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Institute of Biomedical Ethics and History of Medicine (IBME)

New open access case study by Tania Manríquez Roa and Nikola Biller-Andorno

We are glad to announce the new open access case study by Tania Manríquez Roa  and Nikola Biller-Andorno in «Research Ethics in Epidemics and Pandemics: A Casebook». This book is the result of a collaborative effort as part of an Epidemic Ethics / WHO initiative.
The case study is titled «Self-Experimentation in the Development of COVID-19 Vaccines» and is included in Chapter 3 «Research Quality and Dissemination». The authors present the case of a group of researchers, innovators and citizen science enthusiasts in a country in the Americas that embarked on self-experimentation with the aim of developing a COVID-19 vaccine. This initiative involved designing, producing and self- administering progressive generations of nasal inoculations. This group was established as a not-for-profit organization and shared its knowledge through a website. They worked under open licences without using patents or asserting their intellectual property rights.
This group of scientists released information about how to produce and self- administer their intranasal inoculation. They made publicly available a “white paper”: an in-depth report about their product, which contains terms of use, advice about informed consent, goals, technical features, materials, methods, preparation and instructions on how to administer the potential vaccine, as well as an assessment of the immune response in recipients.

This research was not approved by a research ethics committee, and the intranasal inoculation was developed without the authorization of the national authority responsible for regulating the development of vaccines. After the publication of an earlier version of the “white paper” in 2020, a professor from a different country offered to produce the nasal inoculation against COVID-19 in his laboratory and to distribute it to the public for free. However, the self-experimenters claimed in their website that they could not guarantee that their nasal vaccine was safe, and that although preliminary essays had shown positive indications regarding efficacy, this required ongoing confirmation that would be available in another “white paper”. A later version of their “white paper”, released in September 2021, stated that no expectation was given concerning efficacy in granting protection against SARS- CoV-2.
This case study raises questions on whether self-experimentation should be used or not in the development of vaccines or therapies during a pandemic; on the role that national systems for ethical and regulatory review should play with respect to self-experimentation during a pandemic; and on whether it was responsible to release a product formula to the public without knowing if it led to the creation of antibodies against COVID-19 in humans.