The Institute Ethics Committee, NIT Meghalaya (IEC-NIT Meghalaya) shall carry out the ethical review of the research proposals involving the use of human samples/participants in accordance with the ICMR and other regulatory guidelines and the SOP of the Ethics Committee.

DHR Registration number: EC/NEW/INST/2024/4828

Institute Ethics Committee, NIT Meghalaya (IEC-NIT Meghalaya) members

Sl. No.

Name & Designation

To function as

1

Prof. (Dr.) Manoj Kumar Choudhury,
An eminent surgeon and one of the pioneers of laparoscopic surgery in India

Chairman

2

Prof. (Dr.) Bhaskar Borgohain,
Professor & HoD, Orthopaedics, NEIGRIHMS, Shillong

Member

3

Prof. Mousumi Guha Banerjee,
Professor,
Department of English Literature,
EFLU Regional Campus Shillong

Member

4

Smt. Pubalee Dutta Bujarbaruah,
Sr. Advocate,
Meghalaya High Court

Member

5

Prof. Sambit Mallick
Professor of Sociology
Department of Humanities and Social Sciences
Indian Institute of Technology Guwahati

Member

6

Mrs. Jhumki Bhattacharjee
Assistant Teacher, Laitukhrah, Bengali Higher Secondary School, Laitukhrah, Shillong 793003

Member

7

Prof. Harish Chandra Das,
Dean (PRB&R),
Professor,
Department of Mechanical Engineering, NIT Meghalaya

Member

8

Dr. Salam Shuleenda Devi,
Assistant Professor,
Department of Electronics & Communication Engineering,
NIT Meghalaya

Member

9

Dr. Gitish Kishore Dutta,
Professor
Department of Chemical & Biological Sciences,
NIT Meghalaya

Member Secretary

Standard Operating Procedures (SOP)

Responsibilities of the Committee

  • Review research projects involving human subjects, including human biological materials and human biological data, regardless of the funding agency.
  • Ensure research and Institutional activities comply with relevant ethical guidelines, laws, regulations, and policies.
  • Investigate and address ethical issues or complaints related to research or institutional activities.
  • Supervise the welfare and rights of human and animal subjects involved in research, ensuring the safety and well-being of all individuals involved.
  • Evaluate the informed consent process, risk-benefit ratio, distribution of burdens and benefits, and provisions for appropriate compensations when necessary.
  • Monitor and review ongoing research activities to ensure compliance with ethical standards.
  • To provide training and guidance to researchers and staff on ethical practices and procedures.
  • Identify and manage any potential conflicts of interest that could affect research integrity.

 

The Committee operates as per the following guidelines.

  1. National Ethical Guidelines for Biomedical and Health Research Involving Human Subjects.

 https://ethics.ncdirindia.org/asset/pdf/ICMR_National_Ethical_Guidelines.pdf

  1. New Drugs and Clinical Trials Rules, 2019.

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4OA==

  1. National Guidelines for Biomedical Research Involving Children

https://thsti.res.in/pdf/National_Ethical_Guidelines_for_BioMedical_Research_Involving_Children.pdf

  1. Medical Device Rules, 2017

https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules,%202017.pdf

  1. National Guidelines for Stem Cells Research

https://dbtindia.gov.in/sites/default/files/National_Guidelines_StemCellResearch-2017.pdf

 

Application Form for Initial Review_NIT Meghalaya

Annexure 1 application for expediated review

Annexure 2 application for review exemption

Annexure 3 Continuing Review Annual report format

Annexure 4 Application or Notification form for Amendments

Annexure 5 Deviation in protocol

Annexure 6 Serious adverse event report

Annexure 7 Project closure report

Annexure 8 Application Form for Clinical Trials

Annexure 8 Application Form for Clinical Trials

Annexure 9 Serious Adverse Event Reporting Format (Clinical trials)

Annexure 10 application for Human genetics study

Annexure 11 Social and behavioural study application

Annexure 12 Study completion report

Annexure 13 Format for CV

Annexure 14 Project extension

Annexure 15 Participant Information and Consent form