The National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of Quality Council of India, has issued draft accreditation standards for clinical trial sites, ethics committees and investigators.  The NABH has prepared this draft document in consultation with various stakeholders for starting new accreditation programme.

The criteria to be followed for accreditation of ethics committee, investigator and the sites where clinical trials are to be carried out are given separately in the draft document.  

As per the draft document, the list of mandatory procedures for ethics committee include Composition, procedures for new induction and resignation of members; Frequency of ethics committee meetings, receipt, review and decision making of proposals; Review of protocol amendments; Procedure for deliberations and maintaining minutes; Periodic review and oversight; Procedure to be followed for vulnerable population; Review of informed Consent Document (subject information sheet and informed consent form) and informed consent process; Reporting, analysis of SAEs and making opinion on compensation; Handling issues related to noncompliances, protocol violation, complaints by the participants and other stakeholders; Declaration of conflict of interest and confidentiality agreement; Financial declaration of payments received and disbursed; Training for committee members; and Communication with different stakeholders.

For the accreditation of investigator, the procedures include Investigator role and responsibilities; and Investigator education, qualification and experience. Investigator will follow site SOPs and study protocol for all essential trial activities. If there is a contradiction, study protocol requirements takes a upper hand.

The list of mandatory procedures for accreditation of clinical trial site include Subject protection policy (including transparent mechanism of enrollment); Informed consent, including procedures for audio-visual recording of consent; Medical management of adverse events; Adverse events and serious adverse events reporting (including emergency care); Roles and responsibilities of study team; Site research team training; Research pharmacy (investigational product management); Protocol compliance and protocol deviations; Documentation policy; Storage and retention of trial related documents; Conflict of interest disclosure form; Equipment calibration and maintenance; and Quality management plan (including quality control measures).

The NABH was set up to establish and operate accreditation programme for healthcare organisations. The board is structured to cater to much desired needs of the consumers and to set benchmarks for progress of health industry.  The board while being supported by all stakeholders including industry, consumers, government, have full functional autonomy in its operation.

The NBH has invited comments, suggestions, objections, including deletions/additions if required in the draft document from public at large, including the stakeholders like hospitals and other clinical establishments, industry, consumer groups, etc before December 15.