Response of the authors to the Letter "Concerns with regard to an article" published online on April 5, 2019.

Response of the authors to the Letter "Concerns with regard to an article" published online on April 5, 2019 (DOI: 10.20529/IJME.2019.014) on the IJME website.

Consultations on human infection studies in India: Do people's voices really count?

The Controlled Human Infection Model or CHIM, sometimes described as a human challenge study, is a relatively specialised medical research technique. Researchers infect healthy participants with a weakened strain of a pathogen in a controlled setting, in order to learn more about the infection and the disease, or to develop new vaccines for that disease. Unlike in other human clinical trials, where participants face a risk of harm because of, for example, the drug's side effects, healthy participants in CHIM trials are deliberately harmed through infection - contrary to every principle and guideline of medical practice and research.

Law and ethics in consensual harm.

In recent times there has been an emerging interest in conducting Controlled Human Infection Model studies in low-and-middle-income countries, in which healthy human beings are infected with weakened pathogen strains under controlled conditions. These volunteers are monitored closely so that cures and prevention methods can be developed for the disease. Such studies call into question the legal sophistry of taking consent to harm a person by justifying it for the greater good or advancement of science. This paper analyses the law on the subject and the ethics of obtaining consent to harm another human being as in the context of Controlled Human Infection Models.

Ethical and legal challenges of vaccines and vaccination: Reflections.

Vaccines and vaccination have emerged as key medical scientific tools for prevention of certain diseases. Documentation of the history of vaccination shows that the initial popular resistance to universal vaccination was based on false assumptions and eventually gave way to acceptance of vaccines and trust in their ability to save lives. The successes of the global eradication of smallpox, and now of polio, have only strengthened the premier position occupied by vaccines in disease prevention. However, the success of vaccines and public trust in their ability to eradicate disease are now under challenge, as increasing numbers of people refuse vaccination, questioning the effectiveness of vaccines and the need to vaccinate.

Identifying ethical issues in the development of vaccines and in vaccination.

Vaccines are a widely accepted public health intervention. They are also a profitable tool for pharmaceutical companies manufacturing vaccines. There are many vaccines in the pipeline, for various diseases, or as combination vaccines for several diseases. However, there is also a growing concern about vaccines and the manner in which they are developed and approved by the authorities. Approvals are fast tracked and adverse events and serious adverse events following vaccination are seldom reported once the vaccine gets its marketing approval. Thus, vaccines have been clouded with many controversies and their use as a public health tool to prevent diseases is constantly under challenge.

Abortion rights judgment: a ray of hope!

While granting a prisoner the right to abort her foetus, a recent Bombay High Court judgment recognised a woman's absolute right to abortion. This article discusses the judgment in detail and the bioethical debates over abortion rights. It deals with the restrictions imposed by the law not only on when the foetus can be aborted, but also who can get the abortion done and in what circumstances.

Response to proposed research to reverse brain death: more than regulatory failure.

In early May 2016, reports of a bizarre study to attempt a reversal of brain death made the headlines, but there was not even a squeak from the authorities. The "Reanima Project" is a collaboration between an Indian surgeon, Himanshu Bansal, and a US-based biotech company, Bioquark Inc. The research will be conducted by Bansal's own biotech company, Revita Life Sciences, at his Anupam hospital in Rudrapur, a city in Uttarakhand state.

A million little pieces of broken trust.

In April 2015, the Union Cabinet approved the Juvenile Justice (Care and Protection of Children) Bill, 2014, which proposes to bring about regressive changes in the law, that would not only be unconstitutional but also unethical. In May 2015, the Ministry of Women and Child Development introduced the Bill in the Lok Sabha, where it was passed. If the Rajya Sabha, passes the Bill and the President gives his assent to it, the youth of this country will be harmed in a manner that could break the very fabric of the nation.