EPA Study Subjects Humans To Noxious Diesel Fumes

Apparently they were doing it here in my state, as well:

http://nlpc.org/stories/2012/09/25/epa-sued-over-heinous-experiments-humans

From the link:

Calm down, don't react yet, we want to see how far PETA, Greenpeace and the Celebs will go.

If it were animals, they would be freaking out.

I guess humans have become the new, expendable test subjects.

Everyone remain calm, read the article and the associated consent form. They were warned quite clearly they would be exposed to diesel fumes AND that it had risks!

Anyone here not think, say, sticking your mouth over a tail pipe of a diesel vehicle for 2 hours is risk free, come on people. Just another case of the media being a bunch of fuc..@.....,.;ljkukbhndbksdks <zzzz>

I can't tell if you're being sarcastic. I can't find it, although I can't imagine how they would get people to volunteer for this.

This is the EPA writeup about fine particles:

http://epahumantesting.files.wordpress.com/2012/08/screen-shot-2012-08-16-at-3-45-08-pm.gif

What do you mean cant imagine how they would find people willing?

I can give you a list of at least 10 people I know in one way or another that would happily suck on a diesel engine exhaust pipe if you told them it will give them a wicked buzz and they will get $100 for their time after they wake up.

No sarcasm intended.

Have a look at the consent form, in addition to the warnings about cancer and diesel exhaust (clear indications there is an amount of risk) and long term effects.

Yes, given the available reported information they should have made the risk of fine particles clearer but these were a component of diesel exhaust that were being tested, 'Diesel exhaust' being the key phrase.

Anyone who doesn't think there is a risk of breathing diesel fumes in a lab environment for extended periods of time is rather foolish. Anyone who doesn't think the air they breath every day comprising vehicle exhaust and industrial byproducts is a risk is also foolish.

In addition the news article is written in a very inflammatory and vague way, primarily to rile people up. The link you yourself provided from the EPA indicates 2.5 um particles exist naturally in our modern environment.

Your points are noted (the consent form should have been clearer of the potential risks - simple mistake or deliberate ommission, who knows), however I thought an apposing point of view might help balance things out.

The EPA is still being sued over this.

But you are right; as more and more people come to fully trust and depend on government, government should be able to do anything they want to them, as long as they have consent.

Works for me; there are too many dummies out there anyway. To make it more efficient, I would suggest that the government build larger chambers. Maybe able to hold a couple hundred at a time, and pump the exhaust into them.

Umm.. I think it was a different government that started down that trail about 70 years ago. This appears to be a bit different.

Works for me; there are too many dummies out there anyway. To make it more efficient, I would suggest that the government build larger chambers. Maybe able to hold a couple hundred at a time, and pump the exhaust into them.

Or maybe up to 6 million or more? What ethnic group would you prefer?

That was kind of my point.

Interesting gang here at CR4. Everyone else I talk to about this, agrees that the government shouldn't be carrying out these kinds of tests on humans; consent or not.

The article doesn't provide the relevant information to support the allegation that the test subjects were not informed of the risks. The "excerpt" from the consent form doesn't mention particulate matter - unless they show the consent form in full, should we take it for granted that particulate matter is not discussed at all? Given the inflammatory tone, I would need more concrete information before assuming this is true.

The article suggests acute and mortal risks were suffered by the participants - so what happened? Did anyone agree to this and unexpectedly die?

"Fully informed and freely given consent" is what is required for research on human subjects. Not saying that is never violated (for sure!) but is there really a case here?

It wasn't intended to be inflammatory. My point was, and the point of the lawsuit, is that the government has no business pumping diesel exhaust into people's lungs, with or without consent. People are stupid. The government justifies it's entire existence on the premise that they are here to protect everyone.

I'm sure these test subjects have been brainwashed to the point that they think the government would not harm them.

There is a partial interview with one of the subjects here:

http://www.wncn.com/story/20949352/lawsuit-claims-human-subjects-in-epa-trial-at-unc-inhaled-dangerous-fumes

Here is the section on diesel exhaust from the EPA Q & A page:

Q: How Can Diesel Particulate Matter Affect My Health?

A: Diesel exhaust causes health effects from both short term or acute exposures and also long term chronic exposures, such as repeated occupational exposures. The type and severity of health effects depends upon several factors including the amount of chemical you are exposed to and the length of time you are exposed. Individuals also react differently to different levels of exposure. There is limited information on exposure to just diesel particulate matter but there is enough evidence to indicate that inhalation exposure to diesel exhaust causes acute and chronic health effects.

Acute exposure to diesel exhaust may cause irritation to the eyes, nose, throat and lungs, some neurological effects such as lightheadedness. Acute exposure may also elicit a cough or nausea as well as exacerbate asthma. Chronic exposure in experimental animal inhalation studies have shown a range of dose dependent lung inflammation and cellular changes in the lung and there are also diesel exhaust immunological effects. Based upon human and laboratory studies, there is considerable evidence that diesel exhaust is a likely carcinogen. Human epidemiological studies demonstrate an association between diesel exhaust exposure and increased lung cancer rates in occupational settings.

You guys are okay with this practice?

I'm not okay with it, Kram. Exposing human subjects to known carcinogens and mortal risks for research which is not therapeutic is not okay. I think it should be reasonable for a person in dire need of treatment to have the freedom to consent to an experimental treatment with objectively serious (or unknown but potentially serious) risks, with the hope that they will find a cure. That is the only case where exposure to serious risks should be permitted, IMO.

It's clear from the interview that there was not informed consent, the subject was deceived and was also paid to obtain consent. None of this should have ever been approved by the IRB. This is the kind of thing that ultimately is going to lead to the loss of the privilege of self-regulation which has been abused.

Afaik the Canadian ethics model laid out in the Tri-Council Policy Statement (TCPS) has been widely adopted and used as a framework in other countries. This model has some serious flaws and leaves obvious loopholes which can be abused and put research subjects at risk. The major problems arise from the definition of risk in the document. A risk which is deemed equivalent to risks already faced by the research population in question, is defined and referred to as "minimal risk". Therefore a research population which already faces objectively significant statistical risks (eg consider smokers, cancer patients, etc.) can be exposed to objectively serious risks, which are however referred to as "minimal risk". This means that, in obtaining "informed" consent, the prospective subject may be misled with the words "minimal risk" even though the risks are objectively serious.

That's why this quote from the interview raised a red flag for me: "The institute says the EPA has exposed unhealthy patients to high levels of PM2.5..." making me wonder whether they deliberately chose "unhealthy" research subjects so that the risks could be referred to as "minimal".

To make matters worse, under the TCPS, research which has been deemed "minimal risk" (by the proponent) is eligible for "expedited review", in which approval can be given by a single member of the Research Ethics Board (Canadian REB = American IRB), and is also the first precondition for formal ethical approval of waivers or alterations of informed consent for so termed "naturalistic" research ("therapeutic" research is formally excluded but not health research nor basic research per se).

REB's in Canada are almost exclusively composed of parties who are themselves involved in research, with token representation by an ethics professional and a representative of the public. While the individual REB member is absented from approval process of his/her own research, that doesn't stop ethics review from being reduced to collegial backscratching, and the provisions for 'expedited review' clearly make it nothing more, and allow the complete exclusion of review by the token ethics professional and public rep.

There is no global governance body to oversee or review the performance of individual REB/IRB's afaik, it is up to the individual institution. Unethical research may be rejected for publication by peer review, but that is the only scrutiny to which it might be subject - if publication is the objective, which isn't always the case. Research involving waivers of consent can be kept secret, under the present system, and research not intended for publication can be 'approved' in a back room.

I suppose I'm a cynic, I reckon that any loophole that can be abused, will be abused... mainly because research is driven by motives of gain. What surprises me about this story is that the sponsor is EPA. This only makes me wonder, has exploitation and abuse of human subjects become so commonplace that it is accepted as 'ethical' and taken for granted by all and sundry? What other dirt will be found by digging into those 'ethical approval' files?

There's no telling.

People think I'm anti-goverrnment, which is not true in the least; but when it comes to the government's relationship with it's own citizens, I believe that everything should be transparent, and that secrets should not exist. It keeps them honest, and that's not something we can afford to lose. They have a nasty habit of getting into things they shouldn't be.

http://rense.com/general36/history.htm

"They have a nasty habit of getting into things they shouldn't be."

You can apply that to the medical profession and industry, in general (and of course I agree about government, since the worst examples of their abuses also tend to involve governments - as in the case of the nazi medical experiments, soviet incarceration of dissidents in mental hospitals, Ewan Cameron experimenting for the CIA on Canadian patients, etcetera.)

The Declaration of Helsinki is periodically revised, and in 2004 the stipulation was added that the design of all research involving human subjects should be publicly available (#16, last sentence). This requirement (if followed) would be sufficient to ensure that any abuses would come to light. However it seems to have been promptly commuted in 2008 to #19 " Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject." which omits ALL the research on human subjects that isn't a 'clinical trial' and doesn't require any detail of the design to be public in any case. All the power of approval and oversight is clearly delegated to the "committee" ie REB/IRB in the present and official version. Backscratchers and back rooms rule. No transparency whatsoever.

Sorry to say, but when a perfectly reasonable requirement for protection of research subjects is ERASED from the official ethics, somebody's got something to hide. Are these people in complete denial of 'pre-clinical' research on human subjects? They don't even acknowledge it.

I see "expert consultation" for the next revision is under way for the 50th anniversary version in 2014:

http://www.wma.net/en/50events/20otherevents/50doh2013_1/index.html

Wonder if they'll allow any input from the public.

I think that debate and disagreement between us little people is healthy, but there is one thing that we all must agree on; we cannot allow government to do things that directly harm any of us. If we allow it, complete tyranny will be on it's heels.