Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

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

LinkId | Text | Definition | Answer
--- | --- | --- | ---
consent-form-populate-exampleQR |  | QuestionnaireResponse |
c1 | Research Study |  |
c1.1 | Study Title |  | Study of Drug A for arthritis
c1.2 | IRB Protocol Number |  | PRO098765
c38 | Study Site |  |
ExternalDataFor_c38.1 | External Data For linkId c38.1 |  |
c38.1 | Select 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
c38.2 | Is 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
c40 | Study Site Principal Investigator and Study Site |  |
c40.1 | Multi-site statement |  | 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.
c40.3 | Statement 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.
c40.5 | Principal Investigator at Study Site |  |
c40.5.2 | First Name |  | Xi-Yang
c40.5.1 | Last Name |  | Lee
c40.5.6 | Suffix |  | Jr.
c40.5.3 | Degree(s) |  | MD, PhD
c40.5.4 | Associated Institution |  | Test Example University
c40.5.8 | Contact Information |  |
c40.5.8.20 | Phone |  | 6781233456
c40.5.8.21 | Email |  | XiYangLee@teu.med.edu
c40.9 | Study Site Institution |  |
c40.9.1 | Institution Name |  | Test Example University
c40.9.2 | Address |  |
c40.9.2.10 | Street Address |  | 200 Test Example Circle
c40.9.2.11 | City |  | Example
c40.9.2.12 | State |  | MA
c40.9.2.13 | Zip Code |  | 67890
c40.9.2.14 | Country |  | United States
c49 | Lead Principal Investigator and Lead Principal Investigator Site |  |
c49.1 | Statement about Lead PI and Lead PI Site for Consent Form at Relying Site |  | 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.
c49.2 | Lead Principal Investigator |  |
c49.2.2 | First Name |  | Jane
c49.2.1 | Last Name |  | Doe
c49.2.3 | Degree(s) |  | MD
c49.2.5 | Contact Information |  |
c49.2.5.20 | Phone |  | 567-123-1234
c49.2.5.21 | Email |  | drjanedoe@sampleuniversity.edu
c49.5 | Lead Principal Investigator Institution |  |
c49.5.1 | Name |  | Sample University Medical Center
c49.5.2 | Address |  |
c49.5.2.10 | Street Address |  | 105 Sample University Ct.
c49.5.2.11 | City |  | Sample City
c49.5.2.12 | State |  | NC
c49.5.2.13 | Zip Code |  | 27612
c49.5.2.14 | Country |  | United States
c4 | Sponsor or Funding Source |  |
ExternalDataFor_c4.1 | External Data For linkId c4.1 |  |
c4.1 | Sponsor Name |  |
c6 | Is this consent an eConsent? |  | expandedYes-NoIndicator N: No
c7 | Summary Text |  |
c7.1 | Summary Text Statement |  | This 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.
c8 | Introduction and Statement of Research |  |
c8.1 | About Consent Form |  | 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.
c9 | Purpose |  |
c9.1 | Reason for Research |  | This study is to determine the efficacy of Drug A for arthritis and whether it is more effective than the standard of care treatment.
c9.2 | Interactions with others |  | Participants can expect to interact with the study coordinator during their visits, with some other personnel providing clinical services and procedures.
c9.3 | Invited Participants |  | Candidates for this study include patients suffering from arthritis.
c9.4 | Total expected study enrollment |  | 500
c9.5 | Additional Enrollment Text |  | Additional Text can be inserted here.
c9.6 | What 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.
c10 | Assessments |  |
c10.1 | Assessment List |  |
c10.1.1 | Name of the Assessment |  | Initial health history and demographic data survey
c10.1.2 | Description of Assessment |  | Participants will be asked about health history and demographic background
c10.1 | Assessment List |  |
c10.1.1 | Name of the Assessment |  | Baseline Blood Draw
c10.1.2 | Description of Assessment |  | 4 tubes of blood will be drawn
c10.1 | Assessment List |  |
c10.1.1 | Name of the Assessment |  | Recurring monthly blood draws
c10.1.2 | Description of Assessment |  | 2 tubes of blood will be drawn
c10.1 | Assessment List |  |
c10.1.1 | Name of the Assessment |  | End of Study Blood Draw
c10.1.2 | Description of Assessment |  | 4 tubes of blood will be drawn
c10.2 | Assessment Supplemental Text |  | Additional Text about the assessments can be included here.
c10.3 | Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire? |  | expandedYes-NoIndicator N: No
c11 | Visits and Procedures |  |
c11.1 | Visit Introductory Text |  | explain any additional detail or information about the visit schedule.
c11.2 | Visit List |  |
c11.2.1 | Visit Type |  | Initial visit
c11.2.2 | Visit Description |  | Collection of health history and demographic data
c11.2.3 | Visit Duration |  | 2
c11.2.4 | Visit Duration Units |  | Unified Code for Units of Measure (UCUM) h: h
c11.2.5 | Number of Visits |  | 1
c11.2 | Visit List |  |
c11.2.1 | Visit Type |  | Baseline Visit
c11.2.2 | Visit Description |  | Collection of baseline measures
c11.2.3 | Visit Duration |  | 1
c11.2.4 | Visit Duration Units |  | Unified Code for Units of Measure (UCUM) h: h
c11.2.5 | Number of Visits |  | 1
c11.2 | Visit List |  |
c11.2.1 | Visit Type |  | Follow up Visit
c11.2.2 | Visit Description |  | Recurring monthly visits for blood draw and weight check
c11.2.3 | Visit Duration |  | 30
c11.2.4 | Visit Duration Units |  | Unified Code for Units of Measure (UCUM) min: min
c11.2.5 | Number of Visits |  | 6
c11.2 | Visit List |  |
c11.2.1 | Visit Type |  | End of study visit
c11.2.2 | Visit Description |  | Collection of end of study measures
c11.2.3 | Visit Duration |  | 1
c11.2.4 | Visit Duration Units |  | Unified Code for Units of Measure (UCUM) h: h
c11.2.5 | Number of Visits |  | 1
c11.6 | Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire? |  | expandedYes-NoIndicator N: No
c11.3 | Procedure List |  |
c11.3.1 | Name of Procedure |  | Weight check
c11.3.2 | Common Term of Procedure |  | Weight check
c11.3.3 | Description of a Procedure |  | Participants will be weighed on a scale
c11.3.4 | Experimental Procedure Indicator |  | expandedYes-NoIndicator N: No
c11.3.5 | Research Indicator |  | Temporary Codes STDCR: Standard of Care
c11.3.6 | Frequency |  | At baseline visit, at end of study visit and at monthly follow up visits
c11.3.9 | Procedure Duration (minutes) |  | 1
c11.3 | Procedure List |  |
c11.3.1 | Name of Procedure |  | Baseline visit and End of Study visit Venipuncture
c11.3.2 | Common Term of Procedure |  | Blood Draw
c11.3.3 | Description of a Procedure |  | Phelebotomist will draw 4 tubes of blood at Baseline visit and End of Study visit
c11.3.4 | Experimental Procedure Indicator |  | expandedYes-NoIndicator N: No
c11.3.5 | Research Indicator |  | Temporary Codes STDCR: Standard of Care
c11.3.6 | Frequency |  | At Baseline visit and End of Study visit
c11.3.9 | Procedure Duration (minutes) |  | 20
c11.3 | Procedure List |  |
c11.3.1 | Name of Procedure |  | Recurring monthly Venipuncture
c11.3.2 | Common Term of Procedure |  | Blood Draw
c11.3.3 | Description of a Procedure |  | Phelebotomist will draw 2 tubes of blood monthly
c11.3.4 | Experimental Procedure Indicator |  | expandedYes-NoIndicator N: No
c11.3.5 | Research Indicator |  | Temporary Codes STDCR: Standard of Care
c11.3.6 | Frequency |  | monthly
c11.3.9 | Procedure Duration (minutes) |  | 15
c11.4 | Procedure Supplemental Text |  | Additional Text can be captured here
c11.9 | Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire? |  | expandedYes-NoIndicator N: No
c11.5 | Total Duration of Study Participation |  | 7 months
c12 | Risks |  |
c12.1 | Risk List |  |
c12.1.1 | Name of the risk |  | Bruising
c12.1.2 | Description of Risk |  | Blood draw may cause some mild bruising
c12.1.3 | Risk Category |  | Temporary Codes PHYS: Physical
c12.9 | Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire? |  | expandedYes-NoIndicator N: No
c12.2 | Risk Supplemental Text |  | Additional risk text can be included here
c12.3 | Fetal Risks |  | expandedYes-NoIndicator N: No
c13 | Alternative Procedures |  |
c13.1 | Alternative Procedure Text |  | Participants are free to not participate at no additional risk.
c14 | Benefits |  |
c14.1 | Benefits List |  |
c14.1.1 | Name of Benefit |  | Societal Benefit of additional knowledge
c14.1.2 | Description of Benefit |  | Societal Benefit
c14.1.3 | Benefit to you |  | expandedYes-NoIndicator N: No
c14.1.4 | Benefit to society |  | expandedYes-NoIndicator Y: Yes
c14.9 | Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire? |  | expandedYes-NoIndicator N: No
c15 | Compensation |  |
c15.1 | Will there be compensation for participation? |  | expandedYes-NoIndicator Y: Yes
c15.2 | Compensation Supplemental Text |  | Description of compensation can be included
c15.3 | Compensation List |  |
c15.3.1 | What types of visits or milestones will I be compensated for? |  | Baseline
c15.3.2 | How many visits or milestones of this type will there be compensation for? |  | 1
c15.3.3 | How much will be paid per that type of visit? |  | 100
c15.3 | Compensation List |  |
c15.3.1 | What types of visits or milestones will I be compensated for? |  | Followup
c15.3.2 | How many visits or milestones of this type will there be compensation for? |  | 6
c15.3.3 | How much will be paid per that type of visit? |  | 25
c15.3 | Compensation List |  |
c15.3.1 | What types of visits or milestones will I be compensated for? |  | End of Study visit
c15.3.2 | How many visits or milestones of this type will there be compensation for? |  | 1
c15.3.3 | How much will be paid per that type of visit? |  | 100
c15.5 | Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire? |  | expandedYes-NoIndicator N: No
c17 | Participant Rights and whom to contact for answers |  |
c17.2 | Site IRB Contact Information |  |
c17.2.8 | IRB Name |  | X Pharmaceutical Research IRB
c17.2.10 | Street Address |  | 210 Research Drive
c17.2.11 | City |  | Sample City
c17.2.12 | State |  | NC
c17.2.13 | Zip Code |  | 27612
c17.2.14 | Country |  | United States
c17.3 | Study Coordinator Contact Information |  |
c17.3.1 | Study Coordinator Name |  | [Study Coordinator Contact Information]
c17.3.8 | Study Coordinator Institution or Organization |  | [Study Coordinator Contact Information]
c17.3.9 | Department Name or Division |  | [Study Coordinator Contact Information]
c17.3.10 | Street Address |  | [Study Coordinator Contact Information]
c17.3.11 | City |  | [Study Coordinator Contact Information]
c17.3.12 | State |  | [Study Coordinator Contact Information]
c17.3.13 | Zip Code |  | [Study Coordinator Contact Information]
c17.3.14 | Country |  | [Study Coordinator Contact Information]
c17.3.20 | Phone |  | [Study Coordinator Contact Information]
c17.3.21 | Email |  | [Study Coordinator Contact Information]
c17.4 | Site Principal Investigator Contact Information |  |
c17.4.1 | Site Principal Investigator Name |  | Xi-Yang Lee, Jr., MD, PhD
c17.4.8 | Site Principal Investigator Institution |  | Test Example University
c17.4.10 | Street Address |  | 200 Test Example Circle
c17.4.11 | City |  | Example
c17.4.12 | State |  | MA
c17.4.13 | Zip Code |  | 67890
c17.4.14 | Country |  | United States
c17.4.20 | Phone |  | 6781233456
c17.4.21 | Email |  | XiYangLee@teu.med.edu
c18 | Participation |  |
c18.1 | Voluntary Permission Statement |  | 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.
c18.2 | What 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.
c19 | Early Withdrawal |  |
c19.1 | Are there consequences to participant for early withdrawal? |  | expandedYes-NoIndicator Y: Yes
c19.2 | Are there Emotional Consequences of Withdrawal |  | expandedYes-NoIndicator N: No
c19.3 | Are there Physical Consequences of Withdrawal |  | expandedYes-NoIndicator N: No
c19.4 | What are the consequences of withdrawal? |  | Consequences of withdrawal should be included here.
c20 | Confidentiality of Records |  |
c20.1 | Will HIPAA content be included within this document? |  | expandedYes-NoIndicator Y: Yes
c20.2 | Medical information and billing statement |  | 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.
c20.3 | Will confidentiality be protected? |  | expandedYes-NoIndicator Y: Yes
c20.5 | Are there data security or policies that need to be included in the consent, particularly around device use (optional) |  | expandedYes-NoIndicator N: No
c20.7 | Who can use or see participant information? |  |
c20.7.1 | Role or group who will have access to data |  | Temporary Codes OTHINSTRES: Researchers at other institutions
c20.7.2 | Description of Information Disclosed |  | Deidentified demographic data
c20.7 | Who can use or see participant information? |  |
c20.7.1 | Role or group who will have access to data |  | Temporary Codes THISINSTRES: Researchers outside the study team at this institution
c20.7.2 | Description of Information Disclosed |  | Deidentified demographic data
c20.8 | Will the data be released for future use? |  | expandedYes-NoIndicator Y: Yes
c20.9 | Will the future use data be deidentified? |  | expandedYes-NoIndicator Y: Yes
c20.10 | Deidentification detail |  | Only demographic data will be shared
c20.11 | Required 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.
c21 | Specimen Management |  |
c21.1 | Were specimens collected as part of this study? |  | expandedYes-NoIndicator Y: Yes
c21.2 | Is whole genome sequencing being conducted? |  | expandedYes-NoIndicator N: No
c21.3 | Sharing or no Sharing of samples. |  | expandedYes-NoIndicator Y: Yes
c21.4 | Conditions of sharing |  | Deidentified samples will be shared with other investigators at this institution.
c21.5 | Will participant share in profit with commerical use? |  | expandedYes-NoIndicator N: No
c21.6 | Description of Collection and Storage |  | Samples are stored with only a deidentified code. Only the study coordinator will retain this link, which will be destroyed at study conclusion.
c21.7 | Can consent for sample use be revoked? |  | expandedYes-NoIndicator N: No
c22 | Will there be Broad Consent for Storage, maintenance and secondary research use? |  | expandedYes-NoIndicator N: No
c23 | Can the study team contact you for future research? |  | expandedYes-NoIndicator Y: Yes
c23.1 | Conditions about contact for additional sample use, information not currently described or future research |  | Participants can be called for up to 1 year after conclusion of the study
c24 | Will participants share in commercial profit? |  | expandedYes-NoIndicator N: No
c25 | Will the study team contact you with new information that may affect your willingness to remain in the study |  | expandedYes-NoIndicator N: No
c26 | Will the study team disclose clinically relevant study results to you? |  | expandedYes-NoIndicator N: No
c27 | Clinical Trials.gov statement |  | 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.
c28 | Is this study covered under a Certificate of Confidentiality? (default Y in NIH) |  | expandedYes-NoIndicator N: No
c30 | Statement of PHI Authorization Revocation |  | 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.
c31 | Signature |  |
c31.1 | Indicator to include Participant Signature and Date/Time |  | expandedYes-NoIndicator Y: Yes
c31.2 | Indicator to include Assent Signature and Date/Time |  | expandedYes-NoIndicator N: No
c31.3 | Indicator to include Legally Authorized Representative Signature and Date/Time |  | expandedYes-NoIndicator Y: Yes
c31.5 | Indicator to include a Witness Signature and Date/Time |  | expandedYes-NoIndicator Y: Yes
c31.6 | Indicator to include Parent 1 Signature and Date/Time |  | expandedYes-NoIndicator N: No
c31.7 | Indicator to include Parent 2 Signature and Date/Time |  | expandedYes-NoIndicator N: No
c32 | Consent Version |  |
c32.1 | Consent Version Number |  | 2
c32.2 | sIRB Version Date of Consent |  | 2021-08-10
c32.3 | Relying Site Version Date of Consent |  | 2021-08-10
c32.6 | Expiration Date of Consent |  | 2024-08-01T03:59:59.846Z
ADMIN00 | Administrative Use Only |  |
ADMIN01 | Link ID prefix |  | c
ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any |  | initiate-study-populate-exampleQR
ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any |  | ResearchStudyExample-sIRB
Documentation for this format