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Statement of ___________________, a Non-consensual Human Subject who resides in _______________to “Opt-Out” or Discontinue Participation in the Human Subject Research/Experiment
Introduction:
In the Bioethics Commission’s report released on December 15, 2011, the Bioethics Commission suggested that to keep track of the more than 55,000 research projects using human subjects, the Federal government should create a central online portal and database where basic information about the projects are archived and made easily accessible and further concluded that it “cannot say that all federally funded research provides optimal protections against avoidable harms and unethical treatment”. The Bioethics Commission also said although human subjects in US government-funded research are generally protected by existing rules and regulations, their safety and well-being could be enhanced with stronger measures, including increased public transparency and a system of compensating subjects who sustain research-related injuries.
Research is defined by the Common Rule regulations as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or
supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” Medical experiment is defined by California Law, Health &
Safety Code Section 24171 as “the severance or penetration or damaging of tissues of a human subject or the use of a drug or device, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice of research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
Human Subject is defined by the Common Rule regulations as “a living individual about whom an investigator (whether professional or student) conducting research obtains either a) data through intervention or interaction with the individual or b) identifiable private information.” Human subject is defined by FDA regulations as “an
individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. Subject [also] means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.”
Human subject research should adhere to the ethical principles and guidelines for the protection of human research participants summarized in the uniform set of regulations, called the Federal Policy for the
Protection of Human Subjects, 45 CFR 46, Subpart A, formally known as the “Common Rule.” The 45 CFR 46 regulations are based in large part on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research. Today, 45 CFR 46, Subjects A and E: Registration of Institutional Review Boards (added 1/15/2009) is shared by 17 Departments and Agencies, representing most, but not all, of the Federal Departments and Agencies sponsoring human subjects research. Many of them have not adopted Subpart B: Additional Protections for Pregnant Women, Human Fetuses & Neonates Involved in Research, Subpart C: Additional Protections Pertaining to Biomedical & Behavior Research Involving Prisoners as
Subjects, or Subject D: Additional Protections for Children Involved as Subjects in Research. For the past 20 years, 45 CFR 46, have been considered merely “guidelines” and is not a lawfully, promulgated regulation.
Before a research project involving human subjects is initiated, it must be reviewed and approved by an Institutional Review Board (IRB). The IRB has a central role in ensuring that all human subject research is planned and conducted in an ethical manner, and in compliance with federal, state and local regulations. The major responsibilities of the IRB are to assess the risks and benefits of proposed research and to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
Statement of ___________________, a Non-consensual Human Subject who resides in _______________to “Opt-Out” or Discontinue Participation in the Human Subject Research/Experiment
Request to “Opt-Out” or Discontinue Participation as a “Non-consensual” Human Subject
Section I.**Include a couple of lines about your background and a short introduction about yourself.***
I, _____________________ believe I may have been randomly selected as a participant, or human subject, in a research/experiment without my voluntary, informed consent, either orally or written and without my knowledge. I met the definition of being a human subject in a research/medical experiment.
I am being tracked, tortured, monitored, & targeted with information & communications technology by my fellow American citizens.
____________________________________________________
I am being tracked, tortured, monitored, & targeted with information & communications technology by my fellow American citizens.
________________________________________________________________
In the National Institutes of Health, Office for Protection from Research Risks (OPRR) 1993 Institutional Review Board Guidebook states, “attention should be paid to subjects' rights when they decide to withdraw from participation in the study. The federal regulations clearly require that subjects be free to withdraw from participation without penalty or loss of benefits to which they are otherwise entitled [Federal Policy §116(a)
(8)].”
In addition, the National Commission for the Protection of Human Subjects believed that those who are already burdened (e.g., by disabilities or institutionalization) should not be asked to accept the burdens of research
unless other appropriate subjects cannot be found (i.e., if the research concerns their particular disability or circumstance).
This human subject research/experiment has failed to comply with the terms in Title 45 Public Welfare Part 46 Protection of Human Subjects (45 CFR 46). This part of the “Common Rule” is intended to allow IRBs to waive informed consent in its entirety or any of the required elements of informed consent. In order for this
human subject/experiment to waive informed consent it had to meet the 4 criteria in 45 CFR 46.116 (d). An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could
not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Risk is defined in The IRB Guidebook as the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk." Minimal risk is defined in the Common Rule as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
II.** Revise and discuss your pain, violations of your rights, privacy, safety & welfare as a human subject. **
The human research practices, presents a danger to my overall well-being and has violated my rights and welfare as a human subject. which I am experiencing, should be reclassified as “cruel and unusual punishment” or “crimes against humanity”, which goes way beyond the physical or psychological harm that is “normally” encountered in our daily lives or in the routine medical, dental, or psychological examination. I am experiencing intentional
infliction of severe physical pain or suffering, which violates my rights and falls under the purview of 18 USC § 2340 Torture.
_________________________________________________
Section III. ***Discuss about how this waiver adversely affected you rights and welfare as a human subject?***
Personal privacy is important to ethical research as stated in 45 CFR 46.111, but this human subject research has not met all of the requirements to protect the human subjects. My confidentiality and privacy rights have been violated. Invasion of privacy concerns access to a person's body and the “researchers” and countless of men, women, and children, also called “informants” or “perps” who have access to my body 24/7 without my
informed consent or knowledge. The “researchers” have never contacted me about pertinent information after
participation.
___________________________________________________________
Section IV. ***Include this section if children is involved or delete it if it does not impact you ***
Human Subject Research Violates the Rights & Welfare of Vulnerable Population: Children
Children have been included in this human subject research, without receiving the parental/guardian permission consent documentation as defined in 45 CFR 46.408 and these children/minors are not wards of the state or any other agency, institution, or entity as defined in 45 CFR 46.409. No adequate provisions were made for soliciting the assent of children and the no permission was granted from their parents or guardians, as set forth in 45 CFR 46.408 as stated in 45 CFR 46.407 (iii). These children/minor are involve in research, which involves greater than minimal risk as defined in 45 CFR 46.404 and does not present the prospect of direct benefit to them at defined in 45 CFR 46.406. Some of these children are not economically or educationally disadvantaged, but they have been placed in because of their race. This research is not being conducted in accordance with sound ethical
principles as stated in 45 CFR 46.607 (ii).
_________________________________________________________
Both the National Commission for the Protection of Human Subjects and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended that such waivers be granted only if subjects will not be denied benefits or services to which they are otherwise legally entitled. The waiver of informed consent has diminished the protection of my rights and welfare as a non-consensual human subject. I have received no respect as a non-consensual human subject. There is a non-verbal element that “whatever happens to the human subject is of no personal concern to the researcher. They can do whatever they want to the human subject and there is nothing that the human subject can do about because no one will help the human subject.”
For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are availability of medical treatment and compensation in the case of
research-related injury, including who will pay for the treatment and the availability of other financial compensation as stated in 45 CFR 46.116(a)(6).
In July 2005 the National Academy of Sciences came to the conclusion that the preponderance of scientific evidence shows that even very low doses of radiation pose a risk of cancer or other health problem and there is no threshold below, which exposure can be viewed as harmless. According to data from Hiroshima and Nagasaki, show that symptoms may persist for up to 10 years and may also have an increased long-term risk for leukemia and lymphoma. The effects of radiation on the human body can be found at www.atomicarchive.com/Effects/radeffects.shtml.
Will the human subjects of this non-consensual human subject research be compensated due to research-related injury?
The waiver of informed consent has caused adverse consequences for my welfare and for my general well-being, as well as, my loved ones. In addition, our rights, safety, dignity, welfare, and privacy as non-consensual human subjects have been violated. This human subject research/experiment has also failed to comply with the terms of the policy, 45 CFR 46 therefore, as stated in 45 CFR 46.123 it should be subject to termination or suspension. If I continue in this “loosely controlled” research/experiment, it will likely result in irreversible permanent injury, radiation-induced diseases or even pre-mature death for myself (this request also includes my
family members who were systematically included in this because of me), because the “researchers” are operating above the law and below the accepted standard of scientific, ethical, and humane research. I am requesting to “opt-out” or discontinue my participation immediately out of this non-consensual human
subject research/experiment without prejudice. The “Common Rule”, 45 CFR 46.116 (a) (8) states, “and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.” I am not waiving any legal claims, rights or remedies because of my participation as a non-consensual human subject. The legal rights as a human subject may not be waived and the human subject may not be asked to release or appear to release the investigator, the sponsor, the institution or its agents
from liability for negligence.
Section V. Revise this area base as an individual or as a family by changing the tenses
I, ___________________________ certify that my decision to “opt-out” or discontinue participation in this human experiment is without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on my decision. I am requesting to “opt-out” or discontinue my participation because of my rights as a human subject as stated in 45 CFR 46 116 (a) (8). This request includes all of my immediate family members who were thrust in this unethical, human subject research/experiment without their consent or without their
knowledge. I/We have endured grave civil, constitutional & human rights abuses. We have suffered unimaginable pain & suffering, which is needless senseless. Our rights, safety, dignity, welfare, and privacy as a non-consensual human subject(s) have been violated. This human subject research/experiment has also failed to comply with the terms of the policy, 45 CFR 46 therefore, as stated in 45 CFR 46.123 it should be subject to termination or suspension.
Print Name: ________________________________ Date: _______________________
Signature: __________________________________ Email: ___________________________
Address: ____________________________________ Phone No.:________________________
Please send form to: US.HumanSubjects@gmail.com
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Comments
THE WHITE HOUSE June 4, 2012
Dear Letitia:
Thank you for sharing your thoughts with me. Many Americans have written to me about human rights around the world, and I appreciate your perspective.
The United States was founded on the principles of freedom and equality, and our history is marked with triumphs and struggles in fulfilling these timeless ideals. Our task is not finished, and protecting these core values is a shared obligation and a priority for my Administration. No nation should be silent in the fight against human rights
violations. When innocents in places like Sudan, Syria, and the Democratic Republic of Congo are raped, murdered, or tortured, it is a stain on our collective conscience. I am committed to reinvigorating America's leadership on
a range of international human rights issues.
As the struggle for human rights continues around the world, we have witnessed an extraordinary change in the Middle East and North Africa. Country by country, people have risen up across this region to demand their human rights; too often, these calls for change have been answered by violence. The United States opposes the use of
violence and repression against these men and women. Rather, we support a set of universal rights, including free speech, the freedom of peaceful assembly, freedom of religion, equality for men and women under the rule of law, and the right of people to choose their own leaders. We also support political and economic reform in the Middle East and North Africa that can meet the legitimate aspirations of ordinary people throughout the region. While change may not come easily, America will stand squarely on the side of those who are reaching for their rights, knowing their success will bring about a world that is more peaceful, more stable, and more just.
As you may know, the United States has joined the United Nations Human Rights Council and is working to make
this body as effective as possible. My Administration will also advocate for human rights in other international settings. In our relations with other countries, the issue of human rights will continue to be raised as clearly,
persistently, and effectively as possible. Among other things, we will continue to promote accountability for mass atrocities; respect for the rights of minorities and women; freedom of association, speech, and religion; and freedom for people to live as they choose and love whom they chose.
Our commitment to human rights is an essential element of American foreign policy and serves our national security. Through it, we will help to shut down torture chambers, replace tyranny with good governance, and enlist free nations in the common cause of liberty. To learn more about my Administration's human rights agenda, please visit www.HumanRights.gov or www.WhiteHouse.gov/CPo. Thank you, again, for writing.
Sincerely,
Barack Obama