[Submitted] Protection of Research Subjects Act

[Tinfect]

Not only is this largely better scientific method, but it's more ethical as well.

OOC:
I mean, that's bullshit, but it also risks human lives ahead of animal lives. There is a reason we do animal testing, you know.

[Burninati0n]

OOC:
I mean, that's bullshit, but it also risks human lives ahead of animal lives. There is a reason we do animal testing, you know.

Actually, no. Some products are tested on animals to ensure safety of ingredients, but for the most part, in terms of cosmetics, you're talking about things like minor risk of allergic reaction. Human lives aren't at stake, merely human discomfort. And again, the difference is that humans can consent to this, whereas animals cannot. Humans can be compensated, animals cannot understand what is happening to them. In addition, when companies keep animals for the purpose of testing cosmetics, these animals are often kept in conditions that are quite inhumane.

Furthermore, the clauses in the proposal do not eliminate animal testing, merely seek to limit it to the smallest necessary realm, and mandate minimum levels of care for animals kept for testing.

And anyway, if you're looking for RL examples of this kind of policy, you need look no further than the FDA, which states:

FDA supports the development and use of alternatives to whole-animal testing as well as adherence to the most humane methods available within the limits of scientific capability when animals are used for testing the safety of cosmetic products. We will continue to be a strong advocate of methodologies for the refinement, reduction, and replacement of animal tests with alternative methodologies that do not employ the use of animals.

Take note -- you won't hear this from me on much -- but this is an example of a correct policy, and exactly what this proposal seeks from member state regulatory agencies. The related clauses are:

2. Member states must protect members of sentient species who are the subjects of research by:

a. Encouraging research that can reasonably be conducted with sapient species as subjects instead of sentient species be conducted in this manner instead.
b. Eliminating the use of sentient species in research that poses risks to sentient species when the same research objectives may be reasonably be obtained without posing those risks to sentient species, either through research design that eliminates the risk, or through research design that eliminates the use of a sentient species altogether.

Do you:
A) Disagree that this is proper policy [in which case, why? Why should animals suffer needlessly?], or
B) Disagree that this is what the text of the proposal actually recommends [in which case, what should it say?]?

[Imperium Anglorum]

Cosmetics aren't the only thing that have to do with animal testing. We do a lot of animal testing in pharmaceuticals. In fact, currently in all the jurisdictions I am familiar with, all drugs are tested on animals before they are moved on for human trials. A few summers ago, I interned in the legal department for a pharmaceutical company. We had a ton of contracts with significant numbers of laboratories which would test chemotherapy drugs and NSAIDs on rats, beagles, etc. I think there were once hamsters.

However it is, you don't get to human testing before considerable animal testing. In the real world, the US FDA requires in vivo animal testing before those drugs can even be considered to later be administered to humans. In the UK 'by law, all new medicines must first be tested on animals, in order to ensure patient safety. Only when these tests have been shown to be successful will clinical trials will be conducted on humans' (Source).

[Kenmoria]

"We simply cannot support a measure that would support animal rights over sapient ones. In particular clause 2b is problematic."

[Burninati0n]

Cosmetics aren't the only thing that have to do with animal testing. We do a lot of animal testing in pharmaceuticals. In fact, currently in all the jurisdictions I am familiar with, all drugs are tested on animals before they are moved on for human trials. A few summers ago, I interned in the legal department for a pharmaceutical company. We had a ton of contracts with significant numbers of laboratories which would test chemotherapy drugs and NSAIDs on rats, beagles, etc. I think there were once hamsters.

However it is, you don't get to human testing before considerable animal testing. In the real world, the US FDA requires in vivo animal testing before those drugs can even be considered to later be administered to humans. In the UK 'by law, all new medicines must first be tested on animals, in order to ensure patient safety. Only when these tests have been shown to be successful will clinical trials will be conducted on humans' (Source).

Wouldn't that be covered under clause 2b's rather large exception, under:

Eliminating the use of sentient species in research that poses risks to sentient species when the same research objectives may be reasonably be obtained without posing those risks to sentient species

[[Now clause 2a after reorder]]
Basically, I don't disagree with you about this -- I just don't see why these examples are problematic for the clauses as written -- I need to see what you actually think it should say if not that.

As it stands, if you're arguing that those research objectives cannot be obtained without animal trials, then by clause 2b, animal trials are allowed. [[Now clause 2a after reorder]]

"We simply cannot support a measure that would support animal rights over sapient ones. In particular clause 2b is problematic."

Would you mind expanding on the complaint? I don't see how clause 2b supports "animal rights over sapient rights." What clause 2b says is in cases where research objectives may be reasonably obtained without posing risks to animals, researchers should avoid posing risks to animals. Specifically, it suggests two methods that might be available in some cases, eg. research designs that eliminate risk, or research designs that eliminate the use of animal testing altogether.

Do you mean 2a? 2a is a prioritization of consent over no-consent, not a prioritization of the rights of certain species over others. (Animals cannot consent, while sapients can.)
[[Now clause 2c after reorder]]

EDIT:
I tried a minor rewording and reorder of clause 2 that is now showing in the OP. I think the order makes it clearer the intent of the provisions, and the bit that encourages the use of sapient subjects is clarified to being most relevant in low-risk situations where volunteers could likely be found, as is the case with much cosmetics research currently conducted with animal subjects. Perhaps this deals with some of the concerns being brought up by IA, Tinfect, Kenmoria, etc.?

[Araraukar]

Actually, no. Some products are tested on animals to ensure safety of ingredients, but for the most part, in terms of cosmetics, you're talking about things like minor risk of allergic reaction. Human lives aren't at stake, merely human discomfort.

OOC: Have you ever heard of drug development??? You could (and more than likely would) literally kill someone without any intention of doing so, if you had no idea of lethal dose limits (animal testing), or the way it interacts with the myriad metabolical pathways (which cannot be simulated) in a living body? Also, "minor risk of allergic reaction" proves you've never even heard of anaphylaxis, which is a danger even after extensive animal testing, in clinical trials and after the medication has been approved. Animal lives are cheaper than sapient lives, and that's how it should be.

Humans can be compensated

Tell that to the families whose family members you'd be killing by using them as lab animals. Or the people born with thalidomide-related birth defects.

animals cannot understand what is happening to them.

Which is why using them is more humane than using sapient beings.

In addition, when companies keep animals for the purpose of testing cosmetics, these animals are often kept in conditions that are quite inhumane.

https://en.wikipedia.org/wiki/Drug_development

And anyway, if you're looking for RL examples of this kind of policy

I'm not. I'm thinking in general terms of what's reasonable and logical in the NS setting.

Do you:
A) Disagree that this is proper policy [in which case, why? Why should animals suffer needlessly?], or
B) Disagree that this is what the text of the proposal actually recommends [in which case, what should it say?]?

I disagree that the WA should at all be trying to legislate on animal testing.

Also, you seem to be under the strange impression that "animal testing" = "needless animal suffering". Test animals are not cheap to keep, they are not easy to keep, not if you want your test results to be reliable, and if there were easy, safe, cheaper methods, you bet your ass those would/are already in use. But many things, especially when talking about untested chemical compounds, you simply can't justify using people to find out their toxicity and safety. "I'm only encouraging that" does not let you off this hook either.

[Kenmoria]

"In clause 2b, the use of “individuals” to refer to animals seems odd. Perhaps “creatures”, “sentients” or “animals” instead?"

[Burninati0n]

I'm not. I'm thinking in general terms of what's reasonable and logical in the NS setting.

Your entire prior argument was essentially "this is bad policy because it's a hindrance to drug research."

My response is that this is not a proposal concerned merely with drug research or even primarily with drug research, and the proposal -- including the particular clauses you're citing -- specifically say that if research benefits cannot be obtained without animal testing that animal testing is permitted.

I disagree that the WA should at all be trying to legislate on animal testing.

And here is, at base, the issue.

Do you think human rights is a valid GA category? Are humans the only creatures who deserve rights? If that's what you think, I will not be able to modify the proposal to suit you, since I disagree.

I mean, there's a whole category for "bioethics" now apparently -- I'm wondering exactly what you think the category is for.

And as a sidenote for those tempted to continue along an argument like this, I should note that cosmetics testing on animals is specifically banned in several countries, but others actually require it in some cases. This indicates that international standards on this issue in bioethics are quite warranted.

Also, you seem to be under the strange impression that "animal testing" = "needless animal suffering".

You're either parodying my position or not reading it.

My position is not that all animal testing == needless animal suffering. In fact, the proposal specifically permits animal suffering where it is needed.

b. Requiring that organizations keeping members of sentient species for the purposes of research provide a minimum level of care to those individuals with respect to their biological needs, including provision of appropriate sustenance and allowances for other needs that might arise and that the individual would plausibly be able to obtain if it was not a subject of research. In cases where specific research objectives must be achieved through the withholding of such care, only the minimum amount of care required to achieve the research objective may be withheld.

Anyway, my point is that you're the one taking a bizarre position, not me. See below:

Test animals are not cheap to keep, they are not easy to keep, not if you want your test results to be reliable, and if there were easy, safe, cheaper methods, you bet your ass those would/are already in use.

"Slaves are not cheap to keep, they are not easy to keep, not if you want your crop yields to be reliable, and if there were easy, safe, cheaper methods of farm production, you bet your mivongs that those would/are already in use."

That's why we know for a fact that slaves never were subjected to unnecessary suffering and no government oversight was ever needed to alleviate suffering. The free market solves all problems, amirite?

If it is your position that every nation/company/organization that has ever and will ever test a product on animals is doing so in the most responsible available way, it's you who's living in an alternate universe.

[[This argument isn't equating the suffering of human slaves to the suffering of animals, but instead it's pointing out that the form of the argument Araraukar used is fundamentally incorrect.]]

But many things, especially when talking about untested chemical compounds, you simply can't justify using people to find out their toxicity and safety. "I'm only encouraging that" does not let you off this hook either.

I simply do not see the hook.

c. Encouraging research that can reasonably be conducted with sapient species as subjects instead of sentient species be conducted in this manner instead, especially in cases of cosmetics testing where the risks are relatively low and it is probable that willing volunteers could be found.

The goal of this clause is to encourage nations to minimize the use of animals where sapients can reasonably replace them without sacrificing research objectives with the replacement. Nothing more.

Your "hook" is either because (a) I have been unclear, or (b) because you are being intentionally disingenuous on this point due to a fundamental disagreement about whether or not animals should have any kinds of rights or protections, or (c) because you don't realize the huge scope of animal testing in contemporary society and just how much of it is conducted under questionable ethical conditions.

I'm behaving as though we're in situation (a) or (c), but quickly coming to believe we're really in situation (b).

But just in case, for clarity:
The goal of my writing on this point is not to endanger sapient species or hinder legitimate research that needs to use animal test subjects (especially in the realm of pharmaceuticals). Instead it is to ensure that:
1) Animals kept for such purposes are not harmed beyond what is necessary to achieve research goals, and
2) to merely recommend that products that can be tested without animal suffering be tested in that way instead, and to recognize that in many cases, there are tests that carry relatively low risks that could easily find willing test subjects.

And on point (c) :
Draize tests are commonly used to test cosmetics even though they are not required. At issue immediately is the provision of pain relief -- in most cases, while testing cosmetics like cologne, lipstick, shampoo, etc, are tested in super extreme circumstances. One component of Draize testing is the test for acute oral toxicity, where increasing doses of the substances are force fed to rats to find out the dose at which half of them will die within 14 days of exposure. Note that this is research objective that arguably cannot be determined in any other way, so the proposed resolution would not stop such a test from occurring despite the apparent lack of a need for such a test to be carried out (read the list of items we're talking about again before you dispute that last point).

What clause 2b would require in these cases, however, is that some minimum level of support be provided -- for example, pain relief, which is rarely provided to animals subjected to such testing even today. (Here's a source, since this is the section about how animals actually are subjected to unnecessary suffering in test environments since this might be in dispute.)

[Burninati0n]

I did make some substantive edits to the clauses that were taking criticism.

Again, I would seek to submit if there are no comments and I appreciate that more people have commented, but I keep seeing all these commenters on other threads. I want your opinions!

[Kenmoria]

(OOC: This exceeds the character limit, which is currently 5000, by over 300 characters.)

[Burninati0n]

(OOC: This exceeds the character limit, which is currently 5000, by over 300 characters.)

Thanks, I was unaware of the character limit. Now is 4,996 characters. #GoodEnough

[Burninati0n]

Submitted with further revisions to deal with some complaints (hopefully).

Thank you to those of you who have given me input thus far.

[Kenmoria]

"In light of this proposal's submission, and with the additional changes, the Kenmoria WA mission declares its vote FOR this resolution."

[Tekmedias]

The Queendom of Tekmedias wishes to state that the proposed Protection of Research Subjects Act absolutely fails in adequately addressing vital considerations. We would not be voting FOR if this advances to a vote as a resolution, and we strongly suggest to all voting delegates that they do not approve this proposal in it's current state. What follows are listing of issues we have with the proposal, as well as various questions we think the act should answer.

We have noticed an issue with section 1.b.i, which states, in part:

The [Institutional Review Board (IRB)] must be independent ... it must not have a ... stake in the completion of the research.

How would this affect situations requiring an IRB, say for example, the testing of a vaccine in a pandemic scenario? Every sentient researcher would be potentially at risk and thus no one would be suitably distanced from the outcome of a study into a cure or vaccine. Additionally, section 1.b.ii likely faces a potentially similar problem with forming a compliant IRB as it states:

The IRB must be composed of ... experts in the field ... who also do not have a financial or other stake in the completion of the research.

---

Additionally, section 1.c says that:

Should a research subject come to believe that the protections guaranteed by this resolution were not adequately provided, they must be afforded the ability to be removed from the research and pursue whatever civil remedies are available in the jurisdiction in which the alleged violation occurred.

What about scenarios in which being "removed from the research" is not practical without the death or injury to the research subject? Furthermore, who bears the liability for injuries to a research subject who chooses to be removed from a study? Is it the research subject, the researchers, or even the IRB itself who is to be punished? Do the researchers deserve liability even if removal is done despite their objections because of the authority given to research subjects via this proposed resolution? What liabilities or punishments does the responsible party have?

---

Paragraph 4, stating:

AFFIRMING that scientific research is an essential endeavor in the struggle to reduce the impacts of disease, to ensure consumer product safety, and to further the cause of knowledge.

should instead read:

BELIEVING that scientific research is an essential endeavor in the struggle to reduce the impacts of disease, to ensure consumer product safety, and to further the cause of knowledge.

---

Tekmedias also wishes to invite discussion on if passing this proposal onto the assembly, or even passing it into a formal approved resolution, might violate the original Medical Research Ethics Act by violating this mandate from the previously passed act:

MANDATES that the IRBs be free from political pressure in their review of research.

Would passing this resolution or even accepting the proposal potentially violate the freedom of currently formed IRBs to not face political pressure ? Would the political pressure of having the General Assembly pass a new resolution which comes into immediate effect without grandfathering older IRBs require an explicit ammendment of the previous act in any way?

---

[Imperium Anglorum]

You need to write more succinctly.

[Tekmedias]

You need to write more succinctly.

(OOC) Most of the space is formatting and quotes. It's certainly not longer than some of the posts made by the writer of the proposal. I choose to play this part of the game seriously and I enjoy writing things up more formally. You are free to skip my posts if you want, but there is no reason to make snide comments that have nothing to do with the thread's topic just because I put enough effort into a post that it took up a fair amount of space. I am a reasonable person though, so I will try to add spoiler sections to shrink the post's apparent size.

My apologies for misunderstanding. Ignore this response. I'll leave the original text up for posterity though.

[Imperium Anglorum]

Not you. The proposal author. My apologies, since that was unclear.

[Burninati0n]

You need to write more succinctly.

Would you mind giving an example? I can go through the proposal and look for things that I could say with fewer words, but these issues are complex, and I am unsure that I will see the kinds of things you are thinking unless you point to one.

How would this affect situations requiring an IRB, say for example, the testing of a vaccine in a pandemic scenario? Every sentient researcher would be potentially at risk and thus no one would be suitably distanced from the outcome of a study into a cure or vaccine.

The author did not consider such an eventuality. In the likely event that this draft does not achieve a quorum, I will look into this issue.

What about scenarios in which being "removed from the research" is not practical without the death or injury to the research subject? Furthermore, who bears the liability for injuries to a research subject who chooses to be removed from a study? Is it the research subject, the researchers, or even the IRB itself who is to be punished? Do the researchers deserve liability even if removal is done despite their objections because of the authority given to research subjects via this proposed resolution? What liabilities or punishments does the responsible party have?

Without elucidation, the resolution of such issues remains up to each nation. I actually think this is a strength -- attempting to legislate the answers to such questions from the WA floor likely goes beyond the WA's mandate.

I should note that the line quoted requires only that the research subject be afforded the ability to leave the research, which I don't think implies that the subject must actually leave the research. The situation you envision is likely different from that of what the author was trying to address -- I will likely need to revisit the line with your question in mind.

Would passing this resolution or even accepting the proposal potentially violate the freedom of currently formed IRBs to not face political pressure ? Would the political pressure of having the General Assembly pass a new resolution which comes into immediate effect without grandfathering older IRBs require an explicit ammendment of the previous act in any way?

I am uncertain why passing this proposal as a resolution would necessarily lead to such conflicts. I should also note that given that the resolution in question is essentially a subset of this proposal, passage would be followed by a proposed repeal of that resolution, either proposed by myself or by another.

[Araraukar]

OOC: Since 3.a. lets me opt out of this entirely, I'm no longer officially opposed, though will likely still vote against it. Lab animal rights is not something the WA should waste its time on.

[Tekmedias]

Not you. The proposal author. My apologies, since that was unclear.

(OOC) I edited my original post with an apology, but just to make sure you see it I wanted to reply and say sorry for my language. I thought you were being rude but I misunderstood.