[DEFEATED] Medical Research Ethics Act

[The Swiss Guardsmen]

Your Excellency is either making a joke in poor taste or is likely a habitual inebriate. Suffice it to say millions of Keshiq and Nashbaliqi troops will never be inconvenienced by orders to descend upon your Excellency's benighted and barbarous nation, it will be a horde of WA gnomes who shall busy themselves dragging your Excellency's government into compliance with WA law. But your Excellency will remain perfectly entitled to think whatever they wish about the rights of your nation's criminals, the WA has no ability (and doubtless no desire) to coerce your personal conscience.

Absurdly silly threats of war, made in jest or not, do your Excellency's dignity and the already somewhat sullied dignity of your nation no favours.


Yours,

How dare you sir! Our troops are some of the best trained soldiers in the world. We would butcher your hordes of Keshiqs and Nashbaliqis before they even had the chance to set one foot into our country's boundaries. You could never "drag" our proud people to do anything, but we would encourage you to try and fail quite spectacularly doing so. Your armies would be crushed by our forces, and we would continue to run our operations as we have always seen fit, and we will continue to treat our criminals and prisoners of war as we always have. We will "DO" whatever we have to to protect our country's security. We are in no way frightened by your meek, underequipped, underfunded, incompetent military, and we will deal any strike directed at us back tenfold. We warn you to be more careful in the future when addressing governments who have the power to shrug off your delegation's illogical, ignorant, indignant, and hollow threats.

The Office of the Swiss Guardsmen's Military High Command

[Argonius]

Voted against. This is illogical, moreover our Government considers this proposal as a threat for liberty of countries.

Argonius Licius
The President of The Commonwealth And The CEO of Licentia Trade Company

[Charlotte Ryberg]

Thank you to the delegations from NERVUN and Charlotte Ryberg for helping with the language. I think 'people' would be an acceptable term. I could not find a neutral enough word. Thanks again, a newer draft will be presented for your review soon.

Wonderful, honoured ambassador!

Yours etc,

[Quadrimmina]

Alright, this is the current language of our proposal.

Medical Research Ethics Act
Human Rights -> Significant

THIS WORLD ASSEMBLY,

RECOGNIZING the importance of ethical criteria in medical research that involves living persons.

REALIZING that the lack of a common rule of medical research regulation 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 or deception of prospective testing subjects.
ii. Not obtaining proper consent for medical research.
iii. Exploiting weak, undereducated, or emotionally unstable subjects.

DEFINES an Institutional Review Board (IRB) as a board of individuals qualified to impartially analyze medical research proposals.

MANDATES that any entity within a WA nation that performs medical research on any persons have this research verified as ethical by an IRB within the nation.

FORBIDS any medical 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, 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.
ii. The subject consent form, which accurately details the study and provides info about contacts for complaints.
iii. Information concerning qualification and contact info of all research personnel.
iv. Information concerning the types and number of subjects needed and how they are chosen.

FURTHER REQUIRES that research must be reapproved every year by an IRB. If this is not passed, termination of the research must occur when all patients can be considered stable for release, and the IRB may take measures to ensure this happens in a timely manner for quick termination.

EVEN FURTHER REQUIRES that the IRBs, whether they be public or private, be free from political pressure in their review of research.

ALLOWS the creation of Regional IRBs by treaty 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. Cause participation that is not a result of an informed, impartial, and rational decision to provide consent.
ii. Cause death, serious injury, or significant physical or psychological damage to a subject.
iii. Involve nonconsensual experimentation on war prisoners.

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 rights of people, medical ethics, and international and national law. If a country's IRB system is found to be inadequate or ineffective, the MREB will have the ability to shut it down and refer that country’s research to its regional IRB or, failing this, usurp its responsibility until that country’s system is acceptable.

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

GUARANTEES that national policy concerning the legal rights removed from a person by due process of law is not grounds for dismissal of that nation’s IRB law by the MREB.

[Poree]

Not to be overly picky, but three suggestions for your latest draft. Changes in Red, my thoughts in Blue:

REALIZING that the lack of a common rule of medical research regulation can lead to various rights violations in the name of scientific progress.
This takes the word Human out of the draft except for the Catagory and that can not be helped.

MANDATES that any entity within a WA nation that performs medical research on any individuals must have this research verified as ethical by an IRB within the nation.
I think "individuals must" gives this line a little more force.

FURTHER REQUIRES that research must be reapproved every year by an IRB. If the research is not approved, termination of the research must occur when all patients can be considered stable for release, and the IRB may take measures to ensure this happens in a timely manner for quick termination.
"If this is not passed" just felt kind of vague to me.

I realise these are minor nits to be picked on, but I believe they will help the new draft.

[Enn]

After Enn's quite sudden (and unexpected) change in latitude, I have been directed to vote AGAINST this.

Or at least, that's what I made out of Lady Faren's garbled phone message. I wonder whether she might instead be talking about President Fernanda. Lots of 'No! No! Stop this at once!'

Stephanie Fulton,
WA Ambassador for Enn

I would presume that her Ladyship is referring to this Resolution...would her Ladyship have any reason to want to dismiss President Fernanda?

That is a matter between the governments of Enn and Omigodtheykilledkenny. It would not be my place to inform you of the specifics.

Stephanie Fulton, of Enn

[Urgench]

Your Excellency is either making a joke in poor taste or is likely a habitual inebriate. Suffice it to say millions of Keshiq and Nashbaliqi troops will never be inconvenienced by orders to descend upon your Excellency's benighted and barbarous nation, it will be a horde of WA gnomes who shall busy themselves dragging your Excellency's government into compliance with WA law. But your Excellency will remain perfectly entitled to think whatever they wish about the rights of your nation's criminals, the WA has no ability (and doubtless no desire) to coerce your personal conscience.

Absurdly silly threats of war, made in jest or not, do your Excellency's dignity and the already somewhat sullied dignity of your nation no favours.


Yours,

How dare you sir! Our troops are some of the best trained soldiers in the world. We would butcher your hordes of Keshiqs and Nashbaliqis before they even had the chance to set one foot into our country's boundaries. You could never "drag" our proud people to do anything, but we would encourage you to try and fail quite spectacularly doing so. Your armies would be crushed by our forces, and we would continue to run our operations as we have always seen fit, and we will continue to treat our criminals and prisoners of war as we always have. We will "DO" whatever we have to to protect our country's security. We are in no way frightened by your meek, underequipped, underfunded, incompetent military, and we will deal any strike directed at us back tenfold. We warn you to be more careful in the future when addressing governments who have the power to shrug off your delegation's illogical, ignorant, indignant, and hollow threats.

The Office of the Swiss Guardsmen's Military High Command

Your Excellency is tiresome, shameful and dishonoured. Indulgence in hubris, violent threats and boasting are the habits of neerdowells and common braggarts, your people are made laughingstock and traduced by your behaviour. Perhaps your Excellency would be better suited to the ignominious disputes of the ale house than the discourse of international diplomacy.


Yours,

[The Swiss Guardsmen]

[/quote]
Your Excellency is tiresome, shameful and dishonoured. Indulgence in hubris, violent threats and boasting are the habits of neerdowells and common bragarts, your people are made laughingstock and traduced by your behaviour. Perhaps your Excellency would be better suited to the ignominious disputes of the ale house than the discourse of international diplomacy.


Yours,[/quote]

Speak for yourself. You have used even more venomous language than anyone else here. Your comments shame what little dignity your nation has, and we laugh at the prospect that you consider yourself an organized and respectable people. Perhaps your government's talents are better suited working as a comical act in a circus, I'm sure we'd love to buy tickets to come and watch. At least then your Excellency's governing body might finaly serve a purpose.

The Office of the Swiss Guardsmen's Trivial Affairs

[Quadrimmina]

Not to be overly picky, but three suggestions for your latest draft. Changes in Red, my thoughts in Blue:

REALIZING that the lack of a common rule of medical research regulation can lead to various rights violations in the name of scientific progress.
This takes the word Human out of the draft except for the Catagory and that can not be helped.

MANDATES that any entity within a WA nation that performs medical research on any individuals must have this research verified as ethical by an IRB within the nation.
I think "individuals must" gives this line a little more force.

FURTHER REQUIRES that research must be reapproved every year by an IRB. If the research is not approved, termination of the research must occur when all patients can be considered stable for release, and the IRB may take measures to ensure this happens in a timely manner for quick termination.
"If this is not passed" just felt kind of vague to me.

I realise these are minor nits to be picked on, but I believe they will help the new draft.

The delegation from Poree is thanked for their suggestion. Our delegation has reviewed them and approved them for addition to our revised proposal. Thank you for your assistance in ensuring that this legislation is everything we are trying to make it be.

As for debates not concerning this legislation, please try to keep it out of this forum for it is definitely making debate on this issue rather hard to find in the topic.

I'd also like to remark that with 30 minutes left in voting, we've gone from a small margin of victory to an almost 1,000 vote deficit. Is this because of the issues already arised and revised in the second draft or are there deep underlying issues with the legislation that have not yet been addressed by my or other delegations? Please let me know as soon as possible so that The Republic of Quadrimmina may forward our proposal to the Parliament for a floor vote and subsequently send it to the World Assembly for a final vote. Thank you.

[Mitchtown]

Oh? So only 'human' subjects are worthy of protection and not other sapient beings?

The Federation of Mitchtown requests clarification on the definition of sapient beings, and a comprehensive list of the beings included.

[Ardchoille]

Your Excellency is tiresome, shameful and dishonoured. Indulgence in hubris, violent threats and boasting are the habits of neerdowells and common bragarts, your people are made laughingstock and traduced by your behaviour. Perhaps your Excellency would be better suited to the ignominious disputes of the ale house than the discourse of international diplomacy.


Yours,

Speak for yourself. You have used even more venomous language than anyone else here. Your comments shame what little dignity your nation has, and we laugh at the prospect that you consider yourself an organized and respectable people. Perhaps your government's talents are better suited working as a comical act in a circus, I'm sure we'd love to buy tickets to come and watch. At least then your Excellency's governing body might finaly serve a purpose.

The Office of the Swiss Guardsmen's Trivial Affairs

Idly leafing through the One-Stop Rules Shop, I came on this:

Overreaction: Launching nukes at someone because they misspelled some words or posted something you don't like is not a typical first diplomatic step. Irrational belligerence can be seen as flamebaiting, and will be judged accordingly.

Perhaps, now the debate's over, your ambassadors might seek a cooling draught in the Strangers Bar?

[Krioval]

Your Excellency is tiresome, shameful and dishonoured. Indulgence in hubris, violent threats and boasting are the habits of neerdowells and common bragarts, your people are made laughingstock and traduced by your behaviour. Perhaps your Excellency would be better suited to the ignominious disputes of the ale house than the discourse of international diplomacy.


Yours,

Speak for yourself. You have used even more venomous language than anyone else here. Your comments shame what little dignity your nation has, and we laugh at the prospect that you consider yourself an organized and respectable people. Perhaps your government's talents are better suited working as a comical act in a circus, I'm sure we'd love to buy tickets to come and watch. At least then your Excellency's governing body might finaly serve a purpose.

The Office of the Swiss Guardsmen's Trivial Affairs

Idly leafing through the One-Stop Rules Shop, I came on this:

Overreaction: Launching nukes at someone because they misspelled some words or posted something you don't like is not a typical first diplomatic step. Irrational belligerence can be seen as flamebaiting, and will be judged accordingly.

Perhaps, now the debate's over, your ambassadors might seek a cooling draught in the Strangers Bar?

What I don't get is why a government would establish an Office of Trivial Affairs.

Aleksei-kan Volkov
Imperial Chiefdom of Krioval

[Quadrimmina]

Oh? So only 'human' subjects are worthy of protection and not other sapient beings?

The Federation of Mitchtown requests clarification on the definition of sapient beings, and a comprehensive list of the beings included.

Sapient beings are all beings that have wisdom and discernment. Basically, any sentient beings recognized under a government.

[Poree]

The delegation from Poree is thanked for their suggestion. Our delegation has reviewed them and approved them for addition to our revised proposal. Thank you for your assistance in ensuring that this legislation is everything we are trying to make it be.

You are most welcome.

I'd also like to remark that with 30 minutes left in voting, we've gone from a small margin of victory to an almost 1,000 vote deficit. Is this because of the issues already arised and revised in the second draft .....

I can not speak for others, but I did change my vote when I realized you were working on a better draft and felt I would rather see the new draft make it into law.

[WA Mission of NERV-UN]

Honored ambassador of Quadrimmina,

After reading your new draft, we will support this and hope that it might come up for a vote soon.

Regards,
Katsuyama Masashiro, Capt.
Ambassador

[Ardchoille]

Diatraba has received a three-day ban for his activities in this thread.

[Charlotte Ryberg]

Some proofreading by our honoured ambassador:

THIS WORLD ASSEMBLY,

RECOGNIZING the importance of ethicality in medical research that involves living human subjects.

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

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

Honoured ambassador, I think "ethicalness" might be the word you were looking for.
Actually, ignore that: "ethicality" should work fine as pointed out by the honoured ambassador from Urgench. Apologies for being a bit strict on the dictionary.

REQUIRES all prospective researchers to provide the following documentation to an Institutional Review Board, 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.

"Reviewed" may be a better word than "Reapproved" in our opinion.

PROVIDES for the allowance of Regional Institutional Review Boards in regions with 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 either to use an IRB operating in their institution, their nation, or their region. Any of these IRB’s can provide clearance to continue research.

No need for an apostrophe here. "IRBs" should do the trick.

After such edits, the text would be about 3 characters below the limit so you might need to consider brevity if possible. For example, you could say:

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

Then all subsequent references to a Institutional Review Board can be compressed to the acronym IRB. For example: "The regional IRB" or "All IRBs in member states". This should save a few more characters without compromising quality.

Submitted for consideration by the honoured ambassador from Quadrimmina,

[Urgench]

Honoured ambassador, I think "ethicalness" might be the word you were looking for.

No your Excellency, "ethicality" is a far more appropriate and properly formed word, "ethicalness" is not. Though neither is particularly elegant.


Yours,

[Charlotte Ryberg]

Honoured ambassador, I think "ethicalness" might be the word you were looking for.

No your Excellency, "ethicality" is a far more appropriate and properly formed word, "ethicalness" is not. Though neither is particularly elegant.

Yours,

I think I might have been too strict on the dictonary. Please accept my apologies, your Excellency.

Yours,

[Quadrimmina]

The suggestions of the honored ambassador from Charlotte Ryberg have been taken into consideration and will be incorporated into our final draft. Thank you for your suggestions.

[Quadrimmina]

Our newest proposal has been submitted to the World Assembly for review and vote in the following form:

THIS WORLD ASSEMBLY,

RECOGNIZING the importance of ethical criteria in medical research that involves living persons.

REALIZING that the lack of a common rule of medical research regulation can lead to various rights violations in the name of scientific progress.

UNDERSTANDING that ethical dilemmas exist in medical research, including but not limited to:
i. Excessive coercion or deception of prospective testing subjects.
ii. Not obtaining proper consent for medical research.
iii. Exploiting weak, undereducated, or emotionally unstable subjects.

DEFINES an Institutional Review Board (IRB) as a board of individuals qualified to impartially analyze medical research proposals.

MANDATES that any entity within a WA nation that performs medical research on any individuals must have this research verified as ethical by an IRB within the nation.

FORBIDS any medical 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, 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.
ii. The subject consent form, which accurately details the study and provides info about contacts for complaints.
iii. Information concerning qualification and contact info of all research personnel.
iv. Information concerning the types and number of subjects needed and how they are chosen.

FURTHER REQUIRES that research must be reviewed every year by an IRB. If the research is not approved, termination of the research must occur when all patients can be considered stable for release, and the IRB may take measures to ensure this happens in a timely manner for quick termination.

EVEN FURTHER REQUIRES that the IRBs, whether they be public or private, be free from political pressure in their review of research.

ALLOWS the creation of Regional IRBs by treaty 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. Cause participation that is not a result of an informed, impartial, and rational decision to provide consent.
ii. Cause death, serious injury, or significant physical or psychological damage to a subject.
iii. Involve nonconsensual experimentation on war prisoners.

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 rights of people, medical ethics, and international and national law. If a country's IRB system is found to be inadequate or ineffective, the MREB will have the ability to shut it down and refer that country’s research to its regional IRB or, failing this, usurp its responsibility until that country’s system is acceptable.

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

GUARANTEES that national policy concerning the legal rights removed from a person by due process of law is not grounds for dismissal of that nation’s IRB law by the MREB.

[Poree]

The Poree people and the JG Region can support the proposal as it is now.

Well done on the review and edits.

[Quelesh]

I regret that I was not present for the discussion before this proposal was resubmitted. I cast my region's delegate votes in favor of the previous proposal; however, I have reservations about the following clause:

GUARANTEES that national policy concerning the legal rights removed from a person by due process of law is not grounds for dismissal of that nation’s IRB law by the MREB.

What exactly does this mean? Does "dismissal of [a] nation's IRB law by the MREB" mean the MREB "usurp[ing a country's IRB system's] responsibility until that country’s system is acceptable"?

If so, does this mean that, for example, a nation conducting nonconsensual (and possibly physically and psychologically harmful) medical research on prisoners (and that country's IRBs allowing it, or the country's law being written as such that IRB approval is not necessary for medical research on prisoners) is not grounds for the MREB stepping in and terminating the research?

If this is the case, the revised proposal would essentially specifically allow nations to conduct nonconsensual medical research (even harmful research so long as it does not conflict with another WA resolution) on prisoners, or any other people that the nation's "due process of law" (which is severely open to interpretation) decides do not have rights. In my view this would be a radical, and unwelcome, change from the first proposal.

[Quadrimmina]

I regret that I was not present for the discussion before this proposal was resubmitted. I cast my region's delegate votes in favor of the previous proposal; however, I have reservations about the following clause:

GUARANTEES that national policy concerning the legal rights removed from a person by due process of law is not grounds for dismissal of that nation’s IRB law by the MREB.

What exactly does this mean? Does "dismissal of [a] nation's IRB law by the MREB" mean the MREB "usurp[ing a country's IRB system's] responsibility until that country’s system is acceptable"?

If so, does this mean that, for example, a nation conducting nonconsensual (and possibly physically and psychologically harmful) medical research on prisoners (and that country's IRBs allowing it, or the country's law being written as such that IRB approval is not necessary for medical research on prisoners) is not grounds for the MREB stepping in and terminating the research?

If this is the case, the revised proposal would essentially specifically allow nations to conduct nonconsensual medical research (even harmful research so long as it does not conflict with another WA resolution) on prisoners, or any other people that the nation's "due process of law" (which is severely open to interpretation) decides do not have rights. In my view this would be a radical, and unwelcome, change from the first proposal.

The delegation from Quelesh is thanked for their questioning concerning the proposal currently waiting delegate votes to be placed on the WA floor. You are partially correct when you say that's what it means. The MREB, in dismissing national IRB laws, would be able to either refer all research from that nation to a Regional IRB or usurp the responsibility for itself. However, an IRB still cannot allow research that causes physical or psychological harm of an egregious scale. However, whether or not consent is required for medical research by prisoners is the business of independent nations. However, if this research is harmful to the prisoner, then by the appeals process for withdrawal will allow the prisoner to withdraw from the study. At the same time, national sovereignty must be maintained by any proposal, as shown by a good number of the opponents to the first draft. Also, the IRBs must reject research that might "cause participation that is not a result of an informed, impartial, and rational decision to provide consent." Therefore, if a rational person wouldn't consent to it, an IRB would be obligated to deny it. This simply prevents prisoners from refusing to participate in good research, not to refuse to participate in potentially dangerous research that anyone with a brain would decline participation in.

Your concerns are duly noted and I am happy to address any more you have. Thank you.

[Ainocra]

We voted against this the first time around and can see no reason to chage that stance.

This would simply be too great an intrusion on our research and development sectors.