Chauhan Ramesh Chand, Purty Anil J, Singh Neelima
Department of Community Medicine, Pondicherry Institute of Medical Sciences, Puducherry, India.
Department of Obstetrics and Gynaecology, Pondicherry Institute of Medical Sciences, Puducherry, India.
Perspect Clin Res. 2015 Jul-Sep;6(3):159-62. doi: 10.4103/2229-3485.159941.
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.
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.
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.
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.
近年来，对所有参与临床试验的研究对象的同意过程进行音频 - 视频（A - V）记录已成为强制性要求。由于印度的保密规定和社会文化环境，对知情同意过程进行A - V记录是一项巨大挑战。了解同意过程A - V记录的可接受性以及拒绝的原因（若有）对于应对这一新挑战很重要。
对印度南部一个农村社区的150名居民进行了描述性调查。在那些已给出参与研究的知情书面同意书的人群中评估对同意过程A - V记录的可接受性。同时也尝试找出决定拒绝的因素。
超过三分之一（34%）的研究对象拒绝同意对同意过程进行A - V记录。对记录不感兴趣或不喜欢被记录（39%）是拒绝同意对同意过程进行A - V记录的最常见原因。女性和较年轻年龄组的成年对象中拒绝率更高。未发现社会经济地位与拒绝同意A - V记录有显著关联。
在印度南部农村人口中，拒绝同意对同意过程进行A - V记录的比例很高。在任何大型临床试验之前，尤其是现场试验之前，对A - V记录同意情况进行评估将有助于招募研究对象。
