Are researchers allowed to infect humans with viruses/bacteria?

[bozz]

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Is this allowed... (I'm talking about bacteria/viruses with definite harmful effects) with written consent? Does it happen?

I thought of this since I came across practice mcat question asking how it was ACTUALLY historically demonstrated that a certain bacteria caused stomach ulcers...

The answer was that ulcers can be produced in healthy individuals by infecting them with the bacteria. I automatically eliminated this answer since ... it seemed obvious to be that you can't simply infect "individuals" with bacteria... now, if the question was talking about lab mice, the answer would have been a lot clearer to me

Anyways... is this allowed in clinical testing?

 

[ghostfoot]

Is this allowed... (I'm talking about bacteria/viruses with definite harmful effects) with written consent? Does it happen?

I thought of this since I came across practice mcat question asking how it was ACTUALLY historically demonstrated that a certain bacteria caused stomach ulcers...

The answer was that ulcers can be produced in healthy individuals by infecting them with the bacteria. I automatically eliminated this answer since ... it seemed obvious to be that you can't simply infect "individuals" with bacteria... now, if the question was talking about lab mice, the answer would have been a lot clearer to me

Anyways... is this allowed in clinical testing?

You're reading too much into the MCAT question IMO. Know your basics cold, then identify which basic they're testing (and then come up with an answer).

Don't read into it the way that you did here. And "historically" might be a key word in your case.

 

[bozz]

lol it's not about the question itself

I was just wondering if this is allowed

 

[KeyzerSoze]

lol it's not about the question itself

I was just wondering if this is allowed

No, of course it's not allowed. As for the question itself, wikipedia says:

The bacterium was rediscovered in 1979 by Australian pathologist Robin Warren, who did further research on it with Barry Marshall beginning in 1981; they isolated the organisms from mucosal specimens from human stomachs and were the first to successfully culture them.[5] In their original paper,[6] Warren and Marshall contended that most stomach ulcers and gastritis were caused by infection by this bacterium and not by stress or spicy food as had been assumed before.[7]

The medical community was slow to recognize the role of this bacterium in stomach ulcers and gastritis, believing that no microorganism could survive for long in the acidic environment of the stomach. The community began to come around after further studies were done, including one in which Marshall drank a Petri dish of H. pylori, developed gastritis, and the bacteria were recovered from his stomach lining, thereby satisfying three out of the four Koch's postulates. The fourth was satisfied after a second endoscopy ten days after inoculation revealed signs of gastritis and the presence of "H. pylori". Marshall was then able to treat himself using a fourteen day dual therapy with bismuth salts and metronidazole. Marshall and Warren went on to show that antibiotics are effective in the treatment of many cases of gastritis. In 1994, the National Institutes of Health (USA) published an opinion stating that most recurrent gastric ulcers were caused by H. pylori, and recommended that antibiotics be included in the treatment regimen.[8] Evidence has been accumulating to suggest that duodenal ulcers are also associated with H. pylori infection.[9][10] In 2005, Warren and Marshall were awarded the Nobel Prize in Medicine for their work on H. pylori.[11]

So it sounds like he infected himself with it.

 

[bozz]

No, of course it's not allowed. As for the question itself, wikipedia says:



So it sounds like he infected himself with it.

Aah ok.. thanks for the link

 

[MattD]

So it sounds like he infected himself with it.

Right. Ethically this is probably ok, although I don't think even that would get past an IRB today.

The smallpox vaccine is another example among many similar instances, in which the researcher innoculated himself AND HIS FAMILY with some cow-pox virus, and then showed immunity to smallpox. Now what kind of person takes that risk with his family I don't know, but the point is historically it has happened multiple times.

 

[nick_carraway]

Right. Ethically this is probably ok, although I don't think even that would get past an IRB today.

The smallpox vaccine is another example among many similar instances, in which the researcher innoculated himself AND HIS FAMILY with some cow-pox virus, and then showed immunity to smallpox. Now what kind of person takes that risk with his family I don't know, but the point is historically it has happened multiple times.

Maybe he wasn't too happy with his family. It'd be hilarious if a murder/suicide attempt was the source of one of the greatest medical discoveries of the modern age.

 

[bozz]

Maybe he wasn't too happy with his family. It'd be hilarious if a murder/suicide attempt was the source of one of the greatest medical discoveries of the modern age.

lOL

 

[VneZonyDostupa]

Right. Ethically this is probably ok, although I don't think even that would get past an IRB today.

The smallpox vaccine is another example among many similar instances, in which the researcher innoculated himself AND HIS FAMILY with some cow-pox virus, and then showed immunity to smallpox. Now what kind of person takes that risk with his family I don't know, but the point is historically it has happened multiple times.

I don't recall Jenner ever injecting his family to test the vaccine. He injected milk maids, but not family. There was a farmer who infected his family with cow pox a while before Jenner, but he wasn't a researcher and wasn't trying to find a vaccine.

 

[ghostfoot]

Nobody believed that a catheter could be placed in the heart without killing the patient until Forssmann (German physician) slit his anticubital and fed one in (he was fired and awarded the Nobel Prize).

 

[45408]

No, of course it's not allowed. As for the question itself, wikipedia says:

I think there are exceptions. A number of our bacteriology lecturers gave specific infectious doses (for humans) for different bacteria, and I don't think it was data from the '50s either. You obviously need informed consent no matter what.

 

[FinchHead]

Nobody believed that a catheter could be placed in the heart without killing the patient until Forssmann (German physician) slit his anticubital and fed one in (he was fired and awarded the Nobel Prize).

Good god. That's the most intense thing I've ever heard of.

 

[VneZonyDostupa]

I think there are exceptions. A number of our bacteriology lecturers gave specific infectious doses (for humans) for different bacteria, and I don't think it was data from the '50s either. You obviously need informed consent no matter what.

Lethal doses for bacterium toxins are usually given as LD50 (the lethal dose that would kill 50% of the study population). It's a measure of grams of substance/kg b.w., scaled up from mice/rabbits/rats, etc.

I don't think the lecturers were showing you data from humans injected with bacterium. It was either titers taken at death or it was LD50 scaled up from an animal model.

 

[Animus]

I think there are exceptions. A number of our bacteriology lecturers gave specific infectious doses (for humans) for different bacteria, and I don't think it was data from the '50s either. You obviously need informed consent no matter what.

I think you are correct, I remember from a research summary we had during a drug lecture. I believe a person can infect a patient with a disease if they also infect themselves in the process.

 

[neuroprotector]

I met a researcher using attenuated staph infections on humans. It was just on the skin, and they were monitored, but hey, it counts.

 

[Picklesali]

I don't recall Jenner ever injecting his family to test the vaccine. He injected milk maids, but not family. There was a farmer who infected his family with cow pox a while before Jenner, but he wasn't a researcher and wasn't trying to find a vaccine.

I believe the story is Jenner infected a young stable boy with cow pox and then injected him with smallpox 10 times.

 

[beachblonde]

So it sounds like he infected himself with it.

He drank a vat of bacteria, if I remember correctly (don't remember if it was Marshall or Warren). He was adament he was right, and was widely criticized for his view. He's taking his Nobel Prize and laughing his butt off now, I'll bet.

And Jenner infected his gardener's 8 year old with smallpox (after innoculating him). I know he got the scabs and whatnot from the milkmaids, but I'm pretty sure he just went ahead and injected that poor kid. This was the "Don't think, try" guy, after all. But this was after the Royal Family had gone ahead and tried out the idea on prisoners. Ethical considerations were apparently not very important then.

 

[PeepshowJohnny]

He drank a vat of bacteria, if I remember correctly (don't remember if it was Marshall or Warren). He was adament he was right, and was widely criticized for his view. He's taking his Nobel Prize and laughing his butt off now, I'll bet.

And Jenner infected his gardener's 8 year old with smallpox (after innoculating him). I know he got the scabs and whatnot from the milkmaids, but I'm pretty sure he just went ahead and injected that poor kid. This was the "Don't think, try" guy, after all. But this was after the Royal Family had gone ahead and tried out the idea on prisoners. Ethical considerations were apparently not very important then.

It was Barry Marshall who actually downed the concoction. According to a microbio teacher I had who knew him before he got huge for being right the culture smelled AWFUL even by bacteria culture standards.

As for Jenner, there's some debate about his relationship with the kid. Some traditions say he actually had great love for the kid (thought of him as his own) which is why he innoculated him (??). He did end up beying the kid a nice house though, so that's something.

 

[Omyss]

If the subject knows what will happen and the risks involved AND consents to it (and is competent) then it is ok.

 

[dodger84]

This is definitely not allowed in the US today - It's hard enough to get permission to do work on monkeys in the US and sometimes takes years to get the OK.

If you're interested, historically there was a lot of horrible stuff done involving the study of untreated syphilus in tuskeegee in the US as late as the early '70s.

 

[Maxprime]

If the subject knows what will happen and the risks involved AND consents to it (and is competent) then it is ok.

Incorrect. Besides being unethical to trick some ***** into swallowing anthrax because they don't know any better, IRB's will not sign off on things like this. The ethics of it (IMO) are very questionable - who agrees to get an infection?

I could be jaded, but I'm a researcher at a large public university. The biggest fear that exists is some ***** doing something like this, the press freaking out (OMG MRSA!!!!) and the school losing NIH funding. It could be different at smaller research centers. I'm intrigued about the other poster that said they met someone doing staph infections on humans. I'm not questioning them, I'm just curious to read more about the study - anyone have links?

 

[Maxprime]

This is definitely not allowed in the US today - It's hard enough to get permission to do work on monkeys in the US and sometimes takes years to get the OK.

If you're interested, historically there was a lot of horrible stuff done involving the study of untreated syphilus in tuskeegee in the US as late as the early '70s.

That is what I was thinking. I just finished the newly required ethics in biomedical research course that the NIH is requiring of all new biomed grad students. I could still have my head too far in the NIH guide and not in reality, but it's hard enough getting this approved on non-human primates.

The easy reply by the IRB would be "why can't you do this on an animal model?"

 

[Thewrongstuff]

This reminds me of I am legend 😳

measles vaccine>kripp virus wtf?

 

[neuroprotector]

Incorrect. Besides being unethical to trick some ***** into swallowing anthrax because they don't know any better, IRB's will not sign off on things like this. The ethics of it (IMO) are very questionable - who agrees to get an infection?

I could be jaded, but I'm a researcher at a large public university. The biggest fear that exists is some ***** doing something like this, the press freaking out (OMG MRSA!!!!) and the school losing NIH funding. It could be different at smaller research centers. I'm intrigued about the other poster that said they met someone doing staph infections on humans. I'm not questioning them, I'm just curious to read more about the study - anyone have links?

She was a microbiology candidate at my school. I'll see if I can find any info on her.

 

[neuroprotector]

Here it is. My bad, staph is a far cry from H. ducreyi, (the talk was a long time ago...and I'm a neuro kid), but it's still human subjects. There's a whole section devoted to it in the methods.

http://iai.asm.org/cgi/content/full/73/7/3896?view=long&pmid=15972475

 

[Crixivan]

When I interviewed at UNC-Chapel Hill, one of the researchers was studying the pathogenicity of gono by infecting male volunteers (in their urethras). Women were ineligible for the study because of PID. The guys were given ceftriaxone a few days later upon symptom presentation, but apparently gono infects humans only, so there is no suitable human model.

Lemme see if I can recall the faculty member I spoke with...

http://microimm.med.unc.edu/facultydetail.aspx?id=36

 

[45408]

Lethal doses for bacterium toxins are usually given as LD50 (the lethal dose that would kill 50% of the study population). It's a measure of grams of substance/kg b.w., scaled up from mice/rabbits/rats, etc.

I don't think the lecturers were showing you data from humans injected with bacterium. It was either titers taken at death or it was LD50 scaled up from an animal model.

Read it again. I didn't say lethal dose, I said infectious dose. There's a huge difference, and I meant what I said.

 

[45408]

This is definitely not allowed in the US today - It's hard enough to get permission to do work on monkeys in the US and sometimes takes years to get the OK.

If you're interested, historically there was a lot of horrible stuff done involving the study of untreated syphilus in tuskeegee in the US as late as the early '70s.

Are you just guessing or do you actually have information about guidelines that specifically preclude these experiments?

 

[dodger84]

Are you just guessing or do you actually have information about guidelines that specifically preclude these experiments?

Well, the initial question stated that the introduced pathogen has "definite harmful effects".

A direct quote from the criteria for approval of human research by an IRB:

"In order to approve research covered by
this policy the IRB shall determine that all of
the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) By
using procedures which are consistent
with sound research design and which do
not unnecessarily expose subjects to risk,
and (ii) whenever appropriate, by using
procedures already being performed on
the subjects for diagnostic or treatment
purposes."


I would think that introducing into a healthy patient "something with definite harmful effects" would not fall under the category of minimal risk. Somebody mentioned infection with gonorrhea - this would be ok considering it is treatable fairly easily with antibiotics (my apologies to anybody who has suffered from this). I would imagine it took forever to get the studies approved. I thought that the initial question was talking about something more threatening. So the answer is yes you can infect humans with something that is moderately harmful as long as it is treatable, there are no alternative models for the study, there is some benefit from doing the research, the patients give consent, and the research is approved by an IRB - it better be extremely well thought out!

 

[Catalystik]

Is this allowed... (I'm talking about bacteria/viruses with definite harmful effects) with written consent? Does it happen?

When I was in medical school I participated in a study where I was innoculated intranasally with a cold virus and then studied to see if my use of aspirin prolonged viral shedding time. The big bucks offered lured me into permitting them to draw my blood several times a day.

 

[Mr hawkings]

Walter Reed had soldiers sleep outside on porches so they could be bitten by mosquitoes. This was how he proved that the causative agent for yellow fever was transmited via mosquito bite. Many soldiers died.
Of course, he did not directly inject infectious Disease into anyone, but records show that there was little if any informed consent. So the question is, if he knew they would be getting yellow fever, is it the same as if he had injected them with the virus himself by exposing them to the bugs.

 

[45408]

I would think that introducing into a healthy patient "something with definite harmful effects" would not fall under the category of minimal risk. Somebody mentioned infection with gonorrhea - this would be ok considering it is treatable fairly easily with antibiotics (my apologies to anybody who has suffered from this). I would imagine it took forever to get the studies approved. I thought that the initial question was talking about something more threatening. So the answer is yes you can infect humans with something that is moderately harmful as long as it is treatable, there are no alternative models for the study, there is some benefit from doing the research, the patients give consent, and the research is approved by an IRB - it better be extremely well thought out!

So is it "moderately harmful" or "minimal risk"? Even gonorrhea can cause infertility. You also said "definitely not allowed," not "allowed under certain circumstances," which is why I disagreed.

 

[Maxprime]

Walter Reed had soldiers sleep outside on porches so they could be bitten by mosquitoes. This was how he proved that the causative agent for yellow fever was transmited via mosquito bite. Many soldiers died.
Of course, he did not directly inject infectious Disease into anyone, but records show that there was little if any informed consent. So the question is, if he knew they would be getting yellow fever, is it the same as if he had injected them with the virus himself by exposing them to the bugs.

If he ordered them to expose themselves, I don't see how that's any different than injecting it directly. This may be a way to make it legal, but not ethical.

 

[Maxprime]

When I interviewed at UNC-Chapel Hill, one of the researchers was studying the pathogenicity of gono by infecting male volunteers (in their urethras). Women were ineligible for the study because of PID. The guys were given ceftriaxone a few days later upon symptom presentation, but apparently gono infects humans only, so there is no suitable human model.

Lemme see if I can recall the faculty member I spoke with...

http://microimm.med.unc.edu/facultydetail.aspx?id=36

Wow. I think it's pretty cool that the community is still open to doing some testing on human subjects. It's easy to freak out and ban all human experiments without thinking about possible risks/benefits. But I'm still surprised she was allowed to do this - do the risks really outweigh the benefits here?

 

[slicknick5k]

There are various examples of this in US history.....hopefully in our progressive society we have learned from out mistakes and can proceed ethically with advancement in the sciences.

The Tuskegee experiment-Researchers observed the effects of advanced syphilis on 399 poor black sharecroppers from Macon County, Alabama, who were followed clinically but not treated, even after the introduction of penicillin therapy in 1943

Prisoners at the Holmesburg State Prison in Philadelphia are subjected to dioxin, the highly toxic chemical component of Agent Orange used in Viet Nam. The men are later studied for development of cancer, which indicates that Agent Orange had been a suspected carcinogen all along.

More than 1500 six-month old black and hispanic babies in Los Angeles are given an "experimental" measles vaccine that had never been licensed for use in the United States. CDC later admits that parents were never informed that the vaccine being injected to their children was experimental.

Here's a link to other examples of biological experimentation on humans

http://www.apfn.org/apfn/experiment.htm

 

[docdad]

The real story about what is done now is a bit more complex than anyone has discussed here. As a result of some of the horrors discussed above such as the Tuskeegee experiments, but also much research done on prisoners and children, legislation was passed in the US regarding Human Subjects Protection.

In summary, any research study involving humans must be approved by an Institutional Review Board (IRB). The IRB makes sure that the study obtains informed consent from the research subjects (and that they can legitimately provide non-coerced consent) and that the supposed benefit from the study outweighs the risk of harm to the subject. You can read to your heart's content about this stuff here: http://www.hhs.gov/ohrp/

Within the legislation and guidelines, some pretty risky stuff goes on, so I would never jump to any conclusion regarding what is or is not allowed.

You can also take a tutorial on your own here: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp

 

[Mr hawkings]

It sould also be noted that all the regulations apply to researcher and subjects in the US. If an american researcher goes to another country to conduct research, there may not be the same stringent reviews and patient advocacy as there is here so you could get away with more if the gov there does not care.

 

[Law2Doc]

http://www.apfn.org/apfn/experiment.htm

There are some sources on the net that are more credible than others (particularly when there is an underlying agenda).... I'm just saying.

 

[45408]

There are some sources on the net that are more credible than others (particularly when there is an underlying agenda).... I'm just saying.

Oh, come on. That website looks completely legitimate.

 

[Law2Doc]

Oh, come on. That website looks completely legitimate.

LOL 👍

 

[Tenk]

Right. Ethically this is probably ok, although I don't think even that would get past an IRB today.

The smallpox vaccine is another example among many similar instances, in which the researcher innoculated himself AND HIS FAMILY with some cow-pox virus, and then showed immunity to smallpox. Now what kind of person takes that risk with his family I don't know, but the point is historically it has happened multiple times.

Jenner was a badass. Don't mess.

 

[AustinBum]

Yes, but you go to places like Iraq, Afghanistan, or Mexico to do it. No one's going to ask any questions.

 

[0Complications]

No, of course it's not allowed. As for the question itself, wikipedia says:



So it sounds like he infected himself with it.

That was an interesting read. Nice find.