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-8

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

INDEX

Sl.No SOPsSOP code Page No.
Preparation of SOPs for Ethics committee for clinical studies
01Writing, Reviewing, Distributing and Amending Standard Operating Procedures for institutional Ethics CommitteesSOP/01/V81-11
Constituting the Ethics Committee for Research on Human Subjects
02Constitution of an IECSOP/02/V812-25
03Confidentiality/Conflict of  Interest AgreementSOP/03/V826-38
04Training Personnel and Ethics Committee MembersSOP/04/V839-42
05Selection and Responsibilities of Independent consultantsSOP/05/V843-47
Initial  Review Procedures
06Management of protocol submissionsSOP/06/V848-62
07Expedited ReviewSOP/07/V863-69
08Initial Review of submitted protocolSOP/08/V870-96
09Vulnerable populationsSOP/09/V897-102
10Audio Visual (AV) recording of informed consent processSOP/10/V8103-107
Protocol Amendments, Continuing Review and End of  Study
11Review of  Resubmitted protocolsSOP/11/V8108-112
12Review of  Protocol AmendmentsSOP/12/V8113-116
13Continuing Review of Study ProtocolSOP/13/V8117-121
14Review of final reportSOP/14/V8122-124
Monitoring and Evaluation of Adverse Events
15Review of Serious Adverse Events (SAE) ReportsSOP/15/V8125-132
Monitoring Protocol Implementation
16Intervention in Protocol Deviation/Non-Compliance/ ViolationSOP/16/V8133-138
17Response to Research Participants requests/ComplaintsSOP/17/V8139-146
18Management of Study TerminationSOP/18/V8147-149
Site Monitoring
19Site Monitoring visitSOP/19/V8150-155
Preparation of Review Meeting Agenda and Communication Recor
20Agenda Preparation, Meeting Procedures and MinutesSOP/20/V8156-165
Managing Study Files
21Maintenance of active study filesSOP/21/V8166-168
22Archival and retrieval of documentsSOP/22/V8169-175
23Maintaining Confidentiality of IEC DocumentsSOP/23/V8176-181
Evaluating an IEC
24Audit and InspectionSOP/24/V8182-187
24 Patients RecruitementSOP/24/V8182-187

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

Sl.NoDescriptionNumbers
1.  Studies Reviewed30
2.  Ongoing Studies12
3.  Completed02

 

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

Sl.NoDay/Date/MonthTimings
1.    Saturday/16/January11:30 AM
2.    Saturday/13/February11:30 AM
3.    Saturday/27/ February11:30 AM
4.    Saturday/13/March11:30 AM
5.    Saturday/27/ March11:30 AM
6.    Saturday/17/ April11:30 AM
7.    Saturday/22/May11:30 AM
8.    Saturday/12/ June11:30 AM
9.    Saturday/26/ June11:30 AM
10.  Saturday/24/ Jul11:30 AM
11.  Saturday/21/ August11:30 AM
12.  Saturday/18/ September11:30 AM
13.  Saturday/09/ October11:30 AM
14.  Saturday/30/ October11:30 AM
15.  Saturday/20/ November11:30 AM
16.  Saturday/11/ December11:30 AM
17.  Saturday/25/ December11:30 AM

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 coordinator may schedule Two meetings in a month

 

Regards

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

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 trainingDate

Speaker/Trainer

1.ICH-GCP08-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 7.3/201902-Jan-2019

Dr.Subarna Roy- Chairman

Dr.M.S.Ganachari- Member Secretary

3.CITI2017Few IEC members
4.New CT regulations (New Delhi, the 19th March, 2019)01-Apr-2019Dr.M.S.Ganachari- Member Secretary

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

  • 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