Institutional Ethics Committee

The Vice Chancellor of KLE Academy of Higher Education and Research, Belagavi establish the Institutional Ethics Committee. The Ethics committee offers essential assistance, resources, and autonomy to ensure the smooth operation and effective decision-making during the protocol review process. All research that involves human participants must be carried out in accordance with three fundamental ethical principles, encompassing the following:

Respect for persons



ESTD YEAR : 2009

SL.No SOPs SOP Code Page
I Preparation of SOPs for Ethics committee for clinical trials SOP/01/V-8.5 1-13
II Constituting the Ethics Committee for Research on Human Subjects

  • Constitution of an IEC
  • Confidentiality/Conflict of Interest Agreement
  • Training Personnel and Ethics Committee Members
  • Selection and Responsibilities of Independent consultants

SOP/02/ V-8.5

SOP/02/ V-8.5

SOP/02/ V-8.5

SOP/02/ V-8.5






III Initial Review Procedures

  • Management of protocol submissions
  • Expedited Review
  • Initial Review of submitted protocol
  • Vulnerable populations
  • Audio Visual (AV) recording of the informed consent process
  • Review of Resubmitted protocols

SOP/06/ V-8.5

SOP/07/ V-8.5

SOP/08/ V-8.5

SOP/09/ V-8.5

SOP/10/ V-8.5

SOP/11/ V-8.5








IV Protocol Amendments, Continuing Review and End of Study
V Monitoring and Evaluation of Adverse Events
VI Monitoring Protocol Implementation/Compliances
VII Study Monitoring Visit by IEC Members/Secretariat
VIII Preparation and Review Meeting Agenda and Minutes of meeting
IX Managing Study Files
X Evaluating an IEC of KAHER
XI Subjects/Patients recruitment strategies
XII Review of Biomedical and Health Research and CDSCO-Clinical trials During COVID-19 Pandemic

Management of protocol submissions

Trial Status Table 2020 to 2023

Within 21 days [After full board meeting-EC clearance will get within 07 working days]

INR-75000 per protocol review.

Yes, ECR/211/Inst/2013/RR-19 Under ND&CT Rules, 2019

Yes, EC/NEW/INST/2021/1726

Yes, FWA: 00024127

  • > IORG#-0001102
  • –  IRB00001499 JNMC Ethics Committee on Human Subjects Rsc IRB#1
  • –  IRB00012930 KLE Academy of Higher Education and Research IRB#2