Perceptions of members of ethics committees of medical institutions in India on controlled human infection studies (CHIS) following a sensitization workshop: a systematic survey.

Abstract

Controlled Human Infection Studies (CHIS) involving the deliberate exposure of healthy individuals to infectious agents, are emerging as a valuable tool for medical research. This systematic survey explores the perceptions of ethics committee members from various Indian medical research institutions after participating in a sensitization workshop on CHIS. This cross-sectional study was conducted on the workshop participants through an online survey. The workshop was held in a hybrid mode and around 60 participants from four tertiary care institutions and research institutes had participated. A structured questionnaire was used to assess their evolving perspectives, challenges, and recommendations related to CHIS and the effectiveness of the workshop. Both Likert scale and open-ended items were included in the survey. Responses are presented as percentage and views supported through the quotes from responses. Around 43 participants responded to the survey (72%). Participants acknowledged the potential benefits of CHIS but were concerned about the psychological harm and other risks. Challenges were identified in conducting and reviewing CHIS, including regulatory approvals, risk assessment, and robust informed consent. The need for development of regulatory guidelines, specialized training, risk mitigation strategies, community engagement, and compensation mechanisms were highlighted. The sensitization workshop was considered valuable in enhancing participants' understanding of CHIS, although participants expressed a need for continued training and experience to effectively review such studies. With the Indian Council of Medical Research (ICMR) releasing a policy statement on ethical conduct of CHIS in India, this study provides a foundation for future capacity-building initiatives among ethics committee members. The findings emphasize the significance of ongoing dialogue to standardize the ethical review process for CHIS, thus facilitating their acceptance and realization in India's medical research landscape.