Institutional Ethics Committee

About-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

Beneficence

Justice

Genesis of Ethics Committee

ESTD YEAR : 2009

Organogram of Ethics Committee

Standard Operating Procedure

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	14-25 26-37 38-41 42-47
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	48-66 67-73 74-90 91-97 98-102 103-108
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