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
Annual Report of IEC-KLE University
2020-Jan to Dec-2020
| Sl.No | Description | Numbers |
| 1. | Studies Reviewed | 30 |
| 2. | Ongoing Studies | 12 |
| 3. | Completed | 02 |
IEC of KLE University Meeting Schedules-2021
[Online-Offline]
Venue: KLE Site Management Office, KLES Dr.Prabhakar Kore Hospital and MRC, Belagavi
| Sl.No | Day/Date/Month | Timings |
| 1. | Saturday/16/January | 11:30 AM |
| 2. | Saturday/13/February | 11:30 AM |
| 3. | Saturday/27/ February | 11:30 AM |
| 4. | Saturday/13/March | 11:30 AM |
| 5. | Saturday/27/ March | 11:30 AM |
| 6. | Saturday/17/ April | 11:30 AM |
| 7. | Saturday/22/May | 11:30 AM |
| 8. | Saturday/12/ June | 11:30 AM |
| 9. | Saturday/26/ June | 11:30 AM |
| 10. | Saturday/24/ Jul | 11:30 AM |
| 11. | Saturday/21/ August | 11:30 AM |
| 12. | Saturday/18/ September | 11:30 AM |
| 13. | Saturday/09/ October | 11:30 AM |
| 14. | Saturday/30/ October | 11:30 AM |
| 15. | Saturday/20/ November | 11:30 AM |
| 16. | Saturday/11/ December | 11:30 AM |
| 17. | Saturday/25/ December | 11:30 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
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.
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 |
Hon’ble Vice chancellor of KLE University
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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
English
Kannada