[Challenge] Repeal Protection of Biomedical Research

[Sierra Lyricalia]

So we should probably deal with this. Yea/nay? (Yea for me).

Rule Broken: Honest Mistake

Appalled that this absurdly broad restriction prohibits (or at least would prohibit, should prior legislation be repealed) member states from, among other things:
securing legal protection from harmful medical experimentation to the historically vulnerable class of persons who, while not "provably sentient or sapient at the time of research" may indeed regain such capacity, such as individuals in comas or persistent vegetative states,

This clause, due to the mandates of Resolution 29, Resolution 299, (which collectively provide a definition of legal guardianship and competence, and allow for determinations regarding medical procedures to be made by legal guardians,) and Resolution 355, (which extends the protections granted to sapient species to any and all members of said species, regardless of any disability,) is an Honest Mistake violation, as it claims the resolution does something it is incapable of doing.

granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication,

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research.

mandating that biomedical researchers abide by reasonable financial disclosure and conflict of interest rules, and

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as disclosing or eliminating any biases is a legitimate scientific interest in ensuring the legitimacy of any research. Further, such is entirely outside the scope of the Resolution, as regulations regarding the disclosure of financial interests or other biases are procedural regulations, rather than scientific standards.

providing adequate legal protection for the environment in the context of biomedical research, at least with respect to non-sapient plant, bacterial, and fungal life such as coral reefs and old-growth forests,

This clause, due to environmental regulations being entirely outside the scope of the resolution, as per the definition of 'Biomedical Research' within the resolution, is an Honest Mistake Violation.

Understanding that significant portions of the remainder of the target resolution are largely redundant in light of GAR #111, "Medical Research Ethics Act" and GAR #219, "Biomedical Innovation Org", for the following reasons:
the target resolution requires the Biomedical Innovation Organization (BIO) to coordinate "international efforts at biomedical research", despite the fact that GAR #219 already requires the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations",

This clause, due to the fact that Biomedical Research encompasses a vast field of research, not at all limited to those utilizing Biomedical Tissues, such as the development of Pacemakers, Medical Prosthesis, or other such endeavors, is an Honest Mistake Violation.

the target resolution mandates the BIO with developing minimum scientific and ethical standards for biomedical research and serving as an advisory body for biomedical ethics organizations and regulatory bodies, even though GAR #111 already establishes and regulates bodies required for upholding medical research ethics in member states,

This clause, due to the fact the IRBs established via Resolution 111 serve to determine whether a research effort can be considered Ethical, whereas BIO's expanded role within the Resolution is to establish a minimum standard of ethicality, is an Honest Mistake Violation.

the target resolution establishes an "internationally-accessible database of ongoing biomedical research within Member-States", even though GAR #219 already requires the BIO to include "research data for biomedical innovations as a part of the Database Of Clinical Treatments Under Study"

This clause, due to the fact that a Database for Biomedical Innovations, and a Database for Ongoing Biomedical Research, are literally two entirely different things, is an honest mistake violation.

Repeal "Protection of Biomedical Research"
Category: Repeal | Resolution: GAR #420

Affirming in principle the importance of biomedical research in improving quality of life in all World Assembly member states,

Simultaneously insisting on the necessity of appropriate bioethical regulation in order to protect the fundamental rights of individuals and other legitimate public interests,

Condemning the target resolution GAR #420, "Protection of Biomedical Research", a resolution that primarily serves to frustrate the responsible regulation of biomedical research by member states,

Noting that the target resolution bars member states from engaging in any regulation of biomedical research except for "scientific standards" and "ethics standards and regulations [that] serve specifically to minimize or eliminate harm to life provably sentient or sapient at the time of research",

Emphasizing the critical importance of numerous ethical regulations that are relevant in the context of biomedical research and in service of legitimate public interests, even though they cannot be established as preventing direct harm to particular sapient or sentient life,

Appalled that this absurdly broad restriction prohibits (or at least would prohibit, should prior legislation be repealed) member states from, among other things:

1. securing legal protection from harmful medical experimentation to the historically vulnerable class of persons who, while not "provably sentient or sapient at the time of research" may indeed regain such capacity, such as individuals in comas or persistent vegetative states,
2. granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication,
3. requiring appropriate reverence for the remains of deceased sapient life in the course of biomedical research,
4. mandating that biomedical researchers abide by reasonable financial disclosure and conflict of interest rules, and
5. providing adequate legal protection for the environment in the context of biomedical research, at least with respect to non-sapient animal, plant, bacterial, and fungal life such as coral reefs and old-growth forests,

Understanding that significant portions of the remainder of the target resolution are largely redundant in light of GAR #111, "Medical Research Ethics Act" and GAR #219, "Biomedical Innovation Org", for the following reasons:

1. the target resolution requires the Biomedical Innovation Organization (BIO) to coordinate "international efforts at biomedical research", despite the fact that GAR #219 already requires the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations",
2. the target resolution mandates the BIO with developing minimum scientific and ethical standards for biomedical research and serving as an advisory body for biomedical ethics organizations and regulatory bodies, even though GAR #111 already establishes and regulates bodies required for upholding medical research ethics in member states, and
3. the target resolution establishes an "internationally-accessible database of ongoing biomedical research within Member-States", even though GAR #219 already requires the BIO to include "research data for biomedical innovations as a part of the Database Of Clinical Treatments Under Study",

Seeking to remove harmful and redundant legislation from the pages of international law,

The General Assembly,

Repeals GAR #420, "Protection of Biomedical Research".

https://www.nationstates.net/page=WA_past_resolutions/council=1?start=419

Protection of Biomedical Research

A resolution to modify universal standards of healthcare.

Category: Health

Area of Effect: Research

Proposed by: Tinfect Diplomatic Enclave

Recognizing the vast potential of biomedical research to improve and save the lives of the citizens of Member-States,

Applauding the great strides already made in the field by Member-States,

Seeking to greatly expand these efforts through the expansion and facilitation of International collaboration in the field,

And condemning the placement of unjust and illegitimate restrictions on life-saving biomedical research,

The World Assembly hereby;

Defines Biomedical Research as the fields of research investigating the causes of disease, disease prevention, treatment, and the mitigation or elimination of medical conditions including, but not limited to: Cancer, Paraplegia, and Motor Neuron Diseases,

Expands the mandate of the Biomedical Innovation Organization of the World Health Authority to include:

Coordination of international efforts at biomedical research,

Development of a set of minimum scientific and ethical standards for biomedical research, to be met by Member-States,

Service as an advisory body for biomedical ethics organizations and biomedical ethics regulatory bodies within Member-States,

Maintenance of an internationally-accessible database of ongoing biomedical research within Member-States, excepting information regarding research efforts which are protected by Member-States as a matter of security,

Mandates:

That Member-States place no restrictions on biomedical research beyond those that are necessary to ensure that research efforts meet ethical and scientific standards,

That Member-States rescind any and all biomedical research ethics standards and regulations that do not serve specifically to minimize or eliminate harm to life provably sentient or sapient at the time of research, and,

Clarifies that the above provisions are subject to extant legislation,

And reminds Member-States that any and all determinations of sapience or sentience are subject to extant World Assembly legislation and scientific procedure.

My first reaction is that 1) the "Appalled..." clause a. is in fact an Honest Mistake, since that concern is amply covered by other WA legislation. Auralia updated that clause since I made that objection, but I still don't think it's a reasonable interpretation of the target or of existing law. I no longer object to anything in the "Understanding..." section.

TL;dr - only "Appalled... a. securing legal protection..." counts as an Honest Mistake; the rest of the repeal consists of reasonable interpretations and is legal.

[Bananaistan]

My first reaction is that 1) the "Appalled..." clause a. is in fact an Honest Mistake, since that concern is amply covered by other WA legislation. Auralia updated that clause since I made that objection, but I still don't think it's a reasonable interpretation of the target or of existing law. I no longer object to anything in the "Understanding..." section.

TL;dr - only "Appalled... a. securing legal protection..." counts as an Honest Mistake; the rest of the repeal consists of reasonable interpretations and is legal.

The initial part of the appalled clause includes "or at least would prohibit, should prior legislation be repealed". Doesn't that sort of negate the ample protections of prior legislation argument?

[Bears Armed]

Re the "Appalled" clause: I suppose there is potentially a possibility that the legal guardian of somebody who's unable to make the decision themselves due to their condition might consent to experimentation on that patient beyond the level to which that patient would actually consent if able to discuss the matter in person, and thus a slight gap in the legal protection provided by earlier resolutions...

[Bears Armed]

Re the "Appalled" clause: I suppose there is potentially a possibility that the legal guardian of somebody who's unable to make the decision themselves due to their condition might consent to experimentation on that patient beyond the level to which that patient would actually consent if able to discuss the matter in person, and thus a slight gap in the legal protection provided by earlier resolutions...

The initial part of the appalled clause includes "or at least would prohibit, should prior legislation be repealed". Doesn't that sort of negate the ample protections of prior legislation argument?

Also this. Yes.

[Christian Democrats]

I think the "should prior legislation be repealed" caveat removes any legality concerns.

[Sierra Lyricalia]

OK, so... short memorandum saying "we think there's no illegality in the current draft" or words to that effect? I don't see a need to be lengthy about this, so if nobody else wants to I'll do a paragraph sometime tonight.

[Bananaistan]

Code: Select all

Further to section 7 of the Rules and Procedures of the GA Secretariat, GenSec has chosen not to hear the question.

If the General Secretariat decline to grant a question a review, each member that voted not to grant the question a review shall provide their reasoning publicly and promptly.

Then it's up to those who voted against hearing it to publish our reasons. Rather straightforwardly, mine is that I don't see that there are any honest mistake violations in the proposed repeal.

OTOH it might be fairer to the general public if we rebutted each of Tinfect's point, even if we just lift directly from Auralia's rebuttal.

[Bananaistan]

After significant internal discussion, GenSec has decided not to hear this challenge further to section 7 of the Rules and Procedures of the GA Secretariat, for the following reasons.

Rule Broken: Honest Mistake

1) Previous legislation

Appalled that this absurdly broad restriction prohibits (or at least would prohibit, should prior legislation be repealed) member states from, among other things:
securing legal protection from harmful medical experimentation to the historically vulnerable class of persons who, while not "provably sentient or sapient at the time of research" may indeed regain such capacity, such as individuals in comas or persistent vegetative states,

This clause, due to the mandates of Resolution 29, Resolution 299, (which collectively provide a definition of legal guardianship and competence, and allow for determinations regarding medical procedures to be made by legal guardians,) and Resolution 355, (which extends the protections granted to sapient species to any and all members of said species, regardless of any disability,) is an Honest Mistake violation, as it claims the resolution does something it is incapable of doing.

2) Validity and legitimacy of research; scientific v ethical standards

granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication,

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research.

3) Disclosure; Procedural v ethical v scientific standards

mandating that biomedical researchers abide by reasonable financial disclosure and conflict of interest rules, and

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as disclosing or eliminating any biases is a legitimate scientific interest in ensuring the legitimacy of any research. Further, such is entirely outside the scope of the Resolution, as regulations regarding the disclosure of financial interests or other biases are procedural regulations, rather than scientific standards.

4) Environmental regulation v ethical standards

providing adequate legal protection for the environment in the context of biomedical research, at least with respect to non-sapient plant, bacterial, and fungal life such as coral reefs and old-growth forests,

This clause, due to environmental regulations being entirely outside the scope of the resolution, as per the definition of 'Biomedical Research' within the resolution, is an Honest Mistake Violation.

5) GAR#219 v the target; biomedical research v biomedical tissues

Understanding that significant portions of the remainder of the target resolution are largely redundant in light of GAR #111, "Medical Research Ethics Act" and GAR #219, "Biomedical Innovation Org", for the following reasons:
the target resolution requires the Biomedical Innovation Organization (BIO) to coordinate "international efforts at biomedical research", despite the fact that GAR #219 already requires the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations",

This clause, due to the fact that Biomedical Research encompasses a vast field of research, not at all limited to those utilizing Biomedical Tissues, such as the development of Pacemakers, Medical Prosthesis, or other such endeavors, is an Honest Mistake Violation.

6) GAR#111 v the target; minimum standard of ethicality

the target resolution mandates the BIO with developing minimum scientific and ethical standards for biomedical research and serving as an advisory body for biomedical ethics organizations and regulatory bodies, even though GAR #111 already establishes and regulates bodies required for upholding medical research ethics in member states,

This clause, due to the fact the IRBs established via Resolution 111 serve to determine whether a research effort can be considered Ethical, whereas BIO's expanded role within the Resolution is to establish a minimum standard of ethicality, is an Honest Mistake Violation.

7) GAR#219 v the target; biomedical innovations and databases

the target resolution establishes an "internationally-accessible database of ongoing biomedical research within Member-States", even though GAR #219 already requires the BIO to include "research data for biomedical innovations as a part of the Database Of Clinical Treatments Under Study"

This clause, due to the fact that a Database for Biomedical Innovations, and a Database for Ongoing Biomedical Research, are literally two entirely different things, is an honest mistake violation.

1) Previous legislation
The entire “Appalled” clause is conditional on the phrase “or at least would prohibit, should prior legislation be repealed”. The assertion in subclause a is a reasonable interpretation based on the qualification “should prior legislation be repealed”. This must also be borne in mind regarding the challenger’s points 2, 3 and 4 which all deal with subclauses of the appalled clause.

2) Validity and legitimacy of research; scientific v ethical standards
The relevant clause in the repeal (clarified by adding part of the header of the appalled clause) is:
"… prohibits (or at least would prohibit, should prior legislation be repealed) member states from … granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication". The relevant clause of the target resolution (mandates clause, subclause 2) directs member states to “rescind any and all biomedical research ethics standards and regulations that do not serve specifically to minimize or eliminate harm to life provably sentient or sapient at the time of research”.

The challenger claims that “ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research” and “[a] breach of Ethical Standards in research casts doubt on the legitimacy of research outcomes and methodology.”

The repeal author claims that the target “makes a clear separation between "scientific" and "ethical" standards and [the mandates clause, subclause 2] applies clear restrictions to the latter, such there can be no ethical standards for the benefit of potentially sentient or sapient life that has not yet been definitively "proven" to be such at the time of research”. This assertion is persuasive. It is a fact that the target mandates that member states abolish all “ethics standards …” excepting only those in respect of harm to life which is provably sentient or sapient at the time of research. The claim in the repeal that this clause prohibits regulation of potentially harmful medical experimentation on life which has not been proven to be sentient or sapient is valid.

3) Disclosure; Procedural v ethical v scientific standards
The challenger attempts to set up a distinction between procedural standards, ethical standards and scientific standards and where there is overlap, such standards that are also ethical and procedural remain within the target’s mandates regarding scientific standards rather than ethical standards. However, the mandates clause, subclause 2 makes no such distinction and mandates the abolition of all ethical standards other than those which serve to protect provably sentient or sapient life. Member states are prohibited from maintaining ethical standards which do not serve to protect such life, such as the repeal’s examples of financial and conflict of interest disclosure standards. Such standards may be classified as purely ethical standards or both ethical and scientific. In either case, member states are prohibited from enforcing them.

4) Environmental regulation v ethical standards
The challenger asserts that all environmental regulation is outside the scope of the target due to the definition of biomedical research included in in the target. The repeal author sets out an example of environmental regulation which could well fall within the target’s prohibition of ethical standards other than those which protect provably sentient or sapient life. In this case we are now weighing up ethical standards versus environmental protection standards (or regulations). Again where there is overlap between the two, it would appear that the target outright prohibits member states from enforcing such overlapping standards due to the fact that such standards may be ethical in nature and do not act to protect provably sentient or sapient life from harm.

5) GAR#219 v the target; biomedical research v biomedical tissues
The repeal specifically claims that the significant portions of the remainder of the target (IE the clauses dealing with the committee) are largely redundant. The distinction between this, and, say all of the rest of the target is entirely redundant is important.

The claim in the understanding clause, subclause a, is that the target requires the BIO to coordinate "international efforts at biomedical research" while GAR#219 has already required the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations". The repeal effectively asserts that under GAR#219’s mandates, the committee is already “largely” dealing with biomedical research. This appears to be reasonable, or at worst, it falls within the allowable embellishments and exaggerations under the honest mistake rule.

6) GAR#111 v the target; minimum standard of ethicality
The challenger again asserts a distinction between ethical standards and procedural standards. These are not mutually exclusive, as detailed above in the discussion regarding scientific v ethical v procedural standards.

The challenger asserts a distinction between the “minimum standard of ethicality” established in the target and the determination by IRBs further to GAR#111 as to whether research can be considered ethical. Again, these are not two mutually exclusive concepts. If anything, there would appear to significant overlap between the two. Any research which is consider ethical has to have met a “minimum standard of ethicality”. The repeal’s argument appear reasonable in this light.

7) GAR#219 v the target; biomedical innovations and databases
The claim in the repeal is only that such work now mandated by the target is largely redundant. Again we are faced with significant overlap and the “largely” qualifier is important. On the one hand we have biomedical innovations and on the other we have ongoing biomedical research. The challenger claims that the two databases are two entirely different things. They may well be two entirely different databases but there can be no doubt that there would be significant overlap between the two. It is imaginable that there would be an awful lot of research which qualify for addition to both databases. Given this obvious overlap between the two, it is not valid to claim that they are two entirely different things. The repeal’s claims that the committee’s additional work mandated by the target is largely redundant appears reasonable.

---

Debates transcript (sorted by illegality claim)
1) Previous legislation

Appalled that this absurdly broad restriction prohibits (or at least would prohibit, should prior legislation be repealed) member states from, among other things:
securing legal protection from harmful medical experimentation to the historically vulnerable class of persons who, while not "provably sentient or sapient at the time of research" may indeed regain such capacity, such as individuals in comas or persistent vegetative states,

This clause, due to the mandates of Resolution 29, Resolution 299, (which collectively provide a definition of legal guardianship and competence, and allow for determinations regarding medical procedures to be made by legal guardians,) and Resolution 355, (which extends the protections granted to sapient species to any and all members of said species, regardless of any disability,) is an Honest Mistake violation, as it claims the resolution does something it is incapable of doing.

First of all, resolutions such as the ones listed only establish a minimum standard of requiring the consent of a legal guardian for medical procedures, for research purposes or otherwise. But there are cases where a legal guardian might inappropriately consent to medical experimentation on behalf of a person who is not "provably sentient or sapient at the time of research". Although not medical experimentation, there are certainly examples in real life of persons being administered medical procedures such as involuntary euthanasia with the consent of a legal guardian; see Aktion T4 and the Groningen Protocol.

It is not clear whether existing resolutions provide adequate legal protection for such persons in these circumstances. For ethical reasons, member states may wish to prohibit certain kinds of experimentation on such persons notwithstanding the consent of a legal guardian, but GAR #420 would prohibit them from doing so under mandate 2.

Regardless, the fact remains that whatever legal protection is in fact provided by the listed resolutions for persons who are not "provably sentient or sapient at the time of research" would disappear should those resolutions be repealed, and GAR #420 would certainly prevent such protection from being reinstated under mandate 2. The proposal notes this distinction clearly when it states that GAR #420 "prohibits (or at least would prohibit [adequate legal protection to persons who are not "provably sentient or sapient at the time of research"], should prior legislation be repealed) [emphasis added]".

The issue of euthanasia is irrelevant to the resolution as it concerns only Biomedical Research, not euthanasia. Medical Procedures in general, and Euthanasia in particular, are governed by separate International and National laws, which this resolution makes no statement on.

In any case, it is entirely clear that existing legislation provides adequate protections. The standards for legal guardianship, and standing Legislation which provides Sapient legal status to members of a Sapient Species that may, for whatever reason, have the status thrown into question by disabilities or medical conditions. The clause in question is an Honest Mistake Violation as the Resolution is entirely incapable of preventing Member-States from protecting the rights of Comatose, Mentally-Ill, or otherwise disabled patients.

The point of the provided examples has nothing to do with euthanasia specifically. The point was to establish that guardians can arguably consent to harmful medical procedures on behalf of someone else under current WA law, that states may rightly wish to prohibit such conduct even with that consent, and that GAR #420 prohibits states from doing so. Euthanasia is not generally part of biomedical research, but other medical procedures certainly might be.

It is not, in fact, clear that the existing protections are adequate, and I've explained why. The challenger has not addressed my arguments in that regard; they have simply denied their conclusion. They have also not addressed the argument that GAR #420 blocks the reinstatement of these protections should they be repealed.

2) Validity and legitimacy of research; scientific v ethical standards

granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication,

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research.

In the absence of ethical considerations, it is certainly possible to conduct useful medical research on something without first ascertaining whether it is sapient or sentient. Perhaps a member of a particular species produces a compound with interesting medicinal properties, but extracting this compound for research purposes requires killing it. The question of whether or not the compound should be researched is unaffected by the question of whether or not the species is sapient or sentient. In fact, an unscrupulous scientist might deliberately not seek the answer to the latter question in order to provide plausible deniability.

Now, this might impair the "validity and legitimacy" of such research insofar as such research is clearly unethical and most modern scientific communities consider ethical standards to be an important subset of scientific standards. But GAR #420 makes a clear separation between "scientific" and "ethical" standards and mandate 2 applies clear restrictions to the latter, such there can be no ethical standards for the benefit of potentially sentient or sapient life that has not yet been definitively "proven" to be such at the time of research. A "scientific" standard that is only "scientific" precisely because it is "ethical" is still subject to this restriction; the challenger cannot have their cake and eat it too.

Ethicality itself as a Scientific Standard is not threatened by the recognition of differences between Scientific and Ethical Standards. Disregard for Research Ethics renders Research illegitimate and impermissible, as well as raising dire concerns about the actual results of the research in question, as the researchers have already demonstrated that they are willing to disregard ethical standards, and thus their results, in addition to their methodology, fall into question.

The clause is an honest mistake violation.

There is no necessary connection between the quality and usefulness of scientific research and the use of ethical means to procure it. It is not difficult to find examples where unethical experimentation produced valuable results. This fact is, I think, implicitly confirmed by GAR #420 insofar as it distinguishes between ethical and scientific standards in the first place; this would have been unnecessary if ethics standards are necessarily a subset of scientific standards, as the challenger appears to be arguing.

This is ultimately irrelevant, though. Even if one accepts that there is a legitimate scientific basis for ethical standards, the fact remains that a standard that is both "ethical" and "scientific" does not cease to be a "ethics standard" for the purposes of mandate 2 of GAR #420, and therefore remains subject to its restrictions. The provision simply says "ethics standard"; it does not say that the standard must be exclusively motivated by ethical considerations.

Ethicality itself as a Scientific Standard is not threatened by the recognition of differences between Scientific and Ethical Standards. Disregard for Research Ethics renders Research illegitimate and impermissible, as well as raising dire concerns about the actual results of the research in question, as the researchers have already demonstrated that they are willing to disregard ethical standards, and thus their results, in addition to their methodology, fall into question.

Where in the target resolution is "Research Ethics" defined as a scientific standard rather than a purely ethical standard? How are member nations supposed to parse which ethical standards are actually scientific standards versus which are merely "ethical"? In the absence of guidance, I would have to assume that the target means exactly what it says:

any and all biomedical research ethics standards and regulations that do not serve specifically to minimize or eliminate harm to life provably sentient or sapient at the time of research...

I am not arguing anything of the sort. The point being that Scientific Standards may be informed by ethical standards, not that Ethical Standards are Scientific Standards. The breach of Ethical Standards in research casts doubt on the legitimacy of research outcomes and methodology.

3) Disclosure; Procedural v ethical v scientific standards

mandating that biomedical researchers abide by reasonable financial disclosure and conflict of interest rules, and

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as disclosing or eliminating any biases is a legitimate scientific interest in ensuring the legitimacy of any research. Further, such is entirely outside the scope of the Resolution, as regulations regarding the disclosure of financial interests or other biases are procedural regulations, rather than scientific standards.

Again, "scientific" standards that exist for "ethical" reasons are still ethical standards that are subject to the restrictions established for such standards by mandate 2 of GAR #420.

I'm afraid I simply don't understand the unsubstantiated distinction that the challenger is attempting to draw between "procedural regulations" and "scientific and ethical standards". Can scientific and ethical standards not regulate procedures...?

Scientific Standards that are informed by Ethical Standards remain Scientific Standards. As for procedural regulations...

Procedural
Adjective
Relating to an established or official way of doing something.

Legal Regulations regarding the disclosure or elimination of biases are procedural regulations, not scientific standards, which are informed by, but not determined by law, or ethical standards, which are determined both by law, and by legally-empowered review boards informed by the standards set by BIO.

The Clause is an Honest Mistake Violation.

I don't understand any of this. It seems obvious to me that whether a standard has the force of law has no bearing on whether it is motivated by scientific or ethical considerations.

It also seems obvious to me that whether a particular standard falls into the amorphous category of "procedural regulation" is also irrelevant to whether it is also a scientific or ethical standard. A standard does not cease to be motivated by scientific or ethical considerations merely because it "relat[es] to an established or official way of doing something".

4) Environmental regulation v ethical standards

providing adequate legal protection for the environment in the context of biomedical research, at least with respect to non-sapient plant, bacterial, and fungal life such as coral reefs and old-growth forests,

This clause, due to environmental regulations being entirely outside the scope of the resolution, as per the definition of 'Biomedical Research' within the resolution, is an Honest Mistake Violation.

The challenger is attempting to create limitations on the scope of GAR #420 that simply do not exist. Any regulation that is primarily motivated by ethical considerations and that has the practical effect of impeding biomedical research must constitute an "biomedical research ethics standard" for the purposes of GAR #420 and is subject to the restrictions of mandate 2. This includes environmental regulations. A narrower interpretation that considered the restrictions to only apply to regulations that specifically targeted biomedical research as such would render the restrictions meaningless, since any regulation could be easily tailored to evade them. This is not an acceptable statutory construction.

An example of a prohibited environmental regulation would be a member state seeking to halt biomedical research necessitating large quantities of non-sapient plant, bacterial, and fungal life, such as coral reefs and old-growth forests, because the expected benefits of such research were considered to be outweighed by the ethical obligation to preserve such life.

This line of argumentation is highly disingenuous. Restrictions on damaging environments are defitionally not restrictions on Biomedical Research, they are restrictions on Environmental Damage, and are not affected by this legislation. In any case, as there exists standing legislation regarding environmental protection that this Legislation does not, and is incapable of bypassing,[GAR 409] [GAR 66] [GAR 95] [GAR 199] [GAR 291] [ect.] in addition to the fact that the Legislation contains absolutely no language regarding the weighing of raw scientific value vs. legal or ethical obligations, this clause is an Honest Mistake Violation.

The challenger here is simply asserting that restrictions with the practical effect of impeding biomedical research are somehow not restrictions on biomedical research so long as they are nominally directed at something else. I have already explained why this is not a tenable interpretation.

Regarding existing GA environmental regulation, I am sure many would agree that such regulation is far from adequate and that member states often go beyond the WA norm. GAR #420 would indeed affect such regulations. Moreover, the argument regarding the inability to reinstate existing protections should prior resolutions be repealed also applies.

5) GAR#219 v the target; biomedical research v biomedical tissues

Understanding that significant portions of the remainder of the target resolution are largely redundant in light of GAR #111, "Medical Research Ethics Act" and GAR #219, "Biomedical Innovation Org", for the following reasons:
the target resolution requires the Biomedical Innovation Organization (BIO) to coordinate "international efforts at biomedical research", despite the fact that GAR #219 already requires the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations",

This clause, due to the fact that Biomedical Research encompasses a vast field of research, not at all limited to those utilizing Biomedical Tissues, such as the development of Pacemakers, Medical Prosthesis, or other such endeavors, is an Honest Mistake Violation.

Before discussing the remaining clauses of the proposal, it is first important to note that all that is necessary to avoid violating the Honest Mistake rule for these clauses is to show that the expansion of the mandate of the BIO is "largely redundant", not completely redundant.

In this instance, the challenger is using an unnecessarily narrow definition of "treatments involving biomedical tissues". First, GAR #219 does not provide a closed definition of biomedical tissues, so we are free to use an expansive definition. Second, all biomedical research relates to biological organisms, which consist of biomedical tissues; all biomedical research will therefore "involv[e] biomedical tissues" in some way. For example, a pacemaker is designed to ensure proper behaviour of the heart, while prosthetics are designed to interact with existing body parts. Therefore, the BIO already effectively has the mandate of coordinating "international efforts at biomedical research" and giving the BIO this mandate again is redundant.

This interpretation of Resolution 219 is purposely absurd and quite frankly not worth serious consideration. It is patently absurd to define any and all organic materials as 'Biomedical Tissues' under Resolution 219. Such is a blatant and intentionally disingenuous misrepresentation of Resolution 219. The clause is an honest mistake violation.

I would not define biomedical tissue as "any and all organic material". In light of GAR #219's open-ended definition, I would roughly define tissue as "any of the distinct types of material of which animals or plants are made, consisting of specialized cells and their products", and biomedical tissue as any tissue relevant to biomedical research. This is consistent with GAR #219's definition, which encompasses not just organs but also blood and blood products.

I have already explained why this definition encompasses virtually all biomedical research, why the challenger's prior examples of biomedical research that are apparently inconsistent with this definition are in fact consistent with this definition, and why therefore the expansion of the BIO's mandate is redundant.

6) GAR#111 v the target; minimum standard of ethicality

the target resolution mandates the BIO with developing minimum scientific and ethical standards for biomedical research and serving as an advisory body for biomedical ethics organizations and regulatory bodies, even though GAR #111 already establishes and regulates bodies required for upholding medical research ethics in member states,

This clause, due to the fact the IRBs established via Resolution 111 serve to determine whether a research effort can be considered Ethical, whereas BIO's expanded role within the Resolution is to establish a minimum standard of ethicality, is an Honest Mistake Violation.

The IRBs determine whether a particular research effort is ethical on the basis of ethical standards. Anticipating this, GAR #111 indeed establishes a "minimum standard of ethicality" for all medical research, including biomedical research:

REQUIRES that the IRBs reject any research that they reasonably believe may:
i. Cause participation that is not a result of an informed, impartial, and rational decision to provide consent except where the subject’s legal rights were removed by due process of law
ii. Cause preventable death, serious injury, or significant physical or psychological damage to a subject.

It can certainly be argued that the BIO's effort is redundant in light of the minimum standard enacted by GAR #111, especially since the BIO's standards are not in any way defined by GAR #420 and are entirely left up to the committee.

It can be argued that these are procedural regulations on the IRB itself, rather than standards for ethicality to be utilized by the IRB.

It is obvious that the obligations placed on IRBs in GAR #111 are indeed ethical standards, in that they are rules governing medical research that are motivated by ethical considerations. It can be argued that the BIO's additional ethical standards are therefore redundant.

There is no coherent basis for the distinction the challenger is attempting to draw between ethical standards and "procedural regulations", nor the claim that they are somehow exclusive categories. I think it is becoming apparent that the entire category of "procedural regulations"-- a term used nowhere in GAR #420 -- is a fiction created to paper over the unfortunate implications of GAR #420's poorly written second mandate by allowing the challenger to exempt favoured regulation from the mandate.

7) GAR#219 v the target; biomedical innovations and databases

the target resolution establishes an "internationally-accessible database of ongoing biomedical research within Member-States", even though GAR #219 already requires the BIO to include "research data for biomedical innovations as a part of the Database Of Clinical Treatments Under Study"

This clause, due to the fact that a Database for Biomedical Innovations, and a Database for Ongoing Biomedical Research, are literally two entirely different things, is an honest mistake violation.

The challenger's definition of "biomedical innovation" is too narrow. GAR #219 does not define the term, so we are again free to use an expansive definition. An innovation is simply "something new or different introduced", and ongoing biomedical research is generally novel. As such, there is no reason why such research cannot be added to a database of biomedical innovations. This interpretation is supported by GAR #219 itself in that the research data is being added to a database of "treatments under study", which implies that research may be ongoing.

Simply because terms lack specific definition within the Text, does not give one an unequivocal right to redefine them in any way they wish. The word 'International' is not defined within Resolution 219, but it would be patently absurd to claim that it therefore can be interpreted as referring solely to interactions between Iron atoms. It is likewise patently absurd to claim that Biomedical Innovations include any and all Biomedical Research. The clause is an Honest Mistake Violation.

I see nothing unreasonable about describing novel biomedical research as innovative or including it in a database of biomedical innovations. Biomedical research that cannot be characterized as novel or otherwise innovative probably isn't worth cataloguing in an international database anyway. To the extent that such cataloguing is appropriate, therefore, GAR #420 is largely redundant.

[Bears Armed]

I hereby confirm my agreement with the reasoning presented above by Bananaistan.

[Sierra Lyricalia]

This looks excellent. When I'm on a computer instead of my phone I saw one or two little corrections (one of which changes the meaning of the sentence), which I'll have for you tonight EST. Minus those (and I would suggest eliding side commentary such as "I'll get to Auralia's nonsense later"), I confirm agreement with the above analysis.

[Sierra Lyricalia]

As promised, my suggested edits.

...

The repeal author’s assertion claims that the target “makes a clear separation between "scientific" and "ethical" standards and [the mandates clause, subclause 2] applies clear restrictions to the latter, such there can be no ethical standards for the benefit of potentially sentient or sapient life that has not yet been definitively "proven" to be such at the time of research”. This assertion is persuasive. It is a fact that the target mandates that member states abolish all “ethics standards …” excepting only those in respect of harm to life which is only provably sentient or sapient at the time of research. The claim in the repeal, that this clause prohibits regulation of potentially harmful medical experimentation on life which has not been proven to be sentient or sapient, is valid.

...

---

Debates transcript (sorted by illegality claim)

...

2) Validity and legitimacy of research; scientific v ethical standards

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research.

In the absence of ethical considerations, it is certainly possible to conduct useful medical research on something without first ascertaining whether it is sapient or sentient. Perhaps a member of a particular species produces a compound with interesting medicinal properties, but extracting this compound for research purposes requires killing it. The question of whether or not the compound should be researched is unaffected by the question of whether or not the species is sapient or sentient. In fact, an unscrupulous scientist might deliberately not seek the answer to the latter question in order to provide plausible deniability.

Now, this might impair the "validity and legitimacy" of such research insofar as such research is clearly unethical and most modern scientific communities consider ethical standards to be an important subset of scientific standards. But GAR #420 makes a clear separation between "scientific" and "ethical" standards and mandate 2 applies clear restrictions to the latter, such there can be no ethical standards for the benefit of potentially sentient or sapient life that has not yet been definitively "proven" to be such at the time of research. A "scientific" standard that is only "scientific" precisely because it is "ethical" is still subject to this restriction; the challenger cannot have their cake and eat it too.

Ethicality itself as a Scientific Standard is not threatened by the recognition of differences between Scientific and Ethical Standards. Disregard for Research Ethics renders Research illegitimate and impermissible, as well as raising dire concerns about the actual results of the research in question, as the researchers have already demonstrated that they are willing to disregard ethical standards, and thus their results, in addition to their methodology, fall into question.

The clause is an honest mistake violation.

There is no necessary connection between the quality and usefulness of scientific research and the use of ethical means to procure it. It is not difficult to find examples where unethical experimentation produced valuable results. This fact is, I think, implicitly confirmed by GAR #420 insofar as it distinguishes between ethical and scientific standards in the first place; this would have been unnecessary if ethics standards are necessarily a subset of scientific standards, as the challenger appears to be arguing.

This is ultimately irrelevant, though. Even if one accepts that there is a legitimate scientific basis for ethical standards, the fact remains that a standard that is both "ethical" and "scientific" does not cease to be a "ethics standard" for the purposes of mandate 2 of GAR #420, and therefore remains subject to its restrictions. The provision simply says "ethics standard"; it does not say that the standard must be exclusively motivated by ethical considerations.

Where in the target resolution is "Research Ethics" defined as a scientific standard rather than a purely ethical standard? How are member nations supposed to parse which ethical standards are actually scientific standards versus which are merely "ethical"? In the absence of guidance, I would have to assume that the target means exactly what it says:

any and all biomedical research ethics standards and regulations that do not serve specifically to minimize or eliminate harm to life provably sentient or sapient at the time of research...

I am not arguing anything of the sort. The point being that Scientific Standards may be informed by ethical standards, not that Ethical Standards are Scientific Standards. The breach of Ethical Standards in research casts doubt on the legitimacy of research outcomes and methodology.

I'll get to Auralia's nonsense later.

...

[Christian Democrats]

I support the opinion, provided this bit is changed:

After significant internal discussion, GenSec has decided not to hear this challenge further to section 7 of the Rules and Procedures of the GA Secretariat, for the following reasons.

We are hearing the challenge, and we're deciding against the challenger.

[Bananaistan]

As promised, my suggested edits.

Thanks. Edited these in/out as well as the "well written blocker" discussion in part 1.

I support the opinion, provided this bit is changed:

After significant internal discussion, GenSec has decided not to hear this challenge further to section 7 of the Rules and Procedures of the GA Secretariat, for the following reasons.

We are hearing the challenge, and we're deciding against the challenger.

I don't agree. The facts are that we did not vote to hear the challenge.

[Christian Democrats]

I support the opinion, provided this bit is changed:

After significant internal discussion, GenSec has decided not to hear this challenge further to section 7 of the Rules and Procedures of the GA Secretariat, for the following reasons.

We are hearing the challenge, and we're deciding against the challenger.

I don't agree. The facts are that we did not vote to hear the challenge.

What are we doing right now?

[Bananaistan]

I don't agree. The facts are that we did not vote to hear the challenge.

What are we doing right now?

Edit: But tbf if you've now voted to hear it then, that makes two who voted to hear it, you and SL. In which case, we heard it and voted 4-0 that the repeal is legal.

I'll upgrade the opinion so. In the meantime I've posted in the public thread that we've voted 4-0 it's legal.

[Bananaistan]

Some edits to clarify, particularly, in section 6, as well as adding "we find ..." where appropriate.

We find the challenged repeal legal in respect of the honest mistake rule. Bananaistan wrote the majority opinion, joined by … .

1) Previous legislation
The entire “Appalled” clause is conditional on the phrase “or at least would prohibit, should prior legislation be repealed”. The assertion in subclause a is a reasonable interpretation based on the qualification “should prior legislation be repealed”. We find that this is not an honest mistake violation.

The “should prior legislation be repealed” qualification must also be borne in mind regarding the challenger’s points 2, 3 and 4 which all deal with subclauses of the “Appalled” clause.

2) Validity and legitimacy of research; scientific v ethical standards
The relevant clause in the repeal (clarified by adding part of the header of the appalled clause) is: "… prohibits (or at least would prohibit, should prior legislation be repealed) member states from … granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication". The relevant clause of the target resolution (mandates clause, subclause 2) directs member states to “rescind any and all biomedical research ethics standards and regulations that do not serve specifically to minimize or eliminate harm to life provably sentient or sapient at the time of research”.

The challenger claims that “ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research” and “[a] breach of Ethical Standards in research casts doubt on the legitimacy of research outcomes and methodology.”

The repeal author claims that the target “makes a clear separation between "scientific" and "ethical" standards and [the mandates clause, subclause 2] applies clear restrictions to the latter, such there can be no ethical standards for the benefit of potentially sentient or sapient life that has not yet been definitively "proven" to be such at the time of research”. This assertion is persuasive. It is a fact that the target mandates that member states abolish all “ethics standards …” excepting only those in respect of harm to life which is provably sentient or sapient at the time of research. The claim in the repeal that this clause prohibits regulation of potentially harmful medical experimentation on life which has not been proven to be sentient or sapient is valid and, therefore, we find that this is not an honest mistake violation.

3) Disclosure; Procedural v ethical v scientific standards
The challenger attempts to set up a distinction between procedural standards, ethical standards and scientific standards and where there is overlap, such standards that are also ethical and procedural remain within the target’s mandates regarding scientific standards rather than ethical standards. However, the mandates clause, subclause 2 makes no such distinction and mandates the abolition of all ethical standards other than those which serve to protect provably sentient or sapient life. Member states are prohibited from maintaining ethical standards which do not serve to protect such life, such as the repeal’s examples of financial and conflict of interest disclosure standards. Such disclosure standards could be classified as purely ethical standards or both ethical and scientific. In either case, due to their ethical nature, member states are prohibited from enforcing them. We find that this is not an honest mistake violation.

4) Environmental regulation v ethical standards
The challenger asserts that all environmental regulation is outside the scope of the target due to the definition of biomedical research included in in the target. The repeal author sets out an example of environmental regulation which could well fall within the target’s prohibition of ethical standards other than those which protect provably sentient or sapient life. In this case we are now weighing up ethical standards versus environmental protection standards (or regulations). Again where there is overlap between the two, it would appear that the target outright prohibits member states from enforcing such overlapping standards due to the fact that such standards may be ethical in nature and do not act to protect provably sentient or sapient life from harm. We find that this is not an honest mistake violation.

5) GAR#219 v the target; biomedical research v biomedical tissues
The repeal specifically claims that significant portions of the remainder of the target (IE the clauses dealing with the committee) are largely redundant. The distinction between this and, say, all of the rest of the target is entirely redundant is important.

The claim in the understanding clause, subclause a, is that the target requires the BIO to coordinate "international efforts at biomedical research" while GAR#219 has already required the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations". The repeal effectively asserts that under GAR#219’s mandates, the committee is already “largely” dealing with biomedical research. This appears to be reasonable, or at worst, it falls within the allowable embellishments and exaggerations under the honest mistake rule.

6) GAR#111 v the target; minimum standard of ethicality
The challenger again asserts a distinction between ethical standards and procedural standards, effectively that they are mutually exclusive, and that the subset of procedural standards which are also ethical in nature, do not fall within the mandates clause, subclause 2, prohibition. We do not accept the assertion that procedural and ethical standards are mutually exclusive.

The challenger asserts a distinction between the “minimum standard of ethicality” established in the target and the determination by IRBs further to GAR#111 as to whether research can be considered ethical. Again, these are not two mutually exclusive concepts. If anything, there would appear to significant overlap between the two. Any research which is consider ethical has to have met a “minimum standard of ethicality”. The repeal’s arguments appear reasonable in this light and we find that this is not an honest mistake violation.

7) GAR#219 v the target; biomedical innovations and databases
The claim in the repeal is only that such work now mandated by the target is largely redundant. Again we are faced with significant overlap and the “largely” qualifier is important. On the one hand we have biomedical innovations and on the other we have ongoing biomedical research. The challenger claims that the two databases are two entirely different things. They may well be two entirely different databases but there can be no doubt that there would be significant overlap between the two. It is imaginable that there would be an awful lot of research which qualify for addition to both databases. Given this obvious overlap between the two, it is not valid to claim that they are two entirely different things. The repeal’s claims that the committee’s additional work mandated by the target is largely redundant appears reasonable. We find that this is not an honest mistake violation.

---

Debates transcript (sorted by illegality claim)
1) Previous legislation

Appalled that this absurdly broad restriction prohibits (or at least would prohibit, should prior legislation be repealed) member states from, among other things:
securing legal protection from harmful medical experimentation to the historically vulnerable class of persons who, while not "provably sentient or sapient at the time of research" may indeed regain such capacity, such as individuals in comas or persistent vegetative states,

This clause, due to the mandates of Resolution 29, Resolution 299, (which collectively provide a definition of legal guardianship and competence, and allow for determinations regarding medical procedures to be made by legal guardians,) and Resolution 355, (which extends the protections granted to sapient species to any and all members of said species, regardless of any disability,) is an Honest Mistake violation, as it claims the resolution does something it is incapable of doing.

First of all, resolutions such as the ones listed only establish a minimum standard of requiring the consent of a legal guardian for medical procedures, for research purposes or otherwise. But there are cases where a legal guardian might inappropriately consent to medical experimentation on behalf of a person who is not "provably sentient or sapient at the time of research". Although not medical experimentation, there are certainly examples in real life of persons being administered medical procedures such as involuntary euthanasia with the consent of a legal guardian; see Aktion T4 and the Groningen Protocol.

It is not clear whether existing resolutions provide adequate legal protection for such persons in these circumstances. For ethical reasons, member states may wish to prohibit certain kinds of experimentation on such persons notwithstanding the consent of a legal guardian, but GAR #420 would prohibit them from doing so under mandate 2.

Regardless, the fact remains that whatever legal protection is in fact provided by the listed resolutions for persons who are not "provably sentient or sapient at the time of research" would disappear should those resolutions be repealed, and GAR #420 would certainly prevent such protection from being reinstated under mandate 2. The proposal notes this distinction clearly when it states that GAR #420 "prohibits (or at least would prohibit [adequate legal protection to persons who are not "provably sentient or sapient at the time of research"], should prior legislation be repealed) [emphasis added]".

The issue of euthanasia is irrelevant to the resolution as it concerns only Biomedical Research, not euthanasia. Medical Procedures in general, and Euthanasia in particular, are governed by separate International and National laws, which this resolution makes no statement on.

In any case, it is entirely clear that existing legislation provides adequate protections. The standards for legal guardianship, and standing Legislation which provides Sapient legal status to members of a Sapient Species that may, for whatever reason, have the status thrown into question by disabilities or medical conditions. The clause in question is an Honest Mistake Violation as the Resolution is entirely incapable of preventing Member-States from protecting the rights of Comatose, Mentally-Ill, or otherwise disabled patients.

The point of the provided examples has nothing to do with euthanasia specifically. The point was to establish that guardians can arguably consent to harmful medical procedures on behalf of someone else under current WA law, that states may rightly wish to prohibit such conduct even with that consent, and that GAR #420 prohibits states from doing so. Euthanasia is not generally part of biomedical research, but other medical procedures certainly might be.

It is not, in fact, clear that the existing protections are adequate, and I've explained why. The challenger has not addressed my arguments in that regard; they have simply denied their conclusion. They have also not addressed the argument that GAR #420 blocks the reinstatement of these protections should they be repealed.

2) Validity and legitimacy of research; scientific v ethical standards

granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication,

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research.

In the absence of ethical considerations, it is certainly possible to conduct useful medical research on something without first ascertaining whether it is sapient or sentient. Perhaps a member of a particular species produces a compound with interesting medicinal properties, but extracting this compound for research purposes requires killing it. The question of whether or not the compound should be researched is unaffected by the question of whether or not the species is sapient or sentient. In fact, an unscrupulous scientist might deliberately not seek the answer to the latter question in order to provide plausible deniability.

Now, this might impair the "validity and legitimacy" of such research insofar as such research is clearly unethical and most modern scientific communities consider ethical standards to be an important subset of scientific standards. But GAR #420 makes a clear separation between "scientific" and "ethical" standards and mandate 2 applies clear restrictions to the latter, such there can be no ethical standards for the benefit of potentially sentient or sapient life that has not yet been definitively "proven" to be such at the time of research. A "scientific" standard that is only "scientific" precisely because it is "ethical" is still subject to this restriction; the challenger cannot have their cake and eat it too.

Ethicality itself as a Scientific Standard is not threatened by the recognition of differences between Scientific and Ethical Standards. Disregard for Research Ethics renders Research illegitimate and impermissible, as well as raising dire concerns about the actual results of the research in question, as the researchers have already demonstrated that they are willing to disregard ethical standards, and thus their results, in addition to their methodology, fall into question.

The clause is an honest mistake violation.

There is no necessary connection between the quality and usefulness of scientific research and the use of ethical means to procure it. It is not difficult to find examples where unethical experimentation produced valuable results. This fact is, I think, implicitly confirmed by GAR #420 insofar as it distinguishes between ethical and scientific standards in the first place; this would have been unnecessary if ethics standards are necessarily a subset of scientific standards, as the challenger appears to be arguing.

This is ultimately irrelevant, though. Even if one accepts that there is a legitimate scientific basis for ethical standards, the fact remains that a standard that is both "ethical" and "scientific" does not cease to be a "ethics standard" for the purposes of mandate 2 of GAR #420, and therefore remains subject to its restrictions. The provision simply says "ethics standard"; it does not say that the standard must be exclusively motivated by ethical considerations.

Ethicality itself as a Scientific Standard is not threatened by the recognition of differences between Scientific and Ethical Standards. Disregard for Research Ethics renders Research illegitimate and impermissible, as well as raising dire concerns about the actual results of the research in question, as the researchers have already demonstrated that they are willing to disregard ethical standards, and thus their results, in addition to their methodology, fall into question.

Where in the target resolution is "Research Ethics" defined as a scientific standard rather than a purely ethical standard? How are member nations supposed to parse which ethical standards are actually scientific standards versus which are merely "ethical"? In the absence of guidance, I would have to assume that the target means exactly what it says:

any and all biomedical research ethics standards and regulations that do not serve specifically to minimize or eliminate harm to life provably sentient or sapient at the time of research...

I am not arguing anything of the sort. The point being that Scientific Standards may be informed by ethical standards, not that Ethical Standards are Scientific Standards. The breach of Ethical Standards in research casts doubt on the legitimacy of research outcomes and methodology.

3) Disclosure; Procedural v ethical v scientific standards

mandating that biomedical researchers abide by reasonable financial disclosure and conflict of interest rules, and

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as disclosing or eliminating any biases is a legitimate scientific interest in ensuring the legitimacy of any research. Further, such is entirely outside the scope of the Resolution, as regulations regarding the disclosure of financial interests or other biases are procedural regulations, rather than scientific standards.

Again, "scientific" standards that exist for "ethical" reasons are still ethical standards that are subject to the restrictions established for such standards by mandate 2 of GAR #420.

I'm afraid I simply don't understand the unsubstantiated distinction that the challenger is attempting to draw between "procedural regulations" and "scientific and ethical standards". Can scientific and ethical standards not regulate procedures...?

Scientific Standards that are informed by Ethical Standards remain Scientific Standards. As for procedural regulations...

Procedural
Adjective
Relating to an established or official way of doing something.

Legal Regulations regarding the disclosure or elimination of biases are procedural regulations, not scientific standards, which are informed by, but not determined by law, or ethical standards, which are determined both by law, and by legally-empowered review boards informed by the standards set by BIO.

The Clause is an Honest Mistake Violation.

I don't understand any of this. It seems obvious to me that whether a standard has the force of law has no bearing on whether it is motivated by scientific or ethical considerations.

It also seems obvious to me that whether a particular standard falls into the amorphous category of "procedural regulation" is also irrelevant to whether it is also a scientific or ethical standard. A standard does not cease to be motivated by scientific or ethical considerations merely because it "relat[es] to an established or official way of doing something".

4) Environmental regulation v ethical standards

providing adequate legal protection for the environment in the context of biomedical research, at least with respect to non-sapient plant, bacterial, and fungal life such as coral reefs and old-growth forests,

This clause, due to environmental regulations being entirely outside the scope of the resolution, as per the definition of 'Biomedical Research' within the resolution, is an Honest Mistake Violation.

The challenger is attempting to create limitations on the scope of GAR #420 that simply do not exist. Any regulation that is primarily motivated by ethical considerations and that has the practical effect of impeding biomedical research must constitute an "biomedical research ethics standard" for the purposes of GAR #420 and is subject to the restrictions of mandate 2. This includes environmental regulations. A narrower interpretation that considered the restrictions to only apply to regulations that specifically targeted biomedical research as such would render the restrictions meaningless, since any regulation could be easily tailored to evade them. This is not an acceptable statutory construction.

An example of a prohibited environmental regulation would be a member state seeking to halt biomedical research necessitating large quantities of non-sapient plant, bacterial, and fungal life, such as coral reefs and old-growth forests, because the expected benefits of such research were considered to be outweighed by the ethical obligation to preserve such life.

This line of argumentation is highly disingenuous. Restrictions on damaging environments are defitionally not restrictions on Biomedical Research, they are restrictions on Environmental Damage, and are not affected by this legislation. In any case, as there exists standing legislation regarding environmental protection that this Legislation does not, and is incapable of bypassing,[GAR 409] [GAR 66] [GAR 95] [GAR 199] [GAR 291] [ect.] in addition to the fact that the Legislation contains absolutely no language regarding the weighing of raw scientific value vs. legal or ethical obligations, this clause is an Honest Mistake Violation.

The challenger here is simply asserting that restrictions with the practical effect of impeding biomedical research are somehow not restrictions on biomedical research so long as they are nominally directed at something else. I have already explained why this is not a tenable interpretation.

Regarding existing GA environmental regulation, I am sure many would agree that such regulation is far from adequate and that member states often go beyond the WA norm. GAR #420 would indeed affect such regulations. Moreover, the argument regarding the inability to reinstate existing protections should prior resolutions be repealed also applies.

5) GAR#219 v the target; biomedical research v biomedical tissues

Understanding that significant portions of the remainder of the target resolution are largely redundant in light of GAR #111, "Medical Research Ethics Act" and GAR #219, "Biomedical Innovation Org", for the following reasons:
the target resolution requires the Biomedical Innovation Organization (BIO) to coordinate "international efforts at biomedical research", despite the fact that GAR #219 already requires the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations",

This clause, due to the fact that Biomedical Research encompasses a vast field of research, not at all limited to those utilizing Biomedical Tissues, such as the development of Pacemakers, Medical Prosthesis, or other such endeavors, is an Honest Mistake Violation.

Before discussing the remaining clauses of the proposal, it is first important to note that all that is necessary to avoid violating the Honest Mistake rule for these clauses is to show that the expansion of the mandate of the BIO is "largely redundant", not completely redundant.

In this instance, the challenger is using an unnecessarily narrow definition of "treatments involving biomedical tissues". First, GAR #219 does not provide a closed definition of biomedical tissues, so we are free to use an expansive definition. Second, all biomedical research relates to biological organisms, which consist of biomedical tissues; all biomedical research will therefore "involv[e] biomedical tissues" in some way. For example, a pacemaker is designed to ensure proper behaviour of the heart, while prosthetics are designed to interact with existing body parts. Therefore, the BIO already effectively has the mandate of coordinating "international efforts at biomedical research" and giving the BIO this mandate again is redundant.

This interpretation of Resolution 219 is purposely absurd and quite frankly not worth serious consideration. It is patently absurd to define any and all organic materials as 'Biomedical Tissues' under Resolution 219. Such is a blatant and intentionally disingenuous misrepresentation of Resolution 219. The clause is an honest mistake violation.

I would not define biomedical tissue as "any and all organic material". In light of GAR #219's open-ended definition, I would roughly define tissue as "any of the distinct types of material of which animals or plants are made, consisting of specialized cells and their products", and biomedical tissue as any tissue relevant to biomedical research. This is consistent with GAR #219's definition, which encompasses not just organs but also blood and blood products.

I have already explained why this definition encompasses virtually all biomedical research, why the challenger's prior examples of biomedical research that are apparently inconsistent with this definition are in fact consistent with this definition, and why therefore the expansion of the BIO's mandate is redundant.

6) GAR#111 v the target; minimum standard of ethicality

the target resolution mandates the BIO with developing minimum scientific and ethical standards for biomedical research and serving as an advisory body for biomedical ethics organizations and regulatory bodies, even though GAR #111 already establishes and regulates bodies required for upholding medical research ethics in member states,

This clause, due to the fact the IRBs established via Resolution 111 serve to determine whether a research effort can be considered Ethical, whereas BIO's expanded role within the Resolution is to establish a minimum standard of ethicality, is an Honest Mistake Violation.

The IRBs determine whether a particular research effort is ethical on the basis of ethical standards. Anticipating this, GAR #111 indeed establishes a "minimum standard of ethicality" for all medical research, including biomedical research:

REQUIRES that the IRBs reject any research that they reasonably believe may:
i. Cause participation that is not a result of an informed, impartial, and rational decision to provide consent except where the subject’s legal rights were removed by due process of law
ii. Cause preventable death, serious injury, or significant physical or psychological damage to a subject.

It can certainly be argued that the BIO's effort is redundant in light of the minimum standard enacted by GAR #111, especially since the BIO's standards are not in any way defined by GAR #420 and are entirely left up to the committee.

It can be argued that these are procedural regulations on the IRB itself, rather than standards for ethicality to be utilized by the IRB.

It is obvious that the obligations placed on IRBs in GAR #111 are indeed ethical standards, in that they are rules governing medical research that are motivated by ethical considerations. It can be argued that the BIO's additional ethical standards are therefore redundant.

There is no coherent basis for the distinction the challenger is attempting to draw between ethical standards and "procedural regulations", nor the claim that they are somehow exclusive categories. I think it is becoming apparent that the entire category of "procedural regulations"-- a term used nowhere in GAR #420 -- is a fiction created to paper over the unfortunate implications of GAR #420's poorly written second mandate by allowing the challenger to exempt favoured regulation from the mandate.

7) GAR#219 v the target; biomedical innovations and databases

the target resolution establishes an "internationally-accessible database of ongoing biomedical research within Member-States", even though GAR #219 already requires the BIO to include "research data for biomedical innovations as a part of the Database Of Clinical Treatments Under Study"

This clause, due to the fact that a Database for Biomedical Innovations, and a Database for Ongoing Biomedical Research, are literally two entirely different things, is an honest mistake violation.

The challenger's definition of "biomedical innovation" is too narrow. GAR #219 does not define the term, so we are again free to use an expansive definition. An innovation is simply "something new or different introduced", and ongoing biomedical research is generally novel. As such, there is no reason why such research cannot be added to a database of biomedical innovations. This interpretation is supported by GAR #219 itself in that the research data is being added to a database of "treatments under study", which implies that research may be ongoing.

Simply because terms lack specific definition within the Text, does not give one an unequivocal right to redefine them in any way they wish. The word 'International' is not defined within Resolution 219, but it would be patently absurd to claim that it therefore can be interpreted as referring solely to interactions between Iron atoms. It is likewise patently absurd to claim that Biomedical Innovations include any and all Biomedical Research. The clause is an Honest Mistake Violation.

I see nothing unreasonable about describing novel biomedical research as innovative or including it in a database of biomedical innovations. Biomedical research that cannot be characterized as novel or otherwise innovative probably isn't worth cataloguing in an international database anyway. To the extent that such cataloguing is appropriate, therefore, GAR #420 is largely redundant.

---

Rule Broken: Honest Mistake

1) Previous legislation

Appalled that this absurdly broad restriction prohibits (or at least would prohibit, should prior legislation be repealed) member states from, among other things:
securing legal protection from harmful medical experimentation to the historically vulnerable class of persons who, while not "provably sentient or sapient at the time of research" may indeed regain such capacity, such as individuals in comas or persistent vegetative states,

This clause, due to the mandates of Resolution 29, Resolution 299, (which collectively provide a definition of legal guardianship and competence, and allow for determinations regarding medical procedures to be made by legal guardians,) and Resolution 355, (which extends the protections granted to sapient species to any and all members of said species, regardless of any disability,) is an Honest Mistake violation, as it claims the resolution does something it is incapable of doing.

2) Validity and legitimacy of research; scientific v ethical standards

granting precautionary legal protection from potentially harmful medical experimentation to potentially sentient or sapient life that has not yet been definitively "proven" to be such, perhaps due to difficulties in communication,

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as ensuring that a species is properly understood prior to engaging in invasive biomedical research with it, is an obvious requirement of ensuring the validity and legitimacy of any research.

3) Disclosure; Procedural v ethical v scientific standards

mandating that biomedical researchers abide by reasonable financial disclosure and conflict of interest rules, and

This clause, due to the resolutions's allowance of restrictions for scientific interests, is an Honest Mistake Violation, as disclosing or eliminating any biases is a legitimate scientific interest in ensuring the legitimacy of any research. Further, such is entirely outside the scope of the Resolution, as regulations regarding the disclosure of financial interests or other biases are procedural regulations, rather than scientific standards.

4) Environmental regulation v ethical standards

providing adequate legal protection for the environment in the context of biomedical research, at least with respect to non-sapient plant, bacterial, and fungal life such as coral reefs and old-growth forests,

This clause, due to environmental regulations being entirely outside the scope of the resolution, as per the definition of 'Biomedical Research' within the resolution, is an Honest Mistake Violation.

5) GAR#219 v the target; biomedical research v biomedical tissues

Understanding that significant portions of the remainder of the target resolution are largely redundant in light of GAR #111, "Medical Research Ethics Act" and GAR #219, "Biomedical Innovation Org", for the following reasons:
the target resolution requires the Biomedical Innovation Organization (BIO) to coordinate "international efforts at biomedical research", despite the fact that GAR #219 already requires the BIO to coordinate "research on treatments involving biomedical tissues conducted within WA member nations",

This clause, due to the fact that Biomedical Research encompasses a vast field of research, not at all limited to those utilizing Biomedical Tissues, such as the development of Pacemakers, Medical Prosthesis, or other such endeavors, is an Honest Mistake Violation.

6) GAR#111 v the target; minimum standard of ethicality

the target resolution mandates the BIO with developing minimum scientific and ethical standards for biomedical research and serving as an advisory body for biomedical ethics organizations and regulatory bodies, even though GAR #111 already establishes and regulates bodies required for upholding medical research ethics in member states,

This clause, due to the fact the IRBs established via Resolution 111 serve to determine whether a research effort can be considered Ethical, whereas BIO's expanded role within the Resolution is to establish a minimum standard of ethicality, is an Honest Mistake Violation.

7) GAR#219 v the target; biomedical innovations and databases

the target resolution establishes an "internationally-accessible database of ongoing biomedical research within Member-States", even though GAR #219 already requires the BIO to include "research data for biomedical innovations as a part of the Database Of Clinical Treatments Under Study"

This clause, due to the fact that a Database for Biomedical Innovations, and a Database for Ongoing Biomedical Research, are literally two entirely different things, is an honest mistake violation.

[Wrapper]

If you guys don't mind an outside perspective....

When players look at this they are going to say, "Huh?" If your justification for not hearing a challenge is going to take a dozen paragraphs, then it makes little sense to say "we aren't hearing the challenge." Save that for something that can be justified in a sentence or two.

Feel free to consider or ignore, ain't no skin off my nose.

[Sierra Lyricalia]

Yeah this seems an awful lot like we went ahead and heard it. Not hearing the case would look like a (forgive the legal jargon) summary judgment, where we just say "Yeah no, that shit's legal, and we're not gonna bother justifying why because it's obvious for all to see." Here we have (rightly) addressed each argument exhaustively.

[Separatist Peoples]

When we refuse to hear a challenge because it has no merit, that's a de facto ruling. If we're going to issue those, it has to be for reasons devoid of substance, like a poorly formatted challenge or a challenge on something that is clearly going nowhere.

If we bring substance into it, we gotta make it a ruling.

P.S. I'm voluntarily abstaining. I don't entirely agree with the reasoning, but I was active enough with Tinfect evaluating submission strategy that I think its just safer to sit out and avoid any complaints. Helps that my vote won't change anything.

[Bananaistan]

If you guys don't mind an outside perspective....

When players look at this they are going to say, "Huh?" If your justification for not hearing a challenge is going to take a dozen paragraphs, then it makes little sense to say "we aren't hearing the challenge." Save that for something that can be justified in a sentence or two.

Feel free to consider or ignore, ain't no skin off my nose.

When we refuse to hear a challenge because it has no merit, that's a de facto ruling. If we're going to issue those, it has to be for reasons devoid of substance, like a poorly formatted challenge or a challenge on something that is clearly going nowhere.

If we bring substance into it, we gotta make it a ruling.

P.S. I'm voluntarily abstaining. I don't entirely agree with the reasoning, but I was active enough with Tinfect evaluating submission strategy that I think its just safer to sit out and avoid any complaints. Helps that my vote won't change anything.

I agree with the general gist of both of your points. But at no stage had we voted to hear this challenge. SL moved to hear it, nobody else seconded. Therefore, no hearing, ruling or anything. Until CD retrospectively voted to hear it.

Anyways, BA, CD and SL, are you all happy to join the ruling?

[Sierra Lyricalia]

Yes.

[Separatist Peoples]

If you guys don't mind an outside perspective....

When players look at this they are going to say, "Huh?" If your justification for not hearing a challenge is going to take a dozen paragraphs, then it makes little sense to say "we aren't hearing the challenge." Save that for something that can be justified in a sentence or two.

Feel free to consider or ignore, ain't no skin off my nose.

When we refuse to hear a challenge because it has no merit, that's a de facto ruling. If we're going to issue those, it has to be for reasons devoid of substance, like a poorly formatted challenge or a challenge on something that is clearly going nowhere.

If we bring substance into it, we gotta make it a ruling.

P.S. I'm voluntarily abstaining. I don't entirely agree with the reasoning, but I was active enough with Tinfect evaluating submission strategy that I think its just safer to sit out and avoid any complaints. Helps that my vote won't change anything.

I agree with the general gist of both of your points. But at no stage had we voted to hear this challenge. SL moved to hear it, nobody else seconded. Therefore, no hearing, ruling or anything. Until CD retrospectively voted to hear it.

Anyways, BA, CD and SL, are you all happy to join the ruling?

Then we ought not give a detailed response.

[Christian Democrats]

I vote to hear, and I sign the majority opinion.

[Bears Armed]

I vote to hear, and I sign the majority opinion.

Ditto.

[Bananaistan]

Opinion posted including Sciongrad's vote which was twice posted in the Repeal Freedom to Seek Care thread.