Suggestions for Verbal Consent

Verbal consent is an alternative to written consent in research, particularly when traditional written methods might be not feasible or appropriate in some cultural norms. To ensure proper verbal consent, researchers should adhere to the following guidelines.  

 

Preparation

  1. Develop a comprehensive Oral Consent Script (OCS) that includes all essential elements of informed consent. These include:
    a.   Introducing the Researcher's name, affiliation, and organization;
    b.   The purpose of the research;
    c.   Study procedures, Expected duration of participation;
    d.   Compensation, Risks and benefits, Alternatives to participation, Voluntary nature of participation, Withdrawal;
    e.    Contact information. 
        
  2. Ensure the OCS is written in plain language, avoiding technical terms, to facilitate understanding by the research participant. For most adult populations, it should be written at an 8th-grade reading level.
    a.   Use second-person language ("you") rather than first-person ("I").
    b.   The OCS should allow sufficient time for potential participants to ask questions and consider their decision.
    c.   The length and detail of the OCS may vary depending on the nature of the study and whether a separate Participant Information Sheet (PIS) is provided.
       
  3. The verbal consent may be accompanied by a written "Short Form" consent document.
       
  4. Both the OCS and the Short Form must be in the research subject's native language, and must have been approved by NTU-IRB before research participants are approached. Refer to NTU IRB guidelines on Waivers of Appropriate Consent. 

   

Consent Process (i.e. to follow closely the approved OCS)

  1. Explain the study's purpose, procedures, risks, benefits, and alternatives to participation.
       
  2. Emphasize that participation is entirely voluntary.
       
  3. Allow sufficient time for potential participants to ask questions and consider their decision.
       
  4. Assess the participant's comprehension by asking them to explain key points of the study.
       
  5. Obtain verbal agreement to participate.

    

Documentation of the verbal consent

  1. The PI must ensure that all verbal consent processes are properly documented and archived.
       
  2. Document the consent process thoroughly, including date, time, and any witness or translator information. A copy of the audio/video recording should be retained for each participant’s consent.
       
  3. Methods of Documentation:
    a.   Phone: Record consent by putting the phone on speaker mode and record it in audio.
    b.   In-Person: Use an audio recording device.
    c.   Digital Platforms: Video/audio recordings serve as documentation for platforms like Zoom.
  4. Provide participants with a copy of the Participant Information Sheet (PIS) (if available) and Oral Consent Script (OCS) in person or via email.
       
  5. Witnesses:
    a.   Consider having a witness present. The investigator cannot serve as a witness, but an interpreter/translator may.
    b.   Use video calls for studies requiring a witness or translator to ensure participant understanding.
       
  6. Ensure documentation is easily retrievable and maintain an audit trail for monitoring, audits, and inspections.

   

For a generic Oral Consent Script (OCS), refer to our IRB intranet page.