Post by Hockeynutville on Mar 8, 2010 0:49:37 GMT -5
Universal Clinical Trials Act
A resolution to reduce income inequality and increase basic welfare.
A resolution to reduce income inequality and increase basic welfare.
Category: Social Justice
Strength: Mild
Proposed by: Revolutionist Britain
Description: This World Assembly,
BELIEVING that clinical drug trials are essential to safe research and development of medication;
RECOGNISING that drugs which are initially tested before use are safer and more beneficial to the world healthcare system;
WISHING to create a uniform system, recognised by all WA-Nations, which can harmonise the system of drug trials across the world to improve medication therapy for the benefit of humanity.
Hereby:
REQUIRES Clinical Trials to be conducted along these lines;
1) Clinical Trials must have a placebo to be trialled alongside the actual drug, to counteract any possible psychosomatic interefence. These will then be trialled alongside a Control group, who receive no drug at all, to measure it's effects. Other formats of trials (variants of doses, comparisons of similar drug therapy options) will also be valid within this clinical framework.
2) Trials must be conducted in a Double Blind format, whereby neither the test subject, nor the person administering the drug is aware if the subject is taking a drug, or a placebo, in order to negate any influence from healthcare professionals, deliberate or otherwise.
3) All participants in Clinical Trials must have given their consent to be included in the trial.
4) All participants in a Clinical Trial must be made fully aware of any and all possible risks associated with the drug being trialled. Participants who wish to leave a trial, having been fully briefed of the side effects will be free to do so, subject to possible forfeiture of any possible monies earned for their participation.
5) Any persons who by way of age, disability, or mental competence are unable to give consent for the trial themselves, may be able to have a parent, guardian or ward of the court enter a consent on their behalf, if it is shown that there is a benefit to them participating in the trial.
CREATES the Clinical Excellence Commission (CEC), with the authority of overseeing clinical trials are conducted along these guidelines, compiling all unedited trial results and storing them for access from any state or healthcare authority, along with holding enquiries into any potential malpractice;
MANDATES that Clinicians or Nations may apply for exemptions from the regulations to the CEC, but such matters would have to be reviewed on a case by case basis and if any exemptions are granted, it will be due to extreme extenuating circumstances.
RECOMMENDS that the CEC work alongside health authorities of individual member states, in order to promote clinical trial standards and improve the harmony of healthcare across the nations of the World Assembly;