Are your Ethics Committee SOP aligned?

Are your Ethics Committee SOP aligned?

The NABH Accreditation of IRB/EC in India has been generating a lot of debate. Especially around a key question- Is it mandatory?

The purpose of this post in not to add any fuel to that fire.

What I wish to bring forth is the interesting similarities I found in the just released (May 2018) US FDA Guidance to Institutions and IRB on IRB Written Procedures with the NABH Accreditation Standards for Ethics Committees in India.

The requirement for written procedures for IRB/EC has always been there as defined in the ICH GCP.

1.55 Standard Operating Procedures (SOPs) - Detailed, written instructions to achieve uniformity of the performance of a specific function.

3.2.2 The IRB/IEC should perform its functions according to written operating procedures,

Should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).

The recent US FDA document is a welcome guidance for IRB/EC overseeing US FDA regulated studies to ensure compliance. It provides a checklist for IRB’s to use for reviewing/drafting their SOP. If all the boxes on the checklist are checked ‘yes’, the IRB SOP/written procedures would likely be in compliance to 45CRF56 and 21CRF50 and 56.

In India the NABH EC standards have a primary objective of ensuring “The EC is adequately qualified, experienced and knowledgeable in ethical issues and applicable rules and regulations for conduct of clinical trials ensuring scientific integrity and protection of subjects’ rights safety and well-being.”

It is expected that compliance to these standards will ensure competency of the EC to assess risk and scientific validity of trials. Help EC establish appropriate measures to protect subjects’. Finally ensure transparency in EC functioning and procedures.

Let us look at this table I have created comparing NABH standards with US FDA guidance document