title: Consent for audio-video recording of informed consent process in rural South India.
abstract: OBJECTIVE
  In recent times, audio-video (A-V) recording of consent process for all the study subjects entering a clinical trial has been made mandatory. A-V recording of informed consent process is a big challenge due to confidentiality and the sociocultural environment in India. It is important to find out the acceptability for A-V recording of the consent process and reasons for refusal, if any to address this new challenge.
  
  
  METHODS
  A descriptive survey was done among 150 residents of a rural community of South India. Acceptability for A-V recording of consent process was assessed among those who had given the informed written consent for participation in the study. An attempt to find the factors determining the refusal was also made.
  
  
  RESULTS
  More than one-third (34%) of the study subjects refused to give consent for A-V recording of consent process. Not interested in recording or don't like to be recorded (39%) were the most common reasons to refuse for A-V recording of consent process. The refusal was higher among female and younger age-group adult subjects. Socioeconomic status was not found to be significantly associated with refusal to consent for A-V recording.
  
  
  CONCLUSIONS
  Refusal for A-V recording of consent process is high in the South Indian rural population. Before any major clinical trial, particularly a field trial, an assessment of consent for A-V recording would be helpful in recruitment of study subjects.
authors.affiliation: Department of Community Medicine, Pondicherry Institute of Medical Sciences, Puducherry, India.
authors.forename: Ramesh Chand
authors.initials: RC
authors.lastname: Chauhan
authors.affiliation: Department of Community Medicine, Pondicherry Institute of Medical Sciences, Puducherry, India.
authors.forename: Anil J
authors.initials: AJ
authors.lastname: Purty
authors.affiliation: Department of Obstetrics and Gynaecology, Pondicherry Institute of Medical Sciences, Puducherry, India.
authors.forename: Neelima
authors.initials: N
authors.lastname: Singh
keywords: Audio-video recording; clinical trials; informed consent