by Elisheva “Eli” Nemetz, BA, MBE

The field of bioethics emerged as a result of the atrocities attested to in the Nuremberg Trials and the inhumanity of the Tuskegee Syphilis Study. People were a means to an end, and perverted minds engaged in medical experimentation on vulnerable individuals. These barbaric and sadistic ‘projects’ led to critical changes like the Nuremberg Code, which stated that voluntary consent from participants is essential for research (The Nuremberg Code, 1947).

Over time we have absorbed these lessons and applied them. Research ethics boards recognize and require the application of principles such as rationale for the research project, stated public or scientific benefit, determination of short-term and long-term risks, disclosure of any potential or foreseeable harms, and sharing of information surrounding data collection and data disposal, amongst other requirements. Since the creation of the Nuremberg Code, research can no longer be completed without the researchers obtaining informed consent from study participants. 

The four-month delay between administering the two requisite dosages of the COVID-19 vaccine is a research project being conducted in Canada on human participants. Canada is the only country in the world which has elected to delay the timing between the vaccine dosages by four months. Although it is clear that Canada has embarked on an unregulated research project, let us examine to what extent this research project meets the normative criteria of research studies. Canada is examining the outcomes of vaccinating participants with two dosages four months apart from one another and collecting data on its effectiveness to COVID-19 infection rates and death.

The National Advisory Committee on Immunization (NACI) has stated that there is a lack of information on the effectiveness of administering vaccines with a delay of four months. Additionally, this four-month delay is refuted as appropriate by pharmaceutical companies manufacturing the COVID-19 vaccines, who have examined the available data.

Viewing the four-month delay as a research study gives rise to serious ethical concerns, as the study does not meet the basic requirements established for research approval. Minimal rationale for the delay has been provided, with the sole explanation proffered that it allows greater access to the first dosage of the COVID-19 vaccine to more Canadians, with negligible data to validate this claim. Public or scientific benefit has not been shared, and conversely, pharmaceutical companies have stated that the four-month delay may place individuals at risk and therefore recommend against delay. Furthermore, there has not been transparency on the data collection tools being utilized on the four-month efficacy between the first and second vaccine dose. What data is being collected? In addition to participants’ health card number and name, how much data is being recorded? Who has access to the data? Which public and private companies are analyzing the data? How long will the information be collected for? How is private health data being linked to COVID-19 deaths and infection rates? How will the data be disposed of? How will the confidentiality of participants be protected?

Lastly, the most grievous concern is that informed consent is not sought from participants who engage in this research study of receiving the two requisite doses of the COVID-19 vaccine four months apart. The counter argument is that the mere fact that a participant attends a vaccine appointment to obtain their first vaccine establishes implied consent. But consent cannot be achieved if there is a failure to share the risks of the delay, the research plan, and no effort to protect participants’ confidentiality. Therefore, any consent participants can provide, even implied, is rescinded. 

We are in a time where medicine is being replaced by politics, and a race to return to normalcy, with immorality. We need to hold governing bodies’ actions accountable and question practices that may result in more harm than good, as we were taught to first, do no harm.