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Human Rights Defenders

“All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.”

 Universal Declaration of Human Rights

Article 1

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Human Experimentation

Human Subjects Protections

Human Subjects Protections

Directives for Human Experimentation

 

NUREMBERG CODE

 

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.

 

The Tuskegee Experiments

Apology to Survivors of Tuskegee Syphilis Survivors

Nuremburg Code

http://ohsr.od.nih.gov/guidelines/nuremberg.html

The Belmont Report

Protection of the Human Rights of Patients - Human Subjects

The Committee for the Prevention of Torture (CPT) has stated:  "Patients should, as a matter of principle, be placed in a position to give their free and informed consent to treatment. The admission of a person to a psychiatric establishment on an involuntary basis should not be construed as authorizing treatment without his consent. It follows that every competent patient, whether voluntary or involuntary, should be given the opportunity to refuse treatment or any other medical intervention. Any derogation from this fundamental principle should be based upon law and only relate to clearly and strictly defined exceptional circumstances." 

 

UN Special Rapporteur on Torture, Manfred Nowak stated in the Interim report A/63/150. 28. July 2008. 

“Torture, as the most serious violation of the human right to personal integrity and dignity, presupposes a situation of powerlessness, whereby the victim is under the total control of another person. Persons with disabilities often find themselves in such situations, for instance when they are deprived of their liberty in prisons or other places, or when they are under the control of their caregivers or legal guardians. In a given context, the particular disability of an individual may render him or her more likely to be in a dependent situation and make him or her an easier target of abuse.  However, it is often circumstances external to the individual that render them “powerless” such as when one’s exercise of decision-making and legal capacity is taken away by discriminatory laws or practices and given to others.”

 

UN Special Rapporteur on Torture, Manfred Nowak stated:

“Medical treatments of an intrusive and irreversible nature, when they  aim at correcting or alleviating a disability, may constitute torture and ill-treatment if enforced or administered without the free and informed consent of the person concerned.” …”The administration in detention and psychiatric institutions of drugs, including neuroleptics that cause trembling, shivering and contractions and make the subject apathetic and dull his or her intelligence, has been recognized as a form of torture.”   “The Special Rapporteur notes that forced and non-consensual administration of psychiatric drugs, and in particular of neuroleptics, for the treatment of a mental condition needs to be closely scrutinized. Depending on the circumstances of the case, the suffering inflicted and the effects upon the individual’s health may constitute a form of torture or ill-treatment.”

SRT (2008) UN Special Rapporteur on Torture. Interim report A/63/150. 28. July 2008.

 

The prohibition of torture is one of the few absolute and non-derogable human rights. Medical interventions can become inhuman and degrading treatment. They might arguably meet the criteria for torture, which is prohibited by international law.  The United States of America has a duty to have to prevent, prosecute and redress abuses in health care. (Inter-American Convention to Prevent and Punish Torture).

There are many more cases of torture and ill-treatment in health-care settings than are officially reported to US authorities.  Victim/survivors of this kind of abuse often are unable or unwilling to report what has happened to them.  Thus, official reports represent only a small fraction of this problem.  Ill treatment is not justified by health care system inadequacies or lack of medical resources.  Individuals have the right to an adequate standard of health care (“right to health”).  The right to be protected from torture and ill treatment also provides objective restrictions on certain kinds of therapies.

 

Crucial to the protection of the human rights of vulnerable patients are:

1) Right to Legal Capacity (Right of recognition of juridical personality and civil rights)

 2) Right to Free, Prior and Informed Consent

3) Right for an individual to choose a surrogate decision maker or Guardian that will best represent his/her wishes

4) Protection for Human Subjects in medical, social and behavioral research

 

These rights have been delineated in multiple international human rights documents and in the relevant case law, but unfortunately color of law, and color of official right violations of these rights routinely happen within mental health institutions, prison and correctional institutions, long term care facilities and in the provision of health care to financially disadvantaged populations such as foster children. 

The doctor-patient and doctor-human subject relationship is a relationship in which the doctor has great power and authority.  In this imbalance of power, ethical violations of human rights can and do occur.  The persons most vulnerable to exploitation as human subjects of medical research are those who are already marginalized and disadvantaged.  Groups such as migrants, prisoners, children, people with disabilities, racial and ethnic minorities are more likely to be targeted by researchers.

Medical research and the approval of prescription drugs are global concerns. Much of the research done by U.S. pharmaceutical companies is happening worldwide. Africa and other nations who are economically disadvantaged have been targeted by large international pharmaceutical companies to be sites of clinical testing.  However, as human rights violations of corporations become known, people in the developing world are less willing to become guinea pigs – and for good reason. This fundamental distrust lies in the paradox of Hobson’s choice “Experimental medicine or no medicine at all”.  Often the medical research offered does not fully protect human rights nor provide to those participating in the research the full benefits of the findings. This leads to another concern regarding the “Right to Life”.  In that persons in the developing world are often denied innovative therapies and important research developments regarding diseases and conditions important to their communities. Even within the U.S.A., there are impacts of the withholding of the potential benefits of research while at the same time exploiting those same vulnerable populations as research subjects. This leads to unequal access to treatment modalities as well as treatment that is not inclusive of the specific needs of those vulnerable populations.

Human subject research includes experiments and observational studies in basic biology, clinical medicine, nursing, psychology, and all other social sciences. There are various codes for the proper and responsible conduct of human experimentation in medical research, the best known of these codes are the Nuremberg Code of 1947,Anchor  and the World Medical Organization’s Helsinki Declaration of 1964 (revised in 1975).Anchor

 

In the U.S.A., the Nuremberg Code and the related Declaration of Helsinki delineates what is considered ethical conduct for human subjects’ research and forms the basis for the US Code of Federal Regulations - Title 45 Volume 46 (The Common Rule). The Nuremberg Code’s influence on global human-rights law and medical ethics has been profound.  Its basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966). ICCPR Article 7 states “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”

 

The US Federal Policy for the Protection of Human Subjects or the “Common Rule” was codified in separate regulations by 15 Federal departments and agencies. The United States Department of Health and Human Services (HHS) regulations 45 CFR part 46 governs all federally-funded research in the United States.  The Right to Informed Consent is delineated in the federal regulation Protection of Human Subjects, 45 CFR 46 also known as the Common Rule under the authority granted by the U.S. Department of Health and Human Services. There are also Welfare Codes for the conduct of social and behavioral research such as that published by the American Psychological Association in 1973.

 

Informed consent is consent obtained freely, without threats or improper inducements, and after appropriate disclosure to the patient of adequate and understandable information in a form and language understood by the patient.  Engaging in an informed-consent process between a clinical doctor and a patient should be an essential part of the standard of care in medicine. Informed consent is a process, not just a formality, and engaging in that process is of the essence of good medical care. Information must be provided to the patient in a timely manner and in accordance with the accepted standard of practice among members of the profession with similar training and experience. A health care professional may be legally liable if a patient does not give "informed consent" to a medical procedure and it results in harm to patient even if the procedure is properly performed.Anchor 

 

Adequate informed-consent process is not just a risk management process; it is good medical practice.  Informed consent should define risks and potential benefits, but also take into consideration alternative treatments. Informed consent is an agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved.  There is a general right for all human persons to be free of inhuman treatment and individuals also have the legal right to privacy under international human rights law. 

 

International human rights case law supports the concept that individuals do have the legal right to decide whether a proposed medical treatment will be performed on them. The human right to decide one's own treatment does not disappear just because it is more convenient or financially more beneficial for the caregivers or for the family members of the individual to force treatment. This right to decide to refuse treatment is a human right we all enjoy. Mental health treatment under human rights law should be the same as other treatments in regards to consent to treatment.  But it is a sad fact that this right has not necessarily been consistently protected and thus through our mental health systems extended to people with mental disabilities. Patients need to have the intellectual capacity to understand basic information about their diagnosis and proposed treatment. Correspondingly doctors have a responsibility to communicate the information in terms the patient can understand and to make efforts to be available to answer questions the patient may have.

 

Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993). The Nuremberg Code focuses on the human rights of research subjects, the Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects, and the federal regulations emphasize the obligations of research institutions in the U.S.A. that receive federal funds. Human subject research includes experiments and observational studies in basic biology, clinical medicine, nursing, psychology, and all other social sciences.

 

Human Subjects of medical experimentation are placed at risk when investigating unconfirmed hypotheses about treatments.  Research subjects can experience serious adverse health effects because of participation in trials including death, shortened life expectancy, or significant decrease in the quality of the person’s life. Patients/Human Subjects can also be placed at risk by patterns of investigative medical practices that are premature and based on an inadequate understanding of a new technique or new drug – or because of direct deceit or fraud by drug or medical device manufacturers about their products.

In 1974, the U.S.A. signed a law empowering the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter called the National Commission or Commission) was charged by the U.S. Congress to identify the basic ethical principles that should underlie the conduct of research involving human subjects. In 1979, the National Commission published the Belmont Anchor concerning the Ethical Principles and Guidelines for the protection of human subjects of research.

The Belmont Report admits that research involving human subjects always inherently raises ethical and moral issues. The Belmont report delineates 3 major principles: Respect for persons, Beneficence and Justice. The Belmont report provides a strong protection regarding informed consent and also discusses justice and injustice in regards to vulnerable populations. Belmont was then adopted in its entirety as a policy statement by U.S. Department of Health, Education, and Welfare (DHEW) - now called the Department for Health and Human Services (DHHS). Its principles of respect for persons, beneficence, and justice are regarded as the three quintessential requirements for the ethical conduct of research involving human subjects by the National Institutes of Health (NIH) Office for Protection from Research Risks (OPRR).  In the US, most research involving human participants funded by federal government agencies is subject to the Common Rule — Title 45 Volume 46 which is a set of regulations delineating the requirements for review by an institutional review board.

Control of pharmaceutical and device products is vested by statute in the Food and Drug Administration (FDA) within HHS.  The involvement of human beings in such research is prohibited unless the subject or the subject’s legally authorized representative has provided prior informed consent, with only very limited exceptions.  A waiver of informed consent by the Institutional Review Board is supposed to be granted only in circumstances where the research presents no more than minimal risk to subjects, and the waiver will not adversely affect subjects’ rights and welfare. However, pharmaceutical companies that fund their own independent research that utilize human subjects in clinical practice, are not subject to the same monitoring as federally funded research institutions and thus escape oversight of their human subject use.

The provision of medical care has become very complex and the worldwide nature of today’s medical community. There is the practice of medical research within clinical therapeutic settings and the use of clinical doctors in their therapeutic settings to research the effects of the newer drugs and treatments. This obtains data on the effects of newer drugs and treatments prior to their full review by the Food and Drug Administration. For this reason, it is difficult for the average patient, a lay person, to understand whether they are getting safe and effective medical care.

 

In the U.S.A., there is an increased use of prescription drugs “off-label” or without the approval for that use by the Food and Drug Administration (FDA).  This essentially means that these drugs have not been proven by scientific evidence to be safe or effective.  These “off-label” medications are quickly marketed in other countries “off-label” as well as in the U.S.A.

 

It is important for medical progress that there be an adequate regulatory process based in transparency, integrity and accountability.  Medical professionals need accurate information about new treatments, drugs and devices.  Medical science is a rapidly evolving field but the human rights of patients should and can still be protected while still providing for the development of meaningful new treatment options.  The efficiency of clinical trials is enhanced by obtaining clinically relevant information. The FDA regulatory process should be firmly grounded in scientific evidence and driven by public health interests.  The Food and Drug Administration regulatory efforts should be based on substantial evidence from adequate and well-controlled clinical trials regarding both safety and efficacy of products and procedures. 

 

The issues involved in the governmental regulation of drug, biologic and medical device industry are increasingly complex.  How that regulation impacts the human rights and clinical outcomes of patients is critically important. There has been limited dissemination of truthful information.  Prescription medications and medical devices have been mis-branded and illegally marketed and prescribed within the U.S.A.  The pharmaceutical and device manufacturers and researchers have powerfully influenced governmental legislation and administration regulatory policy.  This has impacted the decisions of practicing physicians, and ultimately the care of their patients.  Wards of the court and other vulnerable persons who have a surrogate decision maker such as a Guardian involved in their medical care, can become the victims of deceptive marketing practices. 

 

Deceptive and coercive marketing practices by the pharmaceutical industry are common place.  The practice of marketing drugs for purposes not backed by science is called “off-label promotion.” There have been serious conflicts of interest in the selection of published scientific medical journal articles, medical school curriculum and even physician post-doctoral continuing education. Third-Party entities and the media spread mis-information about prescription drugs through the internet and social media.  These sources of information often are the first source of information that health professionals and patients use to find out about both the risks and the benefits of medical products.  These inaccurate statements often refer to medical indications not approved by the FDA and this information has not been reviewed or approved by the FDA.  Thus, misinformation is utilized to advertise prescription drugs and medical devices, and directly impacts treatment decisions by doctors and ultimately clinical outcomes for patients.  

 

What may appear as a consensus of medical approval is a carefully planned marketing effort to influence medical decisions on mental health care.  Among the many marketing strategies used by the pharmaceutical industry are: 1) One-to-one detail marketing to doctors and professionals 2) Continuing education seminars and sponsorship 3) Pharmacy specific advocacy groups 4) Ghost-writing of “scientific” articles and dissemination of unsupported “medication algorithms” 5) Direct-to-consumer advertising 6) Intense legislative lobbying 7) Suppression of research findings through control of research findings and research grantees 8) Illegal marketing of psychotropic drugs for off-label purposes 9) Bribing state officials with cash payments to add atypical antipsychotics on Medicaid formularies.     

 

Monitoring of human subjects in therapeutic clinical trials is inadequate.  A recent report of the US Department of Health and Human Services inspector general, indicated that “federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.”  Anchor

 

There is a global distribution of pharmaceutical products. Medical research done in one nation will be used to obtain regulatory approval in another country.  A drug approved for use in one country will rapidly acquire acceptance in other countries often through reciprocity.  Thus, if one nation has poor regulatory control over medical products or prescription medications, it will affect other nation states as well.

 

In an examination of off-label prescribing of 160 common drugs, off-label use was also found to account for 21% of all prescriptions, and most off-label drug uses (73%) were shown to have little or no scientific support. These drugs are widely prescribed for unapproved uses, including other non-approved conditions significantly boosting their sales.  These prescription drugs do not live up to their marketing promises but instead have been known to cause serious, even fatal side-effects, particularly in children and the elderly.  The highest rates of off-label use were for anticonvulsants (74%), antipsychotics (60%), and antibiotics (41%).  Atypical antipsychotics and antidepressants were particularly likely to be used off-label without strong evidence. Anchor  The very drugs which are most often prescribed off-label with little or no scientific support to indicate that the medication is truly beneficial to the patient, are the same drugs which commonly cause serious debilitating medical conditions and even death. 

 

Research can be disguised as “treatment,” but instead actually be a harmful or deadly experiment done without the patient’s knowledge or informed consent to treatment. All subjects or their representatives who consent to participate in medical research should be enabled 1) to freely choose whether or not to become enrolled, 2) to comprehend what is being told to them, and 3) to understand essential information about what the research entails, and what their options are.

 

The principle of Free, Prior and Informed Consent is an important human right which has been addressed in many international and domestic laws and practices. Guardianship keeps people in institutions and negates the right of people with disabilities to exercise legal capacity, an aspect of the right to recognition as persons before the law.  Often guardianship and the use of surrogate decision-makers is used to circumvent informed consent rather than making an honest attempt to discern the wishes of the person. To refuse to recognize the individual patient's human right to informed consent is contrary to the recognition of the legal capacity of persons with disabilities on an equal basis with others.  Civil commitment laws create a separate regime of detention and involuntary treatment applicable only to persons with psychosocial disabilities that is discriminatory in purpose and effect.

 

In situations of civil commitment and compulsory mental health treatment the U.S. Supreme Court recognizes infringements of the liberty interest (a Constitutional Right) but asserts that these infringements are justified by state interests.Anchor Anchor These practices pose a serious violation of mental and physical integrity by their close connection with disability-based discrimination, as analyzed by UN Special Rapporteur on Torture Manfred Nowak. Anchor

 

Wards of the court have assigned surrogate decision makers for both legal and medical decisions, Anchor Anchor Anchor thus wards are prevented even from effective appeal to the Judge or even to their US Congressmen/Congresswomen. Anchor  In the U.S.A. the guardianship system offers few procedural protections, and has spawned a profit-driven professional guardianship industry that often enriches itself at the expense of society’s most vulnerable members—foster children, the disabled and elderly.Anchor  Anchor Anchor Anchor Anchor Anchor

 

When medical professional chose to proceed with emergency guardianship in the court system, they do so secretly behind closed doors.  By the time the family realizes what is happening, the legal process is already completed and guardianship has been granted by the court. Without ever talking to the patient or the family, Judges are making life changing decisions about these proposed wards. Thus, the ward, who has the most to lose in these proceedings has often little or no input, in addition family members may not even be appraised of the court proceedings until after emergency guardianship has been already established – thus depowering them to act as advocates for their family member. 

 

A Los Angeles Times investigation similarly uncovered numerous instances of egregious abuse by guardians where evidence of abuse was already in the courts’ own files. Nearly 75 percent of America’s courts do not have a computerized data system to track guardianship cases and identify problems. Nearly 20 percent of courts do not require annual accounting of a ward’s finances.  Among courts that do collect such information, more than one third do not have an official who is designated to verify the content of the guardians’ reports, and less than 20 percent verify every report.  In more than 40 percent of courts, no one is assigned to visit individuals under guardianship to determine if they are being abused or financially exploited.Anchor

 

Judges often out of expediency grant the guardian complete powers over a ward despite the principle of limited guardianship.  It is important that the guardian stands for the human rights of the ward not for compliance with the hospital or doctors' wishes.  But Judges routinely accept without question the written documents submitted by the medical proxy decision makers, without questioning their financial and sometimes pharmaceutical research related motives.  Judges should instead make sure that they do true substantial judicial due diligence and insist that wards are transported to the court or that in some manner direct face-to-face communication is established with the Judge.   Judges need to question whether a drug that is not approved by the FDA needs to be used on a ward of the court – especially in light of growing evidence of adverse effects, lack of evidence of efficacy and successful litigation against the drug manufacturer.  Forcing wards of the court to take medications that are “off-label” – not approved for that use by the FDA, is tantamount to human experimentation on the vulnerable wards of the court.

 

Patients need to have the intellectual capacity to understand basic information about their diagnosis and proposed treatment. Correspondingly doctors have a responsibility to communicate the information in terms the patient can understand and to make efforts to be available to answer questions the patient may have. Skepticism by the patient in such circumstances does not mean that the person does not have capacity to make treatment decisions. Even if the patient, due to their disability, cannot believe the doctor's diagnosis that doesn't mean that the patient does not have capacity to make treatment decisions. Essentially, people have the right to make treatment decisions under Principle 19 of the UN's "Principles for the Protection of Persons with Mental Illness." 

 

International human rights case law supports the concept that individuals do have the legal right to decide whether a proposed medical treatment will be performed on them. The human right to decide one's own treatment does not disappear just because it is more convenient or financially more beneficial for the caregivers or for the family members of the individual to force treatment. This right to decide to refuse treatment is a human right we all enjoy. Mental health treatment under human rights law should be the same as other treatments in regards to consent to treatment.  But it is a sad fact that this right has not necessarily been consistently protected and thus through our mental health systems extended to people with mental disabilities. 

 

Because those with mental health disabilities are often detained, this then often automatically leads to forced treatment. This does not necessarily need to happen. It is not theoretically inconsistent with confining someone in a psychiatric facility, but still leaving them with the authority to decide treatment decisions.  No treatment should be provided except in emergency situations until a determination of capacity has been made through a judicial hearing for treatment decisions. The hearing must be by an independent arbiter, and be judicial in character. In addition, there must be a right of the patient to return for re-consideration of the situation at regular intervals. A hearing to determine incapacity is required. Persons, who are lacking capacity, are often institutionalized and over-medicated. 

 

In the U.S.A., many medical institutions are allowed to include wards of the State in research that presents greater than minimal risk to the subject with no prospect of direct benefit for the research subject. Forcing wards of the court to take medications that are “off-label” (not approved for that use by the Food and Drug Administration), is tantamount to human experimentation on the vulnerable wards of the court.  Such violations of human subject provisions are routine with many patients in locked state and federal institutions given psychiatric drugs for “off-label uses.”  Problems of patient abuse occur including: excessive dosing for purposes of chemical restraint, poly-pharmacy with multiple medications, lack of informed consent and the use of medication with little or no direct doctor/patient contact. 

 

There is a clear ethical need for human rights protection of persons used as human subjects in medical, social or behavioral research.  The U.S. government needs to fully review the current administrative and legislative efforts to protect human subjects.

 

 

Anchor Nuremberg Code Directives for Human Experimentation

Anchor World Medical Association Declaration Of Helsinki

Anchor Meador v. Stahler and Gheridian (Middlesex Superior Court C.A. No. 88-6450, Mass. 1993)

Anchor The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Anchor Harris G. Report assails FDA oversight of clinical trials. New York Times 28 Sept 2007. www.nytimes.com/2004/11/19/business/19fda.html

 

Anchor Radley DC, Finkelstein SN, Stafford RS. (2006) “Off-label prescribing among office-based physicians.” Arch Intern Med 2006;166: 1021-6.

Anchor Addington v. Texas, 441 U.S. 418 (1979) (civil commitment).

Anchor U.S. v. Sell, Riggins v. Nevada, 504 U.S. 97 (1992).

Anchor See U.N. Doc. A/63/175 (2008), particularly paragraphs 40, 44, 47, 49, 50, 61-65, 73-74.

Anchor Guardianship for the Elderly: Protecting the Rights and Welfare of seniors with Reduced Capacity, U.S. Senate Special Committee on Aging (2007).

Anchor Commission on Mentally Disabled and Commission on Legal Problems of the Elderly, Guardianship: An Agenda for Reform –Recommendations of the National Guardianship Symposium and Policy of the American Bar Association, 12 A.B.A. 1989 [Wingspread Recommendations].

Anchor Guardianship Abuse of the elderly: A violation of Constitutional Rights Precipitating an extreme punitive civil penalty (see:  http://www.probatecourtreform.com/files/guardianabuse%283%29.pdf).

Anchor Bayles, Fred and McCartney,Scott, “Declared ‘Legally Dead’ by a Troubled System,” in Guardians of the Elderly: An Ailing System, AP Special Report, in Abuses in Guardianship of the Elderly & Infirm: A National Disgrace, H.R. Comm. Print 100-639 (Dec. 1987).

Anchor Wood, Erica F. “The Availability and Utility of Interdisciplinary Data on Elder Abuse: A White Paper for the National Center on Elder Abuse,” American Bar Association Commission on Law and Aging for the National Center on Elder Abuse (Washington, D.C.: May 2006).  

Anchor Wood, Erica F. (2006) “State-Level Adult Guardianship Data: An Exploratory Survey,” American Bar Association Commission on Law and Aging for the National Center on Elder Abuse, August 2006. 

Anchor Teaster, Pamela et al., The 2004 Survey of State Adult Protective Services: Abuse of Adults 60 Years of Age and Older (Boulder, Colo.: February 2006).  

Anchor Leonnig, Carol D.; Sun, Lena H. Sun and Cohen, Sarah.  (2003) “Misplaced Trust: Special Report.” The Washington Post (June 15-16, 2003).

Anchor Kelly, Kowalski & Novak, (2008) “Courts Strip Elders of Their Independence,” Boston Globe, 1/13/08.

Anchor U.S. Government Accountability Office. (2006) Guardianships: Little Progress in Ensuring Protection for Incapacitated Elderly People. Testimony of Barbara D. Bovbjerg, Director Education, Workforce and Income Security, before the Special Committee on Aging, U.S. Senate. No. GAO-06-1086T (2006).

Anchor Fields, Robin; Larrubia, Evelyn: and Leonard, Jack. (2005) “Guardians for Profit.” Los Angeles Times, November 13-16, 2005

The Belmont Report

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

The Common Rule

http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf

Research Ethics

World Medical Association Declaration Of Helsinki

http://www.wma.net/en/30publications/10policies/b3/

Guidelines for NIH Research

http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf

Human Subjects Research

Human Subjects Research

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― Leo Buscaglia

Medical Whistleblower Advocacy Network

MEDICAL WHISTLEBLOWER ADVOCACY NETWORK

P.O. 42700 

Washington, DC 20015

MedicalWhistleblowers (at) gmail.com

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"It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes short again and again, because there is no effort without error and shortcoming; but who does actually strive to do the deeds; who knows great enthusiasms, the great devotions; who spends himself in a worthy cause; who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who neither know victory nor defeat."

Theodore Roosevelt- Excerpt from the speech "Citizenship In A Republic", delivered at the Sorbonne, in Paris, France on 23 April, 1910