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Human [Chat]llenge Trials

MrMisterMrMister Jesus dying on the cross in pain? Morally better than us. One has to go "all in".Registered User regular
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The worldwide COVID-19 pandemic was responsible for tremendous loss of life. Vaccines have turned out to be an invaluable tool in fighting it. In light of the global health crisis, some proposed that efficacy testing of vaccine candidates could be substantially accelerated through the use of controlled human infection (CHI) trials. In such a trial, a relatively small number of participants would be randomized to receive either a vaccine candidate or a placebo, and subsequently, all would be deliberately exposed to SARS-COV-2, the virus behind COVID-19. These trials promised to rapidly generate data about vaccine efficacy or separate out more promising candidates for traditional phase 3 testing. They can also allow for efficacy testing even under conditions where the virus has locally abated.

Recent controlled infection studies, e.g. for malaria or seasonal flu, infect participants with pathogens that are either curable or self-limiting, thereby imposing moderate burdens from e.g. uncomfortable symptoms but only negligible risk of death or long-term injury. If maintaining an appropriate regard for participants’ interests required that diseases studied in controlled infection studies always be curable or self-limiting, then CHIs for SARS-COV-2 could not be ethically conducted; COVID-19 is neither curable nor self-limiting, and it poses a non-negligible chance of death. However, prevailing scholarly opinion holds that controlled infection studies are not fundamentally ethically distinct from other types of biomedical research that impose risks on participants without promising corresponding benefits, and they should be judged by the same fundamental criteria. According to a broad body of bioethical work, as well as the US Federal regulations, informed adults should be permitted to voluntarily assume non-negligible risks of serious harm in the course of participating in socially valuable medical research, provided those risks are not too high.

How high is too high? With respect to research that enrolls competent, consenting adults, the two most prominent proposed standards are that net mortality risks should not be permitted to exceed either those of kidney donation, or 1% absolutely. But although there was strong evidence that CHIs performed with young, healthy volunteers would not exceed these risk levels, and although there was both academic advocacy for, and strong volunteer interest in human challenge trials, none were ever conducted in the United States.

Discuss.

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Posts

  • amateurhouramateurhour One day I'll be professionalhour The woods somewhere in TennesseeRegistered User regular
    edited June 2021
    So we learned something today kids.

    Chanus, our Chanus, that loveable scamp who is dear to us all, was the guitarist and backup vocals for a SKA band called Dolt45 who released their hit single "Cops Should Smoke Bongs" from their debut album "Greatest Hits Vol. 6"



    In this behind the Chat we're gonna get a deeper look into what inspired these songs
    Chanus wrote: »
    OMG 1 minute in tell me you're the backup vocals

    haha yeah

    Into the pioneering technology that created these songs
    Chanus wrote: »
    Hahnsoo1 wrote: »
    Doodmann wrote: »
    I didn't know mumblepunk was a think until now.
    I mean, I think the only reason the vocals are unintelligible is due to the mixing. I think just some sidechain compression and a bit of EQ would make it a bit more understandable.

    yeah it was recorded on a Roland 8-track in my friend's parents' basement

    ...and hopefully, just a little insight into an older, mellower Chanus who just wants to record soft pop covers for Grey's Anatomy

    https://www.youtube.com/watch?v=MrijLCn8VcA

    Or Techno Beat Chanus



    Game Dev Musician Chanus?
    Chanus wrote: »
    haha that time i was going to do an arrangement of that Destiny song and then got bored



    Or my favorite, slappa da bass Chanus



    Chanus is a true inspiration to us all. What is your favorite Chanus

    amateurhour on
    are YOU on the beer list?
  • amateurhouramateurhour One day I'll be professionalhour The woods somewhere in TennesseeRegistered User regular
    (I waited 10 minutes but I'm not arguing video game preferences for another four pages)

    are YOU on the beer list?
  • amateurhouramateurhour One day I'll be professionalhour The woods somewhere in TennesseeRegistered User regular
    Also the SKA thread was posted at 4:20

    are YOU on the beer list?
  • MrMisterMrMister Jesus dying on the cross in pain? Morally better than us. One has to go "all in".Registered User regular
    This is so inspired I'm not even mad

    godbless

  • ChanusChanus Harbinger of the Spicy Rooster Apocalypse The Flames of a Thousand Collapsed StarsRegistered User, Moderator mod
    haha that time i was going to do an arrangement of that Destiny song and then got bored

    Allegedly a voice of reason.
  • DoodmannDoodmann Registered User regular
    Just change the thread title to [SKA] so it doesn't get closed.

    Whippy wrote: »
    nope nope nope nope abort abort talk about anime
    I like to ART
  • amateurhouramateurhour One day I'll be professionalhour The woods somewhere in TennesseeRegistered User regular
    Chanus wrote: »
    haha that time i was going to do an arrangement of that Destiny song and then got bored

    added to OP

    are YOU on the beer list?
  • kedinikkedinik Registered User regular
    It sounds like CHIs are good and we should have performed them, but like, good luck getting a political appointee to sign off on a valuable and ethically sound new form of research that also sounds terrible in a clickbait headline.

  • amateurhouramateurhour One day I'll be professionalhour The woods somewhere in TennesseeRegistered User regular
    (btw this is what you get y'all when you're on my "two beers" list)

    are YOU on the beer list?
  • tyrannustyrannus i am not fat Registered User regular
    posting in the correct thread

  • ChanusChanus Harbinger of the Spicy Rooster Apocalypse The Flames of a Thousand Collapsed StarsRegistered User, Moderator mod
    i am honored

    Allegedly a voice of reason.
  • kedinikkedinik Registered User regular
    tyrannus wrote: »
    posting in the correct thread

    shoutout to the musical stylings of chanus tho

  • navgoosenavgoose Registered User regular
    Chanus!
    Ah-ah
    Savior of the Universe!

  • MrMisterMrMister Jesus dying on the cross in pain? Morally better than us. One has to go "all in".Registered User regular
    edited June 2021
    kedinik wrote: »
    It sounds like CHIs are good and we should have performed them, but like, good luck getting a political appointee to sign off on a valuable and ethically sound new form of research that also sounds terrible in a clickbait headline.

    Some of the politicians expressed interest behind the scenes, and 35 congresspeople even signed an open letter advocating for CHIs.

    imo the failure was, sadly, largely with the ethics establishment (BIG ETHICS!!) which, while not saying that challenge trials couldn't be performed, still hemmed and hawed about how profoundly hard the decision was. As a result, they preserved maximal lack of responsibility for themselves--not even taking the responsibility of a hard "no", which would have been wrong, but respectable! But no, they kept themselves off the hook while also giving absolutely zero cover for anyone else going forward with it.

    Total institutional failure and I'm still mad about it.

    MrMister on
  • ChanusChanus Harbinger of the Spicy Rooster Apocalypse The Flames of a Thousand Collapsed StarsRegistered User, Moderator mod
    kedinik wrote: »
    tyrannus wrote: »
    posting in the correct thread

    shoutout to the musical stylings of chanus tho

    equally life saving i'm sure

    Allegedly a voice of reason.
  • amateurhouramateurhour One day I'll be professionalhour The woods somewhere in TennesseeRegistered User regular
    I was all in to vote Ska Chanus till I heard that funky fourth track down.

    are YOU on the beer list?
  • kedinikkedinik Registered User regular
    shaking my fist at big ethics!

  • 21stCentury21stCentury Call me Pixel, or Pix for short! [They/Them]Registered User regular
    IMMA LET YOU FINISH BUT 21ST CENTURY HAS THE BEST BANGER OF 2015

    i'm sorry, i've just rediscovered my soundcloud.

  • DoodmannDoodmann Registered User regular
    I heard Alphies (my name for the post zoomer generation copyright tm tm) are into ska and thus the 4 generation cycle is renewed.

    Whippy wrote: »
    nope nope nope nope abort abort talk about anime
    I like to ART
  • navgoosenavgoose Registered User regular
    Which chat will get the axe and which mod tapped for execution?

  • japanjapan Registered User regular
    Brabus' latest model looks like it should be advertised during Saturday morning cartoons with a cautionary voiceover stating "action figures sold separately"

    32OZjVkh.jpg

  • TuminTumin Registered User regular
    edited June 2021
    Never seen anything as sad as people's vibe towards Tomas Kalnoky's pre-show solo music before a Streetlight Manifesto show

    Tough ska life

    Tumin on
  • MrMisterMrMister Jesus dying on the cross in pain? Morally better than us. One has to go "all in".Registered User regular
    edited June 2021
    When someone wants to infect themselves with coronavirus in order to contribute to the advancement of medical knowledge and to hasten the development of interventions that will save millions of lives worldwide: no, very bad, cannot be permitted, what kind of society would allow such a heinous thing, haven't you ever heard of the Nazis and their experiments? We need to use to coercive power of the state to shut this down. Let's make sure no one hurts themselves this way.

    When someone wants to infect themselves with coronavirus to own the libs: I guess it's their right, ya know? You might not agree with the decision, but that's just freedom. You don't get to boss them around.

    MrMister on
  • ChanusChanus Harbinger of the Spicy Rooster Apocalypse The Flames of a Thousand Collapsed StarsRegistered User, Moderator mod
    wait just study the maga chuds everybody wins

    Allegedly a voice of reason.
  • japanjapan Registered User regular
    Yours for €610,000

  • TuminTumin Registered User regular
    I didnt consent to being CHALLENGED

    You cant just CHALLENGE people

    Too CHALLENGING

  • SixSix Caches Tweets in the mainframe cyberhex Registered User regular
    Amazing.

    can you feel the struggle within?
  • kedinikkedinik Registered User regular
    MrMister wrote: »
    When someone wants to infect themselves with coronavirus in order to contribute to the advancement of medical knowledge and to hasten the development of interventions that will save millions of lives worldwide: no, very bad, cannot be permitted, what kind of society would allow such a heinous thing, haven't you ever heard of the Nazis and their experiments? We need to use to coercive power of the state to shut this down. Let's make sure no one hurts themselves this way.

    When someone wants to infect themselves with coronavirus to own the libs: I guess it's their right, ya know? You might not agree with the decision, but that's just freedom. You don't get to boss them around.

    holding a flag and weeping rn

  • MrMisterMrMister Jesus dying on the cross in pain? Morally better than us. One has to go "all in".Registered User regular
    Chanus wrote: »
    wait just study the maga chuds everybody wins

    This was definitely a recurring joke

    ...

    <.<
    >.>

  • thatassemblyguythatassemblyguy Janitor of Technical Debt .Registered User regular
    Having some mixed feelings today about a local charity I have supported for the past 5-6(?) years (anonymous donations).

    They operate in a critical role in my region, so I have no problem dropping some coin on them to keep the mission going.

    This week. They sent out a non-trivial gift to donors. I'm like, "no, use money for the folks that need the help. This thing you sent I can get for myself."

    It concerns me that their upping the administrative costs at the expense of their core costs.

    sigh

  • IncenjucarIncenjucar VChatter Seattle, WARegistered User regular
    Okay so Jesus consents but what about Pelor or the Elemental Princes of Evil.

  • JebusUDJebusUD Adventure! Candy IslandRegistered User regular
    Damn, I wish I was as cool as Chanus.

    and I wonder about my neighbors even though I don't have them
    but they're listening to every word I say
  • ChanusChanus Harbinger of the Spicy Rooster Apocalypse The Flames of a Thousand Collapsed StarsRegistered User, Moderator mod
    speaking of challenge trials i am halfway through the last episode of Lady Who and HBO Max has decided it's just not going to play anymore

    does Graham get his helmet off? maybe i'll never know

    Allegedly a voice of reason.
  • ChanusChanus Harbinger of the Spicy Rooster Apocalypse The Flames of a Thousand Collapsed StarsRegistered User, Moderator mod
    Having some mixed feelings today about a local charity I have supported for the past 5-6(?) years (anonymous donations).

    They operate in a critical role in my region, so I have no problem dropping some coin on them to keep the mission going.

    This week. They sent out a non-trivial gift to donors. I'm like, "no, use money for the folks that need the help. This thing you sent I can get for myself."

    It concerns me that their upping the administrative costs at the expense of their core costs.

    sigh

    the bet is that doing things like that attracts more donors

    Allegedly a voice of reason.
  • ChanusChanus Harbinger of the Spicy Rooster Apocalypse The Flames of a Thousand Collapsed StarsRegistered User, Moderator mod
    same

    Allegedly a voice of reason.
  • HonkHonk Honk is this poster. Registered User, __BANNED USERS regular
    My favorite song of yours Chanus is the parrot song

    PSN: Honkalot
  • thatassemblyguythatassemblyguy Janitor of Technical Debt .Registered User regular
    Chanus wrote: »
    Having some mixed feelings today about a local charity I have supported for the past 5-6(?) years (anonymous donations).

    They operate in a critical role in my region, so I have no problem dropping some coin on them to keep the mission going.

    This week. They sent out a non-trivial gift to donors. I'm like, "no, use money for the folks that need the help. This thing you sent I can get for myself."

    It concerns me that their upping the administrative costs at the expense of their core costs.

    sigh

    the bet is that doing things like that attracts more donors

    Just seems like they could have used the $30 to like.. provide some homeless kid with a new/clean pair of socks, hot meal, face masks, and hygiene kit.

  • credeikicredeiki Registered User regular
    @MrMister My friends in Toronto are doing a vaccine trial like that

    There are 4 doses given of it, and people don't know whether the first two are the real two or the second two are the real two, and then I suppose they compare infection rates during the interlude for the people who did and didn't get the dose

    It's really good of them to have signed up! Very ethical.

    Steam, LoL: credeiki
  • JebusUDJebusUD Adventure! Candy IslandRegistered User regular
    Chanus wrote: »
    same

    That guy really has it all. Musical talent. Programming skills. Logistics knowledge. A triple threat.

    and I wonder about my neighbors even though I don't have them
    but they're listening to every word I say
  • credeikicredeiki Registered User regular
    edited June 2021
    (but it isn't the actually getting infected with covid type of study--they are expected to go about their daily lives but not lick doorknobs)

    credeiki on
    Steam, LoL: credeiki
This discussion has been closed.