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Vaccination Ethics, Note tha Keren and Lev are not expressing disagreement…

- - - - How the Therapeutic Misconception Relates to These Concerns:
        (1) The consent is not autonomous, because the participant doesn't actually appreciate/recognise the harms of the trial
        (2) If we think: The researcher tried their best, so it's okay for the trial to proceed --> Then we seem to suggest that informed consent isn't actually NECESSARY for the trial
        (3) There are also challenges to this issue in that, is the doctor obligated to shield their patients from these dangerous trials? If so, there is more than just consent that validates research!
  - - - No Valid Consent
        
        Is the consent given by the participants proper? Can we argue that they don't really understand what's at stake, because why would anyone deliberately put themselves in harms' way?
        
        This relates to Q1: whether the consent is, indeed, autonomous
      - Improper Offer
        
        Are medical researchers allowed to conduct research that deliberately puts peoples in harms' way?
        
        What about the duty of non-maleficence that researchers are bound to?
        
        This relates to Q3: whether consent is SUFFICIENT
      - Personal Concerns
        
        Precedence: If we allow COVID-19 challenge trials, what's to stop researchers from conducting such challenge trials in future? Does it represent a regression AWAY from the good norms of medical research ethics?
        
        Necessity: Given the privilege of hindsight, we know that the Pfizer vaccine was developed in 10-11 months; vaccine development seems to be limited often by bureaucratic/political will, rather than a lack of scientific knowledge?
        
        Culpability and responsibility: Who's to blame if something goes awry in the trial? Does the participant's consent mean it's solely the participant's fault/problem?
    - - If people have a strong altruistic urge, why stop them? The medical profession cannot be too paternalistic anyway!
        
        Also, COVID-19 vaccines have A LOT riding on them!
        
        What does it then mean to respect AUTONOMY, if we deny people the chance to participate in such trials when they willingly want to?
    - - Do No Harm:
        
        If we avoid taking part in research, people cannot receive cures! We are actually causing them harm and denying them the chance to improve themselves
        
        Problem: Doing/Allowing Distinction
        
        Watching a hate crime occur versus actually conducting/doing the hate crime yourself has a fundamental difference (both are bad, but one is complicit, the other is direct)
      - Do Not Free-Ride
        
        How can we enjoy the benefits of something without doing anything, and instead relying on other people to fulfil their moral obligations?
        
        Problem: What does free-ride actually mean?
        
        Free-riding implies that you enjoy the benefits of X, while refusing to contribute to X (e.g. I take a train to London but refuse to pay, while letting others pay for the maintenance etc.)
        
        But, in medical research, your contributions are not to the EXISTING medical systems that are already in place!
        --> EG: A diabetic enjoys treatment X, and his refusal to participate as a subject for treatment Y doesn't change the existence of treatment X. He isn't free-riding in that sense!
        
        Specifically in COVID-19: The end-goal is a system that allows us to mitigate spread of the virus
        
        It's not clear if vaccine research is the ONLY way for people to fulfil their obligations, because treating/managing COVID-19 is a Swiss cheese phenomenon that requires MANY factors
        
        Are we justified in permitting research participation on the count of free-riding in a situation where the risks are very significant?
      - L1 Harris
        
        He isn't saying that we should make everyone participate in medical research; more specifically, he is just arguing that it is IN PRINCIPLE justifiable to have people participate in research based on moral obligations
        
        Arguments are the 'do no harm' and 'do not free ride' reasons
        
        Questions if there are double standards between normal day-to-day life and medical research, but notes that we must STILL ensure the attainment of INFORMED consent first!
        
        A final consideration is the concern about INCENTIVES in medical research: Harris believes that inducements can be allowed, as long as they are not immoral and properly considered
        
        L1 John
        
        Argues, in response to Harris' argument, that people have an imperfect obligation to participate in research, and so it would be logical to modify existing research social structures to permit active participation
        
        Challenges the 'do no harm' and 'no free-riding' arguments of Harris
        
        But believes Harris' fairness argument can be modified if thinking in terms of SYSTEMS; as thinking about the entitlements that a person experiences because of a system (eg. the NHS)
        
        Instead of a strict obligation, we should look at an imperfect obligation, where we account for WHY people do not or CANNOT participate in research --> If people say no, we find alternative trials for them, so that we can distinguish between free-riders and other people who genuinely want to contribute
        
        So its not the case of strictly making people participate, but encouraging this participation by appealing to moral values
    - - L1 Steel et al
        
        As long as participants are competent enough to give informed consent, the trials should occur because the benefits outweigh the costs
        
        (1) The uncertainty involved (about the disease) does NOT invalidate the consent that is given by the participant
        (2) Using risk-levels analysis, SBE argue that the risk levels for mortality for S-CHI is still in the acceptable range for bioethicists
        (3) Presence of unknown risk factors in individuals are NOT a relevant concern/rebuttal, because in research, we never cater to individuals, and always use BEST available information
        
        Personal Thoughts
        
        I agree that uncertainty isn't a necessary reason to validate consent
        
        Having an awareness of more risk factors would boost the morality of the trials, but the time factor (of needing more research) is the problem - can we afford to wait?
        
        Given real-life events, seems to suggest we don't need to use S-CHI to produce a vaccine fast? --> Unless the concern is with VARIANTS
        
        L1 Keren and Lev
        
        Disagree with the issues of consent highlighted by SBE
        
        Consent is valid only under circumstances of UNCERTAIN information, but not WRONG information, because there is a very clear difference in how people make decisions based on uncertain or certain information
        
        The main question about S-CHI is: What are the chances that what we know now could be wrong?
        
        Personal Thought
        
        It is hard to make the distinction between uncertain/wrong information
        
        With a new pandemic, isn't all our information/knowledge likely to be uncertain? Can researchers couch their research in uncertain terms to overcome this?
        
        The concern specifically with K/L is that they think 2nd order uncertainties invalidate your consent
        
        Sure, we can have uncertain information, but the issue is when you don't even know what your uncertainty is!
        EG: "The chances of getting a side-effect from this drug... is between 5 - 20%"
        --> That's where the fine distinction lies
        
        In terms of consent:
        
        Scholars/SBE argue that it is okay as long as these uncertainties are made EXPLICIT to the patient (the patient must KNOW that the doctor too is uncertain)
        
        But for K/L, the doctor/researcher must AT LEAST be sure of the uncertainty that is in their claim! ("How likely is it that what we currently know will change?"
      - L1 Eyal
        
        Uses an A x B model (A = chance of getting COVID, B = chance of dying from COVID) to argue that, when compared to (1) non-participation in trial and (2) participation in a standard efficacy trial, S-CHI could actually be better/more ethical!
        
        To make the difference in A not too big, we can select participants who reside in COVID infection hotspots
        
        Eyal believes that in challenge trials, B will be lower because these trials guarantee participants ACCESS to medical healthcare!
        
        Concerns (and Response)
        
        Exploitation: Eyal's model suggests that we recruit from underdeveloped countries which have poor healthcare infrastructure, and facing rampant COVID-19 infection rates --> We can overcome this by avoiding the use of financial incentives, and focussing these trials in the West (where most of the systems/infrastructure are anyway)
        
        Inability to decline: Would some participants have NO CHOICE but to participate? --> But Eyal notes that this concern would undermine our idea of consent in standard therapeutics, or like in cancer research!
        
        Vaccine Safety: Not necessarily a bigger concern than in standard trials (which as more participants)
        
        Personal Risk Factors: Not relevant because in research trials, researchers always take an average!
        
        Another key concern about Eyal's model:
        
        We are ONLY recruiting young people to make the A x B more palatable/lower/equal --> How can one be certain that the vaccine works for older people?
        
        The issue of extrapolation seems to make the harm-benefit ratio less favourable! (Getz and Baylis)
        
        The conclusion that Eyal's model gives is that:
        
        For human challenge trials to be ethically acceptable, we must: (1) Select young people (low B), (2) these young people must come from infection hotspots (3) and have limited access to proper healthcare (such that their A is lower in challenge trial where they gain good/proper access to healthcare!)
- - - - Sidenote on QALY:
        
        Calculated by estimating the number of life years a person/patient has after treatment
        
        For each year, we assess their score on a scale from 0 to 1, based on their ability to carry out daily lives, freedom from pain.mental disturbances
      - Against Efficiency:
        
        Encourages the use of binary choices, which can be unfair because it means the other group gets NOTHING at all (people are denied by virtue of being in a smaller group)
        
        Helping the vulnerable: A healthcare system needs to help the vulnerable. How can we skip the vulnerable elderly?
        
        L2 Brock
        
        Basically, Brock outlines 9 different problems regarding the use of a utilitarian model in healthcare policy (the Cost Effectiveness Analysis) model. The CEA, Brock argues, should be an AID, not a solution, because of its tendency to neglect issues of equity
        
        The CEA: A model that adopts utilitarian/consequantialist standards, specifically through using QALYs to decide what interventions work best
        
        See the annotated biblio/reading for the 9 problems identified by Brock --> Mainly, its poking the concept of DALYs, noting its limitations, how it dehumanises people, inherently reinforces prejudices, and the concept of fair chances/best outcomes (Peterson)
    - - Against Equity
        
        It wants to alleviate unfairness, but can become counter-intuitive (how can we flip a coin to decide between 10,000 people and 1 person)
        
        Does the 'equal chances' argument matter? Is it important in this context to remove human prejudices?
    - - Against Risk:
        
        Is helping the most vulnerable simply a bias against 'statistical victims'? Simply put, is this framework something that lacks any sort of theoretical basis, even if its intuitive? (EG: comparing 1 in 10,000 versus 1 in 100, it seems like we rather take the risk in 1 in 10,000 even though BOTH have 1 person dying)
        
        Bottomless pit worries: That we have to keep pouring more and more resources to help the most vulnerable --> Though in the context of COVID vaccines I doubt this matters because 2 doses means 2 doses anyway, you can't over-inject someone...
        
        The issue of 'vulnerable' as a definition: How to define?
    - - Accountability for Reasonableness (A4R)
        
        This is a framework that sets out some procedural conditions/expectations to produce an end-result that is fair and legitimate!
        (1) Publicity: Regulators ought to be TRANSPARENT
        (2) Relevance: Reasons for decisions MUST be communicated
        (3) Appeals: Must have platforms for people to CHALLENGE the decisions
        (4) Enforcement: Basically to ensure (1) - (3) happens
        
        Issue: Some may contend that this is a cop-out. It doesn't tell us WHAT to use, but merely just says that it's alright, as long as the people involved can explain to us why they do what they do
        Issue: Circularity; maybe the regulator already has an answer, and just uses A4R to steer people towards what they want
        
        I don't see cop-out as an issue. After all, one cannot think that we will always have a fixed rule for every situation. It's reasonable to have this A4R model, because it ensures that decisions can be challenged legitimately
        
        But in any case, A4R seems like something that only democracies are able to support.
      - L2 Peterson
        
        Peterson tries to combine (1) and (2) by suggesting the use of a weighted lottery
        
        Notes that most countries seem to follow the utilitarian approach of dividing the population into age-determined priority groups, and also giving access to healthcare workers
        
        Peterson uses the idea of chance-prioritarianism, which asserts that the moral gain/loss for higher probabilities is non-linear (i.e. moral gain from 0 to 0.1 > from 0.5 to 0.6) --> So, the most ideal distribution is when everyone has EQUAL chances
        
        A lottery is superior because it doesn't mean the other group's chance of getting the vaccine is 0. This makes a SIGNIFICANT moral difference (chance-prioritarianism)
        
        Personal Thoughts:
        
        Seems that while theoretically ideal/beautiful, this idea falls short practically. It sounds like an impossible task to try and quantify how much 'weight' different people should be given
        
        Also, is vaccination really a strict binary? There are positive externalities to the other group, and its not like the chances are 0 (its just at that point in time only) --> We are NOT saving one group at the expense of the other
        
        Chance-Prioritarianism
        
        Essentially, prioritarianism is the view that we should help/treat those who are WORSE-OFF --> What is powerful about it is that it addresses the problems with utilitarianism (eg. the use of QALYs which discriminates the disabled)
        
        The issue with Peterson's approach however is whether or not prioritarianism is a concept that we can confidently apply to chances and probabilities
        
        Peterson's model of chance-prioritarianism will prodouce/encourage policies that contradict the Prevention Paradox!
        
        Because in the PP, we say: help the people who are at lower/moderate risk to gain the MOST amount of benefits for public health
    - - The Paradox:
        
        We have a large group of people exposed to small risk versus a small group with a lot of risk, but the issue is that the majority of the cases/problems comes from the small-risk large group --> This is the paradox
        
        So, we can deploy population strategies, where we target the large group
        
        But here note the weird situation (John): While the strategy gives huge benefits to the community, the individual doesn't experience much benefit, or may even be harmed.
      - EG: If we force everyone to take COVID-19 vaccine
        --> Young people will be inconvenienced, side-effects etc. It doesn't benefit them much to take it, but it does matter a lot in the grand scheme of helping the population
        --> They benefit in the "ex-ante" sense because their harm is reduced
        --> But not in the "actual outcome" sense, because they wouldn't have died anyway, and were even inconvenienced possibly!
  - - - Note also that when we take a hard approach of just choosing who to vaccinate, eliminating issues of probability, we avoid the problems of chance-prioritarianism!
    - - The authors note the following loopholes:
        (1) That having predetermined groups can be counter-productive since we don't know what we are dealing with
        (2) A failure to see how vaccination goes in tandem or is impacted by other social measures (lockdowns, quarantines)
        (3) Ignoring global responsibilities and global obligations! (which is why we have fears of vaccine nationalism)