5 ms·

Because it is unethical to intentionally harm someone for the benefit of medical research. I need to read up on it, but I expect that this challenge trial has

Because it is unethical to intentionally harm someone for the benefit of medical research. I need to read up on it, but I expect that this challenge trial has been given ethical approval because there is now some evidence from the larger (non challenge) trials that a vaccinated person being exposed has a low risk of harm (for the relevant age group).

jxcl 6y ago
Interestingly, they only mention vaccination in the second phase of the trial. It's not clear to me if this is misreported, or they're planning to expose unvaccinated healthy people to small amounts of the virus in phase 1.
- vilhelm_s 6y ago
  Yes, that's right. > The first stage of this project will explore the feasibility of exposing healthy volunteers to COVID-19. In this initial phase, called the Virus Characterisation Study, the aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19. [...] Once the characterisation study is completed, this Human Challenge Study model can be utilised to conduct COVID-19 Human Challenge Studies from mid-2021 subject to regulatory approvals. There are some more detailed writeups at https://www.gov.uk/government/news/worlds-first-coronavirus-human-challenge-study-receives-ethics-approval-in-the-uk https://www.gov.uk/government/news/worlds-first-coronavirus-... and https://hvivo.com/the-human-challenge-programme/ https://hvivo.com/the-human-challenge-programme/
oli5679 6y ago
"Because it is unethical to intentionally harm someone for the benefit of medical research." People incur additional risk for enjoyment, money or to contribute to a social cause in many aspects of life. If you work as a deep-sea-diver, go skydiving, join the army or even frequently drink a lot of alcohol this can increase personal risk significantly. Voluntary challenge trials with well informed, healthy, young participants testing novel vaccines and treatments during pandemics has a very high net utilitarian impact. A < 1/10,000 risk for several hundred 20-30 year old participants is dwarfed by the death and suffering prevented by more quickly having efficacy information. I'm 27, and shy away from many risks, but signed up for '1 day sooner' soon after the pandemic reached the UK, and would be proud to participate in a challenge trial if needed. People framing it as 'unethical' should lay out exactly what their ethical framework is.
- jedimastert 6y ago
  I think the problem isn't that it's unethical to intentionally put someone in harms way, but rather whether or not there can be an informed consent. When the virus first came up, it was completely unknown that the risk of long term impairment might have been, and now we know it was/is pretty severe.
  - benchaney 6y ago
    This is incorrect. Informed consent requires that people be given the best available information. If that contains a lot of unknowns, and they understand that, and consent to it, that is completely valid.
  - loveistheanswer 6y ago
    >When the virus first came up, it was completely unknown that the risk of long term impairment might have been, and now we know it was/is pretty severe. Only 10% of positive cases (not including untested infections) have any impairment after 3 weeks. https://covid.joinzoe.com/post/covid-long-term?fbclid=IwAR1RxIcmmdL-EFjh_aI- https://covid.joinzoe.com/post/covid-long-term?fbclid=IwAR1R...
- rkangel 6y ago
  > People framing it as 'unethical' should lay out exactly what their ethical framework is I didn't because I thought it clear and obvious from context. We're talking about medical ethics, which is a well developed field of research and practice. There are established procedures in the US and UK to get ethics approval for studies and those panels are not just making it up as they go along (mostly). I suppose when I say 'it is unethical' what I really mean is 'the medical community in the developed world has come to a strong consensus that it is unethical'. Even with informed consent.
  - xyzzyz 6y ago
    To sum up, the notion of “medical ethics” doesn’t actually have much to do with ethics and with what is morally right, and as such should be routinely disregarded when considering how to fight the pandemic crisis.
RalfWausE 6y ago
A long time ago i was a soldier... so, in a sense i signed up to have a risk of getting shot (or blown up, stabbed... you get the point) for the benefit of my society. How is this different?
- rkangel 6y ago
  Because we're not talking about the ethics of the individuals concerned, we're talking about the ethics of the people conducting the study. People volunteering for this and the army have made the choice to put others ahead of themselves, and (as long as they are suitably informed and competent to make the judgement) have the right to make it. The ethics from the other side are broader and subtler - they are not of the individual they are of the masses. Whether the Army acts ethically by recruiting soldiers and sending them to kill and die is a subject of much debate. A large number of people think that it is unethical, and that is why they protest against war.
  - RalfWausE 6y ago
    But in this case, the enemy who shall be destroyed is a virus, and compared to a human enemy is see no ethical problem as long as the "soldiers" in this "campaign" are volunteering...
voldacar 6y ago
Not if they're okay with it. Humans harm themselves (or risk harm) in pursuit of some perceived higher good all the time, anything from smoking a cigarette to fighting in a battle to participating in a risky medical experiment. This is just a natural and normal part of the human experience. Relax.
- rkangel 6y ago
  Individuals are allowed to risk their own lives. Organisations can and should be made to jump through many hoops before risking the loves of members of the public (however well informed). This is a good thing and why medics research ethics approval is needed before any clinical trial.
da_big_ghey 6y ago
No, not necessarily. People donate kidneys all the time, which is a serious procedure with non-negligible chances of short- and long-term complications. And non-medically, people risk their lives to help others all the time. The difference between ethical medical research and the Tuskegee experiments is informed consent.
- rkangel 6y ago
  Informed consent is by far the most important thing missing in the Tuskegee study, but it is not the only thing. To give one example of the complexity of medical ethics: occasionally when running clinical trials, the results are so GOOD that it becomes unethical to not stop the trial and give the drug to the control group.

jxcl 6y ago

Interestingly, they only mention vaccination in the second phase of the trial. It's not clear to me if this is misreported, or they're planning to expose unvaccinated healthy people to small amounts of the virus in phase 1.

vilhelm_s 6y ago
Yes, that's right. > The first stage of this project will explore the feasibility of exposing healthy volunteers to COVID-19. In this initial phase, called the Virus Characterisation Study, the aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19. [...] Once the characterisation study is completed, this Human Challenge Study model can be utilised to conduct COVID-19 Human Challenge Studies from mid-2021 subject to regulatory approvals. There are some more detailed writeups at https://www.gov.uk/government/news/worlds-first-coronavirus-human-challenge-study-receives-ethics-approval-in-the-uk https://www.gov.uk/government/news/worlds-first-coronavirus-... and https://hvivo.com/the-human-challenge-programme/ https://hvivo.com/the-human-challenge-programme/

oli5679 6y ago

"Because it is unethical to intentionally harm someone for the benefit of medical research." People incur additional risk for enjoyment, money or to contribute to a social cause in many aspects of life. If you work as a deep-sea-diver, go skydiving, join the army or even frequently drink a lot of alcohol this can increase personal risk significantly. Voluntary challenge trials with well informed, healthy, young participants testing novel vaccines and treatments during pandemics has a very high net utilitarian impact. A < 1/10,000 risk for several hundred 20-30 year old participants is dwarfed by the death and suffering prevented by more quickly having efficacy information. I'm 27, and shy away from many risks, but signed up for '1 day sooner' soon after the pandemic reached the UK, and would be proud to participate in a challenge trial if needed. People framing it as 'unethical' should lay out exactly what their ethical framework is.

jedimastert 6y ago
I think the problem isn't that it's unethical to intentionally put someone in harms way, but rather whether or not there can be an informed consent. When the virus first came up, it was completely unknown that the risk of long term impairment might have been, and now we know it was/is pretty severe.
- benchaney 6y ago
  This is incorrect. Informed consent requires that people be given the best available information. If that contains a lot of unknowns, and they understand that, and consent to it, that is completely valid.
- loveistheanswer 6y ago
  >When the virus first came up, it was completely unknown that the risk of long term impairment might have been, and now we know it was/is pretty severe. Only 10% of positive cases (not including untested infections) have any impairment after 3 weeks. https://covid.joinzoe.com/post/covid-long-term?fbclid=IwAR1RxIcmmdL-EFjh_aI- https://covid.joinzoe.com/post/covid-long-term?fbclid=IwAR1R...
rkangel 6y ago
> People framing it as 'unethical' should lay out exactly what their ethical framework is I didn't because I thought it clear and obvious from context. We're talking about medical ethics, which is a well developed field of research and practice. There are established procedures in the US and UK to get ethics approval for studies and those panels are not just making it up as they go along (mostly). I suppose when I say 'it is unethical' what I really mean is 'the medical community in the developed world has come to a strong consensus that it is unethical'. Even with informed consent.
- xyzzyz 6y ago
  To sum up, the notion of “medical ethics” doesn’t actually have much to do with ethics and with what is morally right, and as such should be routinely disregarded when considering how to fight the pandemic crisis.

RalfWausE 6y ago

A long time ago i was a soldier... so, in a sense i signed up to have a risk of getting shot (or blown up, stabbed... you get the point) for the benefit of my society. How is this different?

rkangel 6y ago
Because we're not talking about the ethics of the individuals concerned, we're talking about the ethics of the people conducting the study. People volunteering for this and the army have made the choice to put others ahead of themselves, and (as long as they are suitably informed and competent to make the judgement) have the right to make it. The ethics from the other side are broader and subtler - they are not of the individual they are of the masses. Whether the Army acts ethically by recruiting soldiers and sending them to kill and die is a subject of much debate. A large number of people think that it is unethical, and that is why they protest against war.
- RalfWausE 6y ago
  But in this case, the enemy who shall be destroyed is a virus, and compared to a human enemy is see no ethical problem as long as the "soldiers" in this "campaign" are volunteering...

voldacar 6y ago

Not if they're okay with it. Humans harm themselves (or risk harm) in pursuit of some perceived higher good all the time, anything from smoking a cigarette to fighting in a battle to participating in a risky medical experiment. This is just a natural and normal part of the human experience. Relax.

rkangel 6y ago
Individuals are allowed to risk their own lives. Organisations can and should be made to jump through many hoops before risking the loves of members of the public (however well informed). This is a good thing and why medics research ethics approval is needed before any clinical trial.

da_big_ghey 6y ago

No, not necessarily. People donate kidneys all the time, which is a serious procedure with non-negligible chances of short- and long-term complications. And non-medically, people risk their lives to help others all the time. The difference between ethical medical research and the Tuskegee experiments is informed consent.

rkangel 6y ago
Informed consent is by far the most important thing missing in the Tuskegee study, but it is not the only thing. To give one example of the complexity of medical ethics: occasionally when running clinical trials, the results are so GOOD that it becomes unethical to not stop the trial and give the drug to the control group.