Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
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 
<QuestionnaireResponse xmlns="http://hl7.org/fhir">
<id value="CONSENT-QR"/>
<meta>
<versionId value="2"/>
<lastUpdated value="2021-07-28T19:30:37.108+00:00"/>
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</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>questionnaire</b>: <a href="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 27, 2021 3:10:59 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2</p><p><b>text</b>: Site Principal Investigator</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.2</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.1</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.3</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.4</p><p><b>text</b>: Associated Institution</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c2.5</p><p><b>text</b>: Contact Information</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c3</p><p><b>text</b>: Relying Institution</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c3.1</p><p><b>text</b>: Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c3.2</p><p><b>text</b>: Address</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c4</p><p><b>text</b>: Sponsor or Funding Source</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c4.1</p><p><b>text</b>: Sponsor Name</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c6</p><p><b>text</b>: Is this consent an eConsent?</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title="{http://terminology.hl7.org/CodeSystem/v2-0532 N}">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c7</p><p><b>text</b>: Summary Text</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c7.1</p><p><b>text</b>: Summary Text Statement</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c8</p><p><b>text</b>: Introduction and Statement of Research</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c8.1</p><p><b>text</b>: About Consent Form</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9</p><p><b>text</b>: Purpose</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.1</p><p><b>text</b>: Reason for Research</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.2</p><p><b>text</b>: Interactions with others</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.3</p><p><b>text</b>: Invited Participants</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.4</p><p><b>text</b>: Total expected study enrollment</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.5</p><p><b>text</b>: Additional Enrollment Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c9.6</p><p><b>text</b>: What is involved in the study?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c10</p><p><b>text</b>: Assessments</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c10.1</p><p><b>text</b>: Assessment List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c10.1</p><p><b>text</b>: Assessment List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c10.2</p><p><b>text</b>: Assessment Supplemental Text</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11</p><p><b>text</b>: Visits and Procedures</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.2</p><p><b>text</b>: Visit List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.2</p><p><b>text</b>: Visit List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.3</p><p><b>text</b>: Procedure List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.3</p><p><b>text</b>: Procedure List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.4</p><p><b>text</b>: Procedure Supplemental Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c11.5</p><p><b>text</b>: Total Duration of Study Participation</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c12</p><p><b>text</b>: Risks</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c12.1</p><p><b>text</b>: Risk List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c12.2</p><p><b>text</b>: Risk Supplemental Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c12.3</p><p><b>text</b>: Fetal Risks</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c13</p><p><b>text</b>: Alternative Procedures</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c13.1</p><p><b>text</b>: Alternative Procedure Text</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14</p><p><b>text</b>: Benefits</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.1</p><p><b>text</b>: Name of Benefit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.2</p><p><b>text</b>: Description of Benefit</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.3</p><p><b>text</b>: Benefit to you</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c14.4</p><p><b>text</b>: Benefit to society</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15</p><p><b>text</b>: Compensation</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.1</p><p><b>text</b>: Will there be compensation for participation?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.2</p><p><b>text</b>: Compensation Supplemental Text</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.3</p><p><b>text</b>: Compensation List</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c15.3</p><p><b>text</b>: Compensation List</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c16</p><p><b>text</b>: Costs</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c16.1</p><p><b>text</b>: What are the costs of participation, if any?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c16.2</p><p><b>text</b>: Will there be reimbursement for other study visit costs incurred?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c16.3</p><p><b>text</b>: Who will pay for medical treatment if research related injury occurs?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17</p><p><b>text</b>: Participant Rights and whom to contact for answers</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.1</p><p><b>text</b>: What are the rights of a participant?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.2</p><p><b>text</b>: Site IRB Contact Information</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.3</p><p><b>text</b>: Study Coordinator Contact Information</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c17.4</p><p><b>text</b>: Site Principal Investigator Contact Information</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c18</p><p><b>text</b>: Participation</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c18.1</p><p><b>text</b>: Voluntary Permission Statement</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c18.2</p><p><b>text</b>: 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.</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c19</p><p><b>text</b>: Early Withdrawal</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c19.1</p><p><b>text</b>: Are there consequences to participant for early withdrawal?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c19.2</p><p><b>text</b>: Are there Emotional Consequences of Withdrawal</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c19.3</p><p><b>text</b>: Are there Physical Consequences of Withdrawal</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20</p><p><b>text</b>: Confidentiality of Records</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.1</p><p><b>text</b>: Will HIPAA content be included within this document?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.3</p><p><b>text</b>: Will confidentiality be protected?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.4</p><p><b>text</b>: How will confidentiality be protected?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.5</p><p><b>text</b>: Are there data security or policies that need to be included in the consent, particularly around device use (optional)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.7</p><p><b>text</b>: Who can use or see participant information?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.8</p><p><b>text</b>: Will the data be released for future use?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.9</p><p><b>text</b>: Will the future use data be deidentified?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.10</p><p><b>text</b>: Deidentification detail</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c20.11</p><p><b>text</b>: Required text disclosure surrounding future use.</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21</p><p><b>text</b>: Specimen Management</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.1</p><p><b>text</b>: Were specimens collected as part of this study?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.2</p><p><b>text</b>: Is whole genome sequencing being conducted?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.3</p><p><b>text</b>: Sharing or no Sharing of samples.</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.4</p><p><b>text</b>: Conditions of sharing</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.5</p><p><b>text</b>: Will participant share in profit with commerical use?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.6</p><p><b>text</b>: Description of Collection and Storage</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c21.7</p><p><b>text</b>: Can consent for sample use be revoked?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c22</p><p><b>text</b>: Will there be Broad Consent for Storage, maintenance and secondary research use?</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title="{http://terminology.hl7.org/CodeSystem/v2-0532 N}">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c23</p><p><b>text</b>: Can the study team contact you for future research?</p><blockquote><p><b>answer</b></p><p><b>value</b>: <span title="{http://terminology.hl7.org/CodeSystem/v2-0532 Y}">Yes</span></p><blockquote><p><b>item</b></p><p><b>linkId</b>: c23.1</p><p><b>text</b>: Conditions about contact for additional sample use, information not currently described or future research</p></blockquote></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c24</p><p><b>text</b>: Will participants share in commercial profit?</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title="{http://terminology.hl7.org/CodeSystem/v2-0532 N}">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c25</p><p><b>text</b>: Will the study team contact you with new information that may affect your willingness to remain in the study</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title="{http://terminology.hl7.org/CodeSystem/v2-0532 N}">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c26</p><p><b>text</b>: Will the study team disclose clinically relevant study results to you?</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title="{http://terminology.hl7.org/CodeSystem/v2-0532 N}">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c27</p><p><b>text</b>: Clinical Trials.gov statement</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td>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.</td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c28</p><p><b>text</b>: Is this study covered under a Certificate of Confidentiality? (default Y in NIH)</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title="{http://terminology.hl7.org/CodeSystem/v2-0532 N}">No</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c30</p><p><b>text</b>: Statement of PHI Authorization Revocation</p><h3>Answers</h3><table class="grid"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td>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.</td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c31</p><p><b>text</b>: Signature</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c31.1</p><p><b>text</b>: Indicator to include Participant Signature and Date/Time</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c31.2</p><p><b>text</b>: Indicator to include Assent Signature and Date/Time</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c31.3</p><p><b>text</b>: Indicator to include Legally Authorized Representative Signature and Date/Time</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: c32</p><p><b>text</b>: Protocol or Study Number</p><blockquote><p><b>item</b></p><p><b>linkId</b>: c32.1</p><p><b>text</b>: IRB Number</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN00</p><p><b>text</b>: Administrative Use Only</p><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN01</p><p><b>text</b>: Link ID prefix</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN02</p><p><b>text</b>: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN03</p><p><b>text</b>: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any</p></blockquote></blockquote></div>
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value="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire"/>
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<authored value="2021-07-27T15:10:59.524Z"/>
<item>
<linkId value="c1"/>
<text value="Research Study"/>
<item>
<linkId value="c1.1"/>
<text value="Study Title"/>
<answer>
<valueString value="A clinical study of the efficacy of Drug A"/>
</answer>
</item>
<item>
<linkId value="c1.2"/>
<text value="IRB Protocol Number"/>
<answer>
<valueString value="A1234"/>
</answer>
</item>
</item>
<item>
<linkId value="c2"/>
<text value="Site Principal Investigator"/>
<item>
<linkId value="c2.2"/>
<text value="First Name"/>
<answer>
<valueString value="Jane"/>
</answer>
</item>
<item>
<linkId value="c2.1"/>
<text value="Last Name"/>
<answer>
<valueString value="Doe"/>
</answer>
</item>
<item>
<linkId value="c2.3"/>
<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="c2.4"/>
<text value="Associated Institution"/>
<answer>
<valueString value="Research University"/>
</answer>
</item>
<item>
<linkId value="c2.5"/>
<text value="Contact Information"/>
<answer>
<valueString value="jdoe@xresearch.edu"/>
</answer>
</item>
</item>
<item>
<linkId value="c3"/>
<text value="Relying Institution"/>
<item>
<linkId value="c3.1"/>
<text value="Name"/>
<answer>
<valueString value="Study Clinic A"/>
</answer>
</item>
<item>
<linkId value="c3.2"/>
<text value="Address"/>
<answer>
<valueString value="111 Main St, Anytown, NC"/>
</answer>
</item>
</item>
<item>
<linkId value="c4"/>
<text value="Sponsor or Funding Source"/>
<item>
<linkId value="c4.1"/>
<text value="Sponsor Name"/>
<answer>
<valueString value="National Government Funder"/>
</answer>
</item>
</item>
<item>
<linkId value="c6"/>
<text value="Is this consent an eConsent?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c7"/>
<text value="Summary Text"/>
<item>
<linkId value="c7.1"/>
<text value="Summary Text Statement"/>
<answer>
<valueString
value="This field contains 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."/>
</answer>
</item>
</item>
<item>
<linkId value="c8"/>
<text value="Introduction and Statement of Research"/>
<item>
<linkId value="c8.1"/>
<text value="About Consent Form"/>
<answer>
<valueString
value="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."/>
</answer>
</item>
</item>
<item>
<linkId value="c9"/>
<text value="Purpose"/>
<item>
<linkId value="c9.1"/>
<text value="Reason for Research"/>
<answer>
<valueString
value="This study is to determine the efficacy of Drug A and whether it is more effective than the standard of care treatment."/>
</answer>
</item>
<item>
<linkId value="c9.2"/>
<text value="Interactions with others"/>
<answer>
<valueString
value="Participants can expect to interact with the study coordinator during their visits, with some other personnel providing clinical services and procedures."/>
</answer>
</item>
<item>
<linkId value="c9.3"/>
<text value="Invited Participants"/>
<answer>
<valueString
value="Candidates for this study include patients suffering the a common chronic disease."/>
</answer>
</item>
<item>
<linkId value="c9.4"/>
<text value="Total expected study enrollment"/>
<answer>
<valueInteger value="500"/>
</answer>
</item>
<item>
<linkId value="c9.5"/>
<text value="Additional Enrollment Text"/>
<answer>
<valueString value="Additional Text can be inserted here."/>
</answer>
</item>
<item>
<linkId value="c9.6"/>
<text value="What is involved in the study?"/>
<answer>
<valueString
value="This study will involve an initial visit, a baseline clinical visit where several measurements will be taken, a follow up visit and an end of study visit."/>
</answer>
</item>
</item>
<item>
<linkId value="c10"/>
<text value="Assessments"/>
<item>
<linkId value="c10.1"/>
<text value="Assessment List"/>
<item>
<linkId value="c10.1.1"/>
<text value="Name of the Assessment"/>
<answer>
<valueString value="Initial demographic data survey"/>
</answer>
</item>
<item>
<linkId value="c10.1.2"/>
<text value="Description of Assessment"/>
<answer>
<valueString value="Participants will be asked about"/>
</answer>
</item>
</item>
<item>
<linkId value="c10.1"/>
<text value="Assessment List"/>
<item>
<linkId value="c10.1.1"/>
<text value="Name of the Assessment"/>
<answer>
<valueString value="Blood Draw"/>
</answer>
</item>
<item>
<linkId value="c10.1.2"/>
<text value="Description of Assessment"/>
<answer>
<valueString value="3 tubes totaling 15 ml of blood will be drawn."/>
</answer>
</item>
</item>
<item>
<linkId value="c10.2"/>
<text value="Assessment Supplemental Text"/>
<answer>
<valueString value="Additional Text about the assessments."/>
</answer>
</item>
</item>
<item>
<linkId value="c11"/>
<text value="Visits and Procedures"/>
<item>
<linkId value="c11.2"/>
<text value="Visit List"/>
<item>
<linkId value="c11.2.1"/>
<text value="Visit Type"/>
<answer>
<valueString value="Baseline Visit"/>
</answer>
</item>
<item>
<linkId value="c11.2.2"/>
<text value="Visit Description"/>
<answer>
<valueString value="Collection of baseline measures"/>
</answer>
</item>
<item>
<linkId value="c11.2.3"/>
<text value="Visit Duration"/>
<answer>
<valueString value="2"/>
</answer>
</item>
<item>
<linkId value="c11.2.4"/>
<text value="Visit Duration Units"/>
<answer>
<valueCoding>
<system value="http://unitsofmeasure.org"/>
<code value="h"/>
<display value="h"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c11.2.5"/>
<text value="Number of Visits"/>
<answer>
<valueInteger value="1"/>
</answer>
</item>
</item>
<item>
<linkId value="c11.2"/>
<text value="Visit List"/>
<item>
<linkId value="c11.2.1"/>
<text value="Visit Type"/>
<answer>
<valueString value="Follow up Visit"/>
</answer>
</item>
<item>
<linkId value="c11.2.2"/>
<text value="Visit Description"/>
<answer>
<valueString value="Recurring monthly visits"/>
</answer>
</item>
<item>
<linkId value="c11.2.3"/>
<text value="Visit Duration"/>
<answer>
<valueString value="30"/>
</answer>
</item>
<item>
<linkId value="c11.2.4"/>
<text value="Visit Duration Units"/>
<answer>
<valueCoding>
<system value="http://unitsofmeasure.org"/>
<code value="min"/>
<display value="min"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c11.2.5"/>
<text value="Number of Visits"/>
<answer>
<valueInteger value="6"/>
</answer>
</item>
</item>
<item>
<linkId value="c11.3"/>
<text value="Procedure List"/>
<item>
<linkId value="c11.3.1"/>
<text value="Name of Procedure"/>
<answer>
<valueString value="Weight"/>
</answer>
</item>
<item>
<linkId value="c11.3.2"/>
<text value="Common Term of Procedure"/>
<answer>
<valueString value="Weight"/>
</answer>
</item>
<item>
<linkId value="c11.3.3"/>
<text value="Description of a Procedure"/>
<answer>
<valueString value="Participants will be weighed on a scale"/>
</answer>
</item>
<item>
<linkId value="c11.3.4"/>
<text value="Experimental Procedure Indicator"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c11.3.5"/>
<text value="Research Indicator"/>
<answer>
<valueCoding>
<system
value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="STDCR"/>
<display value="Standard of Care"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c11.3.6"/>
<text value="Frequency of Procedures"/>
<answer>
<valueDecimal value="7"/>
</answer>
</item>
<item>
<linkId value="c11.3.7"/>
<text value="Procedure Duration (minutes)"/>
<answer>
<valueDecimal value="1"/>
</answer>
</item>
</item>
<item>
<linkId value="c11.3"/>
<text value="Procedure List"/>
<item>
<linkId value="c11.3.1"/>
<text value="Name of Procedure"/>
<answer>
<valueString value="Venipuncture"/>
</answer>
</item>
<item>
<linkId value="c11.3.2"/>
<text value="Common Term of Procedure"/>
<answer>
<valueString value="Blood Draw"/>
</answer>
</item>
<item>
<linkId value="c11.3.3"/>
<text value="Description of a Procedure"/>
<answer>
<valueString value="Phelebotomist will draw 20 ml of blood"/>
</answer>
</item>
<item>
<linkId value="c11.3.4"/>
<text value="Experimental Procedure Indicator"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c11.3.5"/>
<text value="Research Indicator"/>
<answer>
<valueCoding>
<system
value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="STDCR"/>
<display value="Standard of Care"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c11.3.6"/>
<text value="Frequency of Procedures"/>
<answer>
<valueDecimal value="1"/>
</answer>
</item>
<item>
<linkId value="c11.3.7"/>
<text value="Procedure Duration (minutes)"/>
<answer>
<valueDecimal value="15"/>
</answer>
</item>
</item>
<item>
<linkId value="c11.4"/>
<text value="Procedure Supplemental Text"/>
<answer>
<valueString value="Additional Text can be captured here"/>
</answer>
</item>
<item>
<linkId value="c11.5"/>
<text value="Total Duration of Study Participation"/>
<answer>
<valueString value="7 months"/>
</answer>
</item>
</item>
<item>
<linkId value="c12"/>
<text value="Risks"/>
<item>
<linkId value="c12.1"/>
<text value="Risk List"/>
<item>
<linkId value="c12.1.1"/>
<text value="Name of the risk"/>
<answer>
<valueString value="Bruising"/>
</answer>
</item>
<item>
<linkId value="c12.1.2"/>
<text value="Description of Risk"/>
<answer>
<valueString value="Blood draw may cause some mild bruising"/>
</answer>
</item>
<item>
<linkId value="c12.1.3"/>
<text value="Risk Category"/>
<answer>
<valueCoding>
<system
value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="PHYS"/>
<display value="Physical"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c12.2"/>
<text value="Risk Supplemental Text"/>
<answer>
<valueString value="Additional risk text can be included here"/>
</answer>
</item>
<item>
<linkId value="c12.3"/>
<text value="Fetal Risks"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c13"/>
<text value="Alternative Procedures"/>
<item>
<linkId value="c13.1"/>
<text value="Alternative Procedure Text"/>
<answer>
<valueString
value="Participants are free to not participate at no additional risk."/>
</answer>
</item>
</item>
<item>
<linkId value="c14"/>
<text value="Benefits"/>
<item>
<linkId value="c14.1"/>
<text value="Name of Benefit"/>
<answer>
<valueString value="Societal Benefit of additional knowledge"/>
</answer>
</item>
<item>
<linkId value="c14.2"/>
<text value="Description of Benefit"/>
<answer>
<valueString value="Societal Benefit"/>
</answer>
</item>
<item>
<linkId value="c14.3"/>
<text value="Benefit to you"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c14.4"/>
<text value="Benefit to society"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c15"/>
<text value="Compensation"/>
<item>
<linkId value="c15.1"/>
<text value="Will there be compensation for participation?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c15.2"/>
<text value="Compensation Supplemental Text"/>
<answer>
<valueString value="Description of compensation can be included"/>
</answer>
</item>
<item>
<linkId value="c15.3"/>
<text value="Compensation List"/>
<item>
<linkId value="c15.3.1"/>
<text
value="What types of visits or milestones will I be compensated for?"/>
<answer>
<valueString value="Baseline"/>
</answer>
</item>
<item>
<linkId value="c15.3.2"/>
<text
value="How many visits or milestones of this type will there be compensation for?"/>
<answer>
<valueInteger value="1"/>
</answer>
</item>
<item>
<linkId value="c15.3.3"/>
<text value="How much will be paid per that type of visit?"/>
<answer>
<valueString value="100"/>
</answer>
</item>
</item>
<item>
<linkId value="c15.3"/>
<text value="Compensation List"/>
<item>
<linkId value="c15.3.1"/>
<text
value="What types of visits or milestones will I be compensated for?"/>
<answer>
<valueString value="Followup"/>
</answer>
</item>
<item>
<linkId value="c15.3.2"/>
<text
value="How many visits or milestones of this type will there be compensation for?"/>
<answer>
<valueInteger value="6"/>
</answer>
</item>
<item>
<linkId value="c15.3.3"/>
<text value="How much will be paid per that type of visit?"/>
<answer>
<valueString value="25"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="c16"/>
<text value="Costs"/>
<item>
<linkId value="c16.1"/>
<text value="What are the costs of participation, if any?"/>
<answer>
<valueString
value="Participants will be responsible for costs beyond the provided payment."/>
</answer>
</item>
<item>
<linkId value="c16.2"/>
<text
value="Will there be reimbursement for other study visit costs incurred?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c16.3"/>
<text
value="Who will pay for medical treatment if research related injury occurs?"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="TRTNOTCOV"/>
<display value="Treatment not covered"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c17"/>
<text value="Participant Rights and whom to contact for answers"/>
<item>
<linkId value="c17.1"/>
<text value="What are the rights of a participant?"/>
<answer>
<valueString value="Participant rights text"/>
</answer>
</item>
<item>
<linkId value="c17.2"/>
<text value="Site IRB Contact Information"/>
<answer>
<valueString value="Study Coordinator name, role"/>
</answer>
</item>
<item>
<linkId value="c17.3"/>
<text value="Study Coordinator Contact Information"/>
<answer>
<valueString value="Study Coordinator phone or email"/>
</answer>
</item>
<item>
<linkId value="c17.4"/>
<text value="Site Principal Investigator Contact Information"/>
<answer>
<valueString value="Site PI email or other contact information"/>
</answer>
</item>
</item>
<item>
<linkId value="c18"/>
<text value="Participation"/>
<item>
<linkId value="c18.1"/>
<text value="Voluntary Permission Statement"/>
<answer>
<valueString
value="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."/>
</answer>
</item>
<item>
<linkId value="c18.2"/>
<text
value="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."/>
<answer>
<valueString
value="Participants can be removed from the study if their condition changes such that the study procedures are not advised for their existing conditions."/>
</answer>
</item>
</item>
<item>
<linkId value="c19"/>
<text value="Early Withdrawal"/>
<item>
<linkId value="c19.1"/>
<text value="Are there consequences to participant for early withdrawal?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c19.2"/>
<text value="Are there Emotional Consequences of Withdrawal"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c19.3"/>
<text value="Are there Physical Consequences of Withdrawal"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c20"/>
<text value="Confidentiality of Records"/>
<item>
<linkId value="c20.1"/>
<text value="Will HIPAA content be included within this document?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c20.3"/>
<text value="Will confidentiality be protected?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c20.4"/>
<text value="How will confidentiality be protected?"/>
<answer>
<valueString value="Yes, data will be deidentified in all cases."/>
</answer>
</item>
<item>
<linkId value="c20.5"/>
<text
value="Are there data security or policies that need to be included in the consent, particularly around device use (optional)"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c20.7"/>
<text value="Who can use or see participant information?"/>
<item>
<linkId value="c20.7.1"/>
<text value="Role or group who will have access to data"/>
<answer>
<valueCoding>
<system
value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="OTHINSTRES"/>
<display value="Researchers at other institutions"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c20.7.2"/>
<text value="Description of Information Disclosed"/>
<answer>
<valueString value="Deidentified demographic data"/>
</answer>
</item>
</item>
<item>
<linkId value="c20.8"/>
<text value="Will the data be released for future use?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c20.9"/>
<text value="Will the future use data be deidentified?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c20.10"/>
<text value="Deidentification detail"/>
<answer>
<valueString value="Only demographic data will be shared"/>
</answer>
</item>
<item>
<linkId value="c20.11"/>
<text value="Required text disclosure surrounding future use."/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="DEIDUSED"/>
<display
value="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."/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c21"/>
<text value="Specimen Management"/>
<item>
<linkId value="c21.1"/>
<text value="Were specimens collected as part of this study?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c21.2"/>
<text value="Is whole genome sequencing being conducted?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c21.3"/>
<text value="Sharing or no Sharing of samples."/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c21.4"/>
<text value="Conditions of sharing"/>
<answer>
<valueString
value="Deidentified samples will be shared with other investigators at this institution."/>
</answer>
</item>
<item>
<linkId value="c21.5"/>
<text value="Will participant share in profit with commerical use?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c21.6"/>
<text value="Description of Collection and Storage"/>
<answer>
<valueString
value="Samples are stored with only a deidentified code. Only the study coordinator will retain this link, which will be destroyed at study conclusion."/>
</answer>
</item>
<item>
<linkId value="c21.7"/>
<text value="Can consent for sample use be revoked?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c22"/>
<text
value="Will there be Broad Consent for Storage, maintenance and secondary research use?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c23"/>
<text value="Can the study team contact you for future research?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
<item>
<linkId value="c23.1"/>
<text
value="Conditions about contact for additional sample use, information not currently described or future research"/>
<answer>
<valueString
value="Participants can be called for up to 1 year after conclusion of the study."/>
</answer>
</item>
</answer>
</item>
<item>
<linkId value="c24"/>
<text value="Will participants share in commercial profit?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c25"/>
<text
value="Will the study team contact you with new information that may affect your willingness to remain in the study"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c26"/>
<text
value="Will the study team disclose clinically relevant study results to you?"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c27"/>
<text value="Clinical Trials.gov statement"/>
<answer>
<valueString
value="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."/>
</answer>
</item>
<item>
<linkId value="c28"/>
<text
value="Is this study covered under a Certificate of Confidentiality? (default Y in NIH)"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c30"/>
<text value="Statement of PHI Authorization Revocation"/>
<answer>
<valueString
value="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."/>
</answer>
</item>
<item>
<linkId value="c31"/>
<text value="Signature"/>
<item>
<linkId value="c31.1"/>
<text value="Indicator to include Participant Signature and Date/Time"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="Y"/>
<display value="Yes"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c31.2"/>
<text value="Indicator to include Assent Signature and Date/Time"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="c31.3"/>
<text
value="Indicator to include Legally Authorized Representative Signature and Date/Time"/>
<answer>
<valueCoding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
<code value="N"/>
<display value="No"/>
</valueCoding>
</answer>
</item>
</item>
<item>
<linkId value="c32"/>
<text value="Protocol or Study Number"/>
<item>
<linkId value="c32.1"/>
<text value="IRB Number"/>
<answer>
<valueString value="IRB41512"/>
</answer>
</item>
</item>
<item>
<linkId value="ADMIN00"/>
<text value="Administrative Use Only"/>
<item>
<linkId value="ADMIN01"/>
<text value="Link ID prefix"/>
<answer>
<valueString value="c"/>
</answer>
</item>
<item>
<linkId value="ADMIN02"/>
<text
value="Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any"/>
<answer>
<valueString value="temporarily unavailable"/>
</answer>
</item>
<item>
<linkId value="ADMIN03"/>
<text
value="ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any"/>
<answer>
<valueString value="temporarily unavailable"/>
</answer>
</item>
</item>
</QuestionnaireResponse>
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#0.1.0 based on FHIR 4.0.1. Generated 2021-08-10
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