A cross-sectional study: Need of equal respect for all professionals in the Institutional Ethics Committees' composition.

Perspect Clin Res

Division of Clinical Research, University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, Punjab, India.

Published: January 2017

AI Article Synopsis

  • The study investigates the composition and functioning of Institutional Ethics Committees (IECs) in Punjab, India, focusing on the equal respect given to all members regardless of their profession.
  • The research involved a cross-sectional survey sent to health institutions, revealing a response rate of 56%, with only 81.25% having an IEC and a mere 22% complying with the Drug Controller General of India's guidelines.
  • Findings highlight significant issues such as a low representation of nonscientific members and a concerning lack of regulatory oversight and fair practices in the formation of IECs.

Article Abstract

Background: 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.

Aim: To find out the equality of respect to members of IEC irrespective of nature of their profession.

Materials And Methods: 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.

Results: 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.

Conclusion: 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5384405PMC
http://dx.doi.org/10.4103/2229-3485.203041DOI Listing

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