fbpx
HomeInstitutional Ethics Committee

Institutional Ethics Committee

Institutional Ethics Committee
Of
KLE Academy of Higher Education and Research
JNMC Campus, KLEs Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi-Karnataka-590010
INDEX

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

NAME OF THE IEC Institution Independent Ethics Committee
CATEGORY Clinical trials-Ethics committee
REGULATORY BODY CDSCO-DELHI-MOHFW
CHAIRPERSON Non-Affiliated to Institution-Dr.Subarna Roy, Director & Scientist F-NITM
WEBSITE https://kledeemeduniversity.edu.in/ethics-committee

 

Standard Operating Procedure

Index of Standard Operating Procedures of Ethics Committee

VERSION-8.5
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-8.5 1-13
II. Constituting the Ethics Committee for Research on Human Subjects
02 Constitution of an IEC SOP/02/ V-8.5 14-25
03 Confidentiality/Conflict of Interest Agreement SOP/03/ V-8.5 26-37
04 Training Personnel and Ethics Committee Members SOP/04/ V-8.5 38-41
05 Selection and Responsibilities of Independent consultants SOP/05/ V-8.5 42-47
III. Initial Review Procedures
06 Management of protocol submissions SOP/06/ V-8.5 48-66
07 Expedited Review SOP/07/ V-8.5 67-73
08 Initial Review of submitted protocol SOP/08/ V-8.5 74-90
09 Vulnerable populations SOP/09/ V-8.5 91-97
10 Audio Visual (AV) recording of the informed consent process SOP/10/ V-8.5 98-102
11 Review of Resubmitted protocols SOP/11/ V-8.5 103-108
IV. Protocol Amendments, Continuing Review and End of Study
12 Review of Protocol Amendments SOP/12/ V-8.5 109-115
13 Continuing Review of Study Protocol SOP/13/ V-8.5 116-121
14 Review of Final report SOP/14/ V-8.5 122-125
V. Monitoring and Evaluation of Adverse Events
15 Review of Serious Adverse Events (SAE) Reports SOP/15/ V-8.5 126-136
VI. Monitoring Protocol Implementation
16 Intervention in Protocol Deviation/Non-Compliance/ Violation SOP/16/ V-8.5 137-143
17 Response to Complaints, Queries & Requests SOP/17/ V-8.5 144-152
18 Management of Study Termination SOP/18/ V-8.5 153-157
VII. Site Monitoring Visits
19 Site Monitoring visit SOP/19/ V-8.5 158-165
VIII. Preparation of Review Meeting Agenda and Communication Records
20 Agenda Preparation, Meeting Procedures and Minutes SOP/20/ V-8.5 166-186
IX. Managing Study Files
21 Maintenance of active study files SOP/21/ V-8.5 187-191
22 Archival and retrieval of documents SOP/22/ V-8.5 192-198
23 Maintaining Confidentiality of IEC Documents SOP/23/ V-8.5 199-205
X. Evaluating an IEC KAHER
24 Audit and Inspection SOP/24/ V-8.5 206-212
XI. Subjects/Patients recruitment strategies
25 Subjects/Patients recruitment strategies SOP/25/ V-8.5 213-220
26 Continuous improvement: a corrective and preventive action (CAPA SOP/26/ V-8.5 221-228
XII. Review of Biomedical and Health Research and CDSCO-Clinical trials During COVID-19 Pandemic SOP/27/ V-8.5 229-230

Trial Status

CLINICAL TRIAL STATUS-2021-2023

Year Protocol Reviewed Ongoing Amendments  SAEs  Completed
2021 87 06 31 10 24
2022 51 24 47 06 21
2023 60 40 34 12 16

IEC Meeting Schedules

IEC OF KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH
MEETING SCHUDELES [Tentative List-2024]

Sl.No Month Meeting Day and  Date Time
1 January Friday – 19 3.30 PM
2 February Thursday  – 15 3.30 PM
3 March Thursday – 14 3.30 PM
4 March Thursday – 28 3.30 PM
5 April Tuesday – 16 3.30 PM
6 May Friday – 17 3.30 PM
7 June Monday – 10 3.30 PM
8 July Wednesday – 27 3.30 PM
9 July Tuesday – 16 3.30 PM
10 August Monday – 12 3.30 PM
11 September Wednesday – 12 3.30 PM
12 September Wednesday – 25 3.30 PM
13 October Monday  -21 3.30 PM
14 November Monday – 11 3.30 PM
15 November Thursday – 28 3.30 PM
16 December Friday – 21 3.30 PM

Note : 

  • 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*

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

IEC-Annexure-For Principal Investigators

LIST OF FORMS

Sl. No. Documents Forms Download
1 Confidentiality Agreement Form for IEC members FORM No:06
2 Conflict of Interest Agreement Form for IEC members FORM No:07
3 Confidentiality Agreement Form for Guest Attendees to IEC- KLE Meetings FORM No:08
4 Confidentiality Agreement Form for Independent consultants FORM No:09
5 Confidentiality Agreement for Non-members Requesting Copy of IEC Documents FORM No:10
6 Study Assessment Form -INDEPENDENT CONSULTANT FORMS:14 PART-A
7 Checklist for Investigator Form No: 15
8 Study Assessment Form for New protocol Form No: 16
9 Clinical Trial Agreement Checklist Form No: 17
10 Study Principal Investigator CV Format Form No: 18
11 Contents of the proposed protocol for the Conducting Clinical Trial Form No: 19
12 Guidance for Protocol Submission Form No:22
13 Format for Summary and Detailed Protocol Form No:23
14 Undertaking by investigators Form No:24
15 Guide to Placebo Justification Form No:25
16 IEC approval letter format Form No:26
17 Assent Form-Template   Form No:28
18 Submission of amended study protocol template Form No: 29
19 Amended study protocol assessment form Form No:30
20 Annual Report Template Form No:31
21 Study Completion report template Form No:32
22 Data elements for reporting serious adverse events occurring in a clinical trial or bioavailability or bioequivalence study Form No: 33
23 SAE Reporting Template Form No:34
24 Deviation/Non-Compliance/Violation Record Form No:35
25 Clinical Research Stakeholder’s Request/Complaint Form Form No:36
26 study termination template Form No:41
27 Checklist for IEC members Monitoring Visit Form No:42
28 Format of an Agenda Form No:43
29 Format for IEC Minutes meetings Form No:44
30 IEC Documents Retrieval Record Form Form No:46
31 Audit and Inspection Checklist Form No:50
32 Confidentiality Agreement Form for Auditors/inspectors Form No:51

Accreditation / Recognitions

ACCREDIATATIONS
NABH   :   Accreditation for Ethics Committee Clinical Trial

NABH Certificate
FERCAP  :  Forum for Ethical Review Committees in the Asian and Western Pacific

FERCAP
RECOGNITIONS
CDSCO   :   The Central Drugs Standard Control Organization

CDSCO Certificate
DHR Registration   :  Department of Health Research

   DHR Certificate
OHRP    :   Office for human Research protections

      OHRP Certificate

Clinical Trial Audit / Inspection

USFDA-DCGI- INSPECTION DATE AND PHOTOS

FEI Number Facility Complete Address Dates of Inspections
3001350323 KLES Dr.Prabhakar Kore Hospital and MRC/Ethics committee KLES Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgaum, Karnataka, India 27 – 31 Jan 2020

 

DCGI Facility Complete Address Dates of Inspections

NA

KLES Dr.Prabhakar Kore Hospital and MRC/Ethics committee

KLES Dr.Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgaum, Karnataka, India

25-July-2019

Events

EVENTS/TRAININGS

Sl.No Name of the Topic Host/Conducted by Date

1.

 Recent Developments in Ethical Guidelines of Health Research

KAHER-Research Development Cell

12-Dec-2023

2.

 Bio-Medical Research Ethics & GCP: NDCT rules 2019 perspective

ICMR-Belagavi

26-Aug-2022

3.

 Research Ethics Training-

SIDCER-FERCAP

 11-12 July-2022
4. Online Certification program in New Drugs and Clinical trial rules, 2019

Yenopoya Ethics Committee, Mangalore

26-Sep-2020

Thrust Areas

  • Bioethics: Is the study of the ethical, social, and legal issues that arise in biomedical research. It includes medical ethics, which focuses on health care issues, and research ethics, which focuses on research conduct issues. Bioethics also advocates respect for the human person
  • Genetic Research: known as genomic research, studies how human DNA and environmental factors contribute to disease. This research can help people better understand how disease occurs, and may lead to better detection, treatment, or prevention
  • Stem Cell Research and its Ethics Committee: Institutional Committee for Stem Cell Research (IC SCR) is a committee registered with National Apex Committee for Stem Cell Research and Therapy of ICMR (NAC SCRT) that reviews all research projects involving stem cells

Contacts

  • IEC Secretariat

Mobile No: 0831-2470400
Mail ID: kleclinicalresearch@gmail.com
 

 

  • Chairperson

Mobile No: +91-9449033133

Clinical Trial Participants Feedback Link        : https://forms.gle/HEC4CTepS68292gU8

FAQs

Questions Answer
How can obtain the contact information of the site investigator for KLE? Through CTRI website or www.klehospital.org
What is the timelines for the submission of Dossier to IEC of KAHER? Within 21 days [After full board meeting-EC clearance will get within 07 working days]
What is the Ethics committee fee? INR-110000 per protocol review-Refer-IEC Notification
In whose name should the cheque be drawn for payment of EC fees? The Registrar, KAHER, Belagavi
Does the EC have DCGI approval? Yes, ECR/211/Inst/2013/RR-19 Under ND&CT Rules, 2019
Does the EC have DHR approval? Yes, EC/NEW/INST/2021/1726
Does the site is registered OHRP-FWA? Yes

  • FWA: 00024127
  • IORG#-0001102
  • IRB00001499 JNMC Ethics Committee on Human Subjects Rsc IRB#1
  • IRB00012930 KLE Academy of Higher Education and Research IRB#2
Does the site registered DUNS? YES
en English
en Englishkn Kannada