• Stambh Organization

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

vaccine.

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

scrutiny.

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

husband.

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

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1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2174446/

2 https://www.business-humanrights.org/en/latest-news/indian-regulatory-system-needs-to-be-strengthened-to-improve-clinical-trial-industry-in-india-neuland-labs-cfo/

3 https://edition.cnn.com/2021/02/25/asia/india-vaccine-trials-covid-ethics-intl-dst-hnk/index.html

4 https://www.thehindu.com/opinion/lead/the-debilitating-side-effect-of-a-flawed-vaccine-

trial/article33561550.ece

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