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
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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
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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
Facilities
- Site Standard Operating Procedure
- Infrastructure
- Hospital Link
Therapeutic Area
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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 |
List of Annexure – IEC of KAHER :-
| Sl. No | Annexure Nnumber | Name of the Checklist |
| 1. | AF/IEC/07/06/V-8.3 | Protocol submission |
| 2. | AF/IEC/01/06/V-8.3 | Principal Investigator |
| 3. | AF/IEC/07/06/V-8.3 | Investigator undertaking |
| 4. | AF/IEC/06/08/V-8.3 | IEC Approval Letter template |
| 5. | AF/IEC/06/06/V-8.3 | Study Principal Investigator CV Format |
| 6. | AF/IEC/05/06/V-8.3 | Clinical trial agreement template |
| 7. | AF/IEC/05/08/V-8.3 | Placebo Justification |
| 8. | AF/IEC/05/08/V-8.3 | Study assessment form |
| 9. | AF/IEC/05/08/V-8.3 | Study completion form |
| 10. | AF/IEC/03/06/V-8.3 | Study termination form |
| 11. | AF/IEC/02/09/V-8.3 | Assessment of Vulnerable Population |
| 12. | AF/IEC/02/09/V-8.3 | Informed consent document for reviewer |
Ethics Guidelines to review and conduct of Clinical trials
| Sl.No | Regulation/Guidelines/Rules | Year |
| 1. | ||
| 2. | EC_Guidance_COVID19_06052020 | 2020 |
| 3. | NewDrugs_CTRules_2019 | 2019 |
| 4. | International Standards for Clinical trial registry | 2018 |
| 5. | ICMR_National_Ethical_Guidelines-2017 | 2017 |
| 6. | E6(R2)-Good-Clinical-Practice | 2016 |
| 7. | International Ethical Guidelines for Health-related Research Involving Humans-CIOMS | 2016 |
| 8. | WMA-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects.pdf | 2013 |
| 9. | Standards and Operational-WHO | 2011 |
| 10. | Surveying and Evaluating Ethical Review Practices | 2002 |
English
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