At one of my companies we were encouraged by our investors to do Phase I (and some Phase II) clinical trials in the Dominican Republic, Mexico, Angola, and other such places.
Back then we did do device studies in Germany because the regulations were at the time quite lax (basically you just needed a German MD to decide it was OK and to actually use the device). They've since tightened up the rules.
Interestingly, in the device case, people who were squeamish about doing studies in poor countries with poor IRBs and such were perfectly happy to do the device studies in Germany. Not sure what to make of that.
Isn't it obvious? Germany is a respected western country, what goes there must be OK, even if not according to other western country's laws. And surely there are sanity checks at place there. Angola, on the other hand, is a poor developing country in third world and that just signals that something nefarious is going on. The participants probably felt doing stuff there would have no such sanity checks and it would also taint their reputation.
Well isn't it condescending to assume that Angola can't have reasonable safety laws while Germany can?
Germany is hardly immune to corruption (as a German speaker I am well aware of this) and that indeed was part of the reason why this loophole (placed there at the behest of German medical device manufacturers) was ultimately removed (thanks, EU!) while plenty of poor countries manage to have non-corrupt governments and reasonable protections in place in particular against the depredations of foreign companies.
As it happens Angola this week removed the laws barring same sex relations, making them more liberal than bigger and so-called "more developed" countries like Russia, China, et al.
Few independent observers claim that Russia or China are places with legitimate governments that serve their people well. China is rather well known for its ethics-laundering industry, doing unsafe and polluting manufacturing work for others.
> As it happens Angola this week removed the laws barring same sex relations, making them more liberal than bigger and so-called "more developed" countries like Russia, China, et al.
Liberalism doesn't directly correlate with lack of corruption.
Doing trials on people who don't have the protection of strong consent laws feels pretty unethical as it's got a good chance of doing direct harm to those people.
Testing a device in Germany has only indirect harm, if those substandard devices go on to hurt people later.
Ignoring ethical standards compromises the validity of any evidence and resulting claims: if we know that the author is willing to ignore ethical principles, we have no reason to believe that they aren't lying about their data/results. The baby goes out with the bathwater.
There are plenty of journals (and websites) that will publish junk research, but that's all it is -- junk.
> Ignoring ethical standards compromises the validity of any evidence and resulting claims...
Unfortunately this logic is flawed. Ethical standards are a moving target not the same as scientific standards (also a moving target). For the validity of research I would be only interested in how far scientific standards are met.
To give a current example: a good chunk of scientists think that science should be open access - an ethical standard. They still have no general doubt in the validity of payed journals.
There is plenty of doubt about the validity of paid journals. That's part of why people want open access. Paid journals distort research because they need to sell exciting results. Negative results and failed replications don't make it into the literature, leading to an over-representation of incorrect positive results.
As 'daveFNbuck points out, believing in open access (as I do) does entail an amount of skepticism towards the current journal system -- I do think that the current incentive structure behind journal publishing threatens (if not totally compromises) the results within.
Ethical standards are indeed a moving target, and it's the job of applied ethics to determine that target at any given point. This is exactly how it should be -- it gives prior research ethical historicity that we can revisit and evaluate to determine whether our priors are as sound as we think they are.
While I'm all in all very happy with the current ethical standards, it's worth to point out that in the past science was significantly advanced by transgressing the ethical standards of the time (i.e. [1]) and it's easy to imagine botched ethics that are diametrical to scientific principles.
I stand firm that not following some ethical standard does not invalidate scientific results and consequently that OPs "dark journals" are very well possible (obviously not desirable).
> it's worth to point out that in the past science was significantly advanced by transgressing the ethical standards of the time
This misses the point: Gallileo's persecution was (and is) morally impermissible, even if the powers at the time claimed otherwise. "Transgressing the ethical standards of the time" isn't at all contentious, because the ethical standards were clearly wrong.
By contrast, there's no clear sense in which our current ethical standards (in the domain of scientific research) are actually wrong -- I might (and happen to) disagree with their metaethical foundations, but their actual practice is perfectly satisfactory: harm reduction, respect for fundamental rights, consideration against exploitative forces, &c.
It's perfectly consistent (and correct) to say that following some misguided ethical standard will not invalidate scientific findings. What invalidates those findings is failing to obey our current, very good ethical standards.
>Ignoring ethical standards compromises the validity of any evidence and resulting claims
If I write "just because something is unethical does not make it technically wrong" on a brick and then set about creating a study whereby I determine the speed at which the brick must be swung in order to kill a puppy compared to an unlabeled control brick the fact that it is unethical and morally reprehensible does not by itself make my results incorrect in the technical sense.
Standards of ethical acceptableness are determined by social consensus. Those affect people's actions regarding what is researched and how it is researched. It's perfectly possible to do unethical research and draw valid conclusions from it. The truth doesn't care about social consensus or what we think it right and wrong.
The ethical principles aren't standard. For instance, some IRBs will consider a sum of $20 an inducement while others will not, even if the subject is the same. If the rest of the studies would be the same, that doesn't make the former study junk and the latter non-junk.
Are there journals and sections of the community who look for epistemological validity but with general disregard for the ethics of interacting with the subjects of the study?
There are classified journals that are used to publish classified scientific results from the intelligence, defense, and national security communities. This is what came to mind when you mentioned “dark journals,” although I initially interpreted dark as invisible to the public. Who knows what ethical standards they have? I presume some pretty unethically acquired results could be published in them, say, on the effectiveness of different weapons systems or “enhanced interrogation techniques” in the field.
Journals don't establish the validity of results. That's established by the community through things like replication and building on top of the results. If you don't abide by ethical standards, the community won't validate your work.
Are there factions in the community who will replicate and build on top but not consider the ethics of how you treat the subjects of your research? Considering that the community is global across different cultures and regions it would be unusual if the principles were the same for what is ethical to do to your subjects, even if everyone agrees on what is ethical for the epistemology.
You seem to have two different questions here. The first is about whether there are people who don't won't consider ethics when doing their research. I'm sure there are such people, but they still need funding and other support that they'll lose if they don't follow the ethics guidelines of their institution and/or laws of their country. The scientist who recently announced the birth of genetically modified babies is a particularly strong example of these consequences.
Your second question is about different ethical standards across the globe. You don't need a journal that completely ignores ethics to support people a global community working under different ethical systems. You either need a journal that accepts submissions that passed local ethical review or a locally-run journal that abides by the ethics of its locality.
I was practicing at a medtech company in high school and the team really wanted to conduct tests in China, since the best product testing would be to shoot live pigs from a cannon into a concrete wall for treatment with the device afterward.
To my knowledge it never happened, because adhering to local ethics requirements would be better for seeking investments. But I also think the company went under because of lacking real world results in the limited trials that could be done.
It was a device for use in trauma patients (car crashes being the most common use case). So that's what they wanted to test, and it is an unsafe procedure for trials, requiring sedation and risking the health of the patient, but possibly increasing positive outcomes in real cases.
Of course this has been happening for a while. When I was a child, I recall reading this in the newspaper when it was revealed that Johns Hopkins dodged normal process by testing drugs in India. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1121689/
Interesting that you could simply test on people in India without establishing safety on animals first.
The history of the Tuskegee syphilis experiment along with others shows that you don’t need to leave home to disregard ethical practices. At home or abroad, the rule is that abusive people and companies will target groups without a voice. It’s the same reason people can be tortured or killed by police and jailers, and the public only pays lip service to reform. The only thing that really changes is who has no voice or power, and then becomes victims.
This is the dark side of globalism and it’s not just testing, it’s every aspect of capitalism where it touches countries in the developing world. Everything from the food you buy to the clothes you wear is the result of horrific exploitation.
Back then we did do device studies in Germany because the regulations were at the time quite lax (basically you just needed a German MD to decide it was OK and to actually use the device). They've since tightened up the rules.
Interestingly, in the device case, people who were squeamish about doing studies in poor countries with poor IRBs and such were perfectly happy to do the device studies in Germany. Not sure what to make of that.