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Online Survey Permission & Protocol Submission Guidance

Online Surveys using Qualtrics and REDCap

NHSR, Exempt, Flex Protocols without PHI

NHSR (Not Human Subject Research), Exempt and Flex protocols do not require participants to sign consent forms to participate in the activity. However, the WVU IRB requires that all activities involving collecting/using  information about humans include a question asking for their voluntary permission and an explanation of the activity.    

 If PHI is to be collected, the HSC Version of Qualtrics or REDCap must be used and a HIPAA Authorization must be signed by the participant (OHRP-38) or a HIPAA Waiver approved (OHRP-21).

Online Survey Protocol Submission Requirements (WVU+kc):

  1. Explain the activity to the participant by one of the following methods:
  • Use the   WVU OHRP-25  (informational cover letter Word template) and attach the document to the protocol submission
  • Enter text into the survey to explain the activity to the participant with sufficient detail to make an informed decision about participation.  WVU OHRP-25 provides an optional template which may be adapted for this purpose.
  • Include the following question -  I voluntarily agree to participate and I understand that I can stop participating at any time. (Yes/No)

  • If the activity includes minors (under age18), include a question for a parent/guardian to provide permission for the minor to participate. - I voluntarily agree to allow this minor to participate in this survey and I understand that they can stop participating at any time. (Yes/No)

  • If the activity is an anonymous online survey, ensure the survey settings are set for anonymous data collection (Do not collect IP Addresses).

  • Using eTemplate OHRP e06: WVU OHRP provides an optiona l eTemplate in Qualtrics and REDCap(WVU OHRP e06) for online surveys.  This eTemplate includes a a few standard questions and information that may or may not apply to the activity. The eTemplate can be modified.  Using the  Qualtrics/REDCap WVU OHRP e06 eTemplate  will ensure compliance with the  approved WVU logo and ADA compliant colors and features . Use of the eTemplate is not mandatory, however online surveys are required to be ADA compliant .

  • Protocol Submission: Include the following attach ments and links with the protocol submission as applicable:
    • A PDF of the draft informational cover letter WVU OHRP-25  (if applicable).
    • The link (url) for the online survey  (Include in the WVU+kc notes section).
    • A PDF of the draft online survey. (Add to Attachments in WVU+kc).
    • Include links and PDFs for other electronic materials that will be used.
  • Post Approval: If WVU OHRP-25 was used as a separate document ATTACH the PDF (for ADA compliance) and UPLOAD the image file of WVU OHRP-25 into a survey text question. Skip this step if the informational text was typed directly into the survey.
  • Guidance

    What you need to know:
    • Check the WVU ITS approved software list if Qualtrics or REDCap will not be used. If the product is not listed, contact the WVU OHRP in advance of any due dates as approval of new products may take time.
    • WVU Qualtrics cannot be used for PHI - Use the HSC version of Qualtrics or REDCap
    • STANDARD TEXT: I voluntarily agree to participate and I understand that I can stop participating at any time (Yes/No).