Institutional Ethical Committee | SHKM, Govt. Medical College, Nalhar, Nuh, Haryana.

SHKM Campus

Institutional Ethical Committee(IEC)Vishaka Guidelines



It is mandatory, as per the Chapter II of the ICMR Ethical Guidelines for Biomedical Research On Human Participants that all proposals on biomedical research in SHKM, Govt. Medical College, Nalhar involving human participants should be cleared by an appropriate the Institutional Ethics Committee, in this case, the IEC - SHKM, GMC to safeguard the welfare and the rights of the participants. The IEC is entrusted not only with the initial review of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring of the approved programmes to foresee the compliance of the ethics during the period of the project.

The basic responsibility of the IEC is to ensure a competent review of all ethical aspects of the project proposals received by it in an objective manner. IEC will provide advice to the researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific soundness of the proposed research through appropriate Technical Review Committee.


The major aspects that SHKM, GMC - IEC focusses on are as follows:

1. To ensure that any research using human beings as participants in IITM shall follow the standards and principles prescribed for such trials in the ICMR Ethical Guidelines for Biomedical Research on Human Participants, 2006; and

2. To protect the dignity, rights and well-being of the potential research participants.

3. To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs.

4. To assist in the development and the education of a research community responsive to local health care requirements.


Composition

SHKM, GMC - IEC is multidisciplinary and multisectorial in composition.

S. No. Contact Person Designation
1. Dr. Ravi Gupta Chair Person
2. Dr. Shivani Kalhan Member Secretary
3. Dr. Yamini Clinician
4. Dr. Amit Kumar Clinician
5. Dr. Sonia Hasija Basic Medical Scientist
6. Dr. Vinod Bhardwaj Basic Medical Scientist
7. Mr. Nooruddin Noor Legal Expert
8. Ms. Harshita Gupta Lay Person
9. Ms. Neelofer Anwar Social Scientist
10. Dr. Hitesh Chawla Basic Medical Scientist
11. Dr. Pawan Kumar Goel Clinician
12. Dr. Anurag Ambroz Singh Clinician

RESPONSIBILITY OF IEC:

The responsibilities of the IEC are to ensure that following:

1. The research study protocols are sound in design, scientifically justified, and statistically valid.

2. The research studies are conducted according to the Indian Council of Medical Research and Good Clinical Practice guidelines.

3. The research study does not compromise rights, safety and benefits of the patients/volunteers/study participants.

4. The research studies are conducted under the supervision of trained medical/bio-medical persons with required expertise.

5. The research studies include only those patients or participant who have given voluntary and informed consent without any inducement or coercion.


Ethical approval of a research study: Each research proposal must be submitted to the appropriate institute ethics committee for approval. It should be ensured that no research project is started unless Ethics Clearace/approval is obtained and that no retrospective/Post facto Ethics Clearance/Approval can be provided to research projects which were neither submitted nor vetted by the Institute Ethics Committee