Research & Ethics

Explaining the place of clinical trials in vaccine research.

Did you see how quickly the COVID-19 vaccines were developed? Vaccine approval is a complex process, but these vaccines made it through in record time. It shows what can be done when the world comes together around a deadly medical problem; these are among the safest and best reviewed vaccines we have. The research community and our government agencies deserve praise for how carefully and efficiently they handled the approval process.

One essential step in research is clinical trials. The current vaccines are not available for those under 12 because we don’t yet have results from clinical trials involving children. But even before a clinical trial can start, approval for the research design needs to come from an ethical oversight committee. Ethics review committees follow international standards such as the Helsinki Declaration, or, in Canada, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, a 231-page document. Researchers in Canada complete a course and take a test on this document before they can carry out research on humans (animal research has a parallel ethical approval process). I want to touch on a few fundamental principles in this ethical framework, all close to Christian ethics: respect for persons, concern for welfare, and justice.

Well-designed studies

Respect for persons follows from the commandment to love our neighbour. One way researchers respect participants is by ensuring free, informed and ongoing consent. Research must be clearly explained so that individuals can understand the implications of participating. Explanations must be sensitive to the participant’s educational level and base knowledge. As our research has advanced, however, informed consent forms have become more complex and detailed, making explanations more difficult. Consent is not a one-time event but continued throughout the study. Consent is complicated by situations where the participant is incapable of providing proper informed consent, such as research with children or individuals who have dementia. In such cases, we require consent from the person responsible for the individual’s well-being. Additionally, the child must consent to their level of understanding; a toddler’s understanding is different from a preteen’s (a point also made about children’s participation in the Lord’s Supper).

Concern for welfare means avoiding harm to individuals and ensuring that studies are well designed to provide useful information. It also speaks to what happens in clinical research to participants who do not receive the new treatment – the control condition. To see if the treatment works, there needs to be a control condition.

For a COVID-19 vaccine study, the control group may receive no treatment or a placebo (a sugar pill). In situations where there already is a standard treatment, the control should usually be the current gold-standard treatment: is the new treatment better than the current best treatment. If the current best treatment is complex, there may be disagreement on how this control condition should be treated. In this situation, the advice of independent bodies like ethics review boards becomes essential.

Justice requires that people are treated fairly and equitably. For example, if the treatment proves effective, participants in the control condition should have the opportunity to receive it after the study ends. Researchers should follow up with participants. Sometimes this means working with a whole community, beyond the actual study participants. If any benefits result from the study, participants should share in these.

I am intrigued that these ethical requirements are similar to Christian moral principles. As we all know, living up to our Christian ethical responsibilities is something we aspire to but rarely reach. Likewise, researchers try but sometimes fail to meet their study’s ethical requirements. Let us pray that scientists do not take ethical shortcuts as we take advantage of the research that brought us the COVID-19 vaccines.

  • Rudy Eikelboom is a Professor of Psychology, at Wilfrid Laurier University, who has emerged from the dark side of the University after being department chair for 9 years and now teaches behavioural statistics to graduate and undergraduate psychology students. His retirement looms and he is looking forward to doing more writing on the implications of modern science for our Christian faith. Currently, he serves as a pastoral elder at the Waterloo Christian Reformed Church.

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