Opinion

Informed Consent: Should geriatric populations be told about limited representation in vaccine clinical trials?

Seniors in long-term care homes with dementia or over 85 years old are among those prioritized for COVID-19 vaccination. However, there are ethical questions over whether they or their designated decision-makers have the information needed to give informed consent.

The principle of autonomy underscores the informed consent process and is highly valued in many if not most North American medical practices. The Pfizer and BioNTech vaccine clinical trials included healthy individuals between the ages of 18 and 55 or 65 and 85 who were “willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures,” at risk of acquiring COVID-19 and “capable of giving personal signed informed consent.”

However, people living in congregate settings with dementia and/or over the age of 85 have been prioritized for the vaccine even though they were excluded from the trials.

Canada’s National Advisory Committee on Immunization (NACI) identifies those who are most vulnerable to being infected and harmed by vaccine-preventable diseases, a process that helps clarify who ought to be prioritized. For the COVID-19 vaccine, NACI recommends prioritizing the following: (1) residents and staff of congregate living settings that care for seniors (e.g., long-term care); (2) people over 70 years old, starting with adults over 80; (3) healthcare workers; and (4) adults in Indigenous communities.

Most people who participated in the above-mentioned trials were 18–55 and it seems unlikely that many (if any) people with dementia, an umbrella term that encompasses several brain disorders, would have been included. Furthermore, while most people with dementia are older than 65, the prevalence is much higher among people over 85, which is a subgroup of the population that was also excluded from the trial. Since dementia is a progressive disease, many people eventually reside in long-term care homes to have their care needs met.

Healthcare providers have a duty to ensure that patients make informed decisions and provide informed consent to proposed treatments, including vaccines. According to Ontario’s Health Care Consent Act (HCCA), there are two parts of informed consent. First, a person must receive information about: (1) the nature of the proposed treatment; (2) benefits; (3) risks; (4) side effects; (5) other options available; and (6) consequences of not having the treatment. In short, patients should be given information “that a reasonable person in the same circumstances would require in order to make a decision about the treatment.” Second, a person must have all questions answered.

Insofar as informed consent is legally and ethically significant, then these six criteria ought to be fulfilled when prioritizing COVID-19 vaccinations. And although we recognize the rigor involved in having a clinical trial approved and are not questioning the research or the efficacy of the vaccine, some seniors living in long-term care and/or their substitute decision-makers may value learning about the trial, in particular about the exclusion criteria, as a part of a more fulsome consent process.

A fulsome consent process would involve informing these groups that their specific population was excluded from the clinical trial. While offering clinical trial details is not standard practice for vaccination decision-making, it may be prudent in this circumstance since (a) the vaccine is new and (b) at least one of the vulnerable populations excluded from the trial is being prioritized for the vaccine based on its vulnerability.

Additionally, when thinking about informed consent as per the HCCA, it seems plausible that reasonable people may want to know – but may not know they have the right to ask – if people in their demographic group were included in a new vaccine’s clinical trial since a lack of representation may influence the questions they ask and their ultimate decision. Given that individuals’ needs are unique in terms of what they value, it seems reasonable that this additional information should be offered to them.

From another perspective, however, some may argue that there is reason and possibly an ethical obligation during a pandemic to not disclose that certain subgroups of the population were excluded from the trial, especially if that information may negatively influence public safety by contributing to the vaccine hesitancy that already exists. It may be the case that some people may refuse to be vaccinated solely because their subgroup was excluded from the trial, even if evidence exists that could alleviate concerns.

It is unclear whether and/or to what extent a lack of representation in and of itself would, or should, be relevant to informed decision-making. In the context of protection for the largest number of vulnerable persons during a pandemic, non-disclosure of particular information may be morally justified.

Ultimately, it is important to ensure that everyone can make an informed decision about the COVID-19 vaccine. A well-reasoned argument could be made that in the context of protection for the largest number of vulnerable persons during a pandemic, non-disclosure of particular information may be morally justified. However, to enable fully informed decision-making, long-term care residents (or their substitute decision-makers) who are above the age of 85 and/or with dementia should be made aware that they were not represented in the trial, especially since they are among the first people to receive it.

3 Comments
  • Bob Parke says:

    It was good to read this submission and giving thought to the consent process as it pertains to the COVID-19 vaccines, the population being prioritized who were not research subjects and the consent process. One aspect of the vaccine availability is that it was approved under emergency use provisions of Health Canada, FDA and similar organizations world wide. If there wasn’t the urgency to have therapies available to slow down the spread of COVID-19 with its potential devastating short and long effects, perhaps a broader range of subjects would have been tested? Subjects from our elders, women who are pregnant, those who are immunocompromised and could be more inclusive of racialized populations and socio-economic status.

    In the absence of research subjects from the older population it is important that scientists, researchers, drug manufacturers and healthcare professionals monitor data from cumulative usage to see if efficacy and safety continue across broad ranges of people who are receiving the vaccine. With the newer variants of COVID-19 continued monitoring will be an imperative.

  • Vera-D. says:

    If I had dementia and was past the MAiD competency consent stage, I would rather get Covid and die quickly. My neighbour’s husband had Alzheimer’s and caught pneumonia. She turned down treatment for it so he could die of the “old man’s friend.”

  • Karin says:

    Assuming you’re right that persons over age 85 were not adequately represented in the trials, the decision to take the vaccine still seems obvious. When you compare the outcomes of getting COVID-19 for that age group to getting the vaccine is there really any choice? Are you suggesting people might choose to be in the high risk for dying option? The question I would like answered is whether the vaccine is effective in this age group when given in the current dosage and current schedule. Why take the vaccine if it doesn’t even work for you? Or from a societal perspective why waste a vaccine dose if it doesn’t prevent disease/ transmission/death for that age group? Might be better to vaccine the workers and keep stricter isolation in place.

Authors

Marcia Sokolowski

Contributor

Marcia Sokolowski, C Psych., PhD (Phil), is the director of Ethics at Baycrest Health Sciences, an assistant professor of the Faculty of Medicine at the University of Toronto, and an adjunct professor at the Ben Gurion University of the Desert in Beer Sheva, Israel.

Andria Bianchi

Contributor

Andria Bianchi, PhD, is a Toronto-based bioethicist and an assistant professor (status-only) at the Dalla Lana School of Public Health, University of Toronto.

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