[DEFEATED] Medical Research Ethics Act

[Omigodtheykilledkenny]

OOC: aww, species-wank! How I've missed thee! ...Speaking of which, Bears Armed has been awfully quiet lately; is he still around?

[Quadrimmina]

It would seem that the strongest objections to the act remains the possibilities of patients leaving the trials, either via article v of the IRB mandates or via voluntary consent. Our delegation duly notes this, laments the lack of a possibility of amending the resolution while on the floor, and will amend the resolution if it is defeated. However, since these are case-by-case systems, the best people to review the studies would indeed be the IRBs themselves, to ensure that informed consent is acquired before voluntary withdrawal and to ensure that the study is safe to pull out of. However, I bring this question to the floor:

What language would the honorable delegation from Manticore Reborn and supporters like to see in amendment to this resolution, if it fails, to correct the discrepancies found in the resolution in a second draft?

[Urgench]

Mr. Speaker: I was under the impression that this Resolution could not be applied to non-humans - as I pointed out earlier. Is the Hon. Member for NERVUN trying to tell me that the Resolution can be applied to non-humans, even though it plainly says otherwise in the resolution text? If this is the case, would the Hon. Gentleman please explain why this resolution may be applied to non-humans - and how?

This is why -

Article 1.

a ) All inhabitants of member states are equal in status in law and under its actions, and have the right to equal treatment and protection by the nation they inhabit or in which they are currently present.

b ) All inhabitants of member states are entitled to rights secured to them in international law and the law of the nation they inhabit or in which they are currently present.

c ) All inhabitants of member states have the right not to be and indeed must not be discriminated against on grounds including sex, race, ethnicity, nationality, skin color, language, economic or cultural background, physical or mental disability or condition, religion or belief system, sexual orientation or sexual identity, or any other arbitrarily assigned and reductive categorisation which may be used for the purposes of discrimination, except for compelling practical purposes, such as hiring only female staff to work with battered women who have sought refuge from their abusers.

Taken from resolution #35 - The Charter of Civil Rights. viewtopic.php?f=9&t=30&p=428#p414


We tire of telling your Excellency to be better conversant in the canon of WA laws.


Yours,

[Masucciania]

Fellow Member States of the World Assembly:

I urge you all to vote against this proposed resolution. Even if these ethical review boards are to be run by an entity within each respective state, the sovereignty of every state is nevertheless undermined by international mandate. Each state should determine for itself if it desires an ethical review board. The policies of one state are that state's concern and no one else's.

Thank you

[Urgench]

Mr. Speaker: Thank you for clarifying this point. I remain, as ever, a neutral officer of this Assembly, and thus I relinquish any opinion on this issue.

Your Excellency is no such thing. Indeed if your Excellency is convinced of this fallacy then we fear your Excellency's government has sent a delusional to represent it at the WA. No vote has been held to put your Excellency in such a position, indeed no vote could be held to appoint you "Speaker" and we suspect that functionaries of the WA would never appoint your Excellency Speaker even in the absence of a vote. Please desist in continuing to pretend that your Excellency is an official of the WA and anything other than just another Ambassador to the World Assembly.


Yours,

[Urgench]

I am simply representing the Speaker of this assembly - I do not assume that my Nation is holding the Speaker's chair - I am simply acting as his representative

Yours,

Your Excellency, there is absolutely no need whatsoever for you to pretend to represent the Speaker of the WA. If and when the functionaries of the WA decide it is needful or appropriate for them to do so there is absolutely no impediment to them speaking for themselves, if they choose not to speak then it is safe to presume there is no need to pantomime and ventriloquise what your Excellency thinks they might have said. In any case what authority does your Excellency claim to represent anyone or anything but your own government and it's positions and opinions at this organisation? Have we missed the processes which devolved this responsibility upon your Excellency's shoulders?


Yours,

[Masucciania]

Fellow Member States of the World Assembly:

I urge you all to vote against this proposed resolution. Even if these ethical review boards are to be run by an entity within each respective state, the sovereignty of every state is nevertheless undermined by international mandate. Each state should determine for itself if it desires an ethical review board. The policies of one state are that state's concern and no one else's.

Thank you

Mr Speaker: I must inform the Hon. member that part of the conditions of becoming a member of this assembly was that a nation understood the fact that they relinquished their national sovereignty when they become a member of this Assembly - it is one of the fundamental conditions of joining this assembly - that a member understands that they relinquish their national sovereignty.

Monsieur le Président: Je dois informer l'honorable parlementaire que le cadre des conditions de devenir un membre de cette assemblée, c'est qu'une nation comprend le fait qu'ils ont renoncé à leur souveraineté nationale quand ils devenir membre de cette Assemblée - il est l'une des conditions fondamentales de se joindre à cette assemblée - qui comprend un membre de renoncer à leur souveraineté nationale.

señor Presidente: Debo informar a Su Señoría de que parte de las condiciones de convertirse en miembro de esta asamblea es que una nación entiende el hecho de que renunció a su soberanía nacional cuando se convierten en un miembro de esta Asamblea - es una de las condiciones fundamentales de unirse a esta asamblea - que un miembro entiende que renuncian a su soberanía nacional.

An tUasal Cainteoir: Caithfidh mé in iúl go bhfuil an comhalta onórach chuid de na coinníollacha chun bheith ina chomhalta den náisiún a thionól go dtuigeann an bhfíric go relinquished siad a gceannasacht náisiúnta, nuair a éiríonn siad ina comhalta den Tionól seo - tá sé ar cheann de na coinníollacha bunúsacha de cheanglaíonn cóimeála seo - go dtuigeann siad go scaradh ball dá gceannasacht náisiúnta.

Forgive me Mr. Chief Ambassador, but I must respectfully disagree with your summation of the World Assembly. I believe that the World Assembly charter statesthat member states are required to follow and enforce resolutions which pass the General Assemby (and Security Council), even if they voted against passage. Such language does not necessarily require the surrender of sovereignty of member states because, in theory, resolutions could be passed which did not infringe upon states' sovereignty. For example, the previously passed resolution regarding recreational drugs did not infringe upon states' sovereignty. On the contrary, that resolution reinforced states' sovereignty. If the charter does say otherwise however, please correct me lest I continue to make a fool out of myself and the Confederacy.

Respectfully,

[Manticore Reborn]

What language would the honorable delegation from Manticore Reborn and supporters like to see in amendment to this resolution, if it fails, to correct the discrepancies found in the resolution in a second draft?

The humble representative from the Kingdom of Manticore Reborn thanks the honored Ambassador from The Republic of Quadrimmina for their invitation to contribute to this act. It is our governments belief that the following changes to the clause would be welcomed:

ALLOWS subjects in medical research to terminate their consent at any time with this termination to be given as a notice either to the head researcher or the Institutional Review Board, except where, in the opinion of the head researcher and confirmed by the Institutional Review Board, such termination would be detrimental to the health and well being of the subject.

The representative from the Kingdom of Manticore Reborn yields the floor.

Respectfully,
Hamish Alexander, Thirteenth Earl of White Haven

OOC: If this act passes, could this be made as an amendment to the bill or would the original need to be repealed first?

[Urgench]

OOC: If this act passes, could this be made as an amendment to the bill or would the original need to be repealed first?

OOC. Amendments are illegal, if it passes and you have a problem with it you'll have to repeal it.

[Manticore Reborn]

Mr Speaker: I must inform the Hon. member that part of the conditions of becoming a member of this assembly was that a nation understood the fact that they relinquished their national sovereignty when they become a member of this Assembly - it is one of the fundamental conditions of joining this assembly - that a member understands that they relinquish their national sovereignty.

The representative from the Kingdom of Manticore Reborn would like to point out to the Chargé d'Affaires from Diatraba that Manticore is still, and will always be, an independent sovereign nation. Membership in this august assembly does not imply any type of union, de facto, de jure or otherwise. This representative would hope that before the Chargé d'Affaires from Diatraba makes additional impertinent remarks they have their facts in order.

The humble representative from the Kingdom of Manticore Reborn yields the floor.

Respectfully,
Hamish Alexander, Thirteenth Earl of White Haven

[Sionis Prioratus]

I am simply representing the Speaker of this assembly - I do not assume that my Nation is holding the Speaker's chair - I am simply acting as his representative

Yours,

Your Excellency, there is absolutely no need whatsoever for you to pretend to represent the Speaker of the WA. If and when the functionaries of the WA decide it is needful or appropriate for them to do so there is absolutely no impediment to them speaking for themselves, if they choose not to speak then it is safe to presume there is no need to pantomime and ventriloquise what your Excellency thinks they might have said. In any case what authority does your Excellency claim to represent anyone but your own government's positions and opinions at this organisation? Have we missed the processes which devolved this responsibility upon your Excellency's shoulders?


Yours,

Most Noble Khan, it would seem as our colleague from Diatraba needs to be a holder of an important office. Let it not fall upon our shoulders the guilt of denying the fulfillment of such a primal yearning.

But indeed, a position such as "Speaker" is preposterous; in its lieu, I proposed that the Hon. Ambassador from Diatraba shall henceforth be known as Jester Extraordinaire of the World Assembly.

No one else shall be so close to the positions of power in the WA! Court intrigues! Tuna pies! Think about that!

L'Chaim,

[Manticore Reborn]

...indeed, a position such as "Speaker" is preposterous; in its lieu, I proposed that the Hon. Ambassador from Diatraba shall henceforth be known as Jester Extraordinaire of the World Assembly.

Hear, hear.

[Urgench]

Most Noble Khan, it would seem as our colleague from Diatraba needs to be a holder of an important office. Let it not fall upon our shoulders the guilt of denying the fulfillment of such a primal yearning.

But indeed, a position such as "Speaker" is preposterous; in its lieu, I proposed that the Hon. Ambassador from Diatraba shall henceforth be known as Jester Extraordinaire of the World Assembly.

No one else shall be so close to the positions of power in the WA! Court intrigues! Tuna pies! Think about that!

L'Chaim,

It would be fleetingly amusing to observe that fiction, but it would become as tiresome a chore as the current fiction the honoured Ambassador for Diatraba is insisting we all play along with.


Let us desist in all such fantasies and set about the very real and very important work of this organisation instead.


Yours,

[Quadrimmina]

What language would the honorable delegation from Manticore Reborn and supporters like to see in amendment to this resolution, if it fails, to correct the discrepancies found in the resolution in a second draft?

The humble representative from the Kingdom of Manticore Reborn thanks the honored Ambassador from The Republic of Quadrimmina for their invitation to contribute to this act. It is our governments belief that the following changes to the clause would be welcomed:

ALLOWS subjects in medical research to terminate their consent at any time with this termination to be given as a notice either to the head researcher or the Institutional Review Board, except where, in the opinion of the head researcher and confirmed by the Institutional Review Board, such termination would be detrimental to the health and well being of the subject.

The representative from the Kingdom of Manticore Reborn yields the floor.

Respectfully,
Hamish Alexander, Thirteenth Earl of White Haven

OOC: If this act passes, could this be made as an amendment to the bill or would the original need to be repealed first?

The Republic of Quadrimmina would like to announce its support for the amendments proposed by the honorable delegation from Manticore Reborn but takes some issue with the wording of the amendment. We feel that the Institution Review Board should not be troubled with individual concerns about consent, considering the amount of work they have already. We humbly request an alternative solution, such as including procedures for preventing termination of consent with the submissions to the IRB. We yield the floor for rebuttal.

[The Tollan Resurgence]

For some reason, the version actually at vote was not posted for discussion. For those who wish, I have pasted it below.

RECOGNIZING the importance of ethicality in medical research that involves living citizens, prisoners, and those denied citizenship.

REALIZING that there is no doctrine to ensure that this ethicality is maintained consistently among nations.

FURTHER REALIZING that this lack of a common rule can lead to human rights violations in the name of scientific progress.

UNDERSTANDING that ethical dilemmas exist in medical research, including but not limited to:
i. Excessive coercion of prospective testing subjects.
ii. Misleading subjects about the nature of the research.
iii. Endangering the lives of subjects without proper consent.
iv. Use of criminals or war prisoners as subjects without proper consent.
v. Exploiting weak, undereducated, or emotionally unstable subjects.

DEFINES an Institutional Review Board (IRB) as a board of people qualified to make a decision about the ethicality of medical research.

MANDATES that any entity within a WA nation that performs medical research on living citizens, prisoners, and those denied citizenship have this research verified as ethical by an IRB within the nation.

FORBIDS any research from taking place that is not approved by an IRB.

ALLOWS WA nations to regulate their own IRB system, with all research accountable to some IRB, that nation must have an IRB responsible for the research, be it public or private.

REQUIRES all prospective researchers to provide the following documentation to an IRB, in addition to any other documentation as determined by national law:
i. A protocol must be present.
ii. The subject consent form must be present, which accurately details the study and provides info about contacts for complaints.
iii. Information concerning qualification and contact info of all research personnel must be present.
iv. Information concerning the subjects needed and how they are chosen must be included.
v. The research must be reapproved every year by an IRB. Failure to do this must result in immediate termination of the research until approval is granted.

FURTHER REQUIRES that the IRBs, whether they be government-operated or operated by an institution such as a university, be free from political pressure in their review of research.

ALLOWS the creation of Regional IRBs in regions for collaborative scientific research efforts or to provide for nations that do not have a high amount of medical research. In this case, a researcher can choose to submit research to any IRB in his/her jurisdiction.

MANDATES that the IRBs reject any research that they reasonably believe may:
i. Involve deception or coercion of test subjects to the extent that a reasonable test subject would otherwise refuse to participate in the research, such that the participation cannot be a result of an informed, impartial, and rational decision.
ii. Cause death, serious injury, or significant physical or psychological damage to a subject.

ALLOWS subjects in medical research to terminate their consent at any time.

CREATES a Medical Research Ethics Board, whose purpose is to review research approved by IRBs in WA nations and ensure that the approval is valid, based on conceptions of human rights, medical ethics, and international and national law. If a country's IRBs or IRB laws are found to be inadequate, the MREB will have the ability to shut down national IRBs and take over their role until a suitable replacement is implemented.

[Quadrimmina]

Thank you to the delegation from The Tollan Resurgance. This thread started as the first draft of the legislation and progressed to the final legislation, and was changed to At Vote as a bump while I was out of commission with bronchitis. Due to this, I was unable to update it and missed it during the debates that ensued.

[Manticore Reborn]

The Republic of Quadrimmina would like to announce its support for the amendments proposed by the honorable delegation from Manticore Reborn but takes some issue with the wording of the amendment. We feel that the Institution Review Board should not be troubled with individual concerns about consent, considering the amount of work they have already. We humbly request an alternative solution, such as including procedures for preventing termination of consent with the submissions to the IRB. We yield the floor for rebuttal.

The representative from the Kingdom of Manticore Reborn is pleased that the intent of his government's suggestion was greeted favorably and understands that the wording may not be perfect. The intent was that the subjects should be able to withdraw from the study and not be kept in at the sole discretion of the head researcher. Although this representative believes most researchers are ethical, subjects need to be protected from those that may not be and as such any decision to deny exit from a study should not rest solely on those whom are conducting the research. Since this act provides for the IRB to review the research before said research can take place and perform annual analysis, we can find no more qualified body to confirm such an opinion.

Suggestions on the exact wording of the clause would gratefully received.

The humble representative from the Kingdom of Manticore Reborn yields the floor.

Respectfully,
Hamish Alexander, Thirteenth Earl of White Haven

[The Tollan Resurgence]

I will cast a vote against this legislation on behalf of my nation, and I urge other representatives to do likewise.

MANDATES that any entity within a WA nation that performs medical research on human subjects have this research verified as ethical by an Institutional Review Board within the nation.

FORBIDS any research from taking place that is not approved by an Institutional Review Board.

ALLOWS WA nations to regulate their own Institutional Review Boards in any way they see fit, with the exception that if medical research is done in the nation, that nation must have an Institutional Review Board responsible for the research, be it public or private.

While the above sections of the resolution appear to do no more than mandate the creation of these review boards and subsequently allow them to be run at each nation's discretion (we have no objection to this), further sections below constitute blatant intrusion on national sovereignty.

CREATES a Medical Research Ethics Board, whose purpose is to review research approved by IRBs in WA nations and ensure that the approval is valid, based on conceptions of human rights, medical ethics, and international and national law. If a country's IRBs or IRB laws are found to be inadequate, the MREB will have the ability to shut down national IRBs and take over their role until a suitable replacement is implemented.

The above section is totally unacceptable in our eyes, and we hope it is so in the eyes of other member nations. The clause, in effect, gives total control of approval for all medical research in a given nation to an international board outside that nation. It is, in magnitude, an offense similar to an international organization managing a nation's tax laws, military budget, or educational curriculum for them without their consent. My government has made clear that it will not support this legislation and that it will actively discourage others from doing so. In addition, my government has promised that if this legislation passes, The Tollan Resurgence will withdraw from the WA to avoid having its internal affairs manipulated.

~ Alistair Styke, Ambassador to the WA for The Autocratic Meritocracy of The Tollan Resurgence

[Art Far Grace]

Good day,
I find this proposal quite pretentious, because in a world that is far from Salvation, you want to take away the foundation of survival-ism.
We have ethnic cleansing all over our world, mother earth is angrier than ever, and you want to take back Medical Research 40 years by being unable to test freely on the subject(humans...). Medical research it one of the only thing that the world have that we can relay on.

So my vote is no, I would though like to see a proposal that all murderers are own by the state and obligated to take parts of all types of Medical Research.


The humans are just a bag of meat, but lets make the best situation in all this pain.

Yours Faithfully,
Dahlman, founder of "The Empire of Art Far Grace"

[Dwennimmen]

my government has promised that if this legislation passes, The Tollan Resurgence will withdraw from the WA to avoid having its internal affairs manipulated

Because the Republic of Dwennimmen has laws that severely reduce the rights of criminals, which have committed multiple serious crimes and are over the age of 40, we would also be ready to withdraw from the WA before this current Issue would be passed in the General Assembly. We are hoping that this will not be necessary because this Issue seems to be losing, by a small amount, so far.

[Urgench]

my government has promised that if this legislation passes, The Tollan Resurgence will withdraw from the WA to avoid having its internal affairs manipulated

Because the Republic of Dwennimmen has laws that severely reduce the rights of criminals, which have committed multiple serious crimes and are over the age of 40, we would also be ready to withdraw from the WA before this current Issue would be passed in the General Assembly. We are hoping that this will not be necessary because this Issue seems to be losing, by a small amount, so far.

Your Excellency, whatever the details of these rather dubious sounding policies your government has, it would probably be rather useful for your delegation to properly familiarise itself with the entire canon of WA law to ensure that these policies are in fact legal under current WA regulations.


Yours,

[Gotham Network]

CREATES a Medical Research Ethics Board, whose purpose is to review research approved by IRBs in WA nations and ensure that the approval is valid, based on conceptions of human rights, medical ethics, and international and national law. If a country's IRBs or IRB laws are found to be inadequate, the MREB will have the ability to shut down national IRBs and take over their role until a suitable replacement is implemented.

The above section is totally unacceptable in our eyes, and we hope it is so in the eyes of other member nations. The clause, in effect, gives total control of approval for all medical research in a given nation to an international board outside that nation. It is, in magnitude, an offense similar to an international organization managing a nation's tax laws, military budget, or educational curriculum for them without their consent.

All WA members are already bound by WA statutes concerning human rights. Therefore, the WAMREB would only be ensuring that member nations are carrying out obligations they have previously agreed to.

[Quadrimmina]

The Republic of Quadrimmina humbly reminds the delegations from The Tollan Resurgence, Dwennimmen and Art Far Grace that:

1) Membership in the World Assembly is entirely voluntary.
2) Membership in the World Assembly necessitates adhering to all 90 of the currently adopted resolutions, which would be enforced to a higher degree by the language found in this resolution. However, your support suggests to me that your nations are knowingly and unabashedly violating current WA law. All this law does is regulate that that is already illegal.

Your opposition seems better aimed at other human rights resolutions that protect human rights, violations of which you seem to be blatantly admitting to. Institutional Review Boards are left to the decisions of nations due to the fact that each nation has a different policy as to how human subjects provide consent, and the Republic of Quadrimmina respects each nation's own sovereignty in making such a decision. At the same time, to ensure that international law and basic standards of human decency are met, the MREB ensures that egregious human rights violations are not committed. Your opposition is less aimed toward my proposal as to the WA's current doctrines, as Gotham Network's delegation so kindly stated.

[Quadrimmina]

Regarding Manticore Reborn's amendment calls, I must voice my support for a system that involves allowing the nation to choose its own system for termination of consent, or failing this refer an appeal to the MREB. Would this appease concerns about responsible withdrawal? My issue is that some nations would prefer courts rather than IRBs deal with termination of consent. This is the amendment as I have drafted it:

REQUIRES that WA nations regulate in their own way issues regarding consent of individuals and how that consent can be responsibly terminated, with appeals to be referred to the MREB.

[The Tollan Resurgence]

The Republic of Quadrimmina humbly reminds the delegations from The Tollan Resurgence, Dwennimmen and Art Far Grace that:

1) Membership in the World Assembly is entirely voluntary.
2) Membership in the World Assembly necessitates adhering to all 90 of the currently adopted resolutions, which would be enforced to a higher degree by the language found in this resolution. However, your support suggests to me that your nations are knowingly and unabashedly violating current WA law. All this law does is regulate that that is already illegal.

Your opposition seems better aimed at other human rights resolutions that protect human rights, violations of which you seem to be blatantly admitting to. Institutional Review Boards are left to the decisions of nations due to the fact that each nation has a different policy as to how human subjects provide consent, and the Republic of Quadrimmina respects each nation's own sovereignty in making such a decision. At the same time, to ensure that international law and basic standards of human decency are met, the MREB ensures that egregious human rights violations are not committed. Your opposition is less aimed toward my proposal as to the WA's current doctrines, as Gotham Network's delegation so kindly stated.

There seems to be a degree of misunderstanding as to my nation's objection to this legislation. I never admitted nor implied that The Tollan Resurgence commits human rights violations that are in conflict with previously passed WA legislation. (OOC: My nation isn't a dystopia, its civil rights rating is excellent) My goverment's objection is a matter of principal, not of concern that this legislation would make its practices illegal. We view this legislation as impinging on our sovereignty, not because it prevents the violation of human rights, but because it subjects our government to direct external control. The current draft of the proposal allows the MREB to take action "based on conceptions of human rights, medical ethics, and international and national law". Our nation obeys international law, and national law is a non-issue in this situation, but "conceptions of human rights and medical ethics" are extremely subjective. How will the members of the MREB be accredited impartially? What is to say they will not hold bias against nations over whom they exercise control. More objectionable than the circumstances under which the MREB can use its powers are those powers themselves. "If a country's IRBs or IRB laws are found to be inadequate, the MREB will have the ability to shut down national IRBs" This means that the MREB is being given direct control over the existence or nonexistence of national government agencies. This is analogous to if you handed over control of your Ministry of Finance or Ministry of Defence to "a board of people qualified to make a decision" selected from the international community. My government can envision no nation being willing to give up control of its own agencies in such a manner.

~ Alistair Styke, Ambassador to the WA for The Autocratic Meritocracy of The Tollan Resurgence