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

I say it's quackery...

Medical standards of care originally were based on clinical research and clinical experience; ethical medical standards originally were diagnostic procedures and treatments for symptoms and medical illnesses with known risks and potential benefits discussed for informed consent for prescribed treatment. Standards of care protected patients from unsafe medical practices and unethical professionals. The standards being promulgated for use in standard psychiatric clinical practice and recommended for use in pediatric and general medical clinics currently are written to conform to what is, and has been standard practice in real world mental health clinical practice for decades.

In real world clinical practice, it not unusual for irresponsible off label prescribing of dangerous psychotropic drugs with little, if any empirical support; i.e. drugs are prescribed for no valid, ethical medical purpose. Incredibly, drugs are prescribed without empirical evidence of either the drug's safety or effectiveness for the patient, and/or the condition and/or syptom the drug is prescribed to treat, drugs are sometimes the only "treatment" available. Psychiatry's current standards of care protect psychiatrists and the other medical practitioners who are trained to practice "psychopharmacology," not evidence based medicine, social and political control of individuals based on consensus of professional opinions.  Psychiatric "standard treatment" endangers patients. Obviously, psychotropic drugs which have teratogenic effects and have inherent risks which include cognitive, neurological and physical disabilities and early/sudden death. Once drug impaired, psychiatric patients are limited in their capacity to complain of mistreatment and effectively advocate for themselves. Many will develop drug-induced cognitive, neurological, metabolic, and cardio-vascular impairments which are medically neglected by the doctors who inflict them.

Apparently, it's an article of faith for psychopharmacologically inclined psychiatrists to believe the subjective observations and opinions of psychiatrists can miraculously transubsantially transform agreed upon opinions and beliefs into "scientific evidence" through a quasi-democratic process of consensus. Imagine that! A consensus of the opinions of psychiatrists validates psychiatric diagnostic criteria. Psychiatrists agree teratogenic drugs are therapeutic and "necessary" by legal force if required. Seemingly, by ignoring the direct adverse effects of teratogens on their patients,  psychiatrists become willfully blinded to disabilities and infirmaties, the iatrogenic medical injuries that consensus based psychiatry inflicts upon humanity with seeming impunity.

In every other field of scientific inquiry, subjective observation and opinion is suitable only to support findings and conclusions derived from empirical data collected in research and real world practice. Educated subjective opinions and observations are no substitute for medical knowledge gained from ethical scientific research, and thoughtful consideration of all available data. Using medical terms,  relying on consensus without offering valid empirical evidence to support psychiatric standards of care is an egregious abuse of power, authority and medical  privilege---There is no substitute for empirical evidence, and no excuse for abdicating the use of sound medical judgement and ethical medical principles.

Psychiatry's consensus-based diagnostic manual, the DSM, and consensus-based treatment algorithms such as TMAP and , are not ethically, medically or scientifically valid. TMAP and T-MAY, are consensus-based treatment protocols developed to market drugs and/or unethically "validate" off label prescription of dangerous FDA approved drugs; i.e. off label prescribing becomes psychiatry's "standard of care"absent empirical support or contrary to available evidence of either  drug safety or effectiveness for patient or symptom or condition...

How did off label use of dangerous drugs become so common, more importantly, how can it be considered ethical or even a "standard medical practice?" Psychotropic drugs are teratogens; yet they are prescribed without evidence of effectiveness, even though they have inherent, disabling, even fatal risks.

Abuse of prescription privileges. 

Psychiatry: a consensus-based standard of care. 

Psychiatry's so-called standards of care are commonly used to "validate" the prolific off label prescribing of neuroleptic, or so-called "antipsychotic" and other psychotropic drugs to children, the elderly and traumatized veterans. Treatment algorithms are based on consensus and "validated" by a quasi-democratic process. In reality, what are obviously political decisions are the justification, not exactly the needed evidence base, for so called standards of care. These "standards" which primarily serve to protect practritioners who use them by providing a pre-emptive affirmative defense against medical malpractice for iatrogenic injuries. Standards of care shield psychiatrists against malpractice claims for drug-induced iatrogenic injuries, permanent disabilities weven  fatalities inflicted with impunity. Most victims are mostly poor and/or reliant on Federal Medical programs. Marginalized by poverty, stigmatized with a diagnostic label, patients can be systematically dis-empowered a direct effect of legislating bigotry. Grass roots advocates who proclaim themselves to be "The Nation's Voice on Mental Illness" do not acknowledge psychiatric survivors/victims, much less advocate justice for victims of iatrogenic harm, educate the public about drug-induced disease, disability and death. The Nation's Voice does not speak for those who are killed as a direct result of psychiatric treatment.

via 1 Boring Old Man:

a mess, [still] deserving close attention…

a couple of excerpts:

"Childhood Psychosis is an uncommon finding, but can be associated with significant impairment, and the article mentioned by Dr. Purssey purports to be discussing childhood psychosis. But we all know that the extensive use of Atypical Antipsychotics in children [Medicaid children] isn’t about childhood psychosis at all. It’s off-label uses. The drugs are being prescribed for behavior control. That’s where the costs come from. That’s where the dangers are. That’s where the risk/benefit equation has been massively perverted. That’s the reason for the alarm. These are the kids that were inappropriately labeled Bipolar, justifying the use of these medications.

"There can be little question that the incidence of behavioral problems among the children on Medicaid is quite high. In fact, it would be surprising if that weren’t the case. Many of them are foster children or otherwise born into families in difficult circumstances. And for all its glitches, our foster-care system beats the orphanages of a former time hands down. These medications can be somewhat effective in situations when these children inevitably present with behavior problems, but at a very high price. Foremost, this is not a situation best approached by symptom control. Childhood is not something to be gotten through. It’s the period of complex development that shapes directions for a lifetime. This is a self-evident truth. It’s impossible to imagine that the important work of childhood can proceed through the fog of Antipsychotics – so the side effects such as the metabolic syndromes are an additional burden to children already swimming up-stream. Rampant medication in these situations is a clearly inappropriate and dangerous medical solution to a psycho-social problem. This is not simply something to decry. It needs to be stopped." read here

Here is the latest treatment algorithm to ensure kids will be drugged: 

via The Reach Instittute

T-MAY: Treatment of Maladaptive Aggression in Youth

Psychotropic agents are increasingly prescribed to aggressive youth on an outpatient basis,^5–7 despite limited efficacy and safety data.⁶ For example, sixfold increases in outpatient antipsychotic prescriptions were found between 1993 and 2002,⁸ followed by further increases between 2002 and 2006,⁹ largely with aggressive, nonpsychotic youth. These practices fall largely outside of indications approved by the Food and Drug Administration, raising concerns about efficacy, safety, role of alternative therapies, polypharmacy, and appropriate parent engagement and education.⁹Furthermore, a significant portion of antipsychotic prescribing takes place by primary care physicians, including pediatricians. For example, an estimated 32.2% of antipsychotic prescriptions for children ages 2 to 18 during 1995–2002 were by non–mental health providers.¹⁰ Evidence-based guidance is necessary for implementing care that addresses patients’ severity and source of symptoms, development, primary diagnosis, coexisting conditions, and family situations.¹¹

To address these needs, the Rutgers Center for Education and Research on Mental Health Therapeutics, in collaboration with Columbia University, the REACH Institute, and others, launched a consensus development initiative to address the outpatient management of maladaptive, impulsive aggression in children and adolescents.

Treatment of Maladaptive Aggression in Youth: CERT Guidelines I. Engagement, Assessment, and Management

Treatment of Maladaptive Aggression in Youth: CERT Guidelines II. Treatments and Ongoing Management

updated 2-17-2014

Is the use of coercion and force in psychiatry ethical?

via The New York Times:

LETTER

Forced Drug Treatment

an excerpt:

"In a society presumably under the rule of law, is it proper for physicians and other mental health professionals to coerce innocent individuals and force them to ingest dangerous drugs?"

DAVID COHEN
TOMI GOMORY
STUART A. KIRK
Los Angeles, July 31, 2013

read the letter here

The writers are professors of social welfare and co-authors of “Mad Science: Psychiatric Coercion, Diagnosis and Drugs.”

hat tip:

Forced Drug Treatment http://t.co/fRYbB78mlb #mentalhealth #coercion
— MARY HALL (@PsychVictim) August 5, 2013

Whenever a doctor cannot do good, he must be kept from doing harm.  Hippocrates 

via American Journal of Psychiatry:
The Cost of Assisted Outpatient Treatment:
Can It Save States Money?

SUPPORT: oxygen supplementation experiment in premature babies

via The Alliance for Human Research Protection:

OHRP Caves Under SUPPORT Pressure Re: oxygen experiment tiny premature babies
Wednesday, 05 June 2013
Proposal by powerful medical research stakeholders who "argue for completely eliminating the need for any consent in similar studies."

BEWARE of the powerful influence of institutional medical research.

They have pushed hard to get the federal research oversight agency, OHRP, to backtrack from its oversight action after determining that there was an institutional failure of compliance with Federal regulatory requirements by medical centers that conducted the SUPPORT oxygen supplementation experiment in premature babies. http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf

In a letter to the the University of Alabama (May 4, 2013), OHRP alerts the public that powerful forces are intent on lowering the bar for medical research ethics. The June 4 letter in part states:

"Ultimately the issues come down to fundamental difference between the obligations of clinicians and those of researchers. Doctors are required, even in the face of uncertainty, to do what they view as being best for their individual patients. Researchers do not have the same obligation: Our society relaxes that requirement because of the need to conduct research, the result of which are important to us all. As a trade-off in allowing researchers such flexibility, society requires that researchers tell subjects how participating in the study might alter the risks to which they are exposed."

OHRP does reamain (sic) steadfast in its finding that the SUPPORT consent forms failed to disclose the increased risks to parents--including risk of death:
"it would seem appropriate that the parents of the infants should have been informed of the real concerns withing (sic) the medical community regarding those [high and low end of ] oxygen levels" to which babies may be randomly assigned in the study.

Lest anyone have any doubt about the ultimate goal of the powerful government-sponsored researchers who conduct high risk experiments, OHRP notes that:

"some of the researchers involved in the SUPPORT study and others have argued that there was no need for researchers to have obtained any consent from parents before placing their children in this study.

This discussion takes place in the midst of a much broader discussion regarding a proposal from a distinguished group of scholars that is receiving prominent attention, which argues for completely eliminating the need for any consent in similar studies." (emphasis mine)

"These are crucially important issues, not just with regard to our ability to be able to conduct research with appropriate oversight, but also with regard to fundamental questions about the obligations owed by doctors to patients."

"Most important, given the controversy engendered by our determination in the SUPPORT study, we will ensure that the process for producing guidance [on what the rules are with regard to disclosure of risks in randomized studies whose treatments fall within the range of standard of care] is as open as possible, to allow input from all interested parties."

OHRP promises to conduct an open public meeting on this topic.

In the meantime, OHRP has "put on hold all compliance actions against UAB to the SUPPORT case, and plan to take no further action in studies involving similar designs until the process of producing appropriate guidance is completed."

Take action to prevent a return to pre-Nuremberg medical research standards when medical atrocities were committed "for the greater good."

We, the 99.9% are at increasingly high risk of becoming human guinea pigs without our consent.Vera Sharav here

via the American Medical Association 

Opinion 8.08 - Informed Consent

The patient’s right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice. The patient should make his or her own determination about treatment. The physician's obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice. The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice. Informed consent is a basic policy in both ethics and law that physicians must honor, unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent. In special circumstances, it may be appropriate to postpone disclosure of information, (see Opinion E-8.122, "Withholding Information from Patients").

Physicians should sensitively and respectfully disclose all relevant medical information to patients. The quantity and specificity of this information should be tailored to meet the preferences and needs of individual patients. Physicians need not communicate all information at one time, but should assess the amount of information that patients are capable of receiving at a given time and present the remainder when appropriate. (I, II, V, VIII)

Issued March 1981. Updated November 2006, based on the report "Withholding Information from Patients (Therapeutic Privilege)," 

Opinion 8.082 - Withholding Information from Patients

Withholding pertinent medical information from patients under the belief that disclosure is medically contraindicated, a practice known as “therapeutic privilege,” creates a conflict between the physician’s obligations to promote patients’ welfare and respect for their autonomy by communicating truthfully.   Therapeutic privilege does not encompass  withholding  medical information in emergency situations, or reporting medical errors (see E-8.08, “Informed Consent,” and E-8.121, “Ethical Responsibility to Study and Prevent Error and Harm”). 

Withholding medical information from patients without their knowledge or consent is ethically 

unacceptable.  Physicians should encourage patients to specify their preferences regarding 

communication of their medical information, preferably before the information becomes available.  Moreover, physicians should honor patient requests not to be informed of certain medical information or to convey the information to a designated proxy, provided these requests appear to genuinely represent the patient’s own wishes. 

All information need not be communicated to the patient immediately or all at once; physicians 

should assess the amount of information a patient is capable of receiving at a given time, delaying the remainder to a later, more suitable time, and should tailor disclosure to meet  patients' needs and expectations in light of their preferences. 

Physicians may consider delaying disclosure only if early communication is clearly contraindicated.  Physicians should continue to monitor the patient carefully and offer complete  disclosure when the patient is able to decide whether or not to receive this information. This  should be done according to a definite plan, so that disclosure is not permanently delayed.   

Consultation with patients’ families, colleagues or an ethics committee may help in assessing 

the balance of benefits and harms associated with delayed disclosure.  In all circumstances, 

 physicians should communicate with patients sensitively and respectfully.

More on the SUPPORT study Public Citizen: The SUPPORT Study was Even Worse than We Thought by Michael Carome and Sidney Wolfe via The Hastings Center Bioethics Forum blog

Public Citizen Report to the Secretary of HHS: New Information About Baby Trial Shows It Was Even More Unethical Than Originally Thought via Public Citzen

photo credit: Wikimedia Commons

Please help Mary Weiss find the justice she seeks

He is a poor son whose sonship does not make him 

desire to serve all men's mothers. 

~ Harry Emerson Fosdick

Mothers are the necessity of invention.

~ Bill Watterson

Mary Weiss with her son, Dan Markingson

I have another petition up in the upper right hand corner, the same picture of Mary Weiss and her son Dan Markingson as above--the text of the petition is below... 

Carl Elliott, a bioethics professor at the University of Minnesota, has done a tremendous amount of work attempting to get regulatory authorites to perfom their ethical and legal duties, to investigate and hold accountable the unethical professionals who failed Dan Markingson.  read his post about the petition here

my comment: The ethical failures and medical negligence of doctors Schultz and Olsen are the proximate cause, i.e. an act or failure to act which  resulted in Dan Markingson's death. These two doctors were  unethical, careless and medically negligent.  Why has there been no homicide investigation for what is clearly criminally negligent manslaughter? Plainly, these psychiatrists were aware of the risks, yet they failed to perform essential duties they owed to Dan.  When a patient dies because an unethical doctor is willfully negligent and fails to provide adequate medical care to a vulnerable adult whom the doctor owes both an ethical and legal duty of care to; it is homicide. In my opinion, Dan Markingson is the victim of iatrogenic homicide. 

via Change.org:

Petition by Mike Howard

In November 2003, psychiatrists at the University of Minnesota used the threat of involuntary commitment to force a mentally ill young man named Dan Markingson into a very profitable, industry-funded study of antipsychotic drugs. Dan was enrolled in the study over the objections of his mother, Mary Weiss. For months Mary tried desperately to get him out of the study, warning the psychiatrists that Dan’s condition was deteriorating and that he was in danger of killing himself. The psychiatrists refused to listen to her. On May 8, 2004, Dan committed suicide, and Mary lost her only child.

I feel privileged and humbled to have called Dan my friend. Because of a very unique situation I had a front row seat watching Dan’s resilience as he attempted to overcome not only his original mental and emotional crisis, but also the trauma that occurred when he was betrayed by those who were charged and licensed to provide care, healing and protection. For the past nine years Mary and I have tried unsuccessfully to have the University of Minnesota and its psychiatrists held accountable for Dan’s death. But Mary’s lawsuit against the university was dismissed on a technicality in 2009, and the university used legal threats to force her to give up her right of appeal.

Even so, Mary has refused to back down. In 2009, the Minnesota state legislature passed “Dan’s Law,” which prohibits researchers from recruiting a patient under an involuntary commitment order into a psychiatric drug study. Media outlets such as Mother Jones, the St. Paul Pioneer Press, City Pages and Scientific American have published accounts of Dan’s story. His story was also featured in the documentary film, Off Label. In 2010, AstraZeneca, the sponsor of the study in which Dan died, settled federal fraud charges for $520 million, and a University of Minnesota psychiatrist was implicated. Last year, the Minnesota Board of Social Work found serious wrongdoing by the study coordinator for the research study in which Dan died.

More recently, evidence of fraud and serious privacy violations in psychiatric studies at the university have emerged. It is possible that other research subjects have died or suffered serious injuries, or that they have been mistreated in other ways. Bioethicists at the University of Minnesota itself have called for an external investigation, yet the university still refuses.

I cannot tell anyone else what way of speaking out is most aligned with his or her own personal principles. However, I believe those of us who are personally affected by these issues must break the silence about the human rights violations inherent in coerced participation in psychiatric research. While University of Minnesota researchers used many unethical methods to force Dan to participate in this research study, the most egregious of them was fear. Dan was afraid that there was no alternative to taking part in the study, and that he would face a complete loss of liberty if he did not participate.

Given the repeated failure of university officials to act in good faith, I believe that the Governor of Minnesota, Mark Dayton, should appoint an external panel of experts to investigate ethical wrongdoing in psychiatric research at the University of Minnesota, including the circumstances surrounding Dan’s death. The panel should be given latitude to investigate the University of Minnesota human subject protection program, the Department of Psychiatry, the Office of the General Counsel, and any other university officials involved in the oversight of human research.

Let me finish by allowing Mary Weiss, Dan’s mother, to speak for herself.

Dan and I were very close. I have experienced more anguish than I thought humanly possible since Dan’s death. He had dreams, like everyone. He had a talent for creative writing, and he had hoped one day to write for The New Yorker magazine. Unfortunately, his unfinished life robbed him of this dream. In fact, his short time on earth took many dreams from him, and also from me. The things he wished for, I wanted him to realize. Please demand an investigation into the circumstances surrounding Dan’s death, and help ensure no other family ever suffers such a loss from unregulated and improperly supervised clinical trials. Please sign the petition below. Help us find justice, not vengeance.

Text of the Letter to

To:
Mark Dayton, Governor of Minnesota 

Dear Governor Dayton,

I just signed a petition asking you to investigate possible research misconduct in the Department of Psychiatry at the University of Minnesota.

I am disturbed by the refusal of university officials to investigate the suicide of Dan Markingson in an industry-sponsored research study in 2004. I am also concerned by the university’s refusal to look into the possibility of misconduct in other psychiatric research studies. As a public institution, the University of Minnesota has a responsibility to answer legitimate questions about its research activities and to protect the rights and welfare of research subjects.

I urge you to appoint an impartial, external panel of experts in research ethics and regulation to investigate.

Thank you for your consideration.

Sincerely,
[Your name]

Why are different lower "legal" standards used in Involuntary Commitment proceedings?

"If the physician presumes to take into consideration in his work whether a life has value or not, the consequences are boundless and the physician becomes the most dangerous man in the state. -DR. CURISTOPH HUPELAND (1762-1836)

I have not been myself since the summer of 2010. More accurately, I have been changed by the events which happened when my son had a crisis. I more fully realized that many things are just not at all how they should be, and that many people do not seem to care that they are not. Crimes were committed in the summer of 2010 which violated my son's civil rights, and when I filed complaints with the appropriate authorities on his behalf no appropriate action was taken. My son was traumatized yet again by unethical "mental health professionals" who are not going to be held legally accounable for committing crimes which caused harm to a person they owe an ethical legal duty to. It is standard for no one to be held accountable when victimizing people with a psychiatric diagnosis. Crimes are not even investigated, at least crimes in which my son was the victim never have been...

Although involuntary treatment commitment proceedings are considered, “civil” as opposed to “criminal,” one should have no doubt that a loss of one’s liberty, the loss of legal and political status without being afforded equal protection under the law, is a violation of one’s Human Rights. The consequences are as detrimental, if not more so, than the consequences for a misdemeanor criminal conviction. For one thing the Court Order can be in effect for the remainder of one’s life. The individual rights protections the law allows a person in a civil commitment proceeding are less than those people charged with crimes can count on. Not unlike a misdemeanor criminal conviction, a Court Order for involuntary treatment alters a person’s legal status and temporarily deprives them of their Liberty. However, in civil commitment proceedings, the person’s lowered status often becomes a permanent legal distinction, and the deprivation of Liberty can also become permanent, through either in- or out-patient commitment.

This begs the question, “Why are different lower "legal" standards used in Involuntary Commitment proceedings?” The Involuntary Treatment statutes deprive people of individual rights protection people charged with felony crimes can take for granted.  

1. The “evidence” required to obtain a Court Order to detain, and/or commit a person can consist of nothing more than hearsay, speculation, gossip and innuendo, it is not required to comply with the Rules of Evidence.  

2. It is alleged or implied in the proceedings that the person has a “brain disease” or genetic defect which will be corrected, or “medically treated.” No evidence is offered; nor is any evidence to support the claim stated or implied even asked for.

3. Standard Court Procedures are not followed.

4. A person may be appointed an attorney, however, this does not mean that Effective Assistance of Counsel is provided. Not only are the legal, social and political consequences of a Court Order for Involuntary Treatment  profound; the medical consequences can be lethal.

The obvious detrimental social, political and legal consequences to the person court ordered to Involuntary Treatment really demands that individuals have equal protection under the law. It is ethically, legally and morally indefensible they are allowed much less. It is a civil rights violation. It is a social policy that has “legalized” discrimination against an entire class of people Under Color of Law. It is inhumane to deprive vulnerable people of equal protection under the law. The attempts to justify this social policy by claiming it is in a victim’s “best interest;” or that it is done “for their own good” are juvenile; all things considered, justifying any of this as beneficent or charitable is incomprehensible; truly despicable really.

Medical professionals in theory, police themselves...Doctors (and perhaps, all professions that "police" themselves) seem to do so very ineffectively. While this is a rather broad generalization, I believe there is more than a grain of truth in it...
Part of learning in life and in medicine requires learning from one's own and one another's mistakes; in effect, bearing one another's burdens as well---this reliance upon one another may inhibit one’s ability or willingness to learn how and when one should act in defense of a vulnerable person, and perhaps play a role in having a person held accountable for an error that caused harm to a vulnerable person. The intent and the purpose of accountability is to ensure people are treated with respect and have ethical medical care to protect patients from quackery and unethical practitioners. Performing the ethical duty of policing one’s colleagues more effectively and consistently, would restore and help to effectively preserve the ethical integrity of the evidence base, and the reputation of the medical profession.  

One of the things that I have come to realize, (I have yet to accept it with any grace) is with rare exceptions, basically good people, who were otherwise competent professionals made errors in judgement or behaved in a reckless, abusive or negligent manner when interacting with my son.  For the most part, basically decent people harmed my son. Even more looked the other way; failing their ethical duty to my son. It is of no comfort to me to realise it wasn’t malice or ill intent which motivated their actions; truthfully, the fact that it was simply carelessness or ignorance, has  caused me no small amount of additional sorrow...

I’m at a loss as how to reconcile what I believed and thought was true about people in general, and mental health professionals in particular, with our experiences. The manner in which we were treated, has made it impossible to reconcile how we were treated with the ethical guidelines for medicine, or the principles of social justice. Societal norms of civility and human decency I believed at one time to be "how things are done;" were nowhere to be found in our trek through the mental illness system.  I have spent countless hours doing research looking for answers which could possibly explain any of what happened; and I came across the chapter of a book several weeks ago that offered an explanation of sorts, but is of no comfort at all. I am nonetheless thankful to have found it.  

There is no reason for what we experienced. Reason has nothing to do with good people being wilfully blind; in effect, choosing silent complicity. There is no good reason for continuing to employ people who fail to perform required tasks clearly stated in their job description, when their failure is a crime. The system isn't broken---it's the people who are employed in spite of failing to perform a critical part of their jobs as Paid Public Servants. The fact that is, it's a crime for state employees or contracted providers to not refer complaints to Law Enforcement for investigation when required by law to do so; this seems to be conveniently overlooked; rarely (if ever) prosecuted. Probably because the state is ultimately liable for damages.


I am grateful that I was there to bear witness to how my son was used and abused; more grateful that he survived. I am painfully aware others don't survive; then there are the survivors who have no one to validate their pain, some have no one who listens to them at all. No one should have to bear such burdens alone; no one should be without someone who loves them, validates them, believes them and has confidence in them. Someone who will bear witness for them, should they be too traumatized to tell their own story. My son has been silenced by fear and trauma (de)Voiced by his lived experience; he will be 25 day after tomorrow, silenced by fear.  

I have no understanding for why a psychiatric diagnosis is used as a justification for treating people as if the diagnosis means they are less than human; less than worthy of their Human Rights being preserved or even defended. In truth, it seems to me that if a person is not as able to protect their legal interests temporarily or permanently for any reason, the person would need special consideration to preserve and defend their fundamental Human Rights. Involuntary Treatment statutes lower the standards and allow a much lower standard with less protection for an individual's Human Rights to be used. How is that even ethically or morally justifiable? I know it isn't. I know it is inhumane, that it is discrimination based on *a real or perceived* disability; making it "legal;" but not in reality, since it is unconstitutional, and violates individual rights Under Color of Law. That it uses the same convoluted ignorant reasoning; the same type propaganda, and the same social control tactics that were used to implement Eugenics as a "public health" and "social services" policy in this country is horrifying---Doesn't anyone in America know any American History? Implementing these kind of "beneficent" social service programs which deprive people of their human dignity, their Human Rights, and their freedom for life Under Color of Law has been done before in the US Eugenics Era and in Germany leading up to WWII.

via the New Existentialists:

Eugenics and Psychiatry: A Brief Overview of the History

a couple of excerpts:
"In my casual observations in conversation with colleagues, I find that very few mental health professionals are aware of the historical link between psychiatry and eugenics."

"Has psychiatry today fully exorcised the demons of it’s past? I think not. Children in poverty, especially those on public welfare and in foster care, are much more likely to be drugged with harmful antipsychotic drugs. I see this kind of psychiatric abuse as an extension of the eugenics project, and it needs to stop. Psychiatry is also still used to perpetuate racism. Today, we still see that black men are misdiagnosed with schizophrenia five times more often than white people. It is easier to label a person with madness and force his compliance with antipsychotic drugs than to endure the difficult job of listening to a man who lived with the darkness of a lifetime of victimization by racism. Until we see such patterns disappear from psychiatry practice, I will remain unconvinced that psychiatry has fully escaped the weight of its shameful eugenic legacy."

-- Brent Dean Robbins here

available at Amazon

"IF we want to understand violence as a whole, we cannot leave any of its major manifestations in a fog of half-knowledge. But this is exactly what has happened with an unprecedented occurrence of mass violence, the deliberate killing of large numbers of mental patients, for which psychiatrists were directly responsible. To both the general public and the psychiatric profession, the details and the background are still imperfectly known. This is not only a chapter in the history of violence; it is also a chapter in the history of psychiatry. Silence does not wipe it out, minimizing it does not expunge it. It must be faced. We must try to understand and resolve it." Fredric Wetham, M.D. A SIGN FOR CAIN An Exploration of Human Violence
A SIGN FOR CAIN An Exploration of Human Violence FREDRIC WERTHAM, M.D.Chapter 9 (pdf) http://ow.ly/h5dfY  on Leonard Roy Franks website

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Eugenics photo credit

The Elements of Informed Consent for Clinical Research

via NIMH:

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