FHIR Genomics Implementation Guide

Notice

Important: This guidance is under active development by NHS England and content may be added or updated on a regular basis.
This Implementation Guide is currently in Draft and SHOULD NOT be used for development or active implementation without express direction from the NHS England Genomics Unit.

Questionnaire-RoD-YoungPersonAssentForm-Example

The Young Person Assent Form represented as a FHIR questionnaire. If YPA forms are sent as structured resources, they should be based upon the example below.

Questionnaire

id : Questionnaire-RoD-YoungPersonAssentForm-Example

url : https://fhir.nhs.uk/Questionnaire/Questionnaire-RoD-YoungPersonAssentForm-Example

version : 0.1.0

name : QuestionnaireRoDYoungPersonAssentFormExample

title : National Genomic Research Library Young Person Assent Form (ages 6 – 15)

status : draft

subjectType : Patient

date : 2024-01-18T09:00:00Z

publisher : NHS England

contact

name : NHS England

telecom

system : email

value : interoperabilityteam@nhs.net

use : work

rank : 1

description : This questionnaire is to be used to document the patient consent for young person(ages 6 – 15) before undergoing Genomic testing and their choice of participation in the National Genomic Research Library programme

purpose : Young Person Assent Form (ages 6 – 15) Regarding Genomic Testing

item

type : display

linkId : declaration

text : Feel free to ask any questions before answering the questions below.

item

linkId : patientDetails

text : Patient Details

type : group

item

linkId : givenName

text : First Name

type : string

required : True

item

linkId : familyName

text : Last Name

type : string

required : True

item

linkId : nhs_Number

text : NHS number (or postcode if not not known)

type : string

required : True

item

linkId : birthDate

text : Date of Birth

type : date

required : True

item

type : boolean

linkId : consentQuestion1

text : 1. Have you read information or has someone explained the research to you?

required : True

item

type : boolean

linkId : consentQuestion2

text : 2. Have you asked all the questions you want?

required : True

item

type : boolean

linkId : consentQuestion3

text : 3. Have you had your questions answered in a way you understand?

required : True

item

type : boolean

linkId : consentQuestion4

text : 4. Do you understand it’s OK to say you don’t want to take part – but that your parent(s), or guardian who look after you, will make the final choice?

required : True

item

type : boolean

linkId : consentQuestion5

text : 5. Are you happy to take part?

required : True

type : group

linkId : declarationResponse

text : Please indicate your choices below by ticking the appropriate box:

readOnly : True

item

type : display

linkId : NonWillingToConsent1

text : • Don’t sign your name on this form

item

type : display

linkId : NonWillingToConsent2

text : • Tell your parents and healthcare team how you feel, so they know

type : group

linkId : guidanceNonWillingToConsent

text : If ANY of your answers are ‘NO’, or you don’t want to take part:

item

type : display

linkId : WillingToConsent

text : • Please write your name, signature, and today’s date here:

type : group

linkId : guidanceWillingToConsent

text : If ALL of your answers are ‘YES’:

item

type : boolean

linkId : isRemoteConsentTrue

text : Assent obtained remotely, no participant signature

required : True

item

type : string

linkId : patientNamecombined

text : Patient Name

required : True

item

type : string

linkId : patientSignature

text : Signature

required : True

item

type : dateTime

linkId : datePatientCompletedForm

text : Date

required : True

type : group

linkId : patientValidation

text : Patient Validation

enableWhen

question : consentQuestion1

operator : =

answer : True

enableWhen

question : consentQuestion2

operator : =

answer : True

enableWhen

question : consentQuestion3

operator : =

answer : True

enableWhen

question : consentQuestion4

operator : =

answer : True

enableWhen

question : consentQuestion5

operator : =

answer : True

enableWhen

question : isRemoteConsentTrue

operator : =

answer : False

enableBehavior : all

{
    "resourceType": "Questionnaire",
    "id": "Questionnaire-RoD-YoungPersonAssentForm-Example",
    "url": "https://fhir.nhs.uk/Questionnaire/Questionnaire-RoD-YoungPersonAssentForm-Example",
    "version": "0.1.0",
    "name": "QuestionnaireRoDYoungPersonAssentFormExample",
    "title": "National Genomic Research Library Young Person Assent Form (ages 6 – 15)",
    "status": "draft",
    "subjectType":  [
        "Patient"
    ],
    "date": "2024-01-18T09:00:00Z",
    "publisher": "NHS England",
    "contact":  [
        {
            "name": "NHS England",
            "telecom":  [
                {
                    "system": "email",
                    "value": "interoperabilityteam@nhs.net",
                    "use": "work",
                    "rank": 1
                }
            ]
        }
    ],
    "description": "This questionnaire is to be used to document the patient consent for young person(ages 6 – 15) before undergoing Genomic testing and their choice of participation in the National Genomic Research Library programme",
    "purpose": "Young Person Assent Form (ages 6 – 15) Regarding Genomic Testing",
    "item":  [
        {
            "type": "display",
            "linkId": "declaration",
            "text": "Feel free to ask any questions before answering the questions below."
        },
        {
            "linkId": "patientDetails",
            "text": "Patient Details",
            "type": "group",
            "item":  [
                {
                    "linkId": "givenName",
                    "text": "First Name",
                    "type": "string",
                    "required": true
                },
                {
                    "linkId": "familyName",
                    "text": "Last Name",
                    "type": "string",
                    "required": true
                },
                {
                    "linkId": "nhs_Number",
                    "text": "NHS number (or postcode if not not known)",
                    "type": "string",
                    "required": true
                },
                {
                    "linkId": "birthDate",
                    "text": "Date of Birth",
                    "type": "date",
                    "required": true
                }
            ]
        },
        {
            "item":  [
                {
                    "type": "boolean",
                    "linkId": "consentQuestion1",
                    "text": "1. Have you read information or has someone explained the research to you?",
                    "required": true
                },
                {
                    "type": "boolean",
                    "linkId": "consentQuestion2",
                    "text": "2. Have you asked all the questions you want?",
                    "required": true
                },
                {
                    "type": "boolean",
                    "linkId": "consentQuestion3",
                    "text": "3. Have you had your questions answered in a way you understand?",
                    "required": true
                },
                {
                    "type": "boolean",
                    "linkId": "consentQuestion4",
                    "text": "4. Do you understand it’s OK to say you don’t want to take part – but that your parent(s), or guardian who look after you, will make the final choice?",
                    "required": true
                },
                {
                    "type": "boolean",
                    "linkId": "consentQuestion5",
                    "text": "5. Are you happy to take part?",
                    "required": true
                }
            ],
            "type": "group",
            "linkId": "declarationResponse",
            "text": "Please indicate your choices below by ticking the appropriate box:",
            "readOnly": true
        },
        {
            "item":  [
                {
                    "type": "display",
                    "linkId": "NonWillingToConsent1",
                    "text": "• Don’t sign your name on this form"
                },
                {
                    "type": "display",
                    "linkId": "NonWillingToConsent2",
                    "text": "• Tell your parents and healthcare team how you feel, so they know"
                }
            ],
            "type": "group",
            "linkId": "guidanceNonWillingToConsent",
            "text": "If ANY of your answers are ‘NO’, or you don’t want to take part:"
        },
        {
            "item":  [
                {
                    "type": "display",
                    "linkId": "WillingToConsent",
                    "text": "• Please write your name, signature, and today’s date here:"
                }
            ],
            "type": "group",
            "linkId": "guidanceWillingToConsent",
            "text": "If ALL of your answers are ‘YES’:"
        },
        {
            "type": "boolean",
            "linkId": "isRemoteConsentTrue",
            "text": "Assent obtained remotely, no participant signature",
            "required": true
        },
        {
            "item":  [
                {
                    "type": "string",
                    "linkId": "patientNamecombined",
                    "text": "Patient Name",
                    "required": true
                },
                {
                    "type": "string",
                    "linkId": "patientSignature",
                    "text": "Signature",
                    "required": true
                },
                {
                    "type": "dateTime",
                    "linkId": "datePatientCompletedForm",
                    "text": "Date",
                    "required": true
                }
            ],
            "type": "group",
            "linkId": "patientValidation",
            "text": "Patient Validation",
            "enableWhen":  [
                {
                    "question": "consentQuestion1",
                    "operator": "=",
                    "answerBoolean": true
                },
                {
                    "question": "consentQuestion2",
                    "operator": "=",
                    "answerBoolean": true
                },
                {
                    "question": "consentQuestion3",
                    "operator": "=",
                    "answerBoolean": true
                },
                {
                    "question": "consentQuestion4",
                    "operator": "=",
                    "answerBoolean": true
                },
                {
                    "question": "consentQuestion5",
                    "operator": "=",
                    "answerBoolean": true
                },
                {
                    "question": "isRemoteConsentTrue",
                    "operator": "=",
                    "answerBoolean": false
                }
            ],
            "enableBehavior": "all"
        }
    ]
}

<Questionnaire xmlns="http://hl7.org/fhir">
    <id value="Questionnaire-RoD-YoungPersonAssentForm-Example" />
    <url value="https://fhir.nhs.uk/Questionnaire/Questionnaire-RoD-YoungPersonAssentForm-Example" />
    <version value="0.1.0" />
    <name value="QuestionnaireRoDYoungPersonAssentFormExample" />
    <title value="National Genomic Research Library Young Person Assent Form (ages 6 – 15)" />
    <status value="draft" />
    <subjectType value="Patient" />
    <date value="2024-01-18T09:00:00Z" />
    <publisher value="NHS England" />
    <contact>
        <name value="NHS England" />
        <telecom>
            <system value="email" />
            <value value="interoperabilityteam@nhs.net" />
            <use value="work" />
            <rank value="1" />
        </telecom>
    </contact>
    <description value="This questionnaire is to be used to document the patient consent for young person(ages 6 – 15) before undergoing Genomic testing and their choice of participation in the National Genomic Research Library programme" />
    <purpose value="Young Person Assent Form (ages 6 – 15) Regarding Genomic Testing" />
    <item>
        <linkId value="declaration" />
        <text value="Feel free to ask any questions before answering the questions below." />
        <type value="display" />
    </item>
    <item>
        <linkId value="patientDetails" />
        <text value="Patient Details" />
        <type value="group" />
        <item>
            <linkId value="givenName" />
            <text value="First Name" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="familyName" />
            <text value="Last Name" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="nhs_Number" />
            <text value="NHS number (or postcode if not not known)" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="birthDate" />
            <text value="Date of Birth" />
            <type value="date" />
            <required value="true" />
        </item>
    </item>
    <item>
        <linkId value="declarationResponse" />
        <text value="Please indicate your choices below by ticking the appropriate box:" />
        <type value="group" />
        <readOnly value="true" />
        <item>
            <linkId value="consentQuestion1" />
            <text value="1. Have you read information or has someone explained the research to you?" />
            <type value="boolean" />
            <required value="true" />
        </item>
        <item>
            <linkId value="consentQuestion2" />
            <text value="2. Have you asked all the questions you want?" />
            <type value="boolean" />
            <required value="true" />
        </item>
        <item>
            <linkId value="consentQuestion3" />
            <text value="3. Have you had your questions answered in a way you understand?" />
            <type value="boolean" />
            <required value="true" />
        </item>
        <item>
            <linkId value="consentQuestion4" />
            <text value="4. Do you understand it’s OK to say you don’t want to take part – but that your parent(s), or guardian who look after you, will make the final choice?" />
            <type value="boolean" />
            <required value="true" />
        </item>
        <item>
            <linkId value="consentQuestion5" />
            <text value="5. Are you happy to take part?" />
            <type value="boolean" />
            <required value="true" />
        </item>
    </item>
    <item>
        <linkId value="guidanceNonWillingToConsent" />
        <text value="If ANY of your answers are ‘NO’, or you don’t want to take part:" />
        <type value="group" />
        <item>
            <linkId value="NonWillingToConsent1" />
            <text value="• Don’t sign your name on this form" />
            <type value="display" />
        </item>
        <item>
            <linkId value="NonWillingToConsent2" />
            <text value="• Tell your parents and healthcare team how you feel, so they know" />
            <type value="display" />
        </item>
    </item>
    <item>
        <linkId value="guidanceWillingToConsent" />
        <text value="If ALL of your answers are ‘YES’:" />
        <type value="group" />
        <item>
            <linkId value="WillingToConsent" />
            <text value="• Please write your name, signature, and today’s date here:" />
            <type value="display" />
        </item>
    </item>
    <item>
        <linkId value="isRemoteConsentTrue" />
        <text value="Assent obtained remotely, no participant signature" />
        <type value="boolean" />
        <required value="true" />
    </item>
    <item>
        <linkId value="patientValidation" />
        <text value="Patient Validation" />
        <type value="group" />
        <enableWhen>
            <question value="consentQuestion1" />
            <operator value="=" />
            <answerBoolean value="true" />
        </enableWhen>
        <enableWhen>
            <question value="consentQuestion2" />
            <operator value="=" />
            <answerBoolean value="true" />
        </enableWhen>
        <enableWhen>
            <question value="consentQuestion3" />
            <operator value="=" />
            <answerBoolean value="true" />
        </enableWhen>
        <enableWhen>
            <question value="consentQuestion4" />
            <operator value="=" />
            <answerBoolean value="true" />
        </enableWhen>
        <enableWhen>
            <question value="consentQuestion5" />
            <operator value="=" />
            <answerBoolean value="true" />
        </enableWhen>
        <enableWhen>
            <question value="isRemoteConsentTrue" />
            <operator value="=" />
            <answerBoolean value="false" />
        </enableWhen>
        <enableBehavior value="all" />
        <item>
            <linkId value="patientNamecombined" />
            <text value="Patient Name" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="patientSignature" />
            <text value="Signature" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="datePatientCompletedForm" />
            <text value="Date" />
            <type value="dateTime" />
            <required value="true" />
        </item>
    </item>
</Questionnaire>

Notice

Questionnaire-RoD-YoungPersonAssentForm-Example

Propose a change to Questionnaire-RoD-YoungPersonAssentForm-Example