Topics on this Page
- REDCap Templates
- Qualtrics Templates
- Protocol Submission Requirements
- Guidance Documents
Below are the available templates for electronic informed consent. The description can assist you in determining which template is most appropriate for your project and the table describes what forms should be utilized with the selected template. The WVU OHRP-45 eIC submission worksheet will help you work through the specifics of the electronic informed consent process.
REDCap Templates
All templates can be used for projects with or without PHI.
| Available Template | Description | Use With Forms |
| e01 Remote eConsent | Use this template when consent is happening remotely (i.e., the person obtaining consent and the participant are not physically in the same location and the research is FDA-regulated). This template includes identity verification questions required by FDA regulations as well as signature capabilities for the participant and person obtaining informed consent. |
WVU OHRP-23 Adult Non-Medical Consent Template or WVU OHRP-24 Adult Medical Consent
Template or WVU OHRP-26 Parent-Guardian Consent Form Template
AND WVU OHRP-45 eIC submission worksheet |
| e02 In-Person eConsent |
Use this template when consent is happening in person via eConsent (i.e., the person
obtaining consent and the participant are physically in the same location).
Identity verification is not required for eConsent that happens in person.
This template includes signature capabilities for the participant and person
obtaining informed consent.
|
WVU OHRP-23 Adult Non-Medical Consent Template orWVU OHRP-24 Adult Medical Consent
Template orWVU OHRP-26 Parent-Guardian Consent Form Template
AND WVU OHRP-45 eIC submission worksheet |
| e03 Cover Letter/Informational Sheet | Use this template for exempt, flex, and NHSR protocols that do not require
a signature (no HIPAA authorization and the project is utilizing an informational
sheet) and for expedited protocols with a waiver of documentation (no HIPAA
authorization and the project is using an expedited cover letter consent).
This project does not include signatures.
|
WVU OHRP-25 Exempt, Flex, NHSR Cover Letter Template
OR WVU OHRP-27 Expedited Cover Letter Consent Template |
| e04 Separate HIPAA Authorization |
Use this template when there is a separate HIPAA authorization form (i.e., HIPAA
Authorization is not included in the consent document).
|
WVU OHRP-38 Standalone HIPAA Authorization Form Template
|
| e05 Assent |
Use this template when there is a separate assent process. Consent from a Parent
or LAR is required in addition to this form.
|
WVU OHRP-35 Child Assent Form Template
|
| e08 Recruitment - Send eIC for Review Only |
Use this template to send a blank consent form to the participant/LAR for review
only.
|
- - - |
| e09 CIRB Informed Consent with Signature | Use this template for CIRB or when WVU IRB is NOT the IRB of Record. This includes
consenting researcher signature capability and identity verification.
|
- - - |
Qualtrics Templates
| Available Template | Description | Use With Forms |
| e10 Cover Letter/Informational Sheet (Surveys) | Use this template for exempt, flex, and NHSR protocols that do not require
a signature (no HIPAA authorization and utilizing an informational sheet)
and for expedited protocols with a waiver of documentation (no HIPAA authorization
and using an expedited cover letter consent). This project does not include
signatures.
|
WVU OHRP-25 Exempt, Flex, NHSR Cover Letter Template or WVU OHRP-27 Expedited
Cover Letter Consent Template
|
| e11 Recruitment-Send eIC/Information for Review Only | Use this template to send a blank consent form/informational sheet to the participant/LAR
for review only.
|
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|
e03 eConsent
Non-covered entity only |
Use this template for non-FDA regulated studies that require the participant's signature. | WVU OHRP-23 Adult Non-Medical Consent Template or WVU OHRP-24 Adult Medical
Consent Template or WVU OHRP-26 Parent-Guardian Consent Form Template
AND WVU OHRP-45 eIC submission worksheet |
Protocol Submission Requirements
- Complete the Consent questions in WVU+kc (for Full Board and Expedited).
- Complete the eIC Submission Worksheet, if applicable and attach it to the protocol
application. OHRP Forms web page.
- Include the link (URL) to the eTemplate in eIC Submission Worksheet.
- Attach a PDF of the eTemplate from REDCap/Qualtrics/Other in the WVU+kc Attachments
section.
- Include links and file attachments for all other electronic materials to be used
during informed consent.
- Attach the draft paper consent form/document (Word) in the WVU+kc Attachments section.