Single Institutional Review Board (sIRB) Implementation Guide
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Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

Example QuestionnaireResponse: Example Consent Form Questionnaire Response

LinkIdTextDefinitionAnswerdoco
.. consent-form-populate-exampleQRQuestionnaireResponse
... c1Research Study
.... c1.1Study TitleStudy of Drug A for arthritis
.... c1.2IRB Protocol NumberPRO098765
... c38Study Site
.... ExternalDataFor_c38.1External Data For linkId c38.1
.... c38.1Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below.[not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
.... c38.2Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI?expandedYes-NoIndicator N: No
... c40Study Site Principal Investigator and Study Site
.... c40.1Multi-site statementThis research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed.
.... c40.3Statement for Consent Form at Relying Site (not Lead PI Site)This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site.
.... c40.5Principal Investigator at Study Site
..... c40.5.2First NameXi-Yang
..... c40.5.1Last NameLee
..... c40.5.6SuffixJr.
..... c40.5.3Degree(s)MD, PhD
..... c40.5.4Associated InstitutionTest Example University
..... c40.5.8Contact Information
...... c40.5.8.20Phone6781233456
...... c40.5.8.21EmailXiYangLee@teu.med.edu
.... c40.9Study Site Institution
..... c40.9.1Institution NameTest Example University
..... c40.9.2Address
...... c40.9.2.10Street Address200 Test Example Circle
...... c40.9.2.11CityExample
...... c40.9.2.12StateMA
...... c40.9.2.13Zip Code67890
...... c40.9.2.14CountryUnited States
... c49Lead Principal Investigator and Lead Principal Investigator Site
.... c49.1Statement about Lead PI and Lead PI Site for Consent Form at Relying SiteIn multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information.
.... c49.2Lead Principal Investigator
..... c49.2.2First NameJane
..... c49.2.1Last NameDoe
..... c49.2.3Degree(s)MD
..... c49.2.5Contact Information
...... c49.2.5.20Phone567-123-1234
...... c49.2.5.21Emaildrjanedoe@sampleuniversity.edu
.... c49.5Lead Principal Investigator Institution
..... c49.5.1NameSample University Medical Center
..... c49.5.2Address
...... c49.5.2.10Street Address105 Sample University Ct.
...... c49.5.2.11CitySample City
...... c49.5.2.12StateNC
...... c49.5.2.13Zip Code27612
...... c49.5.2.14CountryUnited States
... c4Sponsor or Funding Source
.... ExternalDataFor_c4.1External Data For linkId c4.1
.... c4.1Sponsor Name
... c6Is this consent an eConsent?expandedYes-NoIndicator N: No
... c7Summary Text
.... c7.1Summary Text StatementThis field should contain a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
... c8Introduction and Statement of Research
.... c8.1About Consent FormThis consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate.
... c9Purpose
.... c9.1Reason for ResearchThis study is to determine the efficacy of Drug A for arthritis and whether it is more effective than the standard of care treatment.
.... c9.2Interactions with othersParticipants can expect to interact with the study coordinator during their visits, with some other personnel providing clinical services and procedures.
.... c9.3Invited ParticipantsCandidates for this study include patients suffering from arthritis.
.... c9.4Total expected study enrollment500
.... c9.5Additional Enrollment TextAdditional Text can be inserted here.
.... c9.6What is involved in the study?This study will involve an initial visit for collection of health history and demographic data, a baseline clinical visit, a follow up visit and an end of study clinical visit.
... c10Assessments
.... c10.1Assessment List
..... c10.1.1Name of the AssessmentInitial health history and demographic data survey
..... c10.1.2Description of AssessmentParticipants will be asked about health history and demographic background
.... c10.1Assessment List
..... c10.1.1Name of the AssessmentBaseline Blood Draw
..... c10.1.2Description of Assessment4 tubes of blood will be drawn
.... c10.1Assessment List
..... c10.1.1Name of the AssessmentRecurring monthly blood draws
..... c10.1.2Description of Assessment2 tubes of blood will be drawn
.... c10.1Assessment List
..... c10.1.1Name of the AssessmentEnd of Study Blood Draw
..... c10.1.2Description of Assessment4 tubes of blood will be drawn
.... c10.2Assessment Supplemental TextAdditional Text about the assessments can be included here.
.... c10.3Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire?expandedYes-NoIndicator N: No
... c11Visits and Procedures
.... c11.1Visit Introductory Textexplain any additional detail or information about the visit schedule.
.... c11.2Visit List
..... c11.2.1Visit TypeInitial visit
..... c11.2.2Visit DescriptionCollection of health history and demographic data
..... c11.2.3Visit Duration2
..... c11.2.4Visit Duration UnitsUnified Code for Units of Measure (UCUM) h: h
..... c11.2.5Number of Visits1
.... c11.2Visit List
..... c11.2.1Visit TypeBaseline Visit
..... c11.2.2Visit DescriptionCollection of baseline measures
..... c11.2.3Visit Duration1
..... c11.2.4Visit Duration UnitsUnified Code for Units of Measure (UCUM) h: h
..... c11.2.5Number of Visits1
.... c11.2Visit List
..... c11.2.1Visit TypeFollow up Visit
..... c11.2.2Visit DescriptionRecurring monthly visits for blood draw and weight check
..... c11.2.3Visit Duration30
..... c11.2.4Visit Duration UnitsUnified Code for Units of Measure (UCUM) min: min
..... c11.2.5Number of Visits6
.... c11.2Visit List
..... c11.2.1Visit TypeEnd of study visit
..... c11.2.2Visit DescriptionCollection of end of study measures
..... c11.2.3Visit Duration1
..... c11.2.4Visit Duration UnitsUnified Code for Units of Measure (UCUM) h: h
..... c11.2.5Number of Visits1
.... c11.6Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire?expandedYes-NoIndicator N: No
.... c11.3Procedure List
..... c11.3.1Name of ProcedureWeight check
..... c11.3.2Common Term of ProcedureWeight check
..... c11.3.3Description of a ProcedureParticipants will be weighed on a scale
..... c11.3.4Experimental Procedure IndicatorexpandedYes-NoIndicator N: No
..... c11.3.5Research IndicatorTemporary Codes STDCR: Standard of Care
..... c11.3.6FrequencyAt baseline visit, at end of study visit and at monthly follow up visits
..... c11.3.9Procedure Duration (minutes)1
.... c11.3Procedure List
..... c11.3.1Name of ProcedureBaseline visit and End of Study visit Venipuncture
..... c11.3.2Common Term of ProcedureBlood Draw
..... c11.3.3Description of a ProcedurePhelebotomist will draw 4 tubes of blood at Baseline visit and End of Study visit
..... c11.3.4Experimental Procedure IndicatorexpandedYes-NoIndicator N: No
..... c11.3.5Research IndicatorTemporary Codes STDCR: Standard of Care
..... c11.3.6FrequencyAt Baseline visit and End of Study visit
..... c11.3.9Procedure Duration (minutes)20
.... c11.3Procedure List
..... c11.3.1Name of ProcedureRecurring monthly Venipuncture
..... c11.3.2Common Term of ProcedureBlood Draw
..... c11.3.3Description of a ProcedurePhelebotomist will draw 2 tubes of blood monthly
..... c11.3.4Experimental Procedure IndicatorexpandedYes-NoIndicator N: No
..... c11.3.5Research IndicatorTemporary Codes STDCR: Standard of Care
..... c11.3.6Frequencymonthly
..... c11.3.9Procedure Duration (minutes)15
.... c11.4Procedure Supplemental TextAdditional Text can be captured here
.... c11.9Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire?expandedYes-NoIndicator N: No
.... c11.5Total Duration of Study Participation7 months
... c12Risks
.... c12.1Risk List
..... c12.1.1Name of the riskBruising
..... c12.1.2Description of RiskBlood draw may cause some mild bruising
..... c12.1.3Risk CategoryTemporary Codes PHYS: Physical
.... c12.9Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire?expandedYes-NoIndicator N: No
.... c12.2Risk Supplemental TextAdditional risk text can be included here
.... c12.3Fetal RisksexpandedYes-NoIndicator N: No
... c13Alternative Procedures
.... c13.1Alternative Procedure TextParticipants are free to not participate at no additional risk.
... c14Benefits
.... c14.1Benefits List
..... c14.1.1Name of BenefitSocietal Benefit of additional knowledge
..... c14.1.2Description of BenefitSocietal Benefit
..... c14.1.3Benefit to youexpandedYes-NoIndicator N: No
..... c14.1.4Benefit to societyexpandedYes-NoIndicator Y: Yes
.... c14.9Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire?expandedYes-NoIndicator N: No
... c15Compensation
.... c15.1Will there be compensation for participation?expandedYes-NoIndicator Y: Yes
.... c15.2Compensation Supplemental TextDescription of compensation can be included
.... c15.3Compensation List
..... c15.3.1What types of visits or milestones will I be compensated for?Baseline
..... c15.3.2How many visits or milestones of this type will there be compensation for?1
..... c15.3.3How much will be paid per that type of visit?100
.... c15.3Compensation List
..... c15.3.1What types of visits or milestones will I be compensated for?Followup
..... c15.3.2How many visits or milestones of this type will there be compensation for?6
..... c15.3.3How much will be paid per that type of visit?25
.... c15.3Compensation List
..... c15.3.1What types of visits or milestones will I be compensated for?End of Study visit
..... c15.3.2How many visits or milestones of this type will there be compensation for?1
..... c15.3.3How much will be paid per that type of visit?100
.... c15.5Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire?expandedYes-NoIndicator N: No
... c17Participant Rights and whom to contact for answers
.... c17.2Site IRB Contact Information
..... c17.2.8IRB NameX Pharmaceutical Research IRB
..... c17.2.10Street Address210 Research Drive
..... c17.2.11CitySample City
..... c17.2.12StateNC
..... c17.2.13Zip Code27612
..... c17.2.14CountryUnited States
.... c17.3Study Coordinator Contact Information
..... c17.3.1Study Coordinator Name[Study Coordinator Contact Information]
..... c17.3.8Study Coordinator Institution or Organization[Study Coordinator Contact Information]
..... c17.3.9Department Name or Division[Study Coordinator Contact Information]
..... c17.3.10Street Address[Study Coordinator Contact Information]
..... c17.3.11City[Study Coordinator Contact Information]
..... c17.3.12State[Study Coordinator Contact Information]
..... c17.3.13Zip Code[Study Coordinator Contact Information]
..... c17.3.14Country[Study Coordinator Contact Information]
..... c17.3.20Phone[Study Coordinator Contact Information]
..... c17.3.21Email[Study Coordinator Contact Information]
.... c17.4Site Principal Investigator Contact Information
..... c17.4.1Site Principal Investigator NameXi-Yang Lee, Jr., MD, PhD
..... c17.4.8Site Principal Investigator InstitutionTest Example University
..... c17.4.10Street Address200 Test Example Circle
..... c17.4.11CityExample
..... c17.4.12StateMA
..... c17.4.13Zip Code67890
..... c17.4.14CountryUnited States
..... c17.4.20Phone6781233456
..... c17.4.21EmailXiYangLee@teu.med.edu
... c18Participation
.... c18.1Voluntary Permission StatementParticipation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
.... c18.2What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.Participants can be removed from the study if their condition changes such that the study procedures are not advised for their existing conditions.
... c19Early Withdrawal
.... c19.1Are there consequences to participant for early withdrawal?expandedYes-NoIndicator Y: Yes
.... c19.2Are there Emotional Consequences of WithdrawalexpandedYes-NoIndicator N: No
.... c19.3Are there Physical Consequences of WithdrawalexpandedYes-NoIndicator N: No
.... c19.4What are the consequences of withdrawal?Consequences of withdrawal should be included here.
... c20Confidentiality of Records
.... c20.1Will HIPAA content be included within this document?expandedYes-NoIndicator Y: Yes
.... c20.2Medical information and billing statementMedical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care.
.... c20.3Will confidentiality be protected?expandedYes-NoIndicator Y: Yes
.... c20.5Are there data security or policies that need to be included in the consent, particularly around device use (optional)expandedYes-NoIndicator N: No
.... c20.7Who can use or see participant information?
..... c20.7.1Role or group who will have access to dataTemporary Codes OTHINSTRES: Researchers at other institutions
..... c20.7.2Description of Information DisclosedDeidentified demographic data
.... c20.7Who can use or see participant information?
..... c20.7.1Role or group who will have access to dataTemporary Codes THISINSTRES: Researchers outside the study team at this institution
..... c20.7.2Description of Information DisclosedDeidentified demographic data
.... c20.8Will the data be released for future use?expandedYes-NoIndicator Y: Yes
.... c20.9Will the future use data be deidentified?expandedYes-NoIndicator Y: Yes
.... c20.10Deidentification detailOnly demographic data will be shared
.... c20.11Required text disclosure surrounding future use.Temporary Codes DEIDUSED: Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.
... c21Specimen Management
.... c21.1Were specimens collected as part of this study?expandedYes-NoIndicator Y: Yes
.... c21.2Is whole genome sequencing being conducted?expandedYes-NoIndicator N: No
.... c21.3Sharing or no Sharing of samples.expandedYes-NoIndicator Y: Yes
.... c21.4Conditions of sharingDeidentified samples will be shared with other investigators at this institution.
.... c21.5Will participant share in profit with commerical use?expandedYes-NoIndicator N: No
.... c21.6Description of Collection and StorageSamples are stored with only a deidentified code. Only the study coordinator will retain this link, which will be destroyed at study conclusion.
.... c21.7Can consent for sample use be revoked?expandedYes-NoIndicator N: No
... c22Will there be Broad Consent for Storage, maintenance and secondary research use?expandedYes-NoIndicator N: No
... c23Can the study team contact you for future research?expandedYes-NoIndicator Y: Yes
.... c23.1Conditions about contact for additional sample use, information not currently described or future researchParticipants can be called for up to 1 year after conclusion of the study
... c24Will participants share in commercial profit?expandedYes-NoIndicator N: No
... c25Will the study team contact you with new information that may affect your willingness to remain in the studyexpandedYes-NoIndicator N: No
... c26Will the study team disclose clinically relevant study results to you?expandedYes-NoIndicator N: No
... c27Clinical Trials.gov statementA description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
... c28Is this study covered under a Certificate of Confidentiality? (default Y in NIH)expandedYes-NoIndicator N: No
... c30Statement of PHI Authorization RevocationParticipants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.
... c31Signature
.... c31.1Indicator to include Participant Signature and Date/TimeexpandedYes-NoIndicator Y: Yes
.... c31.2Indicator to include Assent Signature and Date/TimeexpandedYes-NoIndicator N: No
.... c31.3Indicator to include Legally Authorized Representative Signature and Date/TimeexpandedYes-NoIndicator Y: Yes
.... c31.5Indicator to include a Witness Signature and Date/TimeexpandedYes-NoIndicator Y: Yes
.... c31.6Indicator to include Parent 1 Signature and Date/TimeexpandedYes-NoIndicator N: No
.... c31.7Indicator to include Parent 2 Signature and Date/TimeexpandedYes-NoIndicator N: No
... c32Consent Version
.... c32.1Consent Version Number2
.... c32.2sIRB Version Date of Consent2021-08-10
.... c32.3Relying Site Version Date of Consent2021-08-10
.... c32.6Expiration Date of Consent2024-08-01T03:59:59.846Z
... ADMIN00Administrative Use Only
.... ADMIN01Link ID prefixc
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if anyinitiate-study-populate-exampleQR
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if anyResearchStudyExample-sIRB

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