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Institutional Ethics Committee KAHER

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

1.     NABH- Ethics Committee (For Clinical Trials)
2.     FERCAP-Forum for Ethical Review Committees in the Asian and Western Pacific Region
3.     Department of Health Research- Ethics Committee registration
4.     CDSCO-CT-01
5 Office for Human Research Protections

 

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

VERSION-8.3

INDEX OF STANDARD OPERATING PROCEDURES VERSION-8.3

History of KLE Academy of Higher Education and Research

Sl.No SOPs SOP code Page No.
I. Preparation of SOPs for Ethics committee for clinical studies
01

 

Writing, Reviewing, Distributing and Amending Standard Operating Procedures for institutional Ethics Committees SOP/01/V-8.3 1-13
II. Constituting the Ethics Committee for Research on Human Subjects
02 Constitution of an IEC SOP/02/ V-8.3 14-27
03 Confidentiality/Conflict of Interest Agreement SOP/03/ V-8.3 28-39
04 Training Personnel and Ethics Committee Members SOP/04/ V-8.3 40-43
05 Selection and Responsibilities of Independent consultants SOP/05/ V-8.3 44-48
III. Initial Review Procedures
06 Management of protocol submissions SOP/06/ V-8.3 49-67
07 Expedited Review SOP/07/ V-8.3 68-74
08 Initial Review of submitted protocol SOP/08/ V-8.3 75-93
09 Vulnerable populations SOP/09/ V-8.3 94-102
10 Audio Visual (AV) recording of the informed consent process SOP/10/ V-8.3 103-107
11 Review of Resubmitted protocols SOP/11/ V-8.3 108-113
IV. Protocol Amendments, Continuing Review and End of Study
12 Review of Protocol Amendments SOP/12/ V-8.3 114-120
13 Continuing Review of Study Protocol SOP/13/ V-8.3 121-126
14 Review of Final report SOP/14/ V-8.3 127-129
V. Monitoring and Evaluation of Adverse Events
15 Review of Serious Adverse Events (SAE) Reports SOP/15/ V-8.3 130-142
VI. Monitoring Protocol Implementation
16 Intervention in Protocol Deviation/Non-Compliance/ Violation SOP/16/ V-8.3 143-149
17 Response to Complaints, Queries & Requests SOP/17/ V-8.3 150-158
18 Management of Study Termination SOP/18/ V-8.3 159-162
VII. Site Monitoring Visits
19 Site Monitoring visit SOP/19/ V-8.3 163-169
VIII. Preparation of Review Meeting Agenda and Communication Records
20 Agenda Preparation, Meeting Procedures and Minutes SOP/20/ V-8.3 170-188
IX. Managing Study Files
21 Maintenance of active study files SOP/21/ V-8.3 189-192
22 Archival and retrieval of documents SOP/22/ V-8.3 193-199
23 Maintaining Confidentiality of IEC Documents SOP/23/ V-8.3 200-206
X. Evaluating an IEC
24 Audit and Inspection SOP/24/ V-8.3 207-212
XI. Subjects/Patients recruitment strategies
25 Subjects/Patients recruitment strategies SOP/25/ V-8.3 213-220
26 Continuous improvement: a corrective and preventive action (CAPA SOP/26/ V-8.3 221-228
XII. Review of Biomedical and Health Research and CDSCO-Clinical trials During COVID-19 Pandemic SOP/27/ V-8.3 229-230
  IEC Decision Status/Year wise 2022 2021 2020
  Approved with/without suggestions 17 30 12
  Minor Modifications 8 20 12
  Major Modifications for full board 0 1 3
  Total=103 25* 51 27

IEC of KLE University Meeting Schedules-2022
[Online-Offline]
Venue: KLE Site Management Office, KLES Dr.Prabhakar Kore Hospital and MRC, Belagavi

IEC of KLE Academy of Higher Education and Research, Belagav-590010

Tentative Meeting Details-2022

Sl.No

Day and Date Timings
1           Monday, 13-January 03:30 PM
2           Tuesday-08-February 03:30 PM
3           Saturday-12-March 03:30 PM
4           Saturday-09-April 03:30 PM
5           Saturday-14-May 03:30 PM
6           Saturday 11-June 03:30 PM
7           Saturday 09-July 03:30 PM
8           Saturday -13-August 03:30 PM
9           Saturday -10-September 03:30 PM
10       Saturday -15- October 03:30 PM
11       Saturday -12-November 03:30 PM
12       Saturday 17-December

03:30 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 the 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

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.
IEC Member Training Record Form
Sl.No Name of the training/

Workshops    

Year Speaker/Trainer
1. ICH-GCP training 2018 Dr.Abhidnya.V.Desai- IRB Administrator-TATA memorial Cancer Hospital, Mumbai
3. CITI training 2016- Updation Most of IEC members
4. New CT regulations (New Delhi, the 19th March 2019 Dr.M.S. Ganachari- Member Secretary
5. GCP & NDCT Rules 2020 Yenopoya University- Ethics Expertise
 6. Ethics Review of Health Research 2021 Online Course provided by Swayam-ICMR-NIE-WHO
 7. Basic Research Ethics, GCP 2022 Dr.Arthur Navarrao -FERCAP Lead Surveyor and Team
 8. Bio-Medical Research Ethics & GCP: NDCT Rules 2019 Perspective 26 August 2022 ICMR Expertise

Dr.Roli Mathur

Dr. Lalita Savardekar

Dr. Prasanth Mathur

Dr. Vasantha Muthuswamy

Dr.Subarna Roy

Dr.M.S.Ganachari