Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

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

Questionnaire: Consent Form Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate Version: 1.0.0
Draft as of 2023-04-24 Computable Name: Consent_Questionnaire
Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. Consent_QuestionnaireQuestionnairehttp://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate#1.0.0
... c1Research Study0..1group
.... c1.1Study Title0..1textExpressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.2').answer.value
..... c1.1_helpShort Title of the Research Study0..1display
.... c1.2IRB Protocol Number0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.3').answer.value
... c38Study Site0..1group
.... ExternalDataFor_c38.1External Data For linkId c38.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
.... 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.0..1choice
..... c38.1_helpThis question and its answer will not print on the Consent Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.0..1display
.... 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?1..1choiceOptions: 2 options
Expressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.5.4').answer.valueCoding
..... c38.2_helpThis question and its answer will not print on the Consent Form but are necessary for the form logic.0..1display
... c40Study Site Principal Investigator and Study Site0..1group
.... c40.1Multi-site statement0..1textInitial Value: string = This 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.
.... c40.2Statement for Consent Form at Lead PI Site0..1textEnable When: c38.2 = Yes (expandedYes-NoIndicator#Y)
Initial Value: string = In 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 site where you are participating in the study is the lead or main site. The lead study site is responsible for all study activities for the overall study. The principal investigator(PI) is responsible for the conduct of the study. The PI for your study is the lead principal investigator, responsible for the overall study.
.... c40.3Statement for Consent Form at Relying Site (not Lead PI Site)0..1textEnable When: c38.2 != Yes (expandedYes-NoIndicator#Y)
Initial Value: string = 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 Site0..1group
..... c40.5.2First Name0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value
...... c40.5.2_helpFirst or given name of the relying site PI0..1display
..... c40.5.1Last Name0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value
...... c40.5.1_helpSurname or family name of the relying site PI0..1display
..... c40.5.6Suffix0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value
...... c40.5.6_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... c40.5.3Degree(s)0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value
...... c40.5.3_helpProfessional and Academic degrees of the relying site PI0..1display
..... c40.5.4Associated Institution0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
...... c40.5.4_helpRelying site PI's Academic or Professional Institution0..1display
..... c40.5.8Contact Information0..1group
...... c40.5.8.20Phone0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value
....... c40.5.8.20_help10-digit phone number, including area code0..1display
...... c40.5.8.21Email0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value
...... c40.5.8_helpInformation on how to contact the Site PI.0..1display
..... c40.5_helpPrincipal Investigator at Relying Site conducting the study, responsible for the conduct of the study at the relying site0..1display
.... c40.9Study Site Institution0..1group
..... c40.9.1Institution Name0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
...... c40.9.1_helpPublic or private entity conducting the study- where the participant will go or call0..1display
..... c40.9.2Address0..1group
...... c40.9.2.10Street Address0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value
...... c40.9.2.11City0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value
...... c40.9.2.12State0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value
...... c40.9.2.13Zip Code0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value
...... c40.9.2.14Country0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value
..... c40.9_helpInformation about institution for the site where study will be conducted0..1display
... c49Lead Principal Investigator and Lead Principal Investigator Site0..1groupEnable When: c38.2 != Yes (expandedYes-NoIndicator#Y)
.... c49.1Statement about Lead PI and Lead PI Site for Consent Form at Relying Site0..1textEnable When: c38.2 != Yes (expandedYes-NoIndicator#Y)
Initial Value: string = In 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 Investigator0..1group
..... c49.2.2First Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value
...... c49.2.2_helpFirst or given name of the lead PI0..1display
..... c49.2.1Last Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value
...... c49.2.1_helpSurname or family name of the lead PI0..1display
..... c49.2.6Suffix0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value
...... c49.2.6_helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.0..1display
..... c49.2.3Degree(s)0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
...... c49.2.3_helpProfessional and Academic degrees of the lead PI0..1display
..... c49.2.5Contact Information0..1group
...... c49.2.5.20Phone0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value
....... c49.2.5.20_help10-digit phone number, including area code0..1display
...... c49.2.5.21Email0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
...... c49.2.5_helpInformation on how to contact the Lead PI.0..1display
..... c49.2_helpPerson(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial.0..1display
.... c49.5Lead Principal Investigator Institution0..1groupEnable When: c38.2 != Yes (expandedYes-NoIndicator#Y)
..... c49.5.1Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value
...... c49.5.1_helpPublic or private entity associated with the lead principal investigator conducting the overall study.0..1display
..... c49.5.2Address0..1group
...... c49.5.2.10Street Address0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value
...... c49.5.2.11City0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value
...... c49.5.2.12State0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value
...... c49.5.2.13Zip Code0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value
...... c49.5.2.14Country0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value
..... c49.5_helpInformation about Lead Institution0..1display
... c4Sponsor or Funding Source0..1group
.... ExternalDataFor_c4.1External Data For linkId c4.10..*open-choiceiconExpressions:
  • Initial Value: %lookupInitiateStudy.item.where(repeat(item).where(linkId = 'in5.1' and answer.value.code = 'SFS')).repeat(item).where(linkId = 'in5.2').answer.value
.... c4.1Sponsor Name0..*open-choice
..... c4.1_helpEntity financially supporting the research0..1display
... c5Sponsor Detail0..1text
.... c5_helpAny additional relevant information about the sponsor(s)0..1display
... c6Is this consent an eConsent?0..1choiceOptions: 2 options
.... c6_helpConsent that is obtained electronically0..1display
... c7Summary Text0..1group
.... c7.1Summary Text Statement1..1text
..... c7.1_helpDescribes the basic purpose, procedures and reasons behind the research in easily understood prose0..1display
.... c7_helpSection header for the mandated text describing the basic purpose, procedures and reasons for the study.0..1display
... c8Introduction and Statement of Research0..1group
.... c8.1About Consent Form0..1textInitial Value: string = This 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.
.... c8_helpIntroductory Paragraph to the participant. Includes statement of research and explanation of the consent process.0..1display
... c9Purpose0..1group
.... c9.1Reason for Research0..1text
..... c9.1_helpExplanation about why the study is being conducted0..1display
.... c9.2Interactions with others0..1text
..... c9.2_helpStatement of whom the participant can anticipate interacting with during study participation0..1display
.... c9.3Invited Participants0..1text
..... c9.3_helpHigh level information about what participating in the study will entail for the participant0..1display
.... c9.4Total expected study enrollment0..1integer
..... c9.4_helpThe total number of people targeted for enrollment in the multi-site study0..1display
.... c9.5Additional Enrollment Text0..1text
..... c9.5_helpAdditional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site0..1display
.... c9.6What is involved in the study?0..1text
..... c9.6_helpHigh level information about what participating in the study will entail for the participant.0..1display
... c10Assessments0..1group
.... c10.1Assessment List0..*group
..... c10.1.1Name of the Assessment0..1string
...... c10.1.1_helpShort name of the assessment0..1display
..... c10.1.2Description of Assessment0..1text
...... c10.1.2_helpShort description of the assessment0..1display
.... c10.31null0..1display
.... c10.2Assessment Supplemental Text0..1text
..... c10.2_helpAdditional text to provide additional context about the assessments collected0..1display
.... c10.32null0..1display
.... c10.3Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire?0..1choiceOptions: 2 options
..... c10.3_helpIf you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Assessment List" table in the questionnaire.0..1display
.... c10.4Assessment List Attachment(s)0..*groupEnable When: c10.3 = Yes (expandedYes-NoIndicator#Y)
..... c10.4.1Describe the file that is being attached (optional)0..1string
..... c10.4.2Upload attachment(s) here.0..1attachment
.... c10.33null0..1display
... c11Visits and Procedures0..1group
.... c11.1Visit Introductory Text0..1text
..... c11.1_helpIntroductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule.0..1display
.... c11.2Visit List0..*group
..... c11.2.1Visit Type0..1string
...... c11.2.1_helpUnique visit type, defined by the procedures which are completed within that visit. E.g. Screening, Baseline, Followup, Final0..1display
..... c11.2.2Visit Description0..1text
...... c11.2.2_helpDescription of Visit types, including what procedures it contains0..1display
..... c11.2.3Visit Duration0..1decimal
..... c11.2.4Visit Duration Units0..1choiceOptions: 3 options
...... c11.2.4_helpChoices for visit duration units are minutes (min), hours (h) or days (d).0..1display
..... c11.2.5Number of Visits0..1integer
.... c11.31null0..1display
.... c11.6Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire?0..1choiceOptions: 2 options
..... c11.6_helpIf you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Visit List" table in the questionnaire.0..1display
.... c11.7Visit List Attachment(s)0..*groupEnable When: c11.6 = Yes (expandedYes-NoIndicator#Y)
..... c11.7.1Describe the file that is being attached (optional)0..1string
..... c11.7.2Upload attachment(s) here.0..1attachment
.... c11.32null0..1display
.... c11.3Procedure List0..*group
..... c11.3.1Name of Procedure0..1string
..... c11.3.2Common Term of Procedure0..1string
..... c11.3.3Description of a Procedure0..1text
..... c11.3.4Experimental Procedure Indicator0..1choiceOptions: 2 options
..... c11.3.5Research Indicator0..1choiceOptions: 2 options
..... c11.3.6Frequency0..1string
...... c11.3.6_helpSpecify the procedure frequency and the applicable frequency units. For example, 4 times per year or 2 times per week.0..1display
..... c11.3.9Procedure Duration (minutes)0..1integer
...... c11.3.9_helpSpecify the procedure duration in minutes0..1display
.... c11.33null0..1display
.... c11.4Procedure Supplemental Text0..1text
..... c11.4_helpAdditional Text to include after the procedure table to provide the participant with any additional information needed about procedure schedule0..1display
.... c11.34null0..1display
.... c11.9Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire?0..1choiceOptions: 2 options
..... c11.9_helpIf you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire.0..1display
.... c11.10Procedure List Attachment(s)0..*groupEnable When: c11.9 = Yes (expandedYes-NoIndicator#Y)
..... c11.10.1Describe the file that is being attached (optional)0..1string
..... c11.10.2Upload attachment(s) here.0..1attachment
.... c11.35null0..1display
.... c11.5Total Duration of Study Participation0..1string
..... c11.5_helpTime elapsed for a participant to be part of the study from initial enrollment to final discharge or completion0..1display
... c12Risks0..1group
.... c12.1Risk List0..*group
..... c12.1.1Name of the risk0..1string
..... c12.1.2Description of Risk0..1text
..... c12.1.3Risk Category0..1choiceOptions: 2 options
.... c12.33null0..1display
.... c12.9Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire?0..1choiceOptions: 2 options
..... c12.9_helpIf you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Risk List" table in the questionnaire.0..1display
.... c12.10Risk List Attachment(s)0..*groupEnable When: c12.9 = Yes (expandedYes-NoIndicator#Y)
..... c12.10.1Describe the file that is being attached (optional)0..1string
..... c12.10.2Upload attachment(s) here.0..1attachment
.... c12.37null0..1display
.... c12.2Risk Supplemental Text0..1text
..... c12.2_helpAdditional text for description of other risks0..1display
.... c12.3Fetal Risks0..1choiceOptions: 2 options
..... c12.3_helpIndicates whether risks to the fetus are possible0..1display
.... c12.4Fetal Risk Details0..1textEnable When: c12.3 = Yes (expandedYes-NoIndicator#Y)
..... c12.4_helpTextual description of risks to the fetus0..1display
... c13Alternative Procedures0..1group
.... c13.1Alternative Procedure Text0..1text
..... c13.1_helpDescribe any other treatment/procedure that may be used other than those described for study participation.0..1display
... c14Benefits0..1group
.... c14.1Benefits List0..*group
..... c14.1.1Name of Benefit0..1string
..... c14.1.2Description of Benefit0..1text
..... c14.1.3Benefit to you0..1choiceOptions: 2 options
..... c14.1.4Benefit to society0..1choiceOptions: 2 options
.... c14.31null0..1display
.... c14.9Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire?0..1choiceOptions: 2 options
..... c14.9_helpIf you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire.0..1display
.... c14.10Benefits List Attachment(s)0..*groupEnable When: c14.9 = Yes (expandedYes-NoIndicator#Y)
..... c14.10.1Describe the file that is being attached (optional)0..1string
..... c14.10.2Upload attachment(s) here.0..1attachment
.... c14.33null0..1display
... c15Compensation0..1group
.... c15.1Will there be compensation for participation?0..1choiceOptions: 2 options
..... c15.1_helpIndicates whether compensation will be offered or not for the study0..1display
.... c15.2Compensation Supplemental Text0..1textEnable When: c15.1 = Yes (expandedYes-NoIndicator#Y)
..... c15.2_helpAdditional text about compensation not captured in the compensation table0..1display
.... c15.3Compensation List0..*groupEnable When: c15.1 = Yes (expandedYes-NoIndicator#Y)
..... c15.3.1What types of visits or milestones will I be compensated for?0..1text
..... c15.3.2How many visits or milestones of this type will there be compensation for?0..1integer
..... c15.3.3How much will be paid per that type of visit?0..1text
.... c15.33null0..1display
.... c15.5Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire?0..1choiceOptions: 2 options
..... c15.5_helpIf you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Compensation List" table in the questionnaire.0..1display
.... c15.7Compensation List Attachment(s)0..*groupEnable When: c15.5 = Yes (expandedYes-NoIndicator#Y)
..... c15.7.1Describe the file that is being attached (optional)0..1string
..... c15.7.2Upload attachment(s) here.0..1attachment
.... c15.35null0..1display
... c16Costs0..1group
.... c16.1What are the costs of participation, if any?0..1text
..... c16.1_helpExplanation informing participant if any additional costs will occur to the participant as a result of taking part in the study0..1display
.... c16.2Will there be reimbursement for other study visit costs incurred?0..1choiceOptions: 2 options
..... c16.2_helpReimbursement to participant for other study visit costs not directly associated with a visit0..1display
.... c16.3Will costs be covered for medical treatment if research related injury occurs?0..1choiceOptions: 3 options
..... c16.3_helpIndicates if participant or the participant's insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury0..1display
.... c16.4Additional description of treatment coverage0..1text
..... c16.4_helpDescription of other costs not directly associated with a visit0..1display
... c17Participant Rights and whom to contact for answers0..1group
.... c17.1What are the rights of a participant?0..1text
..... c17.1_helpStatement of particpant rights0..1display
.... c17.2Site IRB Contact Information0..1group
..... c17.2.1IRB Contact Name0..1string
..... c17.2.8IRB Name0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value
..... c17.2.9Department Name or Division0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.10').answer.value
..... c17.2.10Street Address0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.3').answer.value
..... c17.2.11City0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.4').answer.value
..... c17.2.12State0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.5').answer.value
..... c17.2.13Zip Code0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.6').answer.value
..... c17.2.14Country0..1stringExpressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.7').answer.value
..... c17.2.20Phone0..1string
...... c17.2.20_help10-digit phone number, including area code0..1display
..... c17.2.21Email0..1string
..... c17.2_helpContact information for the site IRB contact.0..1display
.... c17.3Study Coordinator Contact Information0..1group
..... c17.3.1Study Coordinator Name0..1string
..... c17.3.8Study Coordinator Institution or Organization0..1string
..... c17.3.9Department Name or Division0..1string
..... c17.3.10Street Address0..1string
..... c17.3.11City0..1string
..... c17.3.12State0..1string
..... c17.3.13Zip Code0..1string
..... c17.3.14Country0..1string
..... c17.3.20Phone0..1string
...... c17.3.20_help10-digit phone number, including area code0..1display
..... c17.3.21Email0..1string
..... c17.3_helpContact information for the study coordinator0..1display
.... c17.4Site Principal Investigator Contact Information0..1group
..... c17.4.1Site Principal Investigator Name0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.where(linkId = 'in8.10').answer.value
..... c17.4.8Site Principal Investigator Institution0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
..... c17.4.9Department Name or Division0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value
..... c17.4.10Street Address0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value
..... c17.4.11City0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value
..... c17.4.12State0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value
..... c17.4.13Zip Code0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value
..... c17.4.14Country0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value
..... c17.4.20Phone0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value
...... c17.4.20_help10-digit phone number, including area code0..1display
..... c17.4.21Email0..1stringExpressions:
  • Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value
..... c17.4_helpContact information for the PI. May be replicated from above.0..1display
... c18Participation0..1group
.... c18.1Voluntary Permission Statement0..1textInitial Value: string = Participation 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.
..... c18.1_helpStandard prepopulated statement, can be edited.0..1display
.... 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.0..1text
..... c18.2_helpAnticipated circumstances under which subject's participation may be terminated by investigator without regard to subject's or legally authorized representative's consent0..1display
... c19Early Withdrawal0..1group
.... c19.1Are there consequences to participant for early withdrawal?0..1choiceOptions: 2 options
.... c19.2Are there Emotional Consequences of Withdrawal0..1choiceEnable When: c19.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
.... c19.3Are there Physical Consequences of Withdrawal0..1choiceEnable When: c19.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
.... c19.4What are the consequences of withdrawal?0..1textEnable When: c19.1 = Yes (expandedYes-NoIndicator#Y)
..... c19.4_helpDescription of the withdrawal consequences, will depend and vary based on type of study.0..1display
... c20Confidentiality of Records0..1group
.... c20.1Will HIPAA content be included within this document?0..1choiceOptions: 2 options
.... c20.2Medical information and billing statement0..1textEnable When: c20.1 = Yes (expandedYes-NoIndicator#Y)
Initial Value: string = Medical 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.
..... c20.2_helpIf template information required for your state differs from text provided, reword to satisfy state requirements.0..1display
.... c20.3Will confidentiality be protected?0..1choiceOptions: 2 options
..... c20.3_helpIndicates if records identifying a subject will be maintained.0..1display
.... c20.4How will confidentiality be protected?0..1textEnable When: c20.3 = Yes (expandedYes-NoIndicator#Y)
..... c20.4_helpExplanation about processes and procedures to support maintaining privacy and confidentiality0..1display
.... c20.5Are there data security or policies that need to be included in the consent, particularly around device use (optional)0..1choiceOptions: 2 options
..... c20.5_helpIndicates if any data security policy applies to this consent, including device use.0..1display
.... c20.6Describe any data security policies and processes protecting the data0..1textEnable When: c20.5 = Yes (expandedYes-NoIndicator#Y)
..... c20.6_helpOptional field for capturing information on IT related data security policies. Example, use of encryption when utilizing mobile data collection0..1display
.... c20.7Who can use or see participant information?0..*group
..... c20.7.1Role or group who will have access to data0..1open-choiceOptions: 3 options
..... c20.7.2Description of Information Disclosed0..1text
.... c20.8Will the data be released for future use?0..1choiceOptions: 2 options
..... c20.8_helpIndicates whether these data will be used beyond the study window0..1display
.... c20.9Will the future use data be deidentified?0..1choiceEnable When: c20.8 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
..... c20.9_helpIndicates if shared data will retain any identifiers.0..1display
.... c20.10Deidentification detail0..1textEnable When: c20.9 = Yes (expandedYes-NoIndicator#Y)
..... c20.10_helpDescription of deidentification details for future use datasets.0..1display
.... c20.11Required text disclosure surrounding future use.0..1choiceEnable When: c20.8 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
..... c20.11_helpSelect the appropriate required text statement about disclosure surrounding future use of participant's data from the two standardized statements.0..1display
... c21Specimen Management0..1group
.... c21.1Were specimens collected as part of this study?0..1choiceOptions: 2 options
.... c21.2Is whole genome sequencing being conducted?0..1choiceEnable When: c21.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
..... c21.2_helpIndicator of if genome sequencing is being conducted in conjunction with study0..1display
.... c21.3Sharing or no Sharing of samples.0..1choiceEnable When: c21.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
..... c21.3_helpIndicator of whether biospecimens will be shared outside of the immediate study team or institution.0..1display
.... c21.4Conditions of sharing0..1textEnable When: c21.3 = Yes (expandedYes-NoIndicator#Y)
..... c21.4_helpTextual description of sharing conditions including, type, when, etc.0..1display
.... c21.5Will participant share in profit with commerical use?0..1choiceEnable When: c21.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
..... c21.5_helpIndicator of any plans to profit share any funds received as a result of commercial use of those samples.0..1display
.... c21.6Description of Collection and Storage0..1textEnable When: c21.1 = Yes (expandedYes-NoIndicator#Y)
..... c21.6_helpTextual description of collection and storage procedures and policies for the study.0..1display
.... c21.7Can consent for sample use be revoked?0..1choiceEnable When: c21.1 = Yes (expandedYes-NoIndicator#Y)
Options: 2 options
..... c21.7_helpIndicator of revocation of sample consent is an option0..1display
... c22Will there be Broad Consent for Storage, maintenance and secondary research use?0..1choiceOptions: 2 options
.... c22.1Statement of Broad Consent for Storage, maintenance and secondary research use0..1textEnable When: c22 = Yes (expandedYes-NoIndicator#Y)
Initial Value: string = Participant identifiable information and identifiable biospecimens will be stored, used and shared for the kinds of future research described in this broad consent form, without anyone asking your permission for each new study. Identifying information may also be removed from your information and biospecimens, allowing them to be used for any future research or other purpose.
... c23Can the study team contact you for future research?0..1choiceOptions: 2 options
.... c23.1Conditions about contact for additional sample use, information not currently described or future research0..1textEnable When: c23 = Yes (expandedYes-NoIndicator#Y)
..... c23.1_helpDescription of the details for which the participant could be contacted0..1display
.... c23_helpIndicator if the participant contact information can be used for future questions or recuitment for this or other studies0..1display
... c24Will participants share in commercial profit?0..1choiceOptions: 2 options
.... c24.1Details about any profit sharing agreements or why profits will not be shared.0..1textEnable When: c24 = Yes (expandedYes-NoIndicator#Y)
.... c24_helpIndicator of participants will receive any commercial profits resulting from their participation in study0..1display
... c25Will the study team contact you with new information that may affect your willingness to remain in the study0..1choiceOptions: 2 options
.... c25_helpIndicator if study team will provide updates that may affect willingness to remain in study0..1display
... c26Will the study team disclose clinically relevant study results to you?0..1choiceOptions: 2 options
.... c26.1Condtions under which the study results will be disclosed to you0..1textEnable When: c26 = Yes (expandedYes-NoIndicator#Y)
..... c26.1_helpTextual description of which results and when will be disclosed to you.0..1display
.... c26_helpIndicator of study team will provide results of lab tests or other feedback of results to you at any time.0..1display
... c27Clinical Trials.gov statement0..1texticonInitial Value: string = A 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)0..1choiceOptions: 2 options
.... c28.1Certificate of Confidentiality Statement0..1texticonEnable When: c28 = Yes (expandedYes-NoIndicator#Y)
Initial Value: string = The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use.[trunc]
..... c28.1_helpIndicator if study is covered under a certificate of confidentiality (automatially issued for NIH studies)0..1display
.... c28.2Required Disclosures based on state law0..1textEnable When: c28 = Yes (expandedYes-NoIndicator#Y)
..... c28.2_helpAdd any required text per your state laws.0..1display
... c29When will the PHI Authorization Expire based on date or time past an event0..1text
.... c29_helpPHI authorization expiration. Might be never, a certain date, or a period after a study milestone, such as 6 months after study closure.0..1display
... c30Statement of PHI Authorization Revocation0..1textInitial Value: string = Participants 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.
... c31Signature0..1group
.... c31.1Indicator to include Participant Signature and Date/Time0..1choiceOptions: 2 options
.... c31.2Indicator to include Assent Signature and Date/Time0..1choiceOptions: 2 options
.... c31.3Indicator to include Legally Authorized Representative Signature and Date/Time0..1choiceOptions: 2 options
.... c31.4Relationship of Legally Authorized Representative0..1choiceOptions: 6 options
.... c31.5Indicator to include a Witness Signature and Date/Time0..1choiceOptions: 2 options
.... c31.6Indicator to include Parent 1 Signature and Date/Time0..1choiceOptions: 2 options
.... c31.7Indicator to include Parent 2 Signature and Date/Time0..1choiceOptions: 2 options
... c32Consent Version0..1group
.... c32.1Consent Version Number0..1string
.... c32.2sIRB Version Date of Consent0..1date
..... c32.2_helpDate that changes whenever a change is made to the consent. It is the versioning system of the sIRB institution, and is updated in accordance with the institution's policy.0..1display
.... c32.3Relying Site Version Date of Consent0..1date
..... c32.3_helpA number that changes whenever a change is made to the consent. It is the versioning system of the relying institution, and is updated in accordance with the institution's policy.0..1display
.... c32.6Expiration Date of Consent0..1dateTime
... c80Other Attachments0..*group
.... c80.1Describe the file that is being attached (optional)0..1string
.... c80.2Attachment0..1attachment
.... c80_helpOther attachments that will be included in the Consent Form that will be provided to the participants should be included here.0..1display
... ADMIN00Administrative Use Only0..1groupicon
.... ADMIN01Link ID prefix0..1stringiconInitial Value: string = c
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any0..1stringiconInitial Value: string = temporarily unavailable
Expressions:
  • Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1stringicon

doco Documentation for this format

Option Sets

Answer options for c38.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c10.3

  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c11.2.4

  • http://unitsofmeasure.org#min ("min")
  • http://unitsofmeasure.org#h ("h")
  • http://unitsofmeasure.org#d ("d")

Answer options for c11.6

  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c11.3.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c11.3.5

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RES ("Research")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#STDCR ("Standard of Care")

Answer options for c11.9

  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c12.1.3

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PHYS ("Physical")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NONPHYS ("Non-Physical")

Answer options for c12.9

  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c12.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c14.1.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c14.1.4

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c14.9

  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c15.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c15.5

  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • iconhttp://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c16.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c16.3

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#TRTNOTCOV ("Treatment not covered")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RRICOV ("Research Related injury covered")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ACNOTCICOV ("Acute but not chronic injury covered")

Answer options for c19.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c19.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c19.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c20.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c20.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c20.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c20.7.1

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OTHINSTRES ("Researchers at other institutions")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#THISINSTRES ("Researchers outside the study team at this institution")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#EXTREGAUTH ("External Regulatory Authorities")

Answer options for c20.8

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c20.9

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c20.11

  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#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.")
  • http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DEIDNOTUSED ("Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.")

Answer options for c21.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c21.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c21.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c21.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c21.7

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c22

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c23

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c24

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c25

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c26

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c28

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c31.1

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c31.2

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c31.3

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c31.4

  • http://terminology.hl7.org/CodeSystem/v2-0063#PAR ("Parent")
  • http://terminology.hl7.org/CodeSystem/v2-0063#SPO ("Spouse")
  • http://terminology.hl7.org/CodeSystem/v2-0063#CHD ("Child")
  • http://terminology.hl7.org/CodeSystem/v2-0063#SIB ("Sibling")
  • http://terminology.hl7.org/CodeSystem/v2-0063#GRD ("Guardian")
  • http://terminology.hl7.org/CodeSystem/v2-0063#OTH ("Other")

Answer options for c31.5

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c31.6

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for c31.7

  • http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
  • http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")