[PASSED] Medical Research Ethics Act

[Quadrimmina]

Medical Research Ethics Act
Category:Human Rights
Strength:Significant

THIS WORLD ASSEMBLY,

RECOGNIZING the importance of medical research in a world where new discoveries save lives every day.

HOWEVER, REALIZING that medical research can be performed unethically, and cause permanent harm to the subject, sometimes without consent.

UNDERSTANDING that ethical dilemmas exist in medical research, includingo:
i. Excessive coercion or deception of prospective testing subjects.
ii. 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.

REQUIRES 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.

ALLOWS WA nations to regulate their own IRB system, with all research accountable to some IRB, be it public or private.

ESTABLISHES that all prospective researchers must 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 subjects and how they are chosen.

FURTHER ESTABLISHES 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.

URGES 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.

ENSURES 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 preventable death, serious injury, or significant physical or psychological damage to a subject.

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.

ENSURES 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, so long as such research could not be dismissed in any other context enumerated above.

DECLARES that war prisoners must never be experimented upon.

THIS WORLD ASSEMBLY,

RECOGNIZING the importance of medical research in supporting the body of knowledge in the field of medicine and improving the quality of life for all peoples.

REALIZING that medical research can be performed unethically, and cause permanent harm to the subject, sometimes without consent.

UNDERSTANDING that ethical dilemmas exist in medical research, including:
i. Excessive coercion or deception of prospective testing subjects.
ii. 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.

DECLARES that the use of prisoners of war for medical research is strictly forbidden.

REQUIRES WA member nations to create and regulate an IRB system, or by treaty to create an IRB system in conjunction with other WA member nations for collaborative scientific research efforts, to provide for nations that do not have a high amount of medical research or where establishing an IRB would be prohibitively expensive to the nation.

FURTHER REQUIRES that any entity within a WA nation that performs medical research on any individuals must have this research verified as ethical by the IRB to which their nation subscribes.

ESTABLISHES that all prospective researchers must provide the following documentation to the IRB:
i. A protocol that defines the purpose of the study, the methods to be used, the expected results and procedures in the event the trial has a negative impact on one or more trial subjects.
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 subjects and how they are chosen.
v. Additional documentation as determined by national law.


FURTHER ESTABLISHES 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.

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


ENSURES that WA nations regulate issues regarding consent of individuals and how that consent can be responsibly terminated.

Co-Authored by Manticore Reborn

[Goddess Relief Office]

DECLARES that war prisoners must never be experimented upon in the nation in which they are held prisoner.

There is a loophole in the above sentence. If a POW is held on foreign soil, they could be experimented upon. (Recall reports about CIA abusing prisoners on planes and in Pakistan and Egypt after they were prevented from doing so on US soil). I suggest just closing the loophole entirely and say "DECLARES that war prisoners must never be experimented upon." (fullstop).

The other sections look good.

[Quadrimmina]

True, thanks for the input. I will have to recall my proposal to change that, but it will be done.

[Embolalia]

I think #82 already covers this.

Also, for what it's worth, my usual convention for thread titles is [DRAFT] when it's still being edited, and then changed to [SUBMITTED] when it has been officially submitted to the WA. (That is, it can no longer be edited unless it fails to reach quorum) Then, if it gets quorum, I change it to [IN QUEUE] while it waits for vote. If my proposal turns out to be illegal or unsupportable, I change the title to [WITHDRAWN], so that people don't keep bumping it up. I think that reduces confusion.

[Quadrimmina]

I think #82 already covers this.

Also, for what it's worth, my usual convention for thread titles is [DRAFT] when it's still being edited, and then changed to [SUBMITTED] when it has been officially submitted to the WA. (That is, it can no longer be edited unless it fails to reach quorum) Then, if it gets quorum, I change it to [IN QUEUE] while it waits for vote. If my proposal turns out to be illegal or unsupportable, I change the title to [WITHDRAWN], so that people don't keep bumping it up. I think that reduces confusion.

Of course. I just forgot to change it back to DRAFT when I withdrew my submission.

And regarding GA#82, its just clinical trials. This is standards for all research. Also, it went to vote after GA#82 was passed without Mod objection already.

[Manticore Reborn]

The Ministry for Heath of the Kingdom of Manticore Reborn has reviewed this proposal. After consultations with various legal experts my government presents the following adjusted legislation:

Medical Research Ethics Act
Human Rights, Significant

THIS WORLD ASSEMBLY,

RECOGNIZING the importance of medical research in supporting the body of knowledge in the field of medicine and improving the quality of life for all peoples

REALIZING that medical research can be performed unethically, and cause permanent harm to the subject, sometimes without consent.

UNDERSTANDING that ethical dilemmas exist in medical research, including:

i. Excessive coercion or deception of prospective testing subjects.
ii. 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.

DECLARES that the use of prisoners of war for medical research is strictly forbidden

REQUIRES WA member nations to create and regulate an IRB system, or by treaty to create an IRB system in conjunction with other WA member nations for collaborative scientific research efforts, to provide for nations that do not have a high amount of medical research or where establishing an IRB would be prohibitively expensive to the nation

FURTHER REQUIRES that any entity within a WA nation that performs medical research on any individuals must have this research verified as ethical by the IRB to which their nation subscribes

ESTABLISHES that all prospective researchers must provide the following documentation to the IRB:

i. A protocol that defines the purpose of the study, the methods to be used, the expected results and procedures in the event the trial has a negative impact on one or more trial subjects.
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 subjects and how they are chosen.
v. Additional documentation as determined by national law

FURTHER ESTABLISHES 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.

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

ENSURES that WA nations regulate issues regarding consent of individuals and how that consent can be responsibly terminated

We eagerly await debate and suggestions to improve this proposal.

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

[Quadrimmina]

The Republic of Quadrimmina has reviewed the revised proposal and approves it. We consider it to be a just change given the absence of the MREB and note that without it, it bears many similarities to our Witness Protection Act.

We thank the delegation from Manticore Reborn for their diligence in editing our proposal and presenting it to the WA.

[Quadrimmina]

Medical Research Ethics Act
Human Rights, Significant

THIS WORLD ASSEMBLY,

RECOGNIZING the importance of medical research in supporting the body of knowledge in the field of medicine and improving the quality of life for all peoples

REALIZING that medical research can be performed unethically, and cause permanent harm to the subject, sometimes without consent.

UNDERSTANDING that ethical dilemmas exist in medical research, including:

i. Excessive coercion or deception of prospective testing subjects.
ii. 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.

DECLARES that the use of prisoners of war for medical research is strictly forbidden.

REQUIRES WA member nations to create and regulate an IRB system, or by treaty to create an IRB system in conjunction with other WA member nations for collaborative scientific research efforts, to provide for nations that do not have a high amount of medical research or where establishing an IRB would be prohibitively expensive to the nation.

FURTHER REQUIRES that any entity within a WA nation that performs medical research on any individuals must have this research verified as ethical by the IRB to which their nation subscribes.

ESTABLISHES that all prospective researchers must provide the following documentation to the IRB:

i. A protocol that defines the purpose of the study, the methods to be used, the expected results and procedures in the event the trial has a negative impact on one or more trial subjects.
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 subjects and how they are chosen.
v. Additional documentation as determined by national law.

FURTHER ESTABLISHES 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.

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

ENSURES that WA nations regulate issues regarding consent of individuals and how that consent can be responsibly terminated.

Co-authored by Manticore Reborn.

The World Assembly Delegation of the Republic of Quadrimmina has reviewed the proposal of the delegation from Manticore Reborn and has referred it to the Ministry of Health and Wellness, as well as the Ministry of Scientific Research. Both have declared their overwhelming support for this measure, as do I and as does Chancellor Forge. We back the resolution as amended by Manticore Reborn's delegation and await further comments from our colleagues concerning this resolution.

[Quadrimmina]

This is a gentle reminder that everyone should vote today before the Act is gone!

[South-Western Dakota]

Before I place my ballot I must enquire as how this affects Death Row prisoners? As it is a very common practice to use the condemned to die as medical test subjects it holds a significant effect upon our nations medical research
-Capo Crescenzo

[Manticore Reborn]

Before I place my ballot I must enquire as how this affects Death Row prisoners? As it is a very common practice to use the condemned to die as medical test subjects it holds a significant effect upon our nations medical research
-Capo Crescenzo

I would refer the honorable ambassador from South-Western Dakota to this passage:

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

I have underlined the appropriate clause that deals with convicted persons.

[South-Western Dakota]

Before I place my ballot I must enquire as how this affects Death Row prisoners? As it is a very common practice to use the condemned to die as medical test subjects it holds a significant effect upon our nations medical research
-Capo Crescenzo

I would refer the honorable ambassador from South-Western Dakota to this passage:

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

I have underlined the appropriate clause that deals with convicted persons.

Unfortunately I overlooked that passage, my apologies and thanks. Thus, I fully support this resolution.

[Neutonica]

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

This delegate would like to seek clarification on how public IRBs would be free from political pressure. Other than this minor issue, Neutonica fully supports the proposal at hand.

Dr Isaac Corrigan
Delegate of Neutonica

[Manticore Reborn]

Unfortunately I overlooked that passage, my apologies and thanks. Thus, I fully support this resolution.

There is no need to apologize. With the amount of documents we are expected to read each day, it is understandable.

[Manticore Reborn]

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

This delegate would like to seek clarification on how public IRBs would be free from political pressure. Other than this minor issue, Neutonica fully supports the proposal at hand.

Dr Isaac Corrigan
Delegate of Neutonica

The intent here is that the governments of nations should not pressure IRBs to approve/disapprove research for political reasons (i.e. the current government of Nation A doesn't like the idea of Stem Cell Research as they think it is immoral. They should not pressure the IRB to reject any research based on this "political" stance.)

We hope that makes the matter as clear as mud and the humble representative from the Kingdom of Manticore Reborn yields the floor.

[Neutonica]

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

This delegate would like to seek clarification on how public IRBs would be free from political pressure. Other than this minor issue, Neutonica fully supports the proposal at hand.

Dr Isaac Corrigan
Delegate of Neutonica

The intent here is that the governments of nations should not pressure IRBs to approve/disapprove research for political reasons (i.e. the current government of Nation A doesn't like the idea of Stem Cell Research as they think it is immoral. They should not pressure the IRB to reject any research based on this "political" stance.)

We hope that makes the matter as clear as mud and the humble representative from the Kingdom of Manticore Reborn yields the floor.

This delegate understands what "free from political pressure" means. What this delegate fails to see, perhaps because of a lack of a proper pair of spectacles or just plain thickness, is how public IRBs can avoid political pressure.

Thank you, and apologies.

Dr Isaac Corrigan
Delegate of Neutonica

[Manticore Reborn]

This delegate understands what "free from political pressure" means. What this delegate fails to see, perhaps because of a lack of a proper pair of spectacles or just plain thickness, is how public IRBs can avoid political pressure.

Thank you, and apologies.

Dr Isaac Corrigan
Delegate of Neutonica

I must apologize as it was not my intent to assume the honorable Dr. Corrigan didn't understand the phrase. However, how does any public body avoid political pressure? The same could be said of a court system in most nations. In Manticore Reborn, our judges are appointed by the Prime Minister and King. Appointments are of course sometimes politically motivated regardless of our sovereign's desires to chose those most qualified. It is up to the individual judges to keep themselves free from pressure from society and politicians. I foresee a similar situation for any IRB.

[Quadrimmina]

This delegate understands what "free from political pressure" means. What this delegate fails to see, perhaps because of a lack of a proper pair of spectacles or just plain thickness, is how public IRBs can avoid political pressure.

Thank you, and apologies.

Dr Isaac Corrigan
Delegate of Neutonica

I must apologize as it was not my intent to assume the honorable Dr. Corrigan didn't understand the phrase. However, how does any public body avoid political pressure? The same could be said of a court system in most nations. In Manticore Reborn, our judges are appointed by the Prime Minister and King. Appointments are of course sometimes politically motivated regardless of our sovereign's desires to chose those most qualified. It is up to the individual judges to keep themselves free from pressure from society and politicians. I foresee a similar situation for any IRB.

Our delegation, upon presenting this resolution months ago for initial review, also considered the same issue. However, freedom from political pressure is rather subjective, and can't really effectively happen. The original version with the MREB actively prevented this by disbanding IRB systems that were ineffectual. However, currently, it would be an honor system type thing. It's the best the WA can do.

[Neutonica]

This delegate understands what "free from political pressure" means. What this delegate fails to see, perhaps because of a lack of a proper pair of spectacles or just plain thickness, is how public IRBs can avoid political pressure.

Thank you, and apologies.

Dr Isaac Corrigan
Delegate of Neutonica

I must apologize as it was not my intent to assume the honorable Dr. Corrigan didn't understand the phrase. However, how does any public body avoid political pressure? The same could be said of a court system in most nations. In Manticore Reborn, our judges are appointed by the Prime Minister and King. Appointments are of course sometimes politically motivated regardless of our sovereign's desires to chose those most qualified. It is up to the individual judges to keep themselves free from pressure from society and politicians. I foresee a similar situation for any IRB.

This delegate thanks Earl Hamish for his explanation. Neutonica sees the light now.

[Quadrimmina]

Our Republic humbly re-proposes this Act, with the requisite amendments as proposed by the Kingdom of Manticore Reborn. As our first widely-supported resolution, we hope it is something that most delegations will find it favorable.

[Manticore Reborn]

I have been instructed to lodge our continued support for this proposal.

--David Hammerer Adjunct to Earl White Haven who has been recalled to New Manticore for consultations with the King.

[Quadrimmina]

I have been instructed to lodge our continued support for this proposal.

--David Hammerer Adjunct to Earl White Haven who has been recalled to New Manticore for consultations with the King.

Thank you sir. Earl White Haven was instrumental in his ability to help us with this proposal. However, such an ambitious agenda as the one we have presented to the World Assembly will take time to properly do. And we are working for success, not for expediency. We are biding our time until the moment is right.

We take it your nation still accepts the role of coauthor?

[Holy Roman Confederate]

The HRC fully supports this proposal, and commends the author and coauthor on a fantastic proposal.

[New Maadim]

History tells us that institutional review boards rarely ruled against the interests of the institution, and in fact, usually did not meet at all. Their purpose was mostly to provide an appearance of regulation to those who found such things reassuring.

New Ma'adim researchers generally rely on funding directed by individuals from assessments on personal income, administered by the large nonprofit collectives. Thus it is important for researchers to both comply with the nonprofit board's ethical standards and to avoid practices that would deter public funding of the collective as a whole.

Generally the work that you would set side for IRBs is conducted here in a Wiki style forum, in which experts and the general public are invited to participate. Several but not all of the ethical guidelines that you suggest are shared by the New Ma'adim community at large. Votes for approval held after these discussions are often by acclamation, where no opponents request a vote - otherwise a consensus is required from the liasons from all relevant workgroups (including consumer and environmental workgroups). Though liasons rarely choose to cast a negative vote, abstention (whether by absence or failure to vote) is customarily taken as a polite sign of dissent; thus proposals which nominally pass are often abandoned or reworked, in order to avoid potential fallout from taxpayer funding choices. ~~~~

[Manticore Reborn]

Generally the work that you would set side for IRBs is conducted here in a Wiki style forum, in which experts and the general public are invited to participate. Several but not all of the ethical guidelines that you suggest are shared by the New Ma'adim community at large. Votes for approval held after these discussions are often by acclamation, where no opponents request a vote - otherwise a consensus is required from the liasons from all relevant workgroups (including consumer and environmental workgroups). Though liasons rarely choose to cast a negative vote, abstention (whether by absence or failure to vote) is customarily taken as a polite sign of dissent; thus proposals which nominally pass are often abandoned or reworked, in order to avoid potential fallout from taxpayer funding choices. ~~~~

There is nothing in this legislation which would make your current system illegal. This proposal does not state how the IRB must be organized, just that one must exist.