05. Informed Consent

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5 Informed Consent
5.1. [INFORMED] Informed consent is an authorization given by an individual to a third party which acknowledges understanding of all the risks and benefits of a medical procedure, product, or treatment after being given all available information.
5.2. [APPLY] Informed consent shall apply to any medical procedure, treatment, product development, research, investigation, or therapy applied or intended to be applied to any human being at any time.
5.3. [ORGANIZED] An informed consent relationship is required any time a branch of the government, a corporation, a medical practitioner, or an organized group of persons intends or effects conveyance of information to a single person or group of persons about any medical treatment, product, therapy, or procedure. An individual, considered to be expressing opinion, not affiliated with any of the aforementioned entities, shall be exempt from this requirement.
5.4. [PERSON] No person shall have their free speech limited, dictated, or prescribed with regards to providing informed consent.
5.5. [MINIMUM] At a minimum, informed consent shall be provided in at least the following:
5.5.1. Medical government regulations, rules, laws, mandates.
5.5.2. Medical corporate policies.
5.5.3. Medical advertising.
5.5.4. Medical research and/or development.
5.5.5. Medical investigations.
5.5.6. Medical education.
5.5.7. Medical training.
5.5.8. Medical advocacy.
5.6. [CRIME] It is felony for any government servant, person(s) of a corporation, or medical practitioner to misrepresent the safety or effectiveness of a medical treatment, procedure, or product.
5.7. [WAIVE] No informed consent, whether oral or written, may include any exculpatory language through which the patient is made to waive, or appear to waive, any of the patient’s legal rights or which releases, or appears to release, the entity giving informed consent from liability for malfeasance.
5.8. [INFORMATION] No person or group of persons may be influenced, coerced, threatened, incentivized, mandated, ordered, or otherwise limited in any way, by any corporation, government, person, or group of persons, from contributing data to any government health information system.
5.9. [HIDE] It is a felony for any person(s), corporation, or government to withhold any information which characterizes a medical treatment, procedure, product, or policy as dangerous or injurious from the general public.
5.10. [INDIVIDUAL] Individual Informed Consent shall be the ultimate authority on the application of any medical procedure, product, or treatment. No government, government agency, corporation, group of persons, or other person may preempt an individual’s right to consent or revoke consent.
5.11. [FREELY] Informed consent must be given freely.
5.11.1. A person may not be coerced, incentivized, punished, limited, manipulated, deceived, or treated differently to achieve informed consent.
5.11.2. The information that is given to the person or the representative shall be in language understandable to the person or the representative.
5.11.3. A person must be informed. A government or corporation providing any medical information contributes to being informed but any entity providing such information remains legally liable for what they claim or fail to claim, even after informed consent is given, understanding the possibility that information may be selectively given in order to achieve a desired outcome. The risk of liability shall be weighed against the entirety of the entity giving informed consent or contributing to it. A government and a medical professional is required to present the aggregate of all available knowledge about the medical treatment or product. Any government, corporation, or medical professional that is identified as having the opportunity to gain new information which is later not distributed to the patient or person or persons, shall be considered in violation of this Act.
5.11.3.1. The most basic elements of being informed include:
5.11.3.1.1. The nature of the treatment.
5.11.3.1.2. The expected benefits.
5.11.3.1.3. The risks and possible side effects.
5.11.3.1.4. The likely consequences of not having the treatment or intervention.
5.11.3.1.5. Any alternative courses of action or treatment.
5.11.3.1.6. Any legal immunity and legal liability that a medical practitioner, government, or manufacturer has in relation to a treatment or medical product.
5.11.4. The person must be capable of giving informed consent. Even if given all available information, the patient has not provided informed consent if they did not understand the information presented. The person must be able to understand the consequences of accepting or rejecting the treatment or use of a medical product.
5.11.5. Consent may be retracted by the person at any time. Any government, corporation, or medical practitioner involved in the informed consent process shall not be immune from criminal violation of this Act if it is later determined that all possible informed consent was not provided.
5.12. [SYSTEM] Congress shall establish and maintain an information system allowing patients or healthcare professionals to document any product which has caused permanent dysfunction, dysfunction exceeding 3 days, or any death, whether causally correlated, temporally correlated, or believed/presumed by a health professional, patient, or any individual associated with that individual.
5.13. [DATABASE] The U.S. Government shall maintain a centralized database of all patient feedback of treatments or medical products from clinical trials, pre-approval use, and post approval use, which will be provided prominently to every patient seeking informed consent about any treatment or medical product.
5.13.1. The database shall not be censored. All patient inputs must be retained in their entirety.
5.13.2. Submissions to the database must be made immediately available via electronic dissemination (website) in their entirety.
5.13.3. Any other database, public or private, containing this data, must simultaneously provide this input data to the government system within 24 hrs of original submission, subject to all the same restrictions aforementioned.
5.13.4. No other system may exist which is intended to dilute reporting to the government system. A system which does not provide data to this system is considered a diluting system.
5.13.5. Any other information system collecting feedback about treatments or medical products shall prominently display information educating the user about the government central reporting system and clearly stating that it is the primary system. This notification shall exist prominently when the user first enters the system and will be displayed persistently in a diminutive fashion subsequently.

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