HUMAN RIGHTS AND CLINICAL
We all are trapped for more than a year now by this unprecedented pandemic
which has distorted the order of everything be its normal life, economy, proving
the existence to others in a positive manner (like India is proving in the field of
providing vaccine to every country) and other aspects of life.
Since the time this noble virus has stroked every country engaged themselves
into a race for providing the first vaccine to the world but while doing so they have
almost forgot the basic rules and ethics that need to keep on priority. There have
been numerous incidents that have been reported where the human trial took
a place without the consent of the person being administered with such claimed
There is an inextricable relation between health and human rights as, the
the manner in which a state accords rights to its citizens manifests in its health
policies, programs, practices and their inclusionary or exclusionary nature,
directly impacting public health. Further, violations of basic human rights have
health impacts too, binding the protection of human rights and health in a
dynamic relationship. Further, building upon Martha Nussbaum’s work on
ethics, rights, and capabilities, while human rights and capabilities are connected
as a violation of human rights inevitably leads to hampering of capabilities, their
the relationship should not be allowed to be proportional in availability; meaning
that a group/section with weaker capabilities should not be seen as deserving
only weaker, second class human rights than capable, privileged groups,
enjoying first-class human rights.
Informed consent procedures, the inclusion of alternative decision-makers, review
by institutional review boards and, more recently, by the data safety monitoring
boards and confidentiality safeguards represent five of the most salient ethical
practices that have been developed.
If clinical trials are not conducted according to the highest ethical standards,
they may infringe upon the right to informed consent and the right to health. ...
However, despite frequent reports of irregularities in clinical trials in
newspapers and NGO publications, few cases have come under judicial
In 2009, the States of Andhra Pradesh and Gujarat launched a research project
for the vaccination against the human papillomavirus (HPV) which can cause
cervical cancer. Adolescent girls between the ages of 10 – 14 in the States of
Andhra Pradesh and Gujarat were to be vaccinated. The vaccines were provided
by GlaxoSmithKline and Merck. The project was designed and executed by
PATH (Program for Appropriate Technology in Health) and funding were
received from the Bill & Melinda Gates Foundation. In April 2010, however,
the Government of India suspended the program as several violations of ethical
standards by PATH were widely reported by human rights organizations.
However, by that time, 24,000 girls were already vaccinated.
Indian regulatory system needs to be strengthened to improve the clinical trial
industry in India: Neuland labs CFO.
The white van arrived in slum areas of Bhopal, a city in central India, blasting a
message over the speaker system that seemed too good to refuse: " Come and
take the coronavirus vaccine and get 750 rupees ($10)." Locals who recalled
hearing it back in December said they scrambled to take up the offer -- 750
rupees was about twice what they'd usually earn for a day's hard labor. And
many had struggled to work at all during the pandemic. " They told us it is the
corona vaccine and we should get it so that we don't fall sick," said, Yashoda Bai
Yadav, a housewife from Bhopal who participated in the trial alongside her
A failure to investigate the conduct of the recent Covaxin phase-3 trial can
affect the course of other studies underway.
Bhopal organizations ask govt. to stop Bharat Biotech COVID-19 vaccine trials;
cite norms violation at site 5