Barriers to the Ethics Committee in India: Ethical and Quality Issues

What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis

“…Attitudes: there was widespread support for the existence and need for ethics committees and ethical review amongst dental professionals, 81 98 137 but variation in satisfaction (high 67 to limited 108 135 ) regarding ethics committee functioning amongst professional groups (medical and contract research organisation staff). Reported challenges faced by ethics committees (as perceived by contract research organisation staff) included conflicts of interest that compromised their independence and pressures from senior management.…”

“… 133 The evolution of stricter regulations and guidelines was described favourably by ethics committee members, but they also felt they were too frequentand too many 76 121 with numerous challenges in implementing some of the newer regulatory changes 76 (such as renewal of committee registration). There was overwhelming support for a single national research ethics committee to consider multi-centric trials to prevent ‘ethics committee shopping’ (where investigators went to different committees until they obtained approval) amongst contract research organisation staff 89 108 but lesser support amongst committee members. 76 Views on how wide the remit of ethics committees should be varied across professional groups (from monitoring serious adverse events to imparting research ethics education to investigators and conducting ongoing monitoring of trials and on-site visits).…”

“…Practice: research on ‘practice’ related aspects of ethics committees suggests there were many areas of concern in relation to their functioning and composition 92 (eg, arbitrariness in member selection and lack of choice in refusing membership amongst those affiliated to institutions), responsibilities 92 101 102 (eg, some committees undertook monitoring of ongoing trials and on-site visits, while others did not), workload 73 92 102 108 130 (frequently described as onerous), the ethics review process 73 101 102 (eg, lack of uniformity in documents and ethical aspects reviewed and guidelines followed) and the dilemmas faced in being expected to align with the international standards for ethical review and the increasing pharmaceuticalisation of society, while also protecting national interests and preventing the perpetuation of existing health and social inequities. 121 …”

“…160 *One study was identified through the consultation exercise. †This includes articles that reported on different aspects of the results derived from the same dataset 73 92 93 107108 or on different datasets obtained through the same grant.113 114 120 126 127 160…”