Informed Consent: An Understanding

Ethics in Clinical Research - Ethical Issues in Human Subjects ... from Medresearch

In September of 1999 the American Journal of Psychiatry had an Op-ed about Informed Consent in clinical research written by Dr. Carpenter, of The Maryland Psychiatric Research Center: Dr. Carpenter wrote the editorial because he said, "I am concerned that more harm to the future of individuals with mental illness is being caused by the rush to allegation and redress than is justified by anticipated benefit." To document Informed Consent he suggests the following:

1. Have patients or their advocates comment on proposed research and consent forms.

2. Ensure that informed consent is an educational procedure taking place in a time frame that enables the prospective subject to understand, appreciate, reason, and freely exercise choice.

3. Include clinicians other than key investigators in the informed consent process and assessment of decision-making capacity, but do not exclude the investigator from personal responsibility and participation.

4. Include significant others as the patient considers participation, but do not compromise the patient’s autonomy and dignity rights if decision-making capacity is adequate.

5. Provide material to all concerned clarifying that clinical care involving research is importantly different from ordinary clinical care. Work with patient subjects to minimize the therapeutic misconception that is commonplace in biomedical research (17).

6. Ensure that patient subjects have contact with a noninvestigator who can help resolve issues relating to research participation.

7. When accepting a consent form, document understanding of basic facts relating to the protocol (the Maryland Psychiatric Research Center administers an ­evaluation-of-signed-consent test [18]).

8. Provide educational and sensitivity-raising sessions in ethics for investigators and staff. Include an appreciation of the fundamental role in subject protection incorporated in institutional-review-board-related procedures.


My son was used in drug trials; on or off the books--it is the only explanation for the number of neuroleptic drugs a federally funded researcher pumped into my precious son after he was 13. Jon McClellan, like most psychiatrists and other mental health treatment professionals in Washington State, claim that parental consent is not necessary if the patient is 13 years old. This federally funded researcher claimed he did not need my Informed Consent consent for my  minor son's "medical" treatment because my son was 13; he then claimed since my son was a Ward of the State, my Informed Consent wasn't needed.

McClellan, intentionally or not, ensured that my son would have a psychotic break by withdrawing him off of Risperdal too rapidly. Risperdal is a neuroleptic drug my son had been on for YEARS, (I was oblivious back then to the corruption and fraud; I still trusted doctors, etc.) The Risperdal wad prescribed off-label, and fraudulently billed to Medicaid; my son is a victim of Johnson and Johnson's illegal marketing of Risperdal. To treat my son's horrific withdrawal psychosis, Jon McClellan pumped massive amounts of neuroleptic drugs with terrible adverse effects into my son; sometimes 2 and 3 neuroleptic drugs concomitantly, along with other psychotropic drugs. It's many miracles my son survived at all. I remember being utterly devastated--I thought my son was going to die.  I know he felt tortured.  I know he was begging me to rescue him.  I know will never forgive myself for not doing more to stop what (what the fuck do you call it/him?!) was doing to my son.  I know I was ridiculed for standing up for my son's Human Rights. I know I was denied my parental rights; specifically my right to make medical decisions and give Informed Consent for my by then floridly psychotic son. By law, I retained my parental rights to make mental health treatment decisions on Isaac's behalf; nonetheless, my rights were effectively denied by the Medical Director of Child Study and Treatment Center, Jon McClellan. He initially claimed he didn't need my consent because Isaac was over the age of thirteen. When I pointed out that Isaac lacked the capacity to give consent, he claimed he didn't need my Informed Consent because Isaac was a ward of the state. I was reassured prior to signing the agreed order for a Consent to Place, that  by law, I retained my parental rights to give consent for Isaac's mental health treatment.  I had to be coerced to sign the agreement-- The order effectively made my son a foster child, e.g. qualified for federal Child Welfare benefits. The Agreed Order was NOT necessary to ensure that Isaac's medical care would continue to be paid for through Medicaid, as I'd been told. Isaac was on SSI & Medicaid as a handicapped child, there was no risk he would lose his medical coverage...

The fact that my son was in fact a ward of the state was somehow perceived as proof I was a bad parent, undeserving of respect.
Dr. Carpenter's Op-Ed in it's entirety: 
The Challenge to Psychiatry as Society’s Agent for Mental Illness Treatment and Research

Society has a moral responsibility for its sick and disabled citizens. Psychiatry assumes this responsibility when clinicians provide care and treatment to mentally ill patients. But these very patients often lack insight into the nature of their afflictions, their causes, and their need for treatment. Experiencing altered perceptions, affects, and beliefs is very different from experiencing other somatic dysfunctions. Both patients and society view the latter as illness requiring medical intervention, whereas the former all too often are viewed as personal attributes rather than disease. Society is uncertain how to assert responsibility, looking simultaneously to law enforcement, religion, psychiatry, the family, and social planning. Given complex and competing themes, psychiatry’s capacity to assert and validate illness models and therapeutic interventions is invaluable. A major advance over the past 40 years has been establishing society’s confidence that psychiatry can identify individuals who suffer from mental disorders and intervene with effective therapeutics. At the same time, society has also advanced the cause of civil liberties for the mentally ill. Here, too, much good has been accomplished, but disquieting problems remain, problems that stir passions as the ethics and politics of personal autonomy and free will clash with the consequences of honoring these virtues.

Gardner and colleagues tackle a vexing paradox in this issue of the Journal. Psychiatry accepts a clinical responsibility for determining which individuals, on the basis of mental disease and law, shall be deprived of autonomy rights and dignity by involuntary commitment to receive protection and (perhaps) treatment through clinical services. This burden of judgment and responsibility weighs heavily on the physician-patient relationship and on the professional identity of the physician. Psychiatrists experience their discipline at risk when their assertion of this authority is criticized by society and by the patient whose autonomy rights are compromised. Nothing is quite as reassuring in the exercise of this responsibility as a grateful patient who has come to appreciate the physician’s action. Stone’s "thank you" theory (1) captured this important dynamic and has been used in support of psychiatry’s wise exercise of this authority.

Gardner and colleagues tested the theory’s validity with empirical data. They found that many patients who did not believe that hospital admission was needed entered as voluntary patients anyway. There is room for negotiation when physician and patient have discordant views. Patients who did not believe that they needed hospitalization but who believed they had a mental illness and accepted voluntary admission were most likely to change their view and agree that a need for hospitalization existed. However, patients who denied that they had a mental illness, felt coerced, and entered as involuntary patients most often sustained their view that hospital care was not needed. The "thank you" from these patients remained theoretical. Most of the patients in this study were given affective or "other" diagnoses, and substance abuse was common. It is uncertain how these results generalize to more specific populations where insight is commonly impaired (e.g., patients with schizophrenia or mania), but results are not likely to be more gratifying.

Psychiatrists most often must accept the responsibility of denying autonomy and dignity rights without the appreciative endorsement of their patients. Clear role definition regarding clinical and social responsibility, valid concepts and assessment procedures to meet legal and clinical standards, and an acceptable degree of predictive validity regarding safety and therapeutic advantage are essential. Most important is that society sanction this role assigned to the psychiatrist in addressing the moral obligation of protection and treatment for the very ill citizen. However, the tension will remain as long as the patients we serve fail to understand their illness and the physician’s purpose. Change in this regard is importantly dependent on new therapeutic advances through scientific research.

The role of the psychiatric investigator in meeting society’s obligation to develop new knowledge to benefit ill citizens is also a vexing paradox: society simultaneously expresses "best hope" and "worst fear" images. No responsible commentator doubts that new knowledge through science is critical to advancing treatment and prevention of mental illness, but current attention in the popular media involves harsh criticism of psychiatric investigations (2–11). Clinical research is not a perfect endeavor, and errors in subject protection procedures and occasional fraudulent investigators have been noted. Much of the criticism, however, is based on misunderstanding of science, misrepresentation of facts, and unsubstantiated allegations. Nonetheless, there is a common ground of concern on the issue of the capacity to make decisions in providing informed consent to research participation.

Subjects in mental illness research are usually presumed to be competent. This may be viewed as respect for the autonomy and dignity rights of persons with mental illness, but the question has also been raised that the presumption of competence permits too many patients with impaired decision-making capacity to sign consent forms they do not understand. Those who believe that valid informed consent can be (and usually is) obtained believe that optimal procedures require continual evolution and that better documentation is needed to enable society to judge the adequacy of the informed consent process. Those who believe that mental illness research is substantially conducted without valid informed consent doubt that investigators and institutional review procedures can ever ensure that this lynchpin of ethical research will be routinely secured. All agree on the urgent need for data that address decision-making capacity for providing consent among prospective subjects for mental illness research. It is here that Appelbaum and colleagues make an important contribution of empirical data in this issue of the Journal.

Using an experimental, but carefully constructed, assessment of decision-making capacity, Appelbaum and colleagues found that depressed patients in a clinical trial had largely unimpaired decisional capacity and, therefore, were likely to be able to exercise their right to self-determination regarding research participation. Moreover, the patients maintained this capacity over time, suggesting that they remained able to exercise important elements of informed consent such as a sustained understanding of the purpose of the research and the right to withdraw. Appelbaum et al. report that decision-making capacity was not significantly related to severity of depression, a finding compatible with the commonplace observation that many psychiatric patients maintain competence for most aspects of everyday life despite severe symptoms. This study involved moderately depressed outpatients. It is not certain how these results apply to more severely depressed or psychotic patients.

Adequacy of informed consent in psychiatric research was the leading issue when the National Bioethics Advisory Commission addressed subject protections in mental illness research (12). The commission’s focus on the mentally ill was not based on evidence of informed consent deficiencies or other abuse of subject protections that distinguished psychiatric research. Nonetheless, the commission made its report and recommendations on mental illness rather than a broader consideration of brain dysfunction, which increases risk for cognitive impairment, or a narrow consideration of individuals who actually lack decisional capacity for the purpose of informed consent. The commission made recommendations for regulatory redress in psychiatric research alone. In testimony to the commission, Dr. Appelbaum presented data from the depression study reported in this issue of the Journal and similarly reassuring data that most subjects with schizophrenia at the Maryland Psychiatric Research Center were able to achieve decision-making capacity similar to that of normal control subjects when participating in an educational informed consent process. Dr. Appelbaum’s view that problems that could be documented should be addressed with solutions that had been tested and subjected to a cost-benefit analysis was not apparent in the recommendations of the National Bioethics Advisory Commission. The result, at least in part, is another expression of society stigmatizing the mentally ill and those who serve them.

I am concerned that more harm to the future of individuals with mental illness is being caused by the rush to allegation and redress than is justified by anticipated benefit. Optimal and ever-evolving procedures for the protection of research subjects, including the mentally ill, are of fundamental importance. Stigmatizing those citizens who receive a psychiatric diagnosis, however, and creating a veil of mistrust between society and psychiatric investigator can be rationally justified only if research procedures in psychiatry are both unique and flawed. Commissions in New York (13) and Maryland (14) recently addressed issues of subject protection in medical research with populations at risk for impaired decision-making capacity. Michels (15)called attention to the substantial difference in tone and content of the New York and Maryland commissions compared with the National Bioethics Advisory Commission report, and the interested reader will see this contrast extended when reading the companion articles by Michels (15) and by Capron (16), a member of the national commission. Michels suggested that the failure of the national commission to include any member with experience and expertise in psychiatric research may explain the difference. In this regard, the two state commissions focused on the decision-making capacity of individuals rather than diagnostic groups, on investigator and review procedures that would enhance capacity assessment and ensure adequacy of consent, on how to design protections in a more realistic relationship to risk, and on how to avoid costly new procedures that would interfere with acquisition of knowledge unless evidence for need and effectiveness was presented. Involvement of psychiatric investigators in these two commissions also reflects the field’s commitment to examining problems and evolving optimal procedures.

The psychiatric investigator lives in interesting times. Although I believe much of the present public attention is ill-informed and unfair, the field has received a wake-up call. Adequate decision-making capacity for providing informed consent to research participation can be assessed and documented. But how well is this being done in all the various settings where research is conducted? What constitutes adequate capacity, and how is this to be determined and documented? Who should participate in informed consent, and how should research be conducted if the person is judged to be too impaired for competent consent? How should these procedures be reviewed, and which stakeholders should participate in the review? These and many other questions are on the table. As they are addressed in new federal procedures and regulations, there is already much to do at the local level to address subject protections. The following suggestions seem reasonable, helpful, not too demanding, and protective of both patient subjects and investigators. Not intended as comprehensive guidelines, these suggestions illustrate actions that can be initiated by clinical investigators and their institutions and have worked well at the Maryland Psychiatric Research Center.


1. Have patients or their advocates comment on proposed research and consent forms.

2. Ensure that informed consent is an educational procedure taking place in a time frame that enables the prospective subject to understand, appreciate, reason, and freely exercise choice.

3. Include clinicians other than key investigators in the informed consent process and assessment of decision-making capacity, but do not exclude the investigator from personal responsibility and participation.

4. Include significant others as the patient considers participation, but do not compromise the patient’s autonomy and dignity rights if decision-making capacity is adequate.

5. Provide material to all concerned clarifying that clinical care involving research is importantly different from ordinary clinical care. Work with patient subjects to minimize the therapeutic misconception that is commonplace in biomedical research (17).

6. Ensure that patient subjects have contact with a noninvestigator who can help resolve issues relating to research participation.

7. When accepting a consent form, document understanding of basic facts relating to the protocol (the Maryland Psychiatric Research Center administers an ­evaluation-of-signed-consent test [18]).

8. Provide educational and sensitivity-raising sessions in ethics for investigators and staff. Include an appreciation of the fundamental role in subject protection incorporated in institutional-review-board-related procedures.

This last point merits brief comment. The media and a handful of severe critics have taken findings of procedural errors and reported them as unethical research and implied that unethical scientists are harming patients (2–11). This I condemn, but clinical investigators have also sometimes regarded such findings as merely procedural. We need to inculcate a deep appreciation of the regulations for review and approval and the monitoring of research as fundamental to the protection of human subjects. These procedures must be conducted with care, and shortcomings must be addressed as a first priority in the ethical conduct of human research.



Address reprint requests to Dr. Carpenter, Director, Maryland Psychiatric Research Center, P.O. Box 21247, Baltimore, MD 21228.



References



1
Stone AA: Mental Health and Law: A System in Transition. Rockville, Md, NIMH Center for Studies of Crime and Delinquency, 1975

2
Hilts PJ: Agency faults a UCLA study for suffering of mental patients. New York Times, March 10, 1994, p A1

3
Hilts PJ: Medical experts testify on tests done without consent. New York Times, May 24, 1994, p A13

4
Hilts PJ: Consensus on ethics in research is elusive. New York Times, Jan 15, 1995, p 24

5
Hilts PJ: Psychiatric researchers under fire for experiments inducing relapse. New York Times, May 19, 1998, p C1

6
Hilts PJ: Psychiatric unit’s faulted. New York Times, May 28, 1998, p A26

7
Wilwerth J: Tinkering with madness. Time, Aug 10, 1993, pp 40–42

8
Whitaker R, Kong D: Testing takes human toll. Boston Globe, Nov 15, 1998, p AO1

9
Kong D: Debatable forms of consent. Boston Globe, Nov 16, 1998, p AO1

10
Whitaker R: Lure of riches fuels testing. Boston Globe, Nov 17, 1998, p AO1

11
Kong D: Still no solution in the struggle on safeguards. Boston Globe, Nov 18, 1998, p AO1

12
Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity, vol I: Report and Recommendations of the National Bioethics Advisory Commission. Rockville, Md, NBAC, Dec 1998

13
New York State Department of Health Advisory Work Group on Human Subject Research Involving the Protected Classes: Recommendations on the Oversight of Human Subject Research Involving the Protected Classes. Albany, New York State Department of Health, 1998

14
Final Report of the Attorney General’s Working Group on Research Involving Decisionally Incapacitated Subjects. Baltimore, Office of the Maryland Attorney General, 1998

15
Michels R: Are research ethics bad for our mental health? N Engl J Med 1999; 340:1427– 1430

16
Capron AM: Ethical and human-rights issues in research on mental disorders that may affect decision-making capacity. N Engl J Med 1999; 340:1430– 1434

17
Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W: False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 1987; 17:20–24

18
DeRenzo EG, Conley RR, Love R: Assessment of capacity to give consent for research: state of the art and beyond. J Health Care Law and Policy 1998; 1:66–87

Do we actually have "Parental Rights" if they are not preserved or defended?

It has been said that parental rights and family values are traditional "American values."  What are 'Parental Rights'?  Are parental rights protected because these rights are defined and codified within civil and administrative law?  When parental rights are diminished, altered, or revoked and a parent's Substantive and/or Procedural Due Process rights were not effectively preserved or observed, there is often no recourse available. This can happen without some parents even realizing that is what has occurred. It is not  uncommon for a  parent's rights to be violated as a matter of course when individuals and families come into contact with Child Protective Services, and or mental health and substance abuse treatment providers.

The average person working within these human service professions receive little to no training on how to preserve or protect the rights of people they will be serving; and just as importantly, how to avoid violating the person's rights out of ignorance...In my experience, social service and mental health professionals do not have even a basic understanding of what a client's individual rights are; nor do they have a minimal awareness of the fact that not observing the effective mechanisms codified within the law meant to preserve and defend those individual rights, means these rights are not effectively preserved; but are in fact violated with impunity. The impact this can have on any child should be of a concern to all of us, as these are people working for us.

The mandate of Child Protective Services is to preserve and foster a family's unity, with the understanding  that a family is the primary social unit within our society and that absent abuse or neglect, a parent has the right to raise a child according to the parent's self-determined morals and values. CPS is mandated to support this by providing social services which assist families who are in crisis, and also by providing foster care when children who are in immediate danger and must be removed due to parental abuse or neglect.  One of the most troubling aspects of this program is the statistic that children removed by 'child protective services,' are abused and killed at a higher rate than those who are not removed from their families. In recent years, parents who are do not consent to giving a child teratogenic drugs has resulted in CPS action, and the removal of children to enforce a prescription of psychotropic drugs; clearly an abuse of power and authority.

This is an ongoing and growing problem caused by the failure to inform/educate individuals who are state employees or state contractors how to perform the legal duties required of them and an abject failure to hold mandated reporters responsible when they fail to file reports with Law Enforcement they are required by law to file. The failure is specific to known or suspected instances of abuse or neglect which victimizes children or vulnerable adults who receive services through DSHS programs. State employees compound the crime by failing to refile the reports they are mandated by law to file. Failure to report is a gross misdemeanor crime. The individuals who commit this crime keep their jobs; the victims are left to tend their injuries with a brutal realization that they are not protected from harm. Supposedly, this is done in service to the state, to protect it from potential liability.

In this instance, "the state" is everybody except the victim(s). This strategy is hardly serving us as a society, it isn't consistent with how potential liability should be defined in such a scenario. Most obviously, allowing people who have failed to act in defense of a child and who fail to report abuse or neglect crimes, should not be in a position of any responsibility; such a person is in fact, a liability. Unless of course, society acknowledges that this approach is used because it serves to protect state employees who increase the state's potential liability for the damages caused by these same employees' ethical and criminal failures. The effect is to protect primarily agents of the state who are putting us at risk of further liability because they lack the fortitude to perform their jobs they are paid to perform. Specifically, taking care of children and vulnerable adults, directly or by performing jobs in support of that mission.

How many times have we heard that Child Protective Services or Adult Protective Services employees have failed to make legally mandated referrals to Law Enforcement for criminal investigation? Has there ever been any criminal investigations and prosecutions for this abject failure?  It seems that the only way anyone is held accountable is by the victim filing a lawsuit. Other than being legally compelled from outside of DSHS, I have never heard of a person experiencing any consequences such as losing their job or being prosecuted for Failure to Report, have you?  The lack of accountability for state employee's or assignee's  failure to perform  the legal duties required of the job; is a liability to the state. It is the individual's ethical and legal failure, which becomes the state's justification to cover up such failures which puts more children and vulnerable adults at risk, so that DSHS can avoid being found negligent and liable for damages.  This strategy ensures that children and vulnerable adults will be victimized and harmed, disabled and killed. Once they are victims, the victims are perceived as be a liability to be avoided. They are not treated as victims to whom the state owes a duty to protect from further harm, nor are they treated as crime victims and provided help to recover.

Children's Administration in effect, acts 'in loco parentis' for children and adolescents in state care, indeed they are the arbiter of who becomes a ward of the state, and who does not. When a child in state care is prescribed drugs and given the drugs without Informed Consent first being obtained from a parent; who is authorizing this be done?  If a child then sustains an iatrogenic, or "physician caused" injury, becomes disabled from the adverse effects of the drugs prescribed which have well-documented potential risks for causing chronic impairments and life-long disabilities; who is responsible? 3-year old drugged in TX
13 year old dies

I know the answer to that. No one is responsible, not the federally funded research psychiatrist, and not Children's Administration; the state pretends there is no need for accountability for harm done by agents of the state. It's impossible for me to pretend that professionals shouldn't be responsible for the harm they've carelessly caused my son.  My son is disabled as a direct result of the state's criminal negligence. According to one of the state's attorneys, the state fulfills some of it's mandated duties; but others require citizens to take legal action against the state. Not the most ethical perspective for a legal advisor responsible for ensuring state designees preserve the individual rights of their clients. This ineffective method serves more often to effectively deny a client any recourse once their rights are violated.  It's as if I've been informed DSHS employees are allowed to violate State and Federal Law, and are allowed to violate a client's individual rights in a Court of Law with impunity. When there is cause to believe crimes were committed, e.g. A well-documented written report detailing how 2 Officers of the Court and 2 mental health professionals used fraud and perjury as "evidence" in Superior Court obtaining a Court Order against a client who was seeking hopitalization---The state has a legal duty to conduct a criminal investigation on behalf of the victim.

After a criminal complaint was filed, the department  proceeded to deny it owes my son, any legal duty. The state has also proceeded to defend the criminal acts of it's designees, the Desigated Mental Health Professional, the psychiatrist, the Deputy Prosecutor, and the Assigned Counsel for the client. The state had a duty to refer a Criminal Complaint to Law Enforcement; and did not. I know I'm more than a little disgusted by the fact that public servants in the state's publicly funded social and mental health "service systems" are obviously enabled to routinely avoid being held accountable for their obviously negligent criminal conduct. I know that as a MadMother, it's more than horrifying to know there is no accountability for ethical and criminal failures of the people whom we entrust to protect children and vulnerable adults who are served by the social services "safety net."

It's not the veracity of the excuse offered in the AAG's message that most troubles me, it is the purpose of the message, i.e. to (again) deny any legal duty to a client victimized by the state's designees, no duty to investigate the Felony Crimes reported. My own perceptions are biased, but I believe my opinions are ethically and legally sound. The state's employees and it's assignees have repeatedly caused my son harm; and whether their actions were merely careless, or criminally negligent, the state enjoys an undeserved immunity. I know that no crime committed by public servants which victimized and injured  my son that I have reported has ever been investigated by Law Enforcement. That tells me that not filing legally mandated reports with Law Enforcement is the rule, not the exception--it explains why unethical behavior is so as common as it is...

There is no way in hell I will become complicit in the crimes which victimized my son. I believe to be silent in some instances is to be complicit. The major flaw in the accountability system for DSHS programs in this state, is that there isn't one. There is no accountability within DSHS; true accountability requires ethical integrity; it should not require a citizen having to take legal action against the state.

I've been living a nightmare for almost twenty years, virtually from the moment I discovered my son was victimized. My horror is compounded by the knowledge CPS had received several credible reports alleging children in the foster home my son was assaulted in, were being abused; prior to his placement there. The damage to my son has been further compounded by the criminal manner employees of the state and it's contracted "service providers" have "provided services" to my son and my family, more often than not, the services were not what was recommended or needed, and caused all of us further harm.
photo credit: weprocessweserve.com

"Your children are not your children..." Do you know what your parental rights are?

Marianna, Kahlil's Sister. Painting by Kahlil Gibran

On Children

Your children are not your children.

They are the sons and daughters of Life's longing for itself.

They come through you but not from you,

And though they are with you yet they belong not to you.

You may give them your love but not your thoughts, 

For they have their own thoughts.

You may house their bodies but not their souls,

For their souls dwell in the house of tomorrow, 

which you cannot visit, not even in your dreams.

You may strive to be like them, 

but seek not to make them like you.

For life goes not backward nor tarries with yesterday.

You are the bows from which your children

as living arrows are sent forth.

The archer sees the mark upon the path of the infinite, 

and He bends you with His might 

that His arrows may go swift and far.

Let your bending in the archer's hand be for gladness;

For even as He loves the arrow that flies, 

so He loves also the bow that is stable.

Kahlil Gibran

via parentalrights on youtube:

Overruled: Government Invasion of your Parental Rights (Official Movie)

"The only thing necessary for evil to triumph is for good men to do nothing." Edmund Burke

"The Bill of Rights was designed trustfully to prohibit forever two favorite crimes of all known governments: the seizure of private property without adequate compensation and the invasion of the citizen's liberty without justifiable cause and due process."  H.L. Mencken 

 quotes from "Quotationary" by Leonard Roy Frank; link to website. 

parentalrights.org

via Nancy Schafer playlist:

Nancy Schaefer "The Unlimited Power of Child Protective Services"





published as 'Parental Rights Under Attack' November 18, 2011 and January 17, 2012 with 'Overruled'

Kahlil Gibran via katzanddogz.com 

Without Informed Consent: When the State Decides Children Should Be Drugged

CPS: Abuse of Power and Authority 

Violation of Parental Rights

Originally posted December 17, 2010, the video features Liza Ortez, a mother from the State of Texas whose 13 year old son died from the effects of neuroleptic drugs. 


"Liza Ortez was having trouble with her and son and turned to Mental Health and Mental Retardation, MHMR for help. Her son was put a number of psychiatric drugs including antidepressants and antipsychotics by a psychiatrist. CPS or Child Protective Services soon became involved and demanded that Liza adhere to the mental health treatment or CPS threatened to take her child away. After being in the system her son become(sic) worse and eventually died from an overdose of antipsychotic drugs." via psychetruth on youtube


The reality is this is happening around the Country---When did CPS, a Federally-funded program, assume the authority to deny parents their Constitutional Rights Without Procedural Due Process of Law?  When was it determined that if a psychiatrist or other "mental health professional" prescribes drugs and a parent does not give an Informed Consent for their child to take them, that CPS will take over?!  CPS will threaten to remove or actually call for police to remove a child from a parent's custody and care (Maryanne Godboldo)---not due to abuse or neglect, but because a parent exercised their judgement, and their Constitutional Rights?!  The woman in the videos below buried her thirteen year old son because he was given unsafe and ineffective psychiatric drugs---at the insistence of CPS; whose involvement in this case, (and in every case where a parent does not give CONSENT to dangerous psychiatric drugs being used to "treat" their child) is a blatant abuse of power and authority.  It is also A Violation  UNDER COLOR OF LAW of Lisa Ortez's Parental Rights protected (in theory) by the United States Constitution.  

 Individual Rights are only a theory when they are not preserved or defended! 

4. Parham v. J.R., 442 US 584, 602-606 (1979)
"This case involves parent’s rights to make medical decisions regarding their children’s mental health. The lower Court had ruled that Georgia’s statutory scheme of allowing children to be subject to treatment in the state’s mental health facilities violated the Constitution because it did not adequately protect children’s due process rights. The Supreme Court reversed this decision upholding the legal presumption that parents act in their children’s best interest. The Court ruled:  Our jurisprudence historically has reflected Western civilization concepts of the family as a unit with broad parental authority over minor children. Our cases have consistently followed that course; our constitutional system long ago rejected any notion that a child is “the mere creature of the State” and, on the contrary, asserted that parents generally “have the right, coupled with the high duty, to recognize and prepare [their children] for additional obligations." (emphasis mine)

video produced by psychetruth

http://www.youtube.com/psychetruth  

3-year-old placed on dangerous psychotropic drugs: “Child Protective Services operates in a manner that is detrimental”

What makes me angry

Jim Edwards' column, Placebo Effect titled, "How the Supreme Court Just Neutered the FDA" on June 24th was about a couple of US Supreme Court decisions.  a few excerpts:


"fear that people would make bad decisions if given truthful information cannot justify content-based burdens on free speech."   This quote is from Justice Anthony Kennedy who seemed to imply that pharmaceutical companies have no duty to be truthful in regards to the utility of their products.   Drug companies have a right to say whatever they want to about the drugs they manufacture in order to sell them or market them "off-label."


Edwards points out that "off-label promotion has previously opened up drug companies to a whole raft of different and often expensive legal liabilities.   It may also harm patients by subjecting them to drugs that don't work for what the companies say they work for."  


I can and do say what I want; but I cannot yell fire in a crowded theater if I wanted to  without fear of being prosecuted; and rightly so.   Freedom is within limits, and is not absolute.  Why can drug companies mislead medical professionals and people who are ill or in distress with drug marketing agendas and/or advertising campaigns?  Does the Consumer Protection Act not apply to FDA approved drugs?

The damage is potentially the same in the above scenarios:  people can be maimed and killed by a panic-stricken, stampeding crowd; people can be disabled or die from taking FDA approved drugs used for FDA-approved uses, as prescribed; or from taking prescription drugs prescribed "off-label" as directed.  The FDA refers to off-label use of FDA approved drugs as "experimental use" which sounds more risky than the innocuous term, "off-label."   The FDA is not doing it's job ethically, with due diligence.   This is painfully apparent when a person is disabled or dies from an adverse effect they were never informed of; particularly when the risk was known to the manufacturer and the FDA. Even worse, the risks are minimized or denied altogether so that the drugs can be FDA approved. The FDA proclaims that it has no ethical duty to share even fatal risks with the American public; supposedly the risks are "trade secrets." The FDA drug approval process is rarely revisited; nor is required after-market drug studies rarely done for drugs approved under PDUFA.  The FDA and the drug companies deny adverse effects of the drugs, and deny responsibility for the harm caused.  When the FDA approves a drug based on deception and fraud, professionals are intentionally misinformed about the the safety and effectiveness of the drug; consequently, doctors cannot give their patients accurate information. Is "Informed Consent" even possible with the pervasive corruption and collusion between the FDA and Big Pharma?   


In 1999, an article in published in Science Direct concluded, "The atypical antipsychotics should be critically assessed and compared to psychosocial interventions; if effective, a combination of both types of treatments should be evaluated."  Judith Rappaport, Child Psychiatry Branch at the NIMH is listed as one of the authors in the article, "Antipsychotics in Children and Adolescents." (behind a paywall) The article is not readily accessible even though it was funded by the American people through the NIMH.   

It does not appear to me that the NIMH acts on recommendations derived from research data that is produced from research that is partially or fully funded by the NIMH.  This seems to be particularly true when the recommendation itself will not further enrich Big Pharma by lessening the dependence on pharmacological treatments in favor of psychosocial and other evidence-based treatments for emotional and behavioral issues.  


In the last few decades, it has become abundantly clear that this duty is not being met:  The NIMH has historically partnered with Big Pharma in funding and conducting drug research.  When joint ventures are conducted there is a universal failure to effectively protect the public's safety interests.  Protecting the public from dangerous drugs,medical devices, etc. is theoretically the primary responsibility of the FDA, and it's failing miserably. People recruited into Federally funded research projects are at a serious disadvantage; but so are many ordinary patients, since professionals are also being misinformed by the FDA and Big Pharma. A degree, or even several, does not signify that a person has ethics or good judgement, neither does a license to practice medicine!  A degree is recognition of a person's education, and a medical license is legal permission to provide medical care. Blindly trusting that pieces of paper signify that a person is always honorable and always provides medical care in accordance with the Ethical Guidelines for Informed Consent is killing some of us...  


My son was given neuroleptic, or "antipsychotic" drugs, drugs that did not work; drugs that have caused him real, lasting harm.  He is not the only one who had these horrifying experiences---I cannot change what I could not stop; but as long as I live and breathe, I will try to keep the same thing from happening to any one else...A MadMother doesn't need a degree to have honor or ethical integrity---no one does.   


No one asked my son's or my permission; we were not informed about the risks or told that  the drugs were NOT APPROVED for pediatric use; therefore, we could not and did not give an "Informed Consent."  As I see it, my son was sacrificed on the altar of NIMH funded psychiatric research and corporate greed, by Jon McClellan.  The man never thought it necessary to ask if the debilitating effects of neuroleptic drugs that ultimately disabled my son would suffice in lieu of the recommended treatment which may have helped him. Instead of treatment for his severe PTSD, my son was repeatedly traumatized while being held prisoner in a locked psychiatric facility. I was lied to by  Jon McClellan, Medical Director of CSTC, and research psychiatrist. Jon mcClellan illegally assumed an authority he did not have and falsely claimed that my consent for my son's "treatment" was not needed, or required.  It took me almost two years to rescue my son---after McClellan finally acknowledged my son no longer needed to be in CSTC---then almost immediately obtained a Court Order for Involuntary Treatment in Pierce County Superior Court in order to prevent me from taking my son home---simultaneously, in Yakima County Superior Court, CSTC was recommending that Isaac be discharged; and the permanent plan to return my son home was implemented.


What makes me angry? The subterfuge and criminal conduct of the State's agents who act with seeming impunity, without conscience; and the knowledge that my son's experience is not uncommon.  No government agency in this State has ethically fulfilled the legal duty it owes my son. When he was a 3 year old child in the State's foster care system, he was the victim of violent crime due to State negligence--so the State tried to cover it up, to shield itself from being held liable for damages---Washington State protected the State and the perpetrator; it did not act in defense of my son, a crime victim to whom the State owed a legal duty.  

Once my son was a crime victim with profound PTSD and Left Temporal Lobe Epilepsy from brain trauma, the State made no effort to provide the recommended treatment for his injuries. The State was criminally negligent when it placed my son in the foster home since  there had been 12 CPS reports for abuse and neglect prior to the State putting my son there. 

The State ultimately violated federal Child Welfare and Medicaid law when it coerced me into signing a "Consent to Place" agreement using the fraudulent claim that it was the only way that Medicaid would pay for my son's continuing medical care. Once again in state custody, my son was repeatedly abused and medically neglected; he was heavily drugged with multiple drugs being used concomitantly, none of them approved for pediatric use. My son was repeatedly traumatized, in effect, my son was tortured by Jon McClellan in the State's psychiatric research facility for children until he was profoundly neurologically and cognitively impaired.

Why was I falsely led to believe that CSTC is a hospital, when it is not?  Why was I coerced into signing a Consent to Place agreement?  I can't help but conclude it was so the State could commit child welfare fraud, and also so the state's lead psychiatric researcher for children, Jon McClellan, could use my son in federally funded neuroleptic drug trials.  The State never acted to protect my son, or his best interests.  In truth, I don't believe my son, or his "best interests" were ever a consideration of the State's employees who had a legal duty to protect my son and his best interests. Under Color of Law, instead of acting in my son's best interests, State employees committed fraud, perjury, and Human Rights Crimes which left my precious son terrified of medical settings and permanently disabled. 

Every wrong seems possible today, and is accepted. 
I don't accept it.  
Pablo Casals

photo credit: technoayurveda.wordpress.com

Corrupt Courts A National Problem

From the Expose Corrupt Courts Blog:  Saturday, March 5, 2011

Judicial System Greed Using Families a National Problem

County Children and Youth - State court is asked to step in
The Times Leader by Terrie Morgan-Beseckertmorgan - March 4, 2011

Attorney’s petition likens workings of county dependency court to “kids-for-cash” scandal.

An attorney who represented parents who have lost custody of their children to Luzerne County Children and Youth Services has asked the state Supreme Court to take jurisdiction over the county’s dependency court based on numerous abuses he alleges are being committed by caseworkers and others involved with the court system. Attorney James Hayward, whose license is now under suspension, said he filed a King’s Bench petition with the Supreme Court on Feb. 18, one day before his suspension took effect. Hayward said he filed the petition – an extraordinary measure that is utilized in cases alleging egregious violations – as a last-ditch effort to help his clients before he began serving the one-year suspension of his law license. “I’ll admit I made mistakes, but that doesn’t change the fact they are stealing kids,” Hayward said in an interview Thursday, referring to Children and Youth.  Read more here.

Is Parham v. J.R., 442 US 584, 602-606 (1979) being ignored? 

Excerpts from this decision:

"Our jurisprudence historically has reflected Western civilization concepts of the family as a unit with broad parental authority over minor children. Our cases have consistently followed that course; our constitutional system long ago rejected any notion that a child is “the mere creature of the State”

"Therefore, it is clear that the Court is recognizing parents as having the right to make judgments concerning their children who are not able to make sound decisions, including their need for medical care. A parent’s authority to decide what is best for the child in the areas of medical treatment cannot be diminished simply because a child disagrees. A parent’s right must be protected and not simply transferred to some state agency. " more here.

A MadMother In Pro Per

"pro per" adj. short for "propria persona," which is Latin for "for oneself," usually applied to a person who represents himself/herself in a lawsuit rather than have an attorney.

This is the report I wrote and served upon The State of Washington in Dependency Court in Yakima County Superior Court.  I was pleading for my son's release from Child Study and Treatment Center; a place I had been misinformed was a hospital; it is in fact a research facility. CSTC staff had documented that my son Isaac no longer needed to be at CSTC; but there had been no effort to move him.  I also served the state with a copy of the Home Care Plan I had developed based on what hospital staff recommended; even though I did not agree with the recommendations.  For one thing, staff insisted that 24 hour awake supervision was necessary; my first thought was, "how in the hell would I be able to sleep?  What the heck would a paid staff person do while everyone was sleeping?!" For this, and many other reasons, I believed the CSTC staff's recommendations were unrealistic, ill-informed, and cost prohibitive. I later discovered none of these professionals had ever sent a child disabled by iatrogenic injuries; i.e. physician caused drug-induced neurological and cognitive impairments.Prior to my son being released from CSTC to come home as the State's permanency plan always stated, CSTC had not ever discharged a seriously cognitively impaired kid home to live with their family. Why CSTC staff pretended to know how to do ssoemthing they had never done, remains a mystery.

CSTC's staff claimed that the recommendations were based upon their professional experience. The only thing staff knew to do, is the only thing staff had done in the past; that is, discharge patients to a residential care facility. In the little over a year between my having the below petition served on the state, on my own attorney, the GAL, and the court, and Isaac finally returning home, I found he Washington State Legislature had commissioned a literature review study to determine what setting and services were in the best interest of children and adolescents with serious behavioral difficulties like my son Isaac experienced. Specifically the study was to determine what kind of treatment services gave children, youth and their families the necessary support to succeed. The conclusion was children and youth were best served by assisting their families to take care of them in their family home since it is cost effective, i.e. less expensive, kids and families have better outcomes. Incredibly, the study concluded, the kids had fewer relapses and required fewer inpatient hospitalizations.  The study was done at the request of Washington State Legislature and cost $50,000.  The work itself was conducted on the same campus where  CSTC is located in Lakewood, Washington.  The study was staff claimed, unknown to them entirely; and never used by the professionals who insisted institutional, residential care was required for Isaac's care upon release from the state's pediatric psychiatric research facility.

When I asked why the research relevant to the discussion was not used, I learned CSTC staff were unaware of the study.  I then asked what studies, or standards the recommendation was based on? The answer: none. Not one staff member could provide any supporting evidence for it's professional recommendation for Isaac's post-discharge care. Adding insult to injury, CSTC staff claimed staff member's professional opinions had no bearing or any potential to influence the state's decision on placement of my son as a state ward. Truthfully, it was CSTC staff who first questioned the permanency plan that had been on every single Court Order from the time Washington State wrested custody away from me falsely claiming placing Isaac in  state custody was required for Medicaid to continue to pay for his medical care...I found out years later this claim was not true, the only benefit of making my son a state ward was that once he was a state ward, the State was able to defraud federal child welfare and Medicaid programs by claiming he had no family. It is against Federal Law to make a child a state ward to compel federal programs to reimburse states for a larger percentage of a child's medical care, residential care costs, it is fraud. CSTC staff were insistent that their recommendation of discharging my son to a Residential Care facility was the only option. Not once in the four plus years Isaac's was at CSTC had the staff tried to alter the state's permanency plan. It was only when I personally forced CSTC into putting in writing my son no longer needed to be at CSTC that staff members attempted to offer it's "professional opinion" on Isaac's custody. The fact is, CSTC staff had been aware throughout Isaac's incarceration at CSTC, the permanent plan on every single dependency Court Order was for Isaac to return home. This permanency plan was only disputed because CSTC staff balked at the idea of Isaac returning home to live. CSTC staff insisted that discharge to a residential care facility was the only viable option---I discovered staff recommended Residential Care since discharging brain damaged kids to such facilities was the only thing CSTC staff had experience doing in real world practice; not because staff had thoroughly investigated what may best serve Isaac's needs, nor did staff include either Isaac or myself in developing their professional recommendation for meeting Isaac's ongoing care requirements.

I wrote the report below and shad it served upon the State in February of 2004. Everyone, including my court-appointed attorney were served by a Process Server.  I was later told, "they never saw you coming."  My son finally came home on January 5, 2005.  At 660.90 a day, the year and a half my son was incarcerated at CSTC when he no longer needed to be, cost the taxpayers $361,842. There were kids waiting to be admitted the entire time; there always is.  Kids waiting to be admitted, just like my son waited---for over a year---from the time his psychiatrist informed Yakima County's children's resource manger Isaac needed long-term psychiatric inpatient treatment. The children's resource manager did nothing to facilitate my son's admission to CSTC for six months.

Isaac was admitted to CSTC when he was twelve and a half year old boy...

I brought him home a couple months before he turned seventeen.

When my son returned home in January 2005, the in-home services were provided by Catholic Community Services out of Pierce County which is across the State; the local mental health clinic CWCMH, refused to provide the services.  The services were much appreciated and were provided by wonderful people.  They were more than what was needed; as I had predicted.  We used the in-home care services for six months---before we determined that tolerating inappropriate, unnecessary services in order to have needed respite available, was too stressful.  The fact is, as I had maintained all along: respite care and appropriate therapeutic rehabilitation services are all we needed; these are still what we need.

The director of Yakima County Human Services, Steve Hill, and the DSHS Region II Children's Administrator, Ken Nichols, failed to do their jobs in an ethical manner. These two public servants failed to perform their ethical duties as public servants; their failure cost the people of the State of Washington over $300,000.; and unnecessarily deprived my son of his liberty for nearly two additional years.  A civil penalty of $1,000. a day is attached to such egregious deprivations of an individual's liberty. The penalty upon the individual, regardless of employment status, including publicly funded work for a government entity; it is a civil penalty that applies to every individual whose actions and/or whose failures to act cause a person to be deprived of their liberty in any locked facility. for those who are incarcerated, individuals are deprived of liberty if they remain incarcerated after serving their sentence. In the case of a people in locked psychiatric facilities, once staff have determined the person no longer requires treatment only available at a psychiatric inpatient hospital or in the case of Child Study and Treatment Center, a psychiatric research facility.  

CSTC had unethically obtained a Court Order in Pierce County Superior Court to Involuntarily Commit my son while simultaneously issuing bi-monthly progress reports to the Yakima County Children's Administration, Yakima County Human Services, GCBH RSN, and Yakima County Superior Court at dependency review hearings that Isaac would be better served in the community, i.e. he no longer needed to be hospitalized. I believe the court order for Involuntary Commitment was sought in Pierce County to prevent me following through with my statement that I could take him home since he was a voluntary patient. This appeared to be perceived as a threat by CSTC staff, particularly by Leah Landis, the psychologist for the unit Isaac was on. The woman actually referred to the kids as "our children" as if the kids belonged to CSTC, in her attempts to persuade me to not actively advocate for my son's release, asking that I at least wait until  "the studies" were completed.  When I asked for clarification, i.e.what studies Ms. Landis was referring to, I was told that because Isaac was a ward of the state, I didn't have the right to know what studies he was enrolled in, my consent, informed or otherwise was not asked for or needed I was repeatedly told by the Medical Director, Jon McClellan.

The fact of the matter is, until Pierce County Superior Court granted the Court Order which allowed CSTC to involuntarily treat my son, I was the only person besides Isaac, who had any legal authority to provide Informed Consent for his treatment at CSTC according to Washington State Law and federal Medicaid guidelines and protection for Human subjects research. In spite of this, the medical director of CSTC, Jon McClellan, a psychiatrist and federally funded psychiatric researcher, repeatedly told me I had no say in treatment decisions. In fact, Jon McClellan maintained he did not need my consent for my son's psychiatric treatment the entire time my son was an inpatient at CSTC; the research facility I had been led to believe was a hospital...

Conflicting claims about Isaac's need for inpatient treatment were maintained for months by CSTC staff in Washington State Superior Courts in two counties. Yakima County was informed that Isaac as ready to be discharged, while Pierce County granted a Court Order for extended involuntary treatment. Obviously, it's not possible he met the legal requirement for a involuntary inpatient treatment and that he was also  ready for discharge from inpatient treatment...The Pierce County Court Order in effect, "legally" deprived me of my parental rights to make decisions about his treatment, although I had effectively been deprived from the beginning of Isaac's stay at CSTC by Jon McClellan. I believe the Court Order was sought to prevent me from following through on my stated intention, take my son home. The court order made taking him home a felony crime. The court order was illegal---evidence of the order's illegality is contained in the written reports that CSTC staff issued every two months stating Isaac no longer needed inpatient psychiatric care, the entire time the court order was in effect...

9-15-2013

Post script: The report I submitted to the court in 2004 states that Isaac got the "recommended treatment;" more accurately, he was hospitalized, as his psychiatrist recommended. The years between Isaac aging out of the ATTACH day treatment program at age six in 1994, and going to CSTC in 2000, he went without day treatment and intensive in home services which were consistently the recommended treatment, but the method of treatment was never actually prioritized; or even available. Day treatment is a priority according to RCW 71.24.035 section 5b; it is a "priority" that is required to participate in the Federal Medicaid program. The mental health services required by the Early Periodic Screening Diagnosis and Treatment for a child's emotional and behavioral difficulties are clearly prioritized within the Revised Code of Washington and Washington State's Administrative Code; and required by numerous contracts between the Federal Medicaid program, the State Medicaid program, the Greater Columbia Behavioral Health Regional Support Network; Yakima County Department of Human Services, and the community mental health service providers, but never available for children and youth. Day treatment, and other EPSDT services for children are still unavailable to this day...  

I first posted my report on December 29, 2010

judge graphic credit Legal Juice