Ethics Committee Accreditation Programme
Ethics Committee Accreditation:The laid down standards on Ethics Committee Accreditation are the basic minimum requirements which needs to be adhered in order to improve the safety of the process of Clinical Trials in India. It is an attempt at standardizing the quality of clinical research in India.
Outline of NABH Ethics Committee Accreditation Standards
1. Authority for formation of Ethics Committee
2. Standard Operating Procedures
3. Ethics Committee Composition
4. Protection of subject rights, safety and well being
5. Administrative support
6. Review Process
7. Decision making and post meeting activities
8. Monitoring
9. Self-Assessment
10. Record Keeping and archival
Benefits of Accreditation
a. Safety and wellbeing of research participants
b. Protection of rights and research participants
c. Robust consent process to ensure patient safety
d. Improves efficiency, effectiveness and overall clinical trial process
e. Commitment to quality and accountability and accreditation
f. Ensures public trust and confidence
Who can apply?
CDSCO Registered Institutional & Independent Ethics Committees involved in review & approval of drug trials (new Investigational product).
Exclusions
Ethics Committee involved in review & approval of Observational studies, Registry Trials, Non-Interventional trials, PG Thesis on Clinical Trials/Research, Biomedical Health Research
How to apply for accreditation?
All aspiring Ethics Committees desirous to achieve accreditation can apply online by registering on the NABH website.
Fees towards accreditation depends on the size of the healthcare organization. To view the complete fee structure please visit important links on NABH website followed by fee structure under quick links.
Are there any trainings conducted for the programme?
NABH conducts various training and awareness programmes round the year on a regular basis. It is advisable that the staff of the aspirant healthcare organizations attend Training Programme on Implementation (POI) for better understanding the standards.
https://nabh.co/EducationTraining.aspx NABH conducts trainings on Good Clinical Practice (GCP) & awareness programmes on Ethics Committee Standards for better understanding of the Accreditation requirements NABH is going to start training program on New Drugs and Clinical Trials Rules very soon.
How to procure a copy of the standards?
The standard is freely available and can be downloaded online from the NABH website
