Ethics Committee

About Ethics Committee

The Institutional Ethics Committee is constituted by The Honb’le Vice-Chancellor / Registrar of KLE Academy of Higher Education and Research, Belagavi.


The Ethics Committee of KAHER was established in 2009 in order to  formalize and specify the Institution’s commitment to promotion of high ethical standards in patient care, professional education, clinical research and community interests.

Applicable to all clinical trials and academic research, including Bioavailability/ Bioequivalence (BA/BE) studies, Phase I, II, III, IV studies, Non Therapeutic and Non-interventional studies and   research projects conducted at KLES Dr. Prabhakar Kore Hospital and MRC.

All research involving human subjects should be conducted in accordance with three basic ethical principles, which include,

  • Respect for persons
  • Beneficence
  • Justice

IEC  members will be appointed by the Hon. Vice Chancellor of KLE Academy of Higher Education and Research in accordance with New Drugs and Clinical Trial Rules, 2019

K.L.E. Academy of Higher Education and Research, Belagavi

Standard Operating Procedures of Ethics Committee

DCGI Registration No.: ECR/211/Inst/KA/201 3/RR-2019

ANNEXURE: 01                                                                                VERSION-8



Sl.No SOPs SOP code Page No.
Preparation of SOPs for Ethics committee for clinical studies
01 Writing, Reviewing, Distributing and Amending Standard Operating Procedures for institutional Ethics Committees SOP/01/V8 1-11
Constituting the Ethics Committee for Research on Human Subjects
02 Constitution of an IEC SOP/02/V8 12-25
03 Confidentiality/Conflict of  Interest Agreement SOP/03/V8 26-38
04 Training Personnel and Ethics Committee Members SOP/04/V8 39-42
05 Selection and Responsibilities of Independent consultants SOP/05/V8 43-47
Initial  Review Procedures
06 Management of protocol submissions SOP/06/V8 48-62
07 Expedited Review SOP/07/V8 63-69
08 Initial Review of submitted protocol SOP/08/V8 70-96
09 Vulnerable populations SOP/09/V8 97-102
10 Audio Visual (AV) recording of informed consent process SOP/10/V8 103-107
Protocol Amendments, Continuing Review and End of  Study
11 Review of  Resubmitted protocols SOP/11/V8 108-112
12 Review of  Protocol Amendments SOP/12/V8 113-116
13 Continuing Review of Study Protocol SOP/13/V8 117-121
14 Review of final report SOP/14/V8 122-124
Monitoring and Evaluation of Adverse Events
15 Review of Serious Adverse Events (SAE) Reports SOP/15/V8 125-132
Monitoring Protocol Implementation
16 Intervention in Protocol Deviation/Non-Compliance/ Violation SOP/16/V8 133-138
17 Response to Research Participants requests/Complaints SOP/17/V8 139-146
18 Management of Study Termination SOP/18/V8 147-149
Site Monitoring
19 Site Monitoring visit SOP/19/V8 150-155
Preparation of Review Meeting Agenda and Communication Recor
20 Agenda Preparation, Meeting Procedures and Minutes SOP/20/V8 156-165
Managing Study Files
21 Maintenance of active study files SOP/21/V8 166-168
22 Archival and retrieval of documents SOP/22/V8 169-175
23 Maintaining Confidentiality of IEC Documents SOP/23/V8 176-181
Evaluating an IEC
24 Audit and Inspection SOP/24/V8 182-187
24 Patients Recruitement SOP/24/V8 182-187

Annual Report of IEC-KLE University
2020-Jan to Dec-2020

Sl.No Description Numbers
1.   Studies Reviewed 30
2.   Ongoing Studies 12
3.   Completed 02


IEC of KLE University Meeting Schedules-2021
Venue: KLE Site Management Office, KLES Dr.Prabhakar Kore Hospital and MRC, Belagavi

Sl.No Day/Date/Month Timings
1.     Saturday/16/January 11:30 AM
2.     Saturday/13/February 11:30 AM
3.     Saturday/27/ February 11:30 AM
4.     Saturday/13/March 11:30 AM
5.     Saturday/27/ March 11:30 AM
6.     Saturday/17/ April 11:30 AM
7.     Saturday/22/May 11:30 AM
8.     Saturday/12/ June 11:30 AM
9.     Saturday/26/ June 11:30 AM
10.   Saturday/24/ Jul 11:30 AM
11.   Saturday/21/ August 11:30 AM
12.   Saturday/18/ September 11:30 AM
13.   Saturday/09/ October 11:30 AM
14.   Saturday/30/ October 11:30 AM
15.   Saturday/20/ November 11:30 AM
16.   Saturday/11/ December 11:30 AM
17.   Saturday/25/ December 11:30 AM


  • Above mentioned date and time are tentative
  • If the proposed dates are changed due to technical reasons, the fresh dates will be communicated.
  • For details  of the schedule of meeting you can contact secretariat
  • In some cases IEC coordinator may schedule Two meetings in a month



Member Secretary of IEC

Therapeutic Area

  • Cardiology/Vascular Diseases
  • Vaccines
  • Pulmonary / Respiratory Diseases
  • Dermatology
  • Endocrinology
  • Family Medicine
  • Obstetrics / Gynecology
  • Gastroenterology
  • Pediatrics / Neonatology
  • Genetic Disease
  • Hematology
  • Hepatology (Liver, Pancreatic, Gall Bladder)
  • Immunology
  • Infections and Infectious Diseases
  • Musculoskeletal
  • Nephrology
  • Neurology
  • Nutrition and Weight Loss
  • Ophthalmology
  • Orthopedics / Orthopedic Surgery
  • Otolaryngology (Ear, Nose, Throat)
  • Plastic Surgery
  • Pharmacology / Toxicology
  • Podiatry
  • Psychiatry / Psychology
  • Sleep
  • Trauma (Emergency, Injury, Surgery)
  • Urology

Patient Rights and Responsibilities


  • To be treated with RESPECT and DIGNITY.
  • To every consideration of PRIVACY concerning their medical care.
  • To expect that all records pertaining to their care are CONFIDENTIAL. Expect when required by law, patients are given the opportunity to approve or refuse their release.
  • To access to INFORMATION concerning their care, including their medical records, as provided by the state and federal laws.
  • To PARTICIPATE in decision involving their health care, except when such participation is not indicated for medical releases.
  • To REFUSE treatment to the extent permitted by law and to be informed of the medical consequences of their actions.
  • To receive all information necessary to sign an INFORMED CONSENT prior to the start of any procedure and/or treatment, except in emergencies where their lives or health may be in serious danger.
  • To voice GRIEVANCES about their managed care organization or the medical care provided.
  • To offer SUGGESTIONS/FEEDBACK for changes in policies and procedures.


  • Adhere to the treatment plan recommended.
  • To be on time for appointments.
  • To inform about your medical history and symptoms.
  • Notify if there are any changes in your address and phone number.

Training and Education


Name of the training Date


1. ICH-GCP 08-Dec-2018

Dr.Abhidnya.V.Desai- IRB Administrator-TATA memorial Cancer Hospital, Mumbai

Dr.Subarna Roy- Chairman

Dr.M.S.Ganachari- Member Secretary

2.  IEC SOP Version 7.3/2019 02-Jan-2019

Dr.Subarna Roy- Chairman

Dr.M.S.Ganachari- Member Secretary

3. CITI 2017 Few IEC members
4. New CT regulations (New Delhi, the 19th March, 2019) 01-Apr-2019 Dr.M.S.Ganachari- Member Secretary

Hon’ble Vice chancellor of KLE University


Dr.Subarna Roy,

Chairperson- Non Affiliated


Member Secretary- Affiliated


    Dr.Harsha V Hegde- Scientific Member

    Dr.P.A.Patil- Basic Medical Scientist

    Dr.S.S.Goudar- Basic Medical Scientist

                   Dr.Nayana Hashilkar- Basic Medical Scientist

    Dr.Roopa Bellad- Clinician

    Dr.Yeshita Pujar- Clinician

    Mrs.Vaishnavi- Social Scientist

    Shri.Praveen Hiremath- Legal Expert

    Shri.Tammanna Dadu Kore- Lay person

           Mrs.Geetanjali Salimath- Scientific Member

                                                                          IEC Secretariat


                                                                          Regulatory authority



                                                                           Principal Investigators

                                                                           Hospital Authorit

  • IEC Submission
    • within 21 day of IEC meeting
  • Offline or online
    • https://www.iecmanager.org//
  • IEC meeting -Presentation From PIs
    • Within 07 Working Days
  • IEC Decision letter
  • Study can be initiated