Is our state allowing clinical trials on our most vulnerable citizens without an ethical review?

Human Subjects Research being done on our most vulnerable citizens with no consent or ethical review.

Senator Adam Kline is proposing legislation, again, which is an experiment on our most vulnerable citizens.  Why are we allowing this happen right under our noses and why aren’t more people calling him and others out on this unethical practice?

The year 2011 saw passage of a bill which legislated age discrimination in violation of the US DD Act and the US Supreme Court Decision Olmstead by not allowing those 21 and under to receive the life saving and life sustaining services in the Residential habilitation Center (RHC).  This bill also called for the closure of one of our state’s RHCs and froze admissions to another one.  There was one negligent death just one year ago of an individual who was evicted from his  RHC home into his “own” community home.  He suffered needlessly due to incompetent and untrained caregivers before dying from swallowing laundry detergent which had been stored on the counter in a milk carton.

Now, Senator Kline is again pushing our DD Service System Task force to run more experiments our most vulnerable.  He is advocating for closure of another RHC (he states 360 people – which is the number of people who reside at Rainier School) in the quote below transcribed from the Task Force meeting on October 9, 2012.

“You’ve got some number of families – of those 360,  would want to have their loved on in a RHC, receiving the kind of care that they have and their choice is in “hither or yon” or in the community.  The whole point of sub F (part of legislation that Senator Kline is trying to get passed)– take a look at it – is to guarantee as best we can – that the treatments – we spell it out – medical, nursing, dental, behavioral, mental, habilitation, employment, day support, that those, that the degree of applicability in the RHC is met in the community above and beyond what the residential provider provides.

So, the point is there may be some people, there will be some people for whom, a small number, for whom it will be more expensive to provide a vast needed bundle of services and supports in the community more expensive than it would be in the RHC.  I get that – for a small number of people and we’ll do it because for the much larger number of people, the same or better services can be provided at less cost and we can eat into that 13,000 waiting list.  Okay, there is an equity involved here, alright? ”

October 9, 2012

Developmental Disabilities Service System Task Force

Olympia, WA

My questions:

Given that Senator Kline is clearly talking about closing an RHC and  he clearly states that community services will be more expensive.  Yet, Senator Kline has idea what the number will be of those whose care will be more expensive in the community than in their current RHC home.  This means that he will have to have a threshold of who will receive appropriate care and who will receive negligent care .

1.  How many people will Senator Kline allow to have their assessed needed services in the community?  10%, 25%, 50% 75%?

2. What is the cut off for not having ones assessed needs met?

3. What happens to those who then fall on the other side of that cut off?

4. Do we accept negligent care for them because their care is now too expensive?

Why would anyone consider moving people who are happy in their homes, not requesting to move and have their assessed services met in a cost effective system to an untested and most likely more expensive system?

Isn’t this illogical and unethical?  Well, this is exactly what Senator Adam Kline and others who are pushing for – an  expensive and experimental system change.  Where are the ethicists in this experiment?

Look at the  Code of  Federal Regulations  and ask about the protection of human subjects.  Why are our legislator allowed to play experiments on our loved ones without an ethical review team looking into this.

Is our state allowing clinical trials on our most vulnerable citizens without an ethical review?

Please look at the Nuremberg Code, the Helsinki Agreement and the Belmont Report (A Guide to Research Ethics, 2003) below and tell me why these experiments are even being talking about without going through an ethical review.

The Nuremberg Code has 10 guidelines:

1. Research participants must voluntarily consent to research participation

2. Research aims should contribute to the good of society

3. Research must be based on sound theory and prior animal testing

4. Research must avoid unnecessary physical and mental suffering

5. No research projects can go forward where serious injury and/or death are potential outcomes

6. The degree  of risk taken with research participants cannot exceed anticipated benefits of results

7. Proper environment and protection for participants is necessary

8. Experiments can be conducted only by scientifically qualified persons

9. Human subjects must be allowed to discontinue their participation at any time

10. Scientists must be prepared to terminate the experiment if there  is cause to believe that continuation will be harmful or result in injury or death

Helsinki Agreement

•  The necessity of using an independent investigator to review potential research projects

•  Employing a medically qualified person to supervise the research and assume responsibility for the health and welfare of human subjects

•  The importance of preserving the accuracy of research results

•  Suggestions on how to obtain informed consent from research participants

•  Rules concerning research with children and mentally incompetent persons

•  Evaluating and using experimental treatments on patients

•  The importance of determining which medical situations and conditions are  appropriate and safe for research

The Belmont Report outlines:

1. The ethical principles for research with human subjects

2. Boundaries between medical practice and research

3. The concepts of respect for persons, beneficence, and justice

4.  Applications of these principles in informed consent (respect for persons), assessing risks and benefits (beneficence), and subject selection (justice)

One comment on “Is our state allowing clinical trials on our most vulnerable citizens without an ethical review?

  1. Below is my letter to the University of Washington School of Disability Studies informing them of this unethical legislation being proposed:

    Dear University of Washington School of Disability Studies Professors

    I am writing to you as a parent, advocate and healthcare professional regarding issues that are occurring in our state with our Developmental Disabilities Service System Task Force and legislation in 2011. I am so concerned about the lack of transparency and false information being passed as truth to the task force, legislators and public regarding care of our most vulnerable citizens.

    Just last year our state passed a bill which legislated allowing age discrimination against those 21 and under by denying their admission to a Residential Habilitation Center (RHC) without having an alternative service. For many of these youth and young adults, the RHC is the ONLY place that they can receive lifesaving and life sustaining care yet they are denied admission only due to their age. If there was a safe alternative this would not be such a critical issue but there are no safe alternatives for these folks.

    In all the discussions that I have heard, research which I have read and documents which I have reviewed with regards to our state’s legislation, I have not ever see any reference to research in an academic setting or medical research done to support these legislative changes that have been and continue to be proposed. The research that the Department of Social and Health Services (DSHS) has published with regards to issues of acuity and support needs of our citizens with developmental disabilities is so flawed that I believe if it needed to be defended as a dissertation it would be not pass. Yet, this “research” is heralded by DSHS as fact and has been used to base legislation on.

    The research that I question is the report “Assessment Findings for Persons with Developmental Disabilities Served in Residential Habilitation Centers and Community Settings” (http://www.dshs.wa.gov/pdf/ms/rda/research/5/36.pdf) The data seems usable but the “Key Findings” are not supported by the data. I have written ad nauseam to the authors of this research and also administration in DSHS questioning the conclusions and have even supplied graphs and explanations of how the authors manipulated the data from 3 categories to 2 for the conclusions which totally gave misleading information to legislators. I have never received a response from anyone regarding my questions.

    Now with the DD Task Force moving forward with yet, again, another experiment on our most vulnerable citizens, I am asking that you look at the ethical issues regarding moving these people out of their homes without their consent or knowledge. Many times, these moves will cause suffering and harm if not death. Below is the post that I wrote today questioning the ethics of our legislature running human experiments without any oversight.

    I am also forwarding this message to those on the Task Force. There has been no input from professionals – medical, nursing, psychological, social, educational, vocational – in making decisions which could very well cause harm to many of our loved ones.

    Please let me know if you have any questions. I would be more than happy to have a discussion concerning not only this task force but the legislation that has transpired in the past couple of years.

    Thank you,

    Cheryl Felak, RN, BSN
    Because We Care – Beyond Inclusion
    http://www.becausewecare1.com

    Like

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