Mandatory adherence to national ethical guidelines to help ‘improve accountability in CTs, ensure safety of participants’
The Central government’s decision to make adherence to the
national ethical guidelines for biomedical research mandatory for the first
time would bring about the much-needed transparency and accountability in this
field, healthcare experts say. Compliance with the guidance document will be
compulsory as per the New Drugs and Clinical Trials Rules 2019 released
recently by health ministry.
The guidance document, prepared by the Indian Council of
Medical Research (ICMR), is aimed at improving the overall quality of research
outcomes while ensuring protection of research participants and responsiveness
to the health needs of Indians. The details are included under clauses 15, 16,
17, 18 of Chapter IV of the clinical trial rules.
The decision to make the guidelines legally binding is
welcomed by researchers. “This is a good step. Finally we have a legal mandate
for the implementation of the ICMR guidelines,” Anant Bhan, a well-known
researcher in bioethics and global health, stated on his Twitter handle. This is
for the first time that biomedical and health research is going to be regulated
through the ethics committees (ECs). The health ministry has designated
Department of Health Research as the authority for registration of ECs that
reviews such research and thereby helps in safeguarding the safety, rights,
welfare of research participants.
As per the guidelines, any institution or organisation that
intends to conduct biomedical and health research shall be required to have an
EC which has been constituted, functions and maintains records in accordance to
ICMR guidelines. ECs shall review the research before initiation and oversee
throughout the duration of the research.
Currently, ECs play a crucial role in the absence of an
effective and fool-proof regulatory system to control clinical trials. The
committees require a team of five to 15 members including biomedical
scientists, clinicians, legal expert and social scientist. The registration
process aims at ensuring that requirements of patient confidentiality and
informed consent are met.
According to civil society groups, of late, the Central Drugs
Standard Control Organisation (CDSCO) has made the rules rigorous and it is not
easy for a committee to get registration. The ECs have to allow inspectors or
officials authorised by the CDSCO to enter its premises to inspect any record,
data or any document related to clinical trials and provide adequate replies to
any query raised by the inspectors.
Furthermore, to expedite clinical trial approval procedures
and reduce transaction cost, the national regulator has discontinued accepting
physical applications for registration of ECs. A task-specific software has
been developed for the purpose and all applications are to be filed mandatorily
on Sugam, an online portal built by the ministry.
Comments
Post a Comment