The Consent Process

Key Considerations

• Regulations consider the consent process as a critical communication link between the PI and the potential participant.
• The process should be an active process of sharing information between the PI and the potential participant.
• All critical information about a study is completely disclosed.
• Potential participants or their legally authorized representative must adequately understand the research through concise documentation written in laymen's terms and provided with adequate opportunity to ask questions.
• The entire participant population must be considered to ensure that information is conveyed and delivered in terms that the potential participant understands and by methods that the potential participant can use to review the information (i.e. devices used in electronic consent, remote consent, videos, etc)
• If the potential participant cannot read or speaks a different language, or other disability, accommodations must be made for an appropriate consent process.
• The privacy and confidentiality of the potential participant must be considered at all times (i.e., the location of consent, who will be in the location, etc.)
• Electronic\Remote Consent - Review the WVU approved methods and products.
• The IRB of Record: if WVU is not the IRB of Record, the WVU informed consent language must be included in the Informed Consent Document. When WVU is not the IRB of Record, amendments are not required to be submitted.

Process Steps

1. Develop and Document the Consent Process for WVU IRB Review
   • Consent begins with the initial approach to the potential participant (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research project.
2. Determine the requirements for informed consent based on the type of research
   • Only Minimal Risk - Exempt. Flex, and Not Human Subject Research (NHSR) typically require a cover letter. Note that there are exceptions (Flex if under 18 or pregnant, a signature is required)
   • Only Minimal Risk Expedited and More than Minimal Risk research require a form requiring the signature of the potential participant and the consenting individual (WVU researcher) must sign the form.
3. Determine how consent will be documented.
   • Face-to face, in person
     • Hard-copy Informed Consent Form
     • Electronic Informed Consent Form
   • Remote
     • Hard copy Informed Consent Form (Sent back to WVU via postal mail or Faxed back to a WVU secure fax machine, scanning and sending signed consent forms via e-mail is not permitted)
     • Electronic Informed Consent Form
4. Determine who will sign the Informed Consent Form:
   • Participant
   • Participant with witness
   • Participant's Legally Authorized Representative
   • Participant's Parent or Legal Guardian
   • A participant who is under 18 years old
   • A participant who is a ward of state or in foster care
5. Provide the document and explain the research.
   • After providing a the potential participant with the Informed Consent Document Determine how the research activity and information included in the Informed Consent form will be explained to a potential participant. Privacy and confidentiality must be considered in all situations. Suggest that the potential participant seek privacy for remote consent.
   • Review the WVU approved methods and products:
   • Face-to-Face in Person
   • Phone Call
   • Video Conference
6. Determine how questions will be answered and how concerns will be addressed.
   • Inform the potential participant of the method for obtaining answers to questions and concerns. Privacy and confidentiality must be considered in all situations. Suggest that the potential participant seek privacy for remote consent.
   • Review the WVU approved methods and products:
     • Face-to-Face in Person
     • Phone Call
     • Video Conference
7. If using remote-electronic consent:
   • Provide information on the alternative method for consent that will be offered to potential participants who do not wish to use the electronic method or cannot use the electronic method.
   • FDA: For remote consent without a witness, the potential participant\LAR's identity must be verified. A suggestion is to obtain the answers to three personal questions before the consent process begins (either through the remote survey-software, or during early communication). The potential participant\LAR must be asked the questions before the consent process begins.
8. Document the Consent Process for IRB Review
   • Describe how videos and other electronic media will be used, the content and if the video or electronic media can be used by the entire target audience. Contact the WVU OHRP before investing resources in the development of electronic media if you are concerned about approval.
9. Create the Informed Consent document
   • Use the applicable WVU IRB approved template.
10. Submit the documentation
    • Describing the entire consent process, electronic media, a copy of electronic survey forms, the link to electronic survey forms, a PDF of the hard copy form, a Word document with track-changes ON, and other materials as needed to the WVU IRB with your protocol submission.
11. After Obtaining Approval
    • Begin consenting participants.
12. Store participant Information
    • Ensure that all participant consent information is stored in encrypted, approved WVU storage. Documents cannot be stored in research email boxes as attachments or stored in any personal or WVU storage that is not approved for sensitive (research) information.
13. Revisions
    • The consent process and documentation should be revised when:
    • Deficiencies in accuracy or completeness are noted, when new information about reasonably foreseeable risks and potential benefits becomes available.
    • Additional information becomes known that will improve the consent process

      Revisions must be reviewed and approved by the WVU IRB prior to the revised consent being utilized except when necessary to eliminate apparent immediate hazards to subjects. Note that amendments for projects when WVU is not the IRB of Record, do not require submission to the WVU IRB.