Kaur Ramandeep, Christopher Ajay Francis, Gupta Vikas, Bansal Parveen
Division of Clinical Research, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, Punjab, India.
Perspect Clin Res. 2017 Apr-Jun;8(2):85-89. doi: 10.4103/2229-3485.203041.
The composition of the Institutional Ethics Committee (IEC) with an equal respect plays a major role in evaluating research proposals to ensure the safety of the subjects and ethical quality of research project. It is mandatory that all research projects with an involvement of human subjects should be approved by the IEC before commencement.
To find out the equality of respect to members of IEC irrespective of nature of their profession.
Methods include a cross-sectional study, the general information and member composition, multidisciplinary nature, independent performance, competence, decision capability, professionally biased of IECs in health research institutions of Punjab, India. A structured self-administered questionnaire was developed and provided to all health/research institutions providing the graduate/postgraduate education in medical sciences under the jurisdiction of Baba Farid University of Health Sciences, Faridkot, Punjab, India.
Of the total 142 institutes, only 80 (56% response rate) institutes responded to the questionnaire. Of the 80 institutes which responded, 65 institutes (81.25%) had IEC, while 15 (18.75%) institutes lacked IEC. The compositions of only 22% IECs were in compliance to Drug Controller General of India (DCGI) guidelines and only nine (14%) institutes of the state of Punjab had approval from the DCGI.
Study clearly indicates the carelessness of regulatory bodies and lack of fair practices toward constitution of the IEC. The ratio of nonscientific members (ethicist, philosopher, and layperson) in the IEC composition was incredibly low. This study also reveals the professionally biased and noncompliance with schedule Y guideline in relation to the representation of lawyers, ethicists, and nonscientific members.
机构伦理委员会（IEC）成员构成秉持平等尊重原则，在评估研究提案以确保受试者安全和研究项目伦理质量方面发挥着重要作用。所有涉及人类受试者的研究项目在启动前必须获得IEC批准，这是强制性要求。
了解不论职业性质，IEC成员是否受到平等尊重。
方法包括横断面研究，涉及印度旁遮普邦健康研究机构IEC的一般信息、成员构成、多学科性质、独立运作情况、能力、决策能力以及专业偏见。设计了一份结构化的自填式问卷，并提供给印度旁遮普邦法里德科特巴巴·法里德健康科学大学管辖下所有提供医学科学研究生/研究生后教育的健康/研究机构。
在总共142所机构中，只有80所机构（回复率56%）回复了问卷。在回复的80所机构中，65所机构（81.25%）设有IEC，而15所机构（18.75%）没有IEC。只有22%的IEC构成符合印度药品总监（DCGI）的指导方针，旁遮普邦只有9所（14%）机构获得了DCGI的批准。
研究清楚地表明监管机构的疏忽以及在IEC组成方面缺乏公平做法。IEC组成中非科学成员（伦理学家、哲学家和外行人）的比例极低。这项研究还揭示了在律师、伦理学家和非科学成员的代表性方面存在专业偏见且不符合附表Y指南的情况。
