securityLabel	extensible	All Security Labels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
Consent.provision.purpose	extensible	NihConsentCodes (a valid code from NIH Consent Codes) https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes from this IG
Consent.provision.class	extensible	ConsentContentClass http://hl7.org/fhir/ValueSet/consent-content-class from the FHIR Standard
Consent.provision.code	example	ConsentContentCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/consent-content-code from the FHIR Standard
Consent.provision.data.meaning	required	ConsentDataMeaning http://hl7.org/fhir/ValueSet/consent-data-meaning|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
completed-consent-code	error	Consent	If category is DS then there must be a ResearchConsentDiseaseAbbreviation : provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Consent	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Consent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Consent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Consent	A resource should have narrative for robust management : text.`div`.exists()
dom-r4b	warning	Consent.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ppc-1	error	Consent	Either a Policy or PolicyRule : policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Differential View

This structure is derived from Consent

Name	Flags	Card.	Type	Description & Constraints
Consent	C	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
category		1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
display		1..1	string	Representation defined by the system Fixed Value: Research Information Access
provision
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
diseaseUseLimitation		0..1	CodeableConcept	Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation Binding: MeSH Terms (example)
purpose		0..*	Coding	Context of activities covered by this rule Binding: NIH Consent Code ValueSet (extensible)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Consent.provision.purpose	extensible	NihConsentCodes (a valid code from NIH Consent Codes) https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
completed-consent-code	error	Consent	If category is DS then there must be a ResearchConsentDiseaseAbbreviation : provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Consent	C	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time ppc-1: Either a Policy or PolicyRule ppc-2: IF Scope=privacy, there must be a patient ppc-3: IF Scope=research, there must be a patient ppc-4: IF Scope=adr, there must be a patient ppc-5: IF Scope=treatment, there must be a patient completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
category	Σ	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
display		1..1	string	Representation defined by the system Fixed Value: Research Information Access
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Consent.status	required	ConsentState http://hl7.org/fhir/ValueSet/consent-state-codes|4.3.0 from the FHIR Standard
Consent.scope	extensible	ConsentScopeCodes http://hl7.org/fhir/ValueSet/consent-scope from the FHIR Standard
Consent.category	extensible	Pattern: research("Research Information Access") http://hl7.org/fhir/ValueSet/consent-category from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
completed-consent-code	error	Consent	If category is DS then there must be a ResearchConsentDiseaseAbbreviation : provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Consent	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Consent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Consent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Consent	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ppc-1	error	Consent	Either a Policy or PolicyRule : policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Consent	C	0..*	Consent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time ppc-1: Either a Policy or PolicyRule ppc-2: IF Scope=privacy, there must be a patient ppc-3: IF Scope=research, there must be a patient ppc-4: IF Scope=adr, there must be a patient ppc-5: IF Scope=treatment, there must be a patient completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Identifier for this record (external references)
status	?!Σ	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
category	Σ	1..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentcategorycodes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
display		1..1	string	Representation defined by the system Fixed Value: Research Information Access
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
patient	Σ	0..1	Reference(Patient)	Who the consent applies to
dateTime	Σ	0..1	dateTime	When this Consent was created or indexed
performer	Σ	0..*	Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Who is agreeing to the policy and rules
organization	Σ	0..*	Reference(Organization)	Custodian of the consent
source[x]	Σ	0..1		Source from which this consent is taken
sourceAttachment			Attachment
sourceReference			Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
policy		0..*	BackboneElement	Policies covered by this consent
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
authority	C	0..1	uri	Enforcement source for policy
uri	C	0..1	uri	Specific policy covered by this consent
policyRule	ΣC	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
verification	Σ	0..*	BackboneElement	Consent Verified by patient or family
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
verified	Σ	1..1	boolean	Has been verified
verifiedWith		0..1	Reference(Patient | RelatedPerson)	Person who verified
verificationDate		0..1	dateTime	When consent verified
provision	Σ	0..1	BackboneElement	Constraints to the base Consent.policyRule
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
diseaseUseLimitation		0..1	CodeableConcept	Consent Code Disease Abbreviation URL: https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation Binding: MeSH Terms (example)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	Σ	0..1	Period	Timeframe for this rule
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
action	Σ	0..*	CodeableConcept	Actions controlled by this rule Binding: ConsentActionCodes (example): Detailed codes for the consent action.
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: NIH Consent Code ValueSet (extensible)
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
code	Σ	0..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: ConsentContentCodes (example): If this code is found in an instance, then the exception applies.
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
provision		0..*	See provision (Consent)	Nested Exception Rules
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Consent.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Consent.status	required	ConsentState http://hl7.org/fhir/ValueSet/consent-state-codes|4.3.0 from the FHIR Standard
Consent.scope	extensible	ConsentScopeCodes http://hl7.org/fhir/ValueSet/consent-scope from the FHIR Standard
Consent.category	extensible	Pattern: research("Research Information Access") http://hl7.org/fhir/ValueSet/consent-category from the FHIR Standard
Consent.policyRule	extensible	ConsentPolicyRuleCodes http://hl7.org/fhir/ValueSet/consent-policy from the FHIR Standard
Consent.provision.type	required	ConsentProvisionType http://hl7.org/fhir/ValueSet/consent-provision-type|4.3.0 from the FHIR Standard
Consent.provision.actor.role	extensible	SecurityRoleType http://hl7.org/fhir/ValueSet/security-role-type from the FHIR Standard
Consent.provision.action	example	ConsentActionCodes http://hl7.org/fhir/ValueSet/consent-action from the FHIR Standard
Consent.provision.securityLabel	extensible	All Security Labels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
Consent.provision.purpose	extensible	NihConsentCodes (a valid code from NIH Consent Codes) https://nih-ncpi.github.io/ncpi-fhir-ig/ValueSet/nih-consent-codes from this IG
Consent.provision.class	extensible	ConsentContentClass http://hl7.org/fhir/ValueSet/consent-content-class from the FHIR Standard
Consent.provision.code	example	ConsentContentCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/consent-content-code from the FHIR Standard
Consent.provision.data.meaning	required	ConsentDataMeaning http://hl7.org/fhir/ValueSet/consent-data-meaning|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
completed-consent-code	error	Consent	If category is DS then there must be a ResearchConsentDiseaseAbbreviation : provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists()
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Consent	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Consent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Consent	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Consent	A resource should have narrative for robust management : text.`div`.exists()
dom-r4b	warning	Consent.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ppc-1	error	Consent	Either a Policy or PolicyRule : policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient : patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

This structure is derived from Consent

Summary

Extensions

This structure refers to these extensions:

• https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation