[DEFEATED] Medical Research Ethics Act

[Quadrimmina]

EDIT: The proposal below is the original. The current proposal can be found here:http://forum.nationstates.net/viewtopic.php?f=9&t=46420&p=1973118#p1973118

Medical Research Ethics Act

Human Rights -> Significant

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.

FURTHER REALIZING that this lack of a unifying code 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 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 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.

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.

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

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.

MANDATES that the Institutional Review Boards reject any proposal that they reasonably believe may do the following:
i. Involve deception of test subjects to the extent that a reasonable test subject would otherwise refuse to participate in the research.
ii. Involve tests that can be reasonably considered to cause death, serious injury, or physical or psychological damage.
iii. Involve coercion of test subjects to the extent that their participation in the study could not be a result of an informed, impartial, and rational decision.

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.

[Krioval]

Universal Clinical Trials Act seems to have covered much of this ground.

Aleksei-kan Volkov
Imperial Chiefdom of Krioval

[Manticore Reborn]

Universal Clinical Trials Act seems to have covered much of this ground.

Aleksei-kan Volkov
Imperial Chiefdom of Krioval

The representative from the Kingdom of Manticore Reborn humbly points out to the honored Ambassador from the Imperial Cheifdom of Krioval that the Universal Clinical Trials Act specifically deals with pharmaceutical testing.

The representative from the Kingdom of Manticore Reborn also wishes to protest several clauses of this proposed legislations. Specifically:

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.

Neither of these clauses respect proprietary research which may not be and should not be available for public consumption. The Kingdom of Manticore Reborn categorically objects to forcing it's scientists to provide any documentation which may hinder their competitive advantages.

Further more the following clause is not adequate

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.

What if the study/test treatment is incomplete and such state is harmful to the subject? What if completion of the testing is the only way to insure that the subject will be able to resume a normal and healthy life?

The Kingdom of Manticore Reborn believes this proposal to much too specific and humbly suggests that the focus should be on genetic manipulation to deprive sapient individuals of their guaranteed rights or the creation of individuals who would not fall within the definition of sapience and would therefore not be subject to the various anti-slavery and basic human rights guaranteed under various other resolutions that are already in existence.

[Quadrimmina]

The Kingdom of Manticore Reborn believes this proposal to much too specific and humbly suggests that the focus should be on genetic manipulation to deprive sapient individuals of their guaranteed rights or the creation of individuals who would not fall within the definition of sapience and would therefore not be subject to the various anti-slavery and basic human rights guaranteed under various other resolutions that are already in existence.

The Quadrimminnan Ambassador to the WA requests additional clarification as to the suggestions offered by the Kingdom of Manticore Reborn.

[Kryozerkia]

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

[Quadrimmina]

Not at all, my original draft protected the lives of all sapient beings. However, considering the best topic for this proposal was "Human Rights", I had to tailor my proposal to fit that.

[Charlotte Ryberg]

The honoured ambassador from Charlotte Ryberg, holding the one-billion-B-pengo note from a unknown nation on her hand, wondered: wouldn't be simpler if we had a freedom of science resolution: a resolution that would allow the freedoms of all kinds of science research in one resolution? Sadly, some good resolutions may have to be repealed, but I think a unified resolution might be better in my opinion.

[Manticore Reborn]

The honoured ambassador from Charlotte Ryberg, holding the one-billion-B-pengo note from a unknown nation on her hand, wondered: wouldn't be simpler if we had a freedom of science resolution: a resolution that would allow the freedoms of all kinds of science research in one resolution? Sadly, some good resolutions may have to be repealed, but I think a unified resolution might be better in my opinion.

Hear, hear

[Kryozerkia]

Not at all, my original draft protected the lives of all sapient beings. However, considering the best topic for this proposal was "Human Rights", I had to tailor my proposal to fit that.

Even if it is "human rights", you can get around it by not using the word human and opting instead for citizens or something similar.

[Quadrimmina]

Not at all, my original draft protected the lives of all sapient beings. However, considering the best topic for this proposal was "Human Rights", I had to tailor my proposal to fit that.

Even if it is "human rights", you can get around it by not using the word human and opting instead for citizens or something similar.

Thank you for the suggestion. The change will be made in the next draft. Are there any other objections you may have concerning this proposal?

[Bears Armed]

Not at all, my original draft protected the lives of all sapient beings. However, considering the best topic for this proposal was "Human Rights", I had to tailor my proposal to fit that.

Even if it is "human rights", you can get around it by not using the word human and opting instead for citizens or something similar.

"I prefer the broader term "people" in this context, because actual "citizenship" isn't necessarily held by everybody within all of the WA's member nations... although I strongly suspect that, even so, some nations will still claim that 'Human Rights' resolutions by definition apply only to Humans and thus that the reference to "citizens/people/whatever" in this proposal would still apply only to those Humans who fall into that category..."



Borrin o Redwood,
Chairbear, Bears Armed Mission.


(OOC: Yes, I am aware that some players -- possibly even including some Mods -- regard the 'Human Rights' category as covering all sapient beings [by default] anyway... However, the fact that several proposals extending rights to sapient non-humans have been drafted -- and in some cases submitted, even brought to vote -- without getting Mod-dismissed as "redundant" would seem to me to indicate that this is not "officially" the case...)

[Quadrimmina]

The honoured ambassador from Charlotte Ryberg, holding the one-billion-B-pengo note from a unknown nation on her hand, wondered: wouldn't be simpler if we had a freedom of science resolution: a resolution that would allow the freedoms of all kinds of science research in one resolution? Sadly, some good resolutions may have to be repealed, but I think a unified resolution might be better in my opinion.

It should be noted that the honored ambassador from Charlotte Ryberg's proposal is one that would be a considerable feat for the World Assembly and its many nations. However, it must also be noted that to successfully complete this would require a coalition of nations to pass the multiple proposals. Unless the WA has Deem and Pass?

[Quadrimmina]

We have decided after the suggestions of Manticore Reborn and Charlotte Ryberg to make this an omnibus research ethics proposal. If there is anything else that is felt needs to be added, please let me know either in this forum or via telegram. Our current proposal with the additions requested is below:

Medical Research Ethics Act

Human Rights -> Significant

THIS WORLD ASSEMBLY,

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 unifying code 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 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 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.

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.

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

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.

MANDATES that the Institutional Review Boards reject any proposal that they reasonably believe may do the following:
i. Involve deception of test subjects to the extent that a reasonable test subject would otherwise refuse to participate in the research.
ii. Involve tests that can be reasonably considered to cause death, serious injury, or physical or psychological damage.
iii. Involve coercion of test subjects to the extent that their participation in the study could not be a result of an informed, impartial, and rational decision.

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.

REQUIRES that any research involving living subjects for the purpose of inducing reproduction or in other ways reproducing life to provide human rights to the reproduced species.



The Quadrimminan Ambassador to the WA
Quadrimmina Ministry of Foreign Affairs

[The Masked Ambassador]

The idea is a better one, but here is the problem I see, which appears clearly in this clause:

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.

Basically, the proposal determines the necessity of all WA nations to have Institutional Review Boards, but each of them can operate as they see fit, with no other international rules. Each of them can have their own judgement about each research, guided by just concepts in which they should reject a research or support it. So the only thing that is really mandated by this resolution is the existence of this boards.

[Quadrimmina]

The idea is a better one, but here is the problem I see, which appears clearly in this clause:

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.

Basically, the proposal determines the necessity of all WA nations to have Institutional Review Boards, but each of them can operate as they see fit, with no other international rules. Each of them can have their own judgement about each research, guided by just concepts in which they should reject a research or support it. So the only thing that is really mandated by this resolution is the existence of this boards.

This is very true, but there are two problems with your statement. The first one is that only WA nations that wish to have medical research need have IRB's, as seen in this clause:

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 Institutional Review Board within the nation.

Also, they can operate them as they see fit, so long as those boards follow the mandates below:

MANDATES that the Institutional Review Boards reject any proposal that they reasonably believe may do the following:
i. Involve deception of test subjects to the extent that a reasonable test subject would otherwise refuse to participate in the research.
ii. Involve tests that can be reasonably considered to cause death, serious injury, or physical or psychological damage.
iii. Involve coercion of test subjects to the extent that their participation in the study could not be a result of an informed, impartial, and rational decision.

The issue with IRBs tends to be how to run the extensive IRB system in a nation. Also, I tried to make this proposal in such a way that it wouldn't be one-size-fits-all. At the same time, the following addition is being considered by my government:

"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 in violation of any of these conceptions, the MREB will have the ability to shut down national IRBs and take over until a suitable replacement is implemented."

Another concern that has been entered into our Senate's debate of this research is specifically that non-WA nations would be stuck with the upper hand in research, due to their not being caught in a binding resolution to ensure ethics in research. Is this a considerable problem in the minds of any nation?

[Sionis Prioratus]

AT VOTE bump.

[Manticore Reborn]

The Kingdom of Manticore Reborn wishes to lodge its' No vote as the following clause is insufficent to protect those whom this resolution is supposed to aid:

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

The Kingdom of Manticore Reborn is displeased to note that there is no a clause insuring that such termination would not be detrimental to the wellbeing of the test subject. If the consent is rescinded at a time with testing is incomplete, the subject may not be able to resume a normal life. This clause needs to be expanded to state termination can only be allowed when the life/wellbeing of the test subject is not in jeopardy.

The Representative from the Kingdom of Manticore Reborn is disappointed that his previous objection to this clause was not heeded.

Respectfully,
Hamish Alexander, Thirteenth Earl of White Haven

[Dwennimmen]

Dwennimmen will vote Against this Issue because of this paragraph:

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

In Dwennimmen, criminals which have performed multiple serious crimes and are over the age of 40 are stripped from the majority of their human rights, except for the right to live (since we make sure that they all live a long life, no matter what horrible crimes they committed). Those criminals would be classified as "living citizens" and therefore would receive far more rights than the representatives of Dwennimmen believe they deserve to have.

[Tzorsland]

"The Rani will hate me, but I don't care. Tzorsland votes AYE. Now if you will excuse me, I will leave this chamber before The Rani sneaks in a dozen T-Rexes just for spite."

"On the other hand, it this passed ages ago, werepenguins would not exist."

*exits the chamber*

*Suddenly, from a round mirror on the far wall, which you can't recall being there the last time you checked, a T-Rex pops out, followed by another, and another and another.*

[Essex and Cromwell]

The Free Land of Essex and Cromwell has an objection to the optional termination of a medical experiment due to the possibility of extension to psychological experiments.

[Schelloy]

Let me first point out that this bill, although calling itself an "Ethics Act" fails to spend more than two sentences on the incredibly complex idea of 'ethics,' and that alone is enough to earn a nay from me.

Second, the term 'Medical Research' appears to be missused in this case. What is commonly referred to as Medical Research is comprised of two main aspects: Research and Clinical Trial. Thus, the technical application of the term "Medical Research" applies only to raw science of laboratory research (i.e. chemical synthesis, molecular conversion, and tissue sample reactions). Therefore, I believe the terms of this bill should be clarified so as to the area of Clinical Trial, which is the only area where a living human would be involved as a test subject.

Third, assuming the above, this bill does not allow for a person to wave article ii. of the mandate section. The result will prohibit a living person from willingly donating their body postmortem to medical research, as it can be assumed that any person can reasonably believe that work done with the body will result in significant physical damage to the subject.

Lastly, the creation of the 'Medical Research Ethics Board' and its suggested powers is an attempt at homogeneity (I am, of course, assuming that no other bill already does that).

In order to solve these four objections, it would be my recommendation to divide the current bill into two new bills. The first bill would tackle the difficult subject of Medical Ethics: it must limit itself to the Medical aspect of ethics dealing solely with humans so as to avoid most of the common variations in ethical considerations. The second bill would do the work of limiting the scope of clinical trials as well as the behavior of research clinicians.

[Sumdull]

The Republic of Sumdull sees no reason to vote against this resolution. Each nation is allowed to regulate its own IRB, granting great freedom in how this is carried out from nation to nation. Many of the tenets of the resolution are necessary to ensure we function as a civilized society.

[New Rockport]

I have been instructed to vote against this resolution due to a loophole in the following mandate:

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.

(emphasis added)

What about immigrants who choose not to apply for citizenship and choose to remain resident aliens? Such people are not citizens and, for the most part, are not prisoners. Nor are they denied citizenship. Such persons would be denied the protection of this resolution.

-Silvana Rossi
Ambassador to the General Assembly
Federal Republic of New Rockport

(OOC: I apologize for not noticing this when the resolution was being drafted. Other matters have kept me away from the NS fora for the past several days.)

[Urgench]

I have been instructed to vote against this resolution due to a loophole in the following mandate:

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.

(emphasis added)

What about immigrants who choose not to apply for citizenship and choose to remain resident aliens? Such people are not citizens and, for the most part, are not prisoners. Nor are they denied citizenship. Such persons would be denied the protection of this resolution.

No they would not, the CoCR would prevent such an outcome, ensuring as it does that all laws, including WA ones, are applied without such unfair discrimination to all inhabitants of member states.


The Confederated Sublime Khanate of Urgench has voted against this statute.


Yours,

[Diatraba]

Not at all, my original draft protected the lives of all sapient beings. However, considering the best topic for this proposal was "Human Rights", I had to tailor my proposal to fit that.

Even if it is "human rights", you can get around it by not using the word human and opting instead for citizens or something similar.

Mr. Speaker: Order. I shall uphold the Honourable Weasel's point - the first line of this resolution alone uses the word "human subjects". Under (albeit unwritten) ethics laws, surely resolutions must take non-human members into account? For example, the Diaspora Church of The Eternal Kwaii - they would be left out by a resolution which is meant to encompass all members - they would also feel that the Author of this Resolution is biased against their nation and others like them (I also quote Kryozoreka as an example). Therefore, even though I am meant to be an impartial officer, I withdraw my support for this Resolution.

M. le Président: Commande. Je vais défendre le point de la belette honorable - la première ligne de cette résolution seul utilise le mot «sujets humains». En vertu de (quoique non écrite) des lois d'éthique, sûrement résolutions doivent prendre les membres non-humains en compte? Par exemple, l'Église de la diaspora Le Kwaii Eternelle - ils seraient laissés de côté à une résolution qui vise à englober tous les membres - ils trouvent aussi que l'auteur de cette résolution est un parti pris contre leur nation et d'autres comme eux (je cite Kryozoreka titre d'exemple). Par conséquent, même si je suis censé être un agent impartial, je retire mon soutien à cette résolution.

Sr. Presidente: Orden. Voy a defender el punto de la comadreja Honorable - la primera línea de la presente resolución sólo usa la palabra "seres humanos". En virtud (aunque no escrita) las leyes de ética, seguramente resoluciones deben llevar a los miembros no humanos en cuenta? Por ejemplo, la Iglesia de La Diáspora Kwaii Eterna - que quedaría fuera por una resolución que pretende abarcar todos los miembros - que también consideran que el autor de esta resolución está sesgado en contra de su nación y otros como ellos (yo también citan Kryozoreka como ejemplo). Por lo tanto, a pesar de que estoy destinado a ser un funcionario imparcial, retiro mi apoyo a esta Resolución.

An tUasal Cainteoir: Ordú. Beidh mé ag seasamh leis an bpointe arna ndéanamh ag na Ballstáit Onórach - an chéad líne an rún seo amháin a úsáideann an focal "na hábhair daonna". Faoi (cé nach bhfuil scríofa fós) reachtaíochta eitice, ní mór do na rúin a ghlacadh comhaltaí neamh-daonna san áireamh? Mar shampla, an Eaglais Diaspóra de na Kwaii Shíoraí - bheadh iad a fhágáil amach le rún a chiallaíonn go gcuimseofar gach ball - bhraitheann siad a bheadh chomh maith go bhfuil an Údar an Rúin seo go mbíonn siad claonta i gcoinne a náisiún agus daoine eile mar iad (I freisin ceanglófar Kryozoreka mar shampla). Dá bhrí sin, cé mé i gceist chun bheith ina oifigeach neamhchlaonta, a tharraingt siar mé mo thacaíocht don Rún seo.