Ethical Governance

Institutional Ethics Committee (IEC)

Safeguarding the rights, safety, dignity, and well-being of research participants through independent, rigorous, and transparent scientific and ethical review.

National Regulatory Registration

Registered with CDSCO & Department of Health Research (ICMR)

The Institutional Ethics Committee of Jothydev's Diabetes Research Centre is fully registered and re-registered with the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, adhering strictly to New Drugs and Clinical Trials Rules (NDCTR), ICMR Guidelines, and ICH-GCP.

Regulatory Framework
ICH-GCP (E6 R2) • NDCTR
ICMR National Ethical Guidelines
Ethics Architecture

Core Mandates & Responsibilities

The IEC operates independently of hospital administration and study investigators to deliver unbiased and timely review of all biomedical research protocols.

Multidisciplinary Composition

Composed of clinicians, pharmacologists, basic medical scientists, legal experts, social scientists/ethicists, and independent laypersons representing public interests.

Protocol & Consent Review

Evaluates study designs, risk-benefit ratios, patient information sheets (PIS), informed consent forms (ICF), and regional vernacular translations for clarity and ethics.

Participant Protection

Ensures strict confidentiality, data privacy, post-trial benefits, access to emergency care, and compensation provisions for research-related injuries in accordance with regulatory laws.

Standard Operating Procedures

Adheres to documented SOPs governing meeting schedules, quorum requirements, expedited reviews for minimal-risk studies, and annual continuing reviews.

SAE Monitoring & Oversight

Continuous monitoring of Serious Adverse Events (SAEs) with expedited reporting to regulatory authorities (DCGI/CDSCO) within stipulated 24-hour / 14-day timelines.

Site Audits & Inspections

Conducts periodic on-site compliance monitoring, investigator file reviews, and consent audit checks to maintain flawless clinical study integrity.

Protocol Submission Desk

Submitting a Protocol for IEC Review?

Principal Investigators and academic researchers seeking ethics clearance must submit complete dossiers along with the prescribed application form, protocol, participant informed consent documents, and investigator credentials.

Email Secretariat: iec@jothydev.netacademics@jothydev.net
Contact IEC Secretariat
Across Kerala

Our Hospital & Research Branches

Accessible, world-class comprehensive diabetes care and clinical research across 5 strategic locations.

TRIVANDRUM HQ

Jothydev's Diabetes Research Centre

JDC Junction, Mudavanmugal, Konkalam, Trivandrum, Kerala, India – 695032
KOCHI

Jothydev's Diabetes Research Centre & Hospitals Pvt Ltd

2nd Floor, Triumph Towers, Seaport-Airport Rd, Vidya Nagar Colony, Thrikkakara, Kalamassery, Kochi – 682021
ATTINGAL

Jothydev's Diabetes Hospital & Research Centre

CSI Mission Hospital Campus, Attingal, Trivandrum, Kerala, India – 695101
HARIPAD

Jothydev's Diabetes Research Centre

Ponvayalil Complex, Near Town Hall Junction, Haripad, Alappuzha, Kerala – 690514
KASARAGOD

Jothydev's Diabetes Research Centre

Kasaragod, Kerala, India. Comprehensive diabetes consultations, telemedicine & patient care.
24/7 SUPPORT AVAILABLE

Diabetes Helpline & Emergency Assistance

Toll-Free (All Branches): 1800-425-40055