A comparative study of the informed consent process with or without audiovisual recording

Area of Science:

• Clinical Trials
• Informed Consent Process
• Participant Comprehension

Background:

• The Central Drugs Standard Control Organization (CDSCO) mandated audiovisual (AV) recording for informed consent in regulatory studies starting November 2013.
• A phase 2/3 trial at the center utilized both written informed consent and AV-recorded consent processes.
• This provided a unique opportunity to compare participant understanding between the two methods.

Purpose of the Study:

• To evaluate the difference in participant understanding between audiovisual (AV) recorded informed consent and traditional written informed consent.
• To assess the impact of AV recording on participant comprehension of key study elements.

Main Methods:

• A validated 16-item questionnaire across six domains (purpose, procedures, risks, benefits, payment, rights/confidentiality) was used.
• Participants from both AV and written consent groups completed the questionnaire.
• Responses were scored, and between-group analyses were performed on total and domain-specific scores.

Main Results:

• Participants in the AV consent group (n=21) demonstrated significantly higher total understanding scores (40.3 ± 5.9) than the written consent group (n=17) (34.8 ± 7.94; p=0.01).
• Significant differences were observed in the 'rights and confidentiality' domain (p=0.01) and 'purpose' domain (p=0.04) for fully correct answers.
• A weak inverse correlation was found between time elapsed since consent and understanding (ρ = -0.3, p=0.01).

Conclusions:

• Audiovisual recording of the informed consent process in clinical trials enhances participant understanding compared to written consent alone.
• AV recording may be a valuable tool for improving participant comprehension and retention of critical study information.
• This method shows particular benefit in clarifying participant rights and study purpose.