Generated Narrative

questionnaire: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire

status: completed

authored: Jul 27, 2021 3:10:59 PM

item

linkId: c1

text: Research Study

item

linkId: c1.1

text: Study Title

item

linkId: c1.2

text: IRB Protocol Number

item

linkId: c2

text: Site Principal Investigator

item

linkId: c2.2

text: First Name

item

linkId: c2.1

text: Last Name

item

linkId: c2.3

text: Degree(s)

item

linkId: c2.4

text: Associated Institution

item

linkId: c2.5

text: Contact Information

item

linkId: c3

text: Relying Institution

item

linkId: c3.1

text: Name

item

linkId: c3.2

text: Address

item

linkId: c4

text: Sponsor or Funding Source

item

linkId: c4.1

text: Sponsor Name

item

linkId: c6

text: Is this consent an eConsent?

Answers

-	Value[x]
*	No

item

linkId: c7

text: Summary Text

item

linkId: c7.1

text: Summary Text Statement

item

linkId: c8

text: Introduction and Statement of Research

item

linkId: c8.1

text: About Consent Form

item

linkId: c9

text: Purpose

item

linkId: c9.1

text: Reason for Research

item

linkId: c9.2

text: Interactions with others

item

linkId: c9.3

text: Invited Participants

item

linkId: c9.4

text: Total expected study enrollment

item

linkId: c9.5

text: Additional Enrollment Text

item

linkId: c9.6

text: What is involved in the study?

item

linkId: c10

text: Assessments

item

linkId: c10.1

text: Assessment List

item

linkId: c10.1

text: Assessment List

item

linkId: c10.2

text: Assessment Supplemental Text

item

linkId: c11

text: Visits and Procedures

item

linkId: c11.2

text: Visit List

item

linkId: c11.2

text: Visit List

item

linkId: c11.3

text: Procedure List

item

linkId: c11.3

text: Procedure List

item

linkId: c11.4

text: Procedure Supplemental Text

item

linkId: c11.5

text: Total Duration of Study Participation

item

linkId: c12

text: Risks

item

linkId: c12.1

text: Risk List

item

linkId: c12.2

text: Risk Supplemental Text

item

linkId: c12.3

text: Fetal Risks

item

linkId: c13

text: Alternative Procedures

item

linkId: c13.1

text: Alternative Procedure Text

item

linkId: c14

text: Benefits

item

linkId: c14.1

text: Name of Benefit

item

linkId: c14.2

text: Description of Benefit

item

linkId: c14.3

text: Benefit to you

item

linkId: c14.4

text: Benefit to society

item

linkId: c15

text: Compensation

item

linkId: c15.1

text: Will there be compensation for participation?

item

linkId: c15.2

text: Compensation Supplemental Text

item

linkId: c15.3

text: Compensation List

item

linkId: c15.3

text: Compensation List

item

linkId: c16

text: Costs

item

linkId: c16.1

text: What are the costs of participation, if any?

item

linkId: c16.2

text: Will there be reimbursement for other study visit costs incurred?

item

linkId: c16.3

text: Who will pay for medical treatment if research related injury occurs?

item

linkId: c17

text: Participant Rights and whom to contact for answers

item

linkId: c17.1

text: What are the rights of a participant?

item

linkId: c17.2

text: Site IRB Contact Information

item

linkId: c17.3

text: Study Coordinator Contact Information

item

linkId: c17.4

text: Site Principal Investigator Contact Information

item

linkId: c18

text: Participation

item

linkId: c18.1

text: Voluntary Permission Statement

item

linkId: c18.2

text: 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.

item

linkId: c19

text: Early Withdrawal

item

linkId: c19.1

text: Are there consequences to participant for early withdrawal?

item

linkId: c19.2

text: Are there Emotional Consequences of Withdrawal

item

linkId: c19.3

text: Are there Physical Consequences of Withdrawal

item

linkId: c20

text: Confidentiality of Records

item

linkId: c20.1

text: Will HIPAA content be included within this document?

item

linkId: c20.3

text: Will confidentiality be protected?

item

linkId: c20.4

text: How will confidentiality be protected?

item

linkId: c20.5

text: Are there data security or policies that need to be included in the consent, particularly around device use (optional)

item

linkId: c20.7

text: Who can use or see participant information?

item

linkId: c20.8

text: Will the data be released for future use?

item

linkId: c20.9

text: Will the future use data be deidentified?

item

linkId: c20.10

text: Deidentification detail

item

linkId: c20.11

text: Required text disclosure surrounding future use.

item

linkId: c21

text: Specimen Management

item

linkId: c21.1

text: Were specimens collected as part of this study?

item

linkId: c21.2

text: Is whole genome sequencing being conducted?

item

linkId: c21.3

text: Sharing or no Sharing of samples.

item

linkId: c21.4

text: Conditions of sharing

item

linkId: c21.5

text: Will participant share in profit with commerical use?

item

linkId: c21.6

text: Description of Collection and Storage

item

linkId: c21.7

text: Can consent for sample use be revoked?

item

linkId: c22

text: Will there be Broad Consent for Storage, maintenance and secondary research use?

Answers

-	Value[x]
*	No

item

linkId: c23

text: Can the study team contact you for future research?

answer

value: Yes

item

linkId: c23.1

text: Conditions about contact for additional sample use, information not currently described or future research

item

linkId: c24

text: Will participants share in commercial profit?

Answers

-	Value[x]
*	No

item

linkId: c25

text: Will the study team contact you with new information that may affect your willingness to remain in the study

Answers

-	Value[x]
*	No

item

linkId: c26

text: Will the study team disclose clinically relevant study results to you?

Answers

-	Value[x]
*	No

item

linkId: c27

text: Clinical Trials.gov statement

Answers

-	Value[x]
*	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.

item

linkId: c28

text: Is this study covered under a Certificate of Confidentiality? (default Y in NIH)

Answers

-	Value[x]
*	No

item

linkId: c30

text: Statement of PHI Authorization Revocation

Answers

-	Value[x]
*	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.

item

linkId: c31

text: Signature

item

linkId: c31.1

text: Indicator to include Participant Signature and Date/Time

item

linkId: c31.2

text: Indicator to include Assent Signature and Date/Time

item

linkId: c31.3

text: Indicator to include Legally Authorized Representative Signature and Date/Time

item

linkId: c32

text: Protocol or Study Number

item

linkId: c32.1

text: IRB Number

item

linkId: ADMIN00

text: Administrative Use Only

item

linkId: ADMIN01

text: Link ID prefix

item

linkId: ADMIN02

text: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any

item

linkId: ADMIN03

text: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any