Questionnaire

Questionnaire-Genomic Testing

The Record of Discussion form represented as a FHIR questionnaire. If RoD forms are sent as structured resources, they should be based upon the example below.

Questionnaire
{
    "resourceType": "Questionnaire",
    "id": "NHSDigital-Questionnaire-Genomics-Example",
    "url": "https://fhir.nhs.uk/Questionnaire/NHSDigital-Questionnaire-Genomics-Example",
    "version": "0.1.0",
    "name": "NHSDigitalQuestionnaireGenomicsExample",
    "title": "Record of Discussion Regarding Genomic Testing-Example",
    "status": "draft",
    "subjectType":  [
        "Patient"
    ],
    "date": "2023-01-03T15:33:46.3652804+00:00",
    "publisher": "HL7 UK",
    "contact":  [
        {
            "name": "HL7 UK",
            "telecom":  [
                {
                    "system": "email",
                    "value": "secretariat@hl7.org.uk",
                    "use": "work",
                    "rank": 1
                }
            ]
        },
        {
            "name": "NHS Digital",
            "telecom":  [
                {
                    "system": "email",
                    "value": "interoperabilityteam@nhs.net",
                    "use": "work",
                    "rank": 2
                }
            ]
        }
    ],
    "description": "This questionnaire is to be used to document the patient consent or the consent of their power of attorney before undergoing Genomic testing and their choice of participation in the National Genomic Research Library programme",
    "purpose": "Record of Discussion Regarding Genomic Testing",
    "item":  [
        {
            "linkId": "declaration",
            "text": "This form relates to the person being tested. One form is required for each person. All of the statements below remain relevant even if the test relates to someone other than yourself, for example your child.",
            "type": "display"
        },
        {
            "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
                }
            ]
        },
        {
            "linkId": "declaration1",
            "text": "I have discussed genomic testing with my health professional and understand the following",
            "type": "group",
            "item":  [
                {
                    "linkId": "familyWiderImplications",
                    "prefix": "Family and wider implications:",
                    "text": "1. The results of my test may have implications for me and members of my family. I understand that my results may also be used to help the healthcare of members of my family and others nationally and internationally. This could be done in discussion with me or through a process that will not personally identify me.",
                    "type": "display"
                },
                {
                    "linkId": "uncertainty",
                    "prefix": "Uncertainty:",
                    "text": "2. The results of my test may have findings that are uncertain and not yet fully understood. To decide whether findings are significant for myself or others, my data may be compared to other patients’ results across the country and internationally. I understand that this could change what my results mean for me and my treatment over time.",
                    "type": "display"
                },
                {
                    "linkId": "unexpectedInfo",
                    "prefix": "Unexpected information:",
                    "text": "3. The results of my test may also reveal unexpected results that are not related to why I am having this test. These may be found by chance and I may need further tests or investigations to understand their significance.",
                    "type": "display"
                },
                {
                    "linkId": "dnaStorage",
                    "prefix": "DNA storage:",
                    "text": "4. Normal NHS laboratory practice is to store the DNA extracted from my sample even after my current testing is complete. My DNA might be used for future analysis and/or to ensure that other testing (for example that of family members) is of high quality.",
                    "type": "display"
                },
                {
                    "linkId": "dataStorage",
                    "prefix": "Data storage:",
                    "text": "5. The data from my genomic test will be securely stored so that it can be looked at again in the future if necessary.",
                    "type": "display"
                },
                {
                    "linkId": "healthRecords",
                    "prefix": "Health records:",
                    "text": "6. Results from my genomic test will be part of my patient record, a copy of which is held in a national system only available to healthcare professionals.",
                    "type": "display"
                },
                {
                    "linkId": "resarch",
                    "prefix": "Research:",
                    "text": "7. I understand that I have the opportunity to take part in research which may benefit myself or others, now or in the future. An offer to join a national research opportunity is available on the following page.",
                    "type": "display"
                }
            ]
        },
        {
            "linkId": "furtherQuestion",
            "text": "For any further questions, my healthcare professional can provide information. More information regarding genomic testing and how my data is protected can be found at www.nhs.uk/conditions/genetics.",
            "type": "display"
        },
        {
            "linkId": "pageOneBottomInstruction",
            "text": "Please sign on page three to confirm your agreement to the genomic test.",
            "type": "display"
        },
        {
            "linkId": "pageTwoTitle",
            "text": "The National Genomic Research Library",
            "type": "group",
            "item":  [
                {
                    "linkId": "declaration2",
                    "text": "The NHS invites you to contribute to the National Genomic Research Library, managed by Genomics England. Genomics England was set up in 2013 by the Department of Health and Social Care to work with the NHS to build a library of human genomes for researchers to study. Combining data from many different patients helps researchers to better understand disease and spot patterns in the data. By agreeing to share your data you might get results which could lead to your own diagnosis, a new treatment, or offers to take part in clinical trials. Your taking part could enable diagnoses for people who don’t have one. Please read the following statements. Feel free to ask any questions before making a decision.",
                    "type": "display"
                },
                {
                    "linkId": "declaration3",
                    "text": "By saying ‘yes’ to research, I understand the following",
                    "type": "group",
                    "item":  [
                        {
                            "linkId": "dataAccess",
                            "prefix": "The National Genomic Research Library",
                            "text": "1. NHS England, on behalf of the Trusts that provided your genomic test, will allow Genomics England to access my personal data including my genomic record.",
                            "type": "display"
                        },
                        {
                            "linkId": "security",
                            "prefix": "Security:",
                            "text": "2. Any samples and data stored by Genomics England and the NHS will always be stored securely. Genomics England will take all reasonable steps to ensure that I cannot be personally identified.",
                            "type": "display"
                        },
                        {
                            "linkId": "recontact3",
                            "prefix": "Re-contact:",
                            "text": "3. My clinical team or Genomics England together with my clinical team, can contact me if the data or samples reveals any clinical trials or other research that I might benefit from.",
                            "type": "display"
                        },
                        {
                            "linkId": "recontact4",
                            "prefix": "Re-contact:",
                            "text": "4. If something is relevant to me or my family, there is a process by which this will be shared with my NHS clinical team.",
                            "type": "display"
                        },
                        {
                            "linkId": "dataSampleUsage",
                            "prefix": "Data and sample usage:",
                            "text": "5. Researchers may include national or international scientists, healthcare companies and NHS staff. To access the data, these researchers must all be approved by an independent committee of experts, including health professionals, clinical academics and patients. There will be no access to the data by personal insurers and marketing companies.",
                            "type": "display"
                        },
                        {
                            "linkId": "dataStorageResearch",
                            "prefix": "Data storage:",
                            "text": "6. Genomics England will collect different aspects of my health data from the NHS and other data from organisations listed at https://www.genomicsengland.co.uk/privacy-policy/.The collection and analysis of my health data for research will continue across my entire lifetime and beyond.",
                            "type": "display"
                        },
                        {
                            "linkId": "withdrawal",
                            "prefix": "Withdrawal",
                            "text": "7. I can change my mind about taking part at any time.",
                            "type": "display"
                        }
                    ]
                }
            ]
        },
        {
            "linkId": "researchInformation",
            "text": "More information regarding research in the National Genomic Research Library can be found at www.genomicsengland.co.uk.For any further questions, my healthcare professional can provide information.",
            "type": "display"
        },
        {
            "linkId": "guidetoSignPage3",
            "text": "Please use page three to indicate your research choices",
            "type": "display"
        },
        {
            "linkId": "declaration4",
            "text": "Confirmation of Your Genomic Test and Research Choices",
            "type": "group",
            "item":  [
                {
                    "linkId": "confirmation",
                    "text": "I confirm that I have had the opportunity to discuss information about genomic testing, I agree to the genomic test, and my research choice is indicated below.",
                    "type": "group",
                    "item":  [
                        {
                            "linkId": "researchConfirmation1",
                            "prefix": "A.",
                            "text": "I have discussed taking part in the National Genomic Research Library. If your answer to A is NO then please ignore B and sign directly below",
                            "type": "boolean",
                            "required": true
                        },
                        {
                            "linkId": "researchConfirmation2",
                            "prefix": "B.",
                            "text": "I agree that my data and remainder sample may contribute to the National Genomic Research Library",
                            "type": "boolean",
                            "enableWhen":  [
                                {
                                    "question": "researchConfirmation1",
                                    "operator": "=",
                                    "answerBoolean": true
                                }
                            ],
                            "required": true
                        }
                    ]
                }
            ]
        },
        {
            "text": "Are you completing this form on behalf of someone?",
            "linkId": "isRespondentAttorney",
            "type": "boolean",
            "required": true
        },
        {
            "linkId": "patientValidation",
            "text": "Patient Validation",
            "type": "group",
            "enableWhen":  [
                {
                    "question": "isRespondentAttorney",
                    "operator": "=",
                    "answerBoolean": false
                }
            ],
            "item":  [
                {
                    "linkId": "patientNamecombined",
                    "text": "Patient Name",
                    "type": "string",
                    "required": true
                },
                {
                    "linkId": "patientSignature",
                    "text": "Signature",
                    "type": "string",
                    "required": true
                },
                {
                    "linkId": "datePatientCompletedForm",
                    "text": "Date",
                    "type": "dateTime",
                    "required": true
                }
            ]
        },
        {
            "linkId": "attorney",
            "text": "If you are signing this form on behalf of someone else (children, adults without capacity or deceased patients) then please indicate your relationship role and  sign below.",
            "type": "group",
            "enableWhen":  [
                {
                    "question": "isRespondentAttorney",
                    "operator": "=",
                    "answerBoolean": true
                }
            ],
            "item":  [
                {
                    "linkId": "attorneyType",
                    "text": "Parent | Guardian | Consultee *(please select your applicable relationship)",
                    "type": "choice",
                    "answerValueSet": "https://fhir.nhs.uk/ValueSet/genomics-patientguardian-types",
                    "required": true
                },
                {
                    "linkId": "attorneyName",
                    "text": "Name",
                    "type": "string",
                    "required": true
                },
                {
                    "linkId": "attorneySignature",
                    "text": "Signature",
                    "type": "string",
                    "required": true
                },
                {
                    "linkId": "dateAttorneyCompletedForm",
                    "text": "Date",
                    "type": "dateTime",
                    "required": true
                }
            ]
        },
        {
            "linkId": "declaration5",
            "text": "Healthcare professional use only",
            "type": "group",
            "item":  [
                {
                    "linkId": "healthcareProfessional",
                    "text": "To be completed by the healthcare professional recording the patient’s choices.",
                    "type": "group",
                    "item":  [
                        {
                            "linkId": "patientCategory",
                            "text": "Patient category",
                            "type": "choice",
                            "required": true,
                            "answerValueSet": "https://fhir.nhs.uk/ValueSet/genomics-patient-choice-category"
                        },
                        {
                            "linkId": "testType",
                            "text": "Test type",
                            "type": "choice",
                            "required": true,
                            "answerValueSet": "https://fhir.nhs.uk/ValueSet/genomics-test-types"
                        },
                        {
                            "linkId": "reasonsforChoiceA",
                            "text": "If answer to research choice A is NO",
                            "type": "choice",
                            "enableWhen":  [
                                {
                                    "question": "researchConfirmation1",
                                    "operator": "!=",
                                    "answerBoolean": true
                                }
                            ],
                            "answerValueSet": "https://fhir.nhs.uk/ValueSet/genomics-patient-choice-researchparticipation",
                            "required": true
                        },
                        {
                            "linkId": "remoteConsent",
                            "text": "Remote consent, recorded remotely by clinician, no patient signature",
                            "type": "boolean",
                            "required": true
                        },
                        {
                            "linkId": "responsibleClinician",
                            "text": "Responsible clinician",
                            "type": "string",
                            "required": true
                        },
                        {
                            "linkId": "patientMRN",
                            "text": "Hospital number",
                            "type": "string",
                            "required": true
                        },
                        {
                            "linkId": "healthcareProfessionalName",
                            "text": "Healthcare professional name",
                            "type": "string",
                            "required": true
                        },
                        {
                            "linkId": "healthcareProfessionalSignature",
                            "text": "Signature",
                            "type": "string",
                            "required": true
                        },
                        {
                            "linkId": "datehealthcareProfessionalCompletedForm",
                            "text": "Date",
                            "type": "dateTime",
                            "required": true
                        }
                    ]
                }
            ]
        }
    ]
}
<Questionnaire xmlns="http://hl7.org/fhir">
    <id value="NHSDigital-Questionnaire-Genomics-Example" />
    <url value="https://fhir.nhs.uk/Questionnaire/NHSDigital-Questionnaire-Genomics-Example" />
    <version value="0.1.0" />
    <name value="NHSDigitalQuestionnaireGenomicsExample" />
    <title value="Record of Discussion Regarding Genomic Testing-Example" />
    <status value="draft" />
    <subjectType value="Patient" />
    <date value="2023-01-03T15:33:46.3652804+00:00" />
    <publisher value="HL7 UK" />
    <contact>
        <name value="HL7 UK" />
        <telecom>
            <system value="email" />
            <value value="secretariat@hl7.org.uk" />
            <use value="work" />
            <rank value="1" />
        </telecom>
    </contact>
    <contact>
        <name value="NHS Digital" />
        <telecom>
            <system value="email" />
            <value value="interoperabilityteam@nhs.net" />
            <use value="work" />
            <rank value="2" />
        </telecom>
    </contact>
    <description value="This questionnaire is to be used to document the patient consent or the consent of their power of attorney before undergoing Genomic testing and their choice of participation in the National Genomic Research Library programme" />
    <purpose value="Record of Discussion Regarding Genomic Testing" />
    <item>
        <linkId value="declaration" />
        <text value="This form relates to the person being tested. One form is required for each person. All of the statements below remain relevant even if the test relates to someone other than yourself, for example your child." />
        <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="declaration1" />
        <text value="I have discussed genomic testing with my health professional and understand the following" />
        <type value="group" />
        <item>
            <linkId value="familyWiderImplications" />
            <prefix value="Family and wider implications:" />
            <text value="1. The results of my test may have implications for me and members of my family. I understand that my results may also be used to help the healthcare of members of my family and others nationally and internationally. This could be done in discussion with me or through a process that will not personally identify me." />
            <type value="display" />
        </item>
        <item>
            <linkId value="uncertainty" />
            <prefix value="Uncertainty:" />
            <text value="2. The results of my test may have findings that are uncertain and not yet fully understood. To decide whether findings are significant for myself or others, my data may be compared to other patients’ results across the country and internationally. I understand that this could change what my results mean for me and my treatment over time." />
            <type value="display" />
        </item>
        <item>
            <linkId value="unexpectedInfo" />
            <prefix value="Unexpected information:" />
            <text value="3. The results of my test may also reveal unexpected results that are not related to why I am having this test. These may be found by chance and I may need further tests or investigations to understand their significance." />
            <type value="display" />
        </item>
        <item>
            <linkId value="dnaStorage" />
            <prefix value="DNA storage:" />
            <text value="4. Normal NHS laboratory practice is to store the DNA extracted from my sample even after my current testing is complete. My DNA might be used for future analysis and/or to ensure that other testing (for example that of family members) is of high quality." />
            <type value="display" />
        </item>
        <item>
            <linkId value="dataStorage" />
            <prefix value="Data storage:" />
            <text value="5. The data from my genomic test will be securely stored so that it can be looked at again in the future if necessary." />
            <type value="display" />
        </item>
        <item>
            <linkId value="healthRecords" />
            <prefix value="Health records:" />
            <text value="6. Results from my genomic test will be part of my patient record, a copy of which is held in a national system only available to healthcare professionals." />
            <type value="display" />
        </item>
        <item>
            <linkId value="resarch" />
            <prefix value="Research:" />
            <text value="7. I understand that I have the opportunity to take part in research which may benefit myself or others, now or in the future. An offer to join a national research opportunity is available on the following page." />
            <type value="display" />
        </item>
    </item>
    <item>
        <linkId value="furtherQuestion" />
        <text value="For any further questions, my healthcare professional can provide information. More information regarding genomic testing and how my data is protected can be found at www.nhs.uk/conditions/genetics." />
        <type value="display" />
    </item>
    <item>
        <linkId value="pageOneBottomInstruction" />
        <text value="Please sign on page three to confirm your agreement to the genomic test." />
        <type value="display" />
    </item>
    <item>
        <linkId value="pageTwoTitle" />
        <text value="The National Genomic Research Library" />
        <type value="group" />
        <item>
            <linkId value="declaration2" />
            <text value="The NHS invites you to contribute to the National Genomic Research Library, managed by Genomics England. Genomics England was set up in 2013 by the Department of Health and Social Care to work with the NHS to build a library of human genomes for researchers to study. Combining data from many different patients helps researchers to better understand disease and spot patterns in the data. By agreeing to share your data you might get results which could lead to your own diagnosis, a new treatment, or offers to take part in clinical trials. Your taking part could enable diagnoses for people who don’t have one. Please read the following statements. Feel free to ask any questions before making a decision." />
            <type value="display" />
        </item>
        <item>
            <linkId value="declaration3" />
            <text value="By saying ‘yes’ to research, I understand the following" />
            <type value="group" />
            <item>
                <linkId value="dataAccess" />
                <prefix value="The National Genomic Research Library" />
                <text value="1. NHS England, on behalf of the Trusts that provided your genomic test, will allow Genomics England to access my personal data including my genomic record." />
                <type value="display" />
            </item>
            <item>
                <linkId value="security" />
                <prefix value="Security:" />
                <text value="2. Any samples and data stored by Genomics England and the NHS will always be stored securely. Genomics England will take all reasonable steps to ensure that I cannot be personally identified." />
                <type value="display" />
            </item>
            <item>
                <linkId value="recontact3" />
                <prefix value="Re-contact:" />
                <text value="3. My clinical team or Genomics England together with my clinical team, can contact me if the data or samples reveals any clinical trials or other research that I might benefit from." />
                <type value="display" />
            </item>
            <item>
                <linkId value="recontact4" />
                <prefix value="Re-contact:" />
                <text value="4. If something is relevant to me or my family, there is a process by which this will be shared with my NHS clinical team." />
                <type value="display" />
            </item>
            <item>
                <linkId value="dataSampleUsage" />
                <prefix value="Data and sample usage:" />
                <text value="5. Researchers may include national or international scientists, healthcare companies and NHS staff. To access the data, these researchers must all be approved by an independent committee of experts, including health professionals, clinical academics and patients. There will be no access to the data by personal insurers and marketing companies." />
                <type value="display" />
            </item>
            <item>
                <linkId value="dataStorageResearch" />
                <prefix value="Data storage:" />
                <text value="6. Genomics England will collect different aspects of my health data from the NHS and other data from organisations listed at https://www.genomicsengland.co.uk/privacy-policy/.The collection and analysis of my health data for research will continue across my entire lifetime and beyond." />
                <type value="display" />
            </item>
            <item>
                <linkId value="withdrawal" />
                <prefix value="Withdrawal" />
                <text value="7. I can change my mind about taking part at any time." />
                <type value="display" />
            </item>
        </item>
    </item>
    <item>
        <linkId value="researchInformation" />
        <text value="More information regarding research in the National Genomic Research Library can be found at www.genomicsengland.co.uk.For any further questions, my healthcare professional can provide information." />
        <type value="display" />
    </item>
    <item>
        <linkId value="guidetoSignPage3" />
        <text value="Please use page three to indicate your research choices" />
        <type value="display" />
    </item>
    <item>
        <linkId value="declaration4" />
        <text value="Confirmation of Your Genomic Test and Research Choices" />
        <type value="group" />
        <item>
            <linkId value="confirmation" />
            <text value="I confirm that I have had the opportunity to discuss information about genomic testing, I agree to the genomic test, and my research choice is indicated below." />
            <type value="group" />
            <item>
                <linkId value="researchConfirmation1" />
                <prefix value="A." />
                <text value="I have discussed taking part in the National Genomic Research Library. If your answer to A is NO then please ignore B and sign directly below" />
                <type value="boolean" />
                <required value="true" />
            </item>
            <item>
                <linkId value="researchConfirmation2" />
                <prefix value="B." />
                <text value="I agree that my data and remainder sample may contribute to the National Genomic Research Library" />
                <type value="boolean" />
                <enableWhen>
                    <question value="researchConfirmation1" />
                    <operator value="=" />
                    <answerBoolean value="true" />
                </enableWhen>
                <required value="true" />
            </item>
        </item>
    </item>
    <item>
        <linkId value="isRespondentAttorney" />
        <text value="Are you completing this form on behalf of someone?" />
        <type value="boolean" />
        <required value="true" />
    </item>
    <item>
        <linkId value="patientValidation" />
        <text value="Patient Validation" />
        <type value="group" />
        <enableWhen>
            <question value="isRespondentAttorney" />
            <operator value="=" />
            <answerBoolean value="false" />
        </enableWhen>
        <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>
    <item>
        <linkId value="attorney" />
        <text value="If you are signing this form on behalf of someone else (children, adults without capacity or deceased patients) then please indicate your relationship role and  sign below." />
        <type value="group" />
        <enableWhen>
            <question value="isRespondentAttorney" />
            <operator value="=" />
            <answerBoolean value="true" />
        </enableWhen>
        <item>
            <linkId value="attorneyType" />
            <text value="Parent | Guardian | Consultee *(please select your applicable relationship)" />
            <type value="choice" />
            <required value="true" />
            <answerValueSet value="https://fhir.nhs.uk/ValueSet/genomics-patientguardian-types" />
        </item>
        <item>
            <linkId value="attorneyName" />
            <text value="Name" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="attorneySignature" />
            <text value="Signature" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="dateAttorneyCompletedForm" />
            <text value="Date" />
            <type value="dateTime" />
            <required value="true" />
        </item>
    </item>
    <item>
        <linkId value="declaration5" />
        <text value="Healthcare professional use only" />
        <type value="group" />
        <item>
            <linkId value="healthcareProfessional" />
            <text value="To be completed by the healthcare professional recording the patient’s choices." />
            <type value="group" />
            <item>
                <linkId value="patientCategory" />
                <text value="Patient category" />
                <type value="choice" />
                <required value="true" />
                <answerValueSet value="https://fhir.nhs.uk/ValueSet/genomics-patient-choice-category" />
            </item>
            <item>
                <linkId value="testType" />
                <text value="Test type" />
                <type value="choice" />
                <required value="true" />
                <answerValueSet value="https://fhir.nhs.uk/ValueSet/genomics-test-types" />
            </item>
            <item>
                <linkId value="reasonsforChoiceA" />
                <text value="If answer to research choice A is NO" />
                <type value="choice" />
                <enableWhen>
                    <question value="researchConfirmation1" />
                    <operator value="!=" />
                    <answerBoolean value="true" />
                </enableWhen>
                <required value="true" />
                <answerValueSet value="https://fhir.nhs.uk/ValueSet/genomics-patient-choice-researchparticipation" />
            </item>
            <item>
                <linkId value="remoteConsent" />
                <text value="Remote consent, recorded remotely by clinician, no patient signature" />
                <type value="boolean" />
                <required value="true" />
            </item>
            <item>
                <linkId value="responsibleClinician" />
                <text value="Responsible clinician" />
                <type value="string" />
                <required value="true" />
            </item>
            <item>
                <linkId value="patientMRN" />
                <text value="Hospital number" />
                <type value="string" />
                <required value="true" />
            </item>
            <item>
                <linkId value="healthcareProfessionalName" />
                <text value="Healthcare professional name" />
                <type value="string" />
                <required value="true" />
            </item>
            <item>
                <linkId value="healthcareProfessionalSignature" />
                <text value="Signature" />
                <type value="string" />
                <required value="true" />
            </item>
            <item>
                <linkId value="datehealthcareProfessionalCompletedForm" />
                <text value="Date" />
                <type value="dateTime" />
                <required value="true" />
            </item>
        </item>
    </item>
</Questionnaire>


Questionnaire-RoD-ConsulteeDeclarationForm-Example

The Consultee Declaration Form represented as a FHIR questionnaire. If CD forms are sent as structured resources, they should be based upon the example below.

Questionnaire
{
    "resourceType": "Questionnaire",
    "id": "Questionnaire-RoD-ConsulteeDeclarationForm-Example",
    "url": "https://fhir.nhs.uk/Questionnaire/Questionnaire-RoD-ConsulteeDeclarationForm-Example",
    "version": "0.1.0",
    "name": "QuestionnaireRoDConsulteeDeclarationFormExample",
    "title": "Consultee declaration regarding whole genome sequencing",
    "status": "draft",
    "subjectType":  [
        "Patient"
    ],
    "date": "2023-09-15T09:00:00Z",
    "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 consent of a patient Consultee before undergoing Genomic testing and their choice of participation in the National Genomic Research Library programme",
    "purpose": "Consultee declaration regarding whole genome sequencing",
    "item":  [
        {
            "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
                },
                {
                    "type": "date",
                    "linkId": "birthDate",
                    "text": "Date of Birth",
                    "required": true
                }
            ],
            "type": "group",
            "linkId": "patientDetails",
            "text": "Patient Details"
        },
        {
            "type": "display",
            "linkId": "consulteeConsentAwareness",
            "text": "Your relative, friend, patient or client has been invited to take part in the National Genomic Research Library. You are being asked to act as a consultee on their behalf."
        },
        {
            "type": "display",
            "linkId": "guidanceForConsultee",
            "text": "Your relative, friend, patient or client is considered to be unable to decide for themselves whether they want their data and samples to be used in research. Someone who can’t make this kind of decision for themselves is described as lacking capacity. When we talk about this person, we will refer to ‘the person who lacks capacity’ or ‘the person’."
        },
        {
            "type": "display",
            "linkId": "roleOfConsultee",
            "text": "The role of a consultee"
        },
        {
            "type": "display",
            "linkId": "roleOfConsultee1",
            "text": "A consultee is someone who will only consider the likely views and interests of the person who lacks capacity. They must set aside their own personal views about participating in research and consider the person they represent. A consultee cannot be part of the person’s NHS clinical team or anyone else acting in a professional or paid capacity (e.g. a person’s solicitor)."
        },
        {
            "item":  [
                {
                    "type": "display",
                    "linkId": "typesOfConsultee1",
                    "text": "• Next of kin (i.e. parent, partner, husband, wife, son or daughter) or friend, family member or carer"
                },
                {
                    "type": "display",
                    "linkId": "typesOfConsultee2",
                    "text": "• A person holding Lasting Power of Attorney for Personal welfare registered with the Public Guardian"
                },
                {
                    "type": "display",
                    "linkId": "typesOfConsultee3",
                    "text": "• A deputy appointed by the Court of Protection"
                }
            ],
            "type": "group",
            "linkId": "typesOfConsultee",
            "text": "They must be an adult who is prepared to be consulted on the person’s behalf. For example:"
        },
        {
            "type": "display",
            "linkId": "guidanceOnConsulteeRole",
            "text": "The law protects the interests of adults who lack capacity. In England and Wales, it states that a consultee can advise about the person’s likely wishes or feelings. If the person does not want to take part, we will respect their wishes. More information about being a consultee and the National Genomic Research Library can be found at www.genomicsengland.co.uk"
        },
        {
            "type": "display",
            "linkId": "consulteeAgreement",
            "text": "The consultee agreement"
        },
        {
            "item":  [
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility1",
                    "text": "• I must only consider the likely views and interests of the person who lacks capacity"
                },
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility2",
                    "text": "• I must consider the aims of the research, the practicalities, risks and benefits"
                },
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility3",
                    "text": "• I will inform the healthcare team of any decisions the person may have already made about research"
                },
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility4",
                    "text": "• I have been made aware and given an opportunity to get independent advice"
                },
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility5",
                    "text": "• If I feel that the person wishes to be withdrawn, I will notify a healthcare professional"
                },
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility6",
                    "text": "• I might be asked to give advice again in the future, for example if more blood or saliva samples were needed"
                },
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility7",
                    "text": "• Hospital staff will tell me if any future changes to the research might affect the person"
                },
                {
                    "type": "display",
                    "linkId": "consulteeResponsibility8",
                    "text": "• I can stop being a consultee at any time"
                }
            ],
            "type": "group",
            "linkId": "consulteeResponsibility",
            "text": "By saying ‘yes’ to be a consultee, I understand that:"
        },
        {
            "type": "display",
            "linkId": "clarificationForConfirmation",
            "text": "Please ask any questions before taking the decisions shown on the following page."
        },
        {
            "item":  [
                {
                    "item":  [
                        {
                            "type": "boolean",
                            "linkId": "choiceConfirmation1",
                            "prefix": "1.",
                            "text": "I have been consulted about this person’s participation in the National Genomic Research Library",
                            "required": true
                        },
                        {
                            "type": "display",
                            "linkId": "isChoiceOfConfirmationFalse",
                            "text": "If your answer to 1 is NO, then please ignore 2 and sign below."
                        },
                        {
                            "type": "boolean",
                            "linkId": "choiceConfirmation2",
                            "prefix": "2.",
                            "text": "I am willing to accept the role of consultee for this person",
                            "enableWhen":  [
                                {
                                    "question": "choiceConfirmation1",
                                    "operator": "=",
                                    "answerBoolean": true
                                }
                            ],
                            "required": true
                        }
                    ],
                    "type": "group",
                    "linkId": "confirmation",
                    "text": "I confirm that I have read and had the opportunity to discuss information about acting as a consultee for the person lacking capacity. My research choices are indicated below."
                }
            ],
            "type": "group",
            "linkId": "confirmationOfDecision",
            "text": "Confirmation of decision"
        },
        {
            "type": "boolean",
            "linkId": "isRemoteConsentTrue",
            "text": "Consent obtained remotely, no consultee signature",
            "required": true
        },
        {
            "item":  [
                {
                    "type": "string",
                    "linkId": "consulteeNamecombined",
                    "text": "Your Name(i.e, the Consultee)",
                    "required": true
                },
                {
                    "type": "dateTime",
                    "linkId": "dateConsulteeCompletedForm",
                    "text": "Date",
                    "required": true
                },
                {
                    "type": "string",
                    "linkId": "consulteeSignature",
                    "text": "Signature",
                    "enableWhen":  [
                        {
                            "question": "isRemoteConsentTrue",
                            "operator": "=",
                            "answerBoolean": false
                        }
                    ],
                    "required": true
                }
            ],
            "type": "group",
            "linkId": "consulteeValidation",
            "text": "Consultee Validation"
        },
        {
            "item":  [
                {
                    "item":  [
                        {
                            "type": "string",
                            "linkId": "healthcareProfessionalName",
                            "text": "Healthcare professional name",
                            "required": true
                        },
                        {
                            "linkId": "healthcareProfessionalSignature",
                            "text": "Signature",
                            "type": "string",
                            "required": true
                        },
                        {
                            "linkId": "datehealthcareProfessionalCompletedForm",
                            "text": "Date",
                            "type": "dateTime",
                            "required": true
                        }
                    ],
                    "type": "group",
                    "linkId": "healthcareProfessional",
                    "text": "To be completed by the healthcare professional recording the consultee’s choices."
                }
            ],
            "type": "group",
            "linkId": "healthcareProfessionalValidation",
            "text": "Healthcare professional use only"
        }
    ]
}
<Questionnaire xmlns="http://hl7.org/fhir">
    <id value="Questionnaire-RoD-ConsulteeDeclarationForm-Example" />
    <url value="https://fhir.nhs.uk/Questionnaire/Questionnaire-RoD-ConsulteeDeclarationForm-Example" />
    <version value="0.1.0" />
    <name value="QuestionnaireRoDConsulteeDeclarationFormExample" />
    <title value="Consultee declaration regarding whole genome sequencing" />
    <status value="draft" />
    <subjectType value="Patient" />
    <date value="2023-09-15T09:00:00Z" />
    <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 consent of a patient Consultee before undergoing Genomic testing and their choice of participation in the National Genomic Research Library programme" />
    <purpose value="Consultee declaration regarding whole genome sequencing" />
    <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="consulteeConsentAwareness" />
        <text value="Your relative, friend, patient or client has been invited to take part in the National Genomic Research Library. You are being asked to act as a consultee on their behalf." />
        <type value="display" />
    </item>
    <item>
        <linkId value="guidanceForConsultee" />
        <text value="Your relative, friend, patient or client is considered to be unable to decide for themselves whether they want their data and samples to be used in research. Someone who can’t make this kind of decision for themselves is described as lacking capacity. When we talk about this person, we will refer to ‘the person who lacks capacity’ or ‘the person’." />
        <type value="display" />
    </item>
    <item>
        <linkId value="roleOfConsultee" />
        <text value="The role of a consultee" />
        <type value="display" />
    </item>
    <item>
        <linkId value="roleOfConsultee1" />
        <text value="A consultee is someone who will only consider the likely views and interests of the person who lacks capacity. They must set aside their own personal views about participating in research and consider the person they represent. A consultee cannot be part of the person’s NHS clinical team or anyone else acting in a professional or paid capacity (e.g. a person’s solicitor)." />
        <type value="display" />
    </item>
    <item>
        <linkId value="typesOfConsultee" />
        <text value="They must be an adult who is prepared to be consulted on the person’s behalf. For example:" />
        <type value="group" />
        <item>
            <linkId value="typesOfConsultee1" />
            <text value="• Next of kin (i.e. parent, partner, husband, wife, son or daughter) or friend, family member or carer" />
            <type value="display" />
        </item>
        <item>
            <linkId value="typesOfConsultee2" />
            <text value="• A person holding Lasting Power of Attorney for Personal welfare registered with the Public Guardian" />
            <type value="display" />
        </item>
        <item>
            <linkId value="typesOfConsultee3" />
            <text value="• A deputy appointed by the Court of Protection" />
            <type value="display" />
        </item>
    </item>
    <item>
        <linkId value="guidanceOnConsulteeRole" />
        <text value="The law protects the interests of adults who lack capacity. In England and Wales, it states that a consultee can advise about the person’s likely wishes or feelings. If the person does not want to take part, we will respect their wishes. More information about being a consultee and the National Genomic Research Library can be found at www.genomicsengland.co.uk" />
        <type value="display" />
    </item>
    <item>
        <linkId value="consulteeAgreement" />
        <text value="The consultee agreement" />
        <type value="display" />
    </item>
    <item>
        <linkId value="consulteeResponsibility" />
        <text value="By saying ‘yes’ to be a consultee, I understand that:" />
        <type value="group" />
        <item>
            <linkId value="consulteeResponsibility1" />
            <text value="• I must only consider the likely views and interests of the person who lacks capacity" />
            <type value="display" />
        </item>
        <item>
            <linkId value="consulteeResponsibility2" />
            <text value="• I must consider the aims of the research, the practicalities, risks and benefits" />
            <type value="display" />
        </item>
        <item>
            <linkId value="consulteeResponsibility3" />
            <text value="• I will inform the healthcare team of any decisions the person may have already made about research" />
            <type value="display" />
        </item>
        <item>
            <linkId value="consulteeResponsibility4" />
            <text value="• I have been made aware and given an opportunity to get independent advice" />
            <type value="display" />
        </item>
        <item>
            <linkId value="consulteeResponsibility5" />
            <text value="• If I feel that the person wishes to be withdrawn, I will notify a healthcare professional" />
            <type value="display" />
        </item>
        <item>
            <linkId value="consulteeResponsibility6" />
            <text value="• I might be asked to give advice again in the future, for example if more blood or saliva samples were needed" />
            <type value="display" />
        </item>
        <item>
            <linkId value="consulteeResponsibility7" />
            <text value="• Hospital staff will tell me if any future changes to the research might affect the person" />
            <type value="display" />
        </item>
        <item>
            <linkId value="consulteeResponsibility8" />
            <text value="• I can stop being a consultee at any time" />
            <type value="display" />
        </item>
    </item>
    <item>
        <linkId value="clarificationForConfirmation" />
        <text value="Please ask any questions before taking the decisions shown on the following page." />
        <type value="display" />
    </item>
    <item>
        <linkId value="confirmationOfDecision" />
        <text value="Confirmation of decision" />
        <type value="group" />
        <item>
            <linkId value="confirmation" />
            <text value="I confirm that I have read and had the opportunity to discuss information about acting as a consultee for the person lacking capacity. My research choices are indicated below." />
            <type value="group" />
            <item>
                <linkId value="choiceConfirmation1" />
                <prefix value="1." />
                <text value="I have been consulted about this person’s participation in the National Genomic Research Library" />
                <type value="boolean" />
                <required value="true" />
            </item>
            <item>
                <linkId value="isChoiceOfConfirmationFalse" />
                <text value="If your answer to 1 is NO, then please ignore 2 and sign below." />
                <type value="display" />
            </item>
            <item>
                <linkId value="choiceConfirmation2" />
                <prefix value="2." />
                <text value="I am willing to accept the role of consultee for this person" />
                <type value="boolean" />
                <enableWhen>
                    <question value="choiceConfirmation1" />
                    <operator value="=" />
                    <answerBoolean value="true" />
                </enableWhen>
                <required value="true" />
            </item>
        </item>
    </item>
    <item>
        <linkId value="isRemoteConsentTrue" />
        <text value="Consent obtained remotely, no consultee signature" />
        <type value="boolean" />
        <required value="true" />
    </item>
    <item>
        <linkId value="consulteeValidation" />
        <text value="Consultee Validation" />
        <type value="group" />
        <item>
            <linkId value="consulteeNamecombined" />
            <text value="Your Name(i.e, the Consultee)" />
            <type value="string" />
            <required value="true" />
        </item>
        <item>
            <linkId value="dateConsulteeCompletedForm" />
            <text value="Date" />
            <type value="dateTime" />
            <required value="true" />
        </item>
        <item>
            <linkId value="consulteeSignature" />
            <text value="Signature" />
            <type value="string" />
            <enableWhen>
                <question value="isRemoteConsentTrue" />
                <operator value="=" />
                <answerBoolean value="false" />
            </enableWhen>
            <required value="true" />
        </item>
    </item>
    <item>
        <linkId value="healthcareProfessionalValidation" />
        <text value="Healthcare professional use only" />
        <type value="group" />
        <item>
            <linkId value="healthcareProfessional" />
            <text value="To be completed by the healthcare professional recording the consultee’s choices." />
            <type value="group" />
            <item>
                <linkId value="healthcareProfessionalName" />
                <text value="Healthcare professional name" />
                <type value="string" />
                <required value="true" />
            </item>
            <item>
                <linkId value="healthcareProfessionalSignature" />
                <text value="Signature" />
                <type value="string" />
                <required value="true" />
            </item>
            <item>
                <linkId value="datehealthcareProfessionalCompletedForm" />
                <text value="Date" />
                <type value="dateTime" />
                <required value="true" />
            </item>
        </item>
    </item>
</Questionnaire>


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
{
    "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>