1Associate Professor, Department of Pathology and Member of IEC, Sri Manakula Vinayagar Medical College and Hospital, Puducherry-605107, India, drvimalm@gmail.com
2Assistant Professor, Department of Pharmacology and Member of IEC, Sri Manakula Vinayagar Medical College and Hospital, Puducherry-605107, India
3Dean (Research), Professor and Head, Department of Community Medicine and Member of IEC, Sri Manakula Vinayagar Medical College and Hospital, Puducherry-605107, India, amolrdongre@gmail.com
4Deputy Director & Dean, Professor and Head, Department of Forensic Medicine and Member Secretary of IEC, Sri Manakula Vinayagar Medical College and Hospital, Puducherry-605107, India, rnkagne@gmail.com
*Corresponding author email id: drnishanthipharm@gmail.com
Online published on 23 July, 2019.
The Institutional Ethics committee (IEC) of our institution was planning to apply for Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) accreditation and as a part of the planning cycle, we proposed to conduct an internal audit of the research proposals submitted to the IEC and evaluate the effectiveness of the regular ethics training sessions for the researchers conducted in the institution.
To study the possible ethical issues identified by the Principal Investigators and their proposed solutions in the research proposal documents submitted to the IEC.
Retrospective data of possible ethicalissues identified by the researchers in their research and their proposed plans to address them were collected from the research proposal documents submitted to the IEC office from July 2016 to December 2017.
Of the total 161 proposals, 134 (83.2%) have identified autonomy, 102 (63.4%) beneficence and non-maleficence, 52 (32.3%) justice and equality, 110 (68.3%) privacy, and 112 (69.6%) confidentiality. Out of the total proposals, 36 involved research on a vulnerable population, of which 25 (69.4%) have identified it. Similarly, 123 studies had therapeutic misconception as an ethical issue and 104 (84.5%) have identified it. Assent form was required in 18 studies, and of it, 14 (77.8%) proposals mentioned the need for it.
Majority of the researchers have mentioned the salient ethical issues and proposed solutions to address them, in their research proposal documents submitted to the IEC. All Ethics committees should adopt a structured template for ethical issues in their research proposal submission format.
Institutional ethics committee, Ethical issues, Research ethics, Ethical review, Research proposals
