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.

Purpose:

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-7.3

AF/IEC/01/01/V7.3LIST OF STANDARD OPERATING PROCEDURES

INDEX

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/V7.3 1-11
Constituting the Ethics Committee for Research on Human Subjects
02 Constitution of an IEC SOP/02/V7.3 12-25
03 Confidentiality/Conflict of  Interest Agreement SOP/03/V7.3 26-38
04 Training Personnel and Ethics Committee Members SOP/04/V7.3 39-42
05 Selection and Responsibilities of Independent consultants SOP/05/V7.3 43-47
Initial  Review Procedures
06 Management of protocol submissions SOP/06/V7.3 48-62
07 Expedited Review SOP/07/V7.3 63-69
08 Initial Review of submitted protocol SOP/08/V7.3 70-96
09 Vulnerable populations SOP/09/V7.3 97-102
10 Audio Visual (AV) recording of informed consent process SOP/10/V7.3 103-107
Protocol Amendments, Continuing Review and End of  Study
11 Review of  Resubmitted protocols SOP/11/V7.3 108-112
12 Review of  Protocol Amendments SOP/12/V7.3 113-116
13 Continuing Review of Study Protocol SOP/13/V7.3 117-121
14 Review of final report SOP/14/V7.3 122-124
Monitoring and Evaluation of Adverse Events
15 Review of Serious Adverse Events (SAE) Reports SOP/15/V7.3 125-132
Monitoring Protocol Implementation
16 Intervention in Protocol Deviation/Non-Compliance/ Violation SOP/16/V7.3 133-138
17 Response to Research Participants requests/Complaints SOP/17/V7.3 139-146
18 Management of Study Termination SOP/18/V7.3 147-149
Site Monitoring
19 Site Monitoring visit SOP/19/V7.3 150-155
Preparation of Review Meeting Agenda and Communication Recor
20 Agenda Preparation, Meeting Procedures and Minutes SOP/20/V7.3 156-165
Managing Study Files
21 Maintenance of active study files SOP/21/V7.3 166-168
22 Archival and retrieval of documents SOP/22/V7.3 169-175
23 Maintaining Confidentiality of IEC Documents SOP/23/V7.3 176-181
Evaluating an IEC
24 Audit and Inspection SOP/24/V7.3 182-187

ANNUAL REPORT OF SMO
KLE S Dr. Prabhakar Kore Hospital and MRC

Annual Report for 2018 -2019
No.of Ongoing Trials: 45
No.of Completed Trials: 10
List of sponsors   List 

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

Rights

  • 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.

Responsibilities

  • 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

Sl.No

Name of the training Date

Speaker/Trainer

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

Institutional Ethics Committee

KLE Academy of Higher Education and Research, Belagavi
[Formerly Known as KLE University]
(Nehru Nagar, J.N.Medical College campus, Belagavi 590010, India)
KLES Dr.Prabhakar Kore Hospital, Belgaum-590010, Karnataka State, India
Ph: 0831-2470400 FAX: 0831-2493099 www.kledeemeduniversity.edu.in
E-mail:kleclinicalresearch@gmail.com

Ethics Committee Meeting Schedule-2019

Month Day Time
January-02nd
January-12th
Wednesday
Thursday
04.00 PM
11.00 AM
February-05th
February-27th
Tuesday
Wednesday
04.00 PM
04.00 PM
March-14th Tuesday 04.00 PM
April-04th
April-26th
Tuesday
Friday
04.00 PM
04.00 PM
May -10th Friday 04.00 PM
June 04th Tuesday 04.00 PM
July-12th Friday 04.00 PM
August-02nd Friday 04.00 PM
September 05th Tuesday 04.00 PM
October-04th Friday 04.00 PM
November-15th Friday 04.00 PM
December-13th Friday 04.00 PM

 

Instructions

  • 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 will schedule the Two meetings in a month*

Dr.M.S.Ganachari
Member-Secretary of IEC,
K.L.E. Academy of Higher Education & Research, Belagavi


IEC Registrations:

  • EC Reg. No.ECR/211/Inst/KA/2013/RR-2016 – Under Rule 122DD of the Drugs and Cosmetics Rules 1945 [DCGI]
  • OHRPReg.No:IRB00008025KLEUniversity, IRB00001499

Hon’ble Vice chancellor of KLE University

 

Dr.Subarna Roy,

Chairperson- Non Affiliated

Dr.M.S.Ganachari, 

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

                                                                          Sponsors

                                                                          Regulatory authority

                                                                           CROs

                                                                           Subjects

                                                                           Principal Investigators

                                                                           Hospital Authorit