Biomedical and Health Research Ethics in India: NDCT Rules 2019 & ICMR Guidelines

This presentation provides an in-depth overview of ethical considerations in biomedical and health research in India, focusing on the New Drugs and Clinical Trials (NDCT) Rules 2019 and ICMR Ethical Guidelines. It covers essential aspects such as the role and mandates of Ethics Committees (ECs), the registration process, exempt vs. expedited reviews, informed consent, compensation policies, regulatory monitoring, SAE reporting, and common compliance pitfalls. Designed for Ethics Committee members, researchers, and clinical trial professionals, this guide ensures adherence to regulatory and ethical standards in India.

1. Biomedical and Health Research Ethics in India Ensuring Compliance with NDCT Rules & ICMR Guidelines Dr. Shivankan Kakkar, MD

2. Agenda Key Definitions (NDCT Rules 2019) Ethics Committee (EC) Mandates Registration Process for ECs Exempt vs. Expedited Reviews Compensation & Medical Management Clinical Trial vs. Biomedical Research Informed Consent & Vulnerable Populations Regulatory Monitoring & SAE Reporting Document Checklist & Common Pitfalls ‹#›

3. Definitions (NDCT Rules 2019) Clinical Trial: Systematic study of new/investigational drugs in humans to verify clinical, pharmacological, or adverse effects. Biomedical & Health Research: Basic, applied, or operational research on diseases/conditions, excluding clinical trials. Ethics Committee (EC): Separate ECs for clinical trials and biomedical research. ‹#›

4. Ethics Committee Mandates For Biomedical Research: Mandatory EC review before initiation. Oversight throughout research duration. Compliance with ICMR Ethical Guidelines. For Clinical Trials: DCGI-registered EC required. SAE reporting within 24 hours. ‹#›

5. EC Registration Process Provisional Registration: Valid for 2 years. Final Registration: Valid for 5 years after scrutiny . Renewal: Apply 90 days before expiry; No fresh documents if unchanged. ‹#›

6. Exemptions from Full EC Review Definition: Proposals with less than minimal risk and no linked identifiers are exempt from review. Research using publicly available data (systematic reviews, meta-analysis) Observational studies on public behavior (no identifiers, no harm) Quality control and institutional audits Comparison of instructional techniques, curricula, or classroom management Consumer acceptance studies (taste, food quality) Govt. public health programs (evaluation, monitoring with no personal identifiers) ‹#›

7. Expedited Review Criteria Definition: Proposals with minimal or no risk may qualify for expedited review. Non-identifiable human specimens (blood/tissue banks, clinical samples) Non-identifiable clinical data/documents Minor modifications (admin changes, typos, researcher change) Previously approved proposals (expedited/full/continuing review) Minor deviations from approved research with no added risk Annual reports with no additional risk (e.g., data analysis) Multicentre studies with main EC approval (local EC reviews site-specific aspects) ‹#›

8. Compensation & Medical Management Injury/Death in Clinical Trials: Sponsor liable for compensation. Biomedical Research: Follow ICMR guidelines for compensation. ‹#›

9. Clinical Trial vs. Biomedical Research Clinical Trial: Requires DCGI approval, SAE reporting, and trial registry (CTRI). Biomedical Research: EC approval suffices; no DCGI permission unless overlapping. ‹#›

10. Informed Consent Mandatory Elements: Patient information sheet + vernacular consent form. Insurance details for > minimal risk studies. Exceptions: Emergency research (deferred consent). ‹#›

11. Vulnerable Populations (ICMR Guidelines) Protections Required: Independent advocates for children/pregnant women. Community consent for tribal/remote groups. EC Responsibilities: SOPs for vulnerable populations. ‹#›

12. SAE Reporting Timeline: Report to DCGI, sponsor, and EC within 24 hours. Delays: Investigator must justify reasons to DCGI. ‹#›

13. EC Suspension/Cancellation Grounds: Non-compliance with NDCT rules. Failure to protect participant rights. Actions: Warning, suspension, or member debarment. ‹#›

14. Document Checklist EC registration certificate Protocol + Investigator's Brochure. Insurance policy for high-risk studies. SAE compensation plan. ‹#›

15. Common Audit Findings Unregistered ECs reviewing trials. Missing compensation clauses in consent forms. Delayed SAE reports (>24 hours). ‹#›

16. Key Updates (NDCT 2019) Requirements: EC renewal every 5 years. Mandatory CTRI registration for trials. Digital submissions. ‹#›

17. Role of ICMR Guidelines Alignment with NDCT Rules. Ethical review standards. Compensation frameworks. Training for EC members. ‹#›

18. Resources Essential References: NDCT Rules 2019. ICMR Ethical Guidelines (2017 & 2023). Clinical Trial Registry of India (CTRI). ‹#›

19. Closing Quote "Ethics Committees are the cornerstone of credible and compliant research in India." ‹#›

20. Summary and Q&A Key Takeaways: EC registration and compliance requirements Review processes and timelines Compensation and reporting obligations Documentation and monitoring standards ‹#›