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
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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 ANNEXURE: 01 VERSION-7.3 AF/IEC/01/01/V7.3LIST OF STANDARD OPERATING PROCEDURES |
INDEX
| Sl.No | SOPs | SOP code | Page No. |
| Preparation of SOPs for Ethics committee for clinical studies | |||
| 01 | Writing, Reviewing, Distributing and Amending Standard Operating Procedures for institutional Ethics Committees | SOP/01/V7.3 | 1-11 |
| Constituting the Ethics Committee for Research on Human Subjects | |||
| 02 | Constitution of an IEC | SOP/02/V7.3 | 12-25 |
| 03 | Confidentiality/Conflict of Interest Agreement | SOP/03/V7.3 | 26-38 |
| 04 | Training Personnel and Ethics Committee Members | SOP/04/V7.3 | 39-42 |
| 05 | Selection and Responsibilities of Independent consultants | SOP/05/V7.3 | 43-47 |
| Initial Review Procedures | |||
| 06 | Management of protocol submissions | SOP/06/V7.3 | 48-62 |
| 07 | Expedited Review | SOP/07/V7.3 | 63-69 |
| 08 | Initial Review of submitted protocol | SOP/08/V7.3 | 70-96 |
| 09 | Vulnerable populations | SOP/09/V7.3 | 97-102 |
| 10 | Audio Visual (AV) recording of informed consent process | SOP/10/V7.3 | 103-107 |
| Protocol Amendments, Continuing Review and End of Study | |||
| 11 | Review of Resubmitted protocols | SOP/11/V7.3 | 108-112 |
| 12 | Review of Protocol Amendments | SOP/12/V7.3 | 113-116 |
| 13 | Continuing Review of Study Protocol | SOP/13/V7.3 | 117-121 |
| 14 | Review of final report | SOP/14/V7.3 | 122-124 |
| Monitoring and Evaluation of Adverse Events | |||
| 15 | Review of Serious Adverse Events (SAE) Reports | SOP/15/V7.3 | 125-132 |
| Monitoring Protocol Implementation | |||
| 16 | Intervention in Protocol Deviation/Non-Compliance/ Violation | SOP/16/V7.3 | 133-138 |
| 17 | Response to Research Participants requests/Complaints | SOP/17/V7.3 | 139-146 |
| 18 | Management of Study Termination | SOP/18/V7.3 | 147-149 |
| Site Monitoring | |||
| 19 | Site Monitoring visit | SOP/19/V7.3 | 150-155 |
| Preparation of Review Meeting Agenda and Communication Recor | |||
| 20 | Agenda Preparation, Meeting Procedures and Minutes | SOP/20/V7.3 | 156-165 |
| Managing Study Files | |||
| 21 | Maintenance of active study files | SOP/21/V7.3 | 166-168 |
| 22 | Archival and retrieval of documents | SOP/22/V7.3 | 169-175 |
| 23 | Maintaining Confidentiality of IEC Documents | SOP/23/V7.3 | 176-181 |
| Evaluating an IEC | |||
| 24 | Audit and Inspection | SOP/24/V7.3 | 182-187 |
ANNUAL REPORT OF SMO
KLE S Dr. Prabhakar Kore Hospital and MRC
| Annual Report for 2018 -2019 | |
| No.of Ongoing Trials: | 45 |
| No.of Completed Trials: | 10 |
| List of sponsors | List |
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
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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 |
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Institutional Ethics CommitteeKLE Academy of Higher Education and Research, Belagavi |
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Ethics Committee Meeting Schedule-2019
| Month | Day | Time |
| January-02nd January-12th |
Wednesday Thursday |
04.00 PM 11.00 AM |
| February-05th February-27th |
Tuesday Wednesday |
04.00 PM 04.00 PM |
| March-14th | Tuesday | 04.00 PM |
| April-04th April-26th |
Tuesday Friday |
04.00 PM 04.00 PM |
| May -10th | Friday | 04.00 PM |
| June 04th | Tuesday | 04.00 PM |
| July-12th | Friday | 04.00 PM |
| August-02nd | Friday | 04.00 PM |
| September 05th | Tuesday | 04.00 PM |
| October-04th | Friday | 04.00 PM |
| November-15th | Friday | 04.00 PM |
| December-13th | Friday | 04.00 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 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
IEC Registrations:
- EC Reg. No.ECR/211/Inst/KA/2013/RR-2016 – Under Rule 122DD of the Drugs and Cosmetics Rules 1945 [DCGI]
- OHRPReg.No:IRB00008025KLEUniversity, IRB00001499
Hon’ble Vice chancellor of KLE University
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Dr.Subarna Roy, Chairperson- Non Affiliated |
Dr.M.S.Ganachari, Member Secretary- Affiliated |
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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 |
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