Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example Questionnaire: Consent Questionnaire

The Consent Form Questionnaire creates the exact Consent Form content word-for-word that will be shown to the sIRB’s Institutional Review Board to be approved to use during the study. The rendering and pdf format created by the software are also provided to the sIRB to be approved.

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. Consent_QuestionnaireQuestionnaire
... c1Research Study0..1group
.... c1.1Study Title0..1text
..... c1.1-helpShort Title of the Research Study0..1display
.... c1.2IRB Protocol Number0..1string
... c2Site Principal Investigator0..1group
.... c2.2First Name0..1string
..... c2.2-helpFirst or given name associated with the site primary responsibility holder0..1display
.... c2.1Last Name0..1string
..... c2.1-helpSurname or family name associated with the site primary responsibility holder0..1display
.... c2.6Suffix0..1string
..... c2.6-helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name0..1display
.... c2.3Degree(s)0..1string
..... c2.3-helpProfessional and Academic degrees associated with the site primary responsibility holder0..1display
.... c2.4Associated Institution0..1string
..... c2.4-helpAcademic or Profressional Institution associated with the site primary responsibility holder0..1display
.... c2.5Contact Information0..1text
..... c2.5-helpInformation on how to contact the Site PI. Can include both email/phone number0..1display
.... c2-helpPI at a site conducting the study, responsible for the conduct of the study at his/her relying institution0..1display
... c3Relying Institution0..1group
.... c3.1Name0..1string
..... c3.1-helpPublic or private entity conducting the study- where the participant will go or call0..1display
.... c3.2Address0..1text
..... c3.2-helpPhysical address0..1display
.... c3-helpInformation about Lead or Site Institution where study will be conducted0..1display
... c4Sponsor or Funding Source0..*group
.... c4.1Sponsor Name0..1string
..... c4.1-helpEntity financially supporting the research0..1display
... c5Sponsor Detail0..1text
.... c5-helpRelevant 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-helpMandated paragraph that describes 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. You may take this consent form home to think about and discuss with family or friends.
.... c8-helpIntroductory Paragraph to the participant. Includes statement of research and explanation of the consent process: 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. You may take this consent form home to think about and discuss with family or friends0..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 who the participant can anticipate interacting with during their study participation0..1display
.... c9.3Invited Participants0..1text
..... c9.3-helpHigh level information about what participating in the study will entail for the participantr0..1display
.... c9.4Total expected study enrollment0..1integer
..... c9.4-helpThe number of people targeted for enrollment for 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
.... c10.2Assessment Supplemental Text0..1text
..... c10.2-helpAdditional text if needed to provide additional context about the assessments collected0..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..1text
..... c11.2.4Visit Duration Units0..1choiceOptions: 3 options
..... c11.2.5Number of Visits0..1integer
.... 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
..... c11.3.6Frequency of Procedures0..1decimal
..... c11.3.7Procedure Duration (minutes)0..1decimal
.... c11.4Procedure Supplemental Text0..1text
..... c11.4-helpAdditional Text to include after the procedure table to provide the participant any additional information needed about procedure schedule0..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
.... c12.2Risk Supplemental Text0..1text
..... c12.2_helpAdditional text for description of other costs not directly associated with a risk0..1display
.... c12.3Fetal Risks0..1choiceDefinition: 9.4
Options: 2 options
..... c12.3-helpIndicates whether risks to the fetus are possible0..1display
.... c12.4Fetal Risk Details0..1textEnable When:
..... c12.4-helpTextual description of risks to the fetus0..1display
... c13Alternative Procedures0..1group
.... c13.1Alternative Procedure Text0..1text
... c14Benefits0..*group
.... c14.1Name of Benefit0..1string
.... c14.2Description of Benefit0..1text
.... c14.3Benefit to you0..1choiceOptions: 2 options
.... c14.4Benefit to society0..1choiceOptions: 2 options
... c15Compensation0..1group
.... c15.1Will there be compensation for participation?0..1choiceDefinition: 12.1
Options: 2 options
..... c15.1-helpIndicates whether compensation will be offered or not for the study0..1display
.... c15.2Compensation Supplemental Text0..1textEnable When:
..... c15.2_helpAdditional text about compensation not captured in the compensation table0..1display
.... c15.3Compensation List0..*groupEnable When:
..... 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
... 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
.... c16.3Who will pay 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..1text
..... c17.2-helpContact information for the site IRB contact.0..1display
.... c17.3Study Coordinator Contact Information0..1text
..... c17.3-helpContact information for the site IRB contact.0..1display
.... c17.4Site Principal Investigator Contact Information0..1text
..... 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..1choiceDefinition: 18.1
Options: 2 options
.... c19.2Are there Emotional Consequences of Withdrawal0..1choiceEnable When:
Options: 2 options
.... c19.3Are there Physical Consequences of Withdrawal0..1choiceEnable When:
Options: 2 options
.... c19.4What are the consequences of withdrawal?0..1textEnable When:
..... 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..1choiceDefinition: 19.2a
Options: 2 options
.... c20.2Medical information and billing statement0..1textEnable When:
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.
.... c20.3Will confidentiality be protected?0..1choiceDefinition: 19.2
Options: 2 options
..... c20.3-helpIndicates if records identifying a subject will be maintained.0..1display
.... c20.4How will confidentiality be protected?0..1textEnable When:
..... c20.4-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..1choiceDefinition: 19.3
Options: 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:
..... c20.6-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..1choiceDefinition: 19.5
Options: 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..1choiceDefinition: 19.5.1
Enable When:
Options: 2 options
..... c20.9-helpIndicates if shared data will retain any identifiers.0..1display
.... c20.10Deidentification detail0..1textEnable When:
..... c20.10-helpDescription of deidentification details for future use datasets. Two standardized statements, can be modified.0..1display
.... c20.11Required text disclosure surrounding future use.0..1choiceEnable When:
Options: 2 options
..... c20.11-helpRequired Text disclosure surrounding future use of participant's data0..1display
... c21Specimen Management0..1group
.... c21.1Were specimens collected as part of this study?0..1choiceDefinition: 20.1
Options: 2 options
.... c21.2Is whole genome sequencing being conducted?0..1choiceEnable When:
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..1choiceDefinition: 20.1.4
Enable When:
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:
..... c21.4-helpTextual description of sharing conditions including, type, when, etc.0..1display
.... c21.5Will participant share in profit with commerical use?0..1choiceEnable When:
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:
..... c21.6-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:
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..1choiceDefinition: 21
Options: 2 options
.... c22.1If selected, 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.0..1displayEnable When:
... c23Can the study team contact you for future research?0..1choiceDefinition: 22
Options: 2 options
.... c23.1Conditions about contact for additional sample use, information not currently described or future research0..1textEnable When:
..... 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..1choiceDefinition: 23
Options: 2 options
.... c24.1Details about any profit sharing agreements or why profits will not be shared.0..1textEnable When:
.... 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..1choiceDefinition: 25
Options: 2 options
.... c26.1Condtions under which the study results will be disclosed to you0..1textEnable When:
..... 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..1textInitial 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..1choiceDefinition: 26
Options: 2 options
.... c28.1Certificate of Confidentiality Statement0..1textEnable When:
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:
... 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
... c32Protocol or Study Number0..1group
.... c32.1IRB Number0..1string
.... c32.2sIRB Version Date of Consent0..1string
..... 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..1string
..... 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
... ADMIN00Administrative Use Only0..1group
.... ADMIN01Link ID prefix0..1stringInitial Value: string = c
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringInitial Value: string = temporarily unavailable
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any0..1stringInitial Value: string = temporarily unavailable
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1string

doco Documentation for this format

Option Sets

Answer options for c6

Answer options for c11.2.4

Answer options for c11.3.4

Answer options for c11.3.5

Answer options for c12.1.3

Answer options for c12.3

Answer options for c14.3

Answer options for c14.4

Answer options for c15.1

Answer options for c16.2

Answer options for c16.3

Answer options for c19.1

Answer options for c19.2

Answer options for c19.3

Answer options for c20.1

Answer options for c20.3

Answer options for c20.5

Answer options for c20.7.1

Answer options for c20.8

Answer options for c20.9

Answer options for c20.11

Answer options for c21.1

Answer options for c21.2

Answer options for c21.3

Answer options for c21.5

Answer options for c21.7

Answer options for c22

Answer options for c23

Answer options for c24

Answer options for c25

Answer options for c26

Answer options for c28

Answer options for c31.1

Answer options for c31.2

Answer options for c31.3

Answer options for c31.4

Answer options for c31.5

Answer options for c31.6

Answer options for c31.7