ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

Clinical TrialsSubscribe to Clinical Trials

Emergency Use Authorisation of COVID-19 Vaccines

In granting EUA to vaccines, both urgency and adherence to protocol should be taken into consideration.

Ethical Challenges in Public Health Research

The eighth Krishna Raj Memorial lecture by Eric Suba, held recently, was based on the visual inspection with acetic acid test for cervical cancer trials held in India and the lack of ethics they involved. Research that uses the absence of care as the foundation of its trial design is exploitative research that violates the rights of its participants who put their faith in researchers to protect them from harm.

Ebola Virus Disease

The Ebola virus disease, which spread in four West African countries, brought to light the feeble health governance system not only in these countries but also at the global level. Weak health infrastructure, resource crunch, non-viability of preventive and curative medication, and distrust of foreign interventions among people not only aggravated the crisis but also led to a schizophrenic portrayal of the disease across the world. A lack of any preventive medication for Ebola--despite a history of recurrence over the last four decades--is a big question confronting health research communities, pharmaceutical companies and global health governing agencies. The recent outbreak of Ebola and a global security threat perception associated with the disease have given rise to many debates, one of them being the debate on medical ethics in a public health emergency. All the ethical issues related with the unavailability of medication, launch of untested medicine in affected areas and also the delay in decision-making and response are the core arguments which this article tries to analyse.

Clinical Trial Compensation: A Clarification

This is with reference to the article “Clinical Trial-Related Injury: Note on Formula to Determine Compensation” (EPW, 4 April 2015). We would like to clarify that we had submitted the article to EPW in May 2014. By April 2015, much has happened, and the compensation formula is no more in the draft...

Clinical Trial-Related Injury

This article provides a detailed critique of the formulae to provide compensation to subjects of clinical trials who may suffer serious adverse effects during their participation. The present formulae used by the Central Drugs Standard Control Organization display a lack of medical ethics and disregard the accepted norms.

Clinical Drug Trials

The controversial clinical drug trials on 26 cancer patients at the Regional Cancer Centre in Thiruvananthapuram, allegedly under a contract with the Johns Hopkins University of the US, could be the tip of the proverbial iceberg, with 'biomedical joint ventures' becoming a buzzword for many leading institutions in the country. Greater public vigilance on biomedical experiments, especially in human beings, is needed to ensure that such trials strictly follow the norms set by the Indian Council of Medical Research and the Helsinki Declaration.

Process of a Vaccine Trial

This paper describes the complex process of a clinical trial of Mw anti-leprosy vaccine. The receivers of the bio-medical products are viewed not as mere cases seen through the protocol of the trial but as persons within different social contexts with their own understanding of the product in relation to their bodies. The issue becomes more complex in the case of the Mw vaccine as it is not only a prophylactic but also a therapeutic vaccine the patients negotiate between their understanding of the disease and the product. This also influences the biomedical discourse as the clinicians have to negotiate a balance between the therapeutic and experimental aspects of their work.
Back to Top