Are Your Loved Ones Lab Rats And You Don’t Know It?

Knowing now what I know about Lewy Body Dementia, I’m concerned there could be individuals in Long Term Care Facilities that are being used for experimentation after finding the following website:  http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R12SOM.pdf

It’s become more widely known the executive functioning, the decision making area, part of the brain is affected with LBD and other forms of Dementia.

Because they can pass the MINI MENSA and other “psychological” evaluations for a long time into their disease progression, THEY HAVE THE ABILITY TO GIVE CONSENT TO PROCEDURES AND TESTS that might cause them more harm, more pain and most importantly, more suffering. 

People with the first stages of Alzheimers and other Dementias also have limited abilities and one might argue distorted executive level abilities that should not be used for actions of this kind.

Every day we see the ads on TV citing the side effects of drugs, even those released on the market, that have provided serious health problems and life ending effects causing them to be pulled from distribution. 

Just because someone may be seen as closer to that "end of life" stage, should this allow our society to condone using Seniors in Long Term Care Facilities as "lab rats"?

Every day medical facilities, and Long Term Care Facilties are classified in this category, are involved in research and trials. It's evident in a cms.gov document quoted below.

WHAT’S GOING ON AT YOUR FACILITY? 

Is this another reason Mom’s facility, in our opinion, and others “assess” residents at a higher level than they actually are and fail to recognize congnitive degeneration – because the residents then can “make decisions” where the facility would benefit? Is a facility compensated for these "trials"?

Most importantly: Why haven't we, the general public, been told about these "trials" being done at Long Term Care Facilities?  Why aren't we provided with a list of facilities that are involved in these tests? And a history of what tests they've participated in. I, for one, want to know before I go!

TRANSPARENCY.     FULL DISCLOSURE.       SUNSHINE LAWS.

Please read the following excerpt from http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R12SOM.pdf

Ask yourself:  Why would this section be a part of Federal documentation if there haven’t been problems, causes for concerns and previous violations?

F155

§483.10(b)(4) -- The resident has the right to refuse treatment, to refuse to

participate in experimental research....

Interpretive Guidelines §483.10(b)(4)

“Treatment” is defined as care provided for purposes of maintaining/restoring health,

improving functional level, or relieving symptoms.

“Experimental research” is defined as development and testing of clinical treatments,

such as an investigational drug or therapy, that involve treatment and/or control groups.

For example, a clinical trial of an investigational drug would be experimental research....

The resident has the right to refuse to participate in experimental research. A resident

being considered for participation in experimental research must be fully informed of the

nature of the experiment (e.g., medication, treatment) and understand the possible

consequences of participating. The opportunity to refuse to participate in experimental

research must occur prior to the start of the research. Aggregated resident statistics that

do not identify individual residents may be used for studies without obtaining residents’

permission.

Procedures §483.10(b)(4)

If the facility participates in any experimental research involving residents, does it have

an Institutional Review Board or other committee that reviews and approves research

protocols? In this regard, §483.75(c), Relationship to Other HHS Regulations applies

(i.e., the facility must adhere to 45 CFR Part 46, Protection of Human Subjects of

Research).

NOTE:  The statement above about being "fully informed". Seniors are generally in Long Term Care because the majority of them cannot provide their own daily life needs and one of these is medications. 

Yes, they can be self administered, if the facility finds the patient is "capable", but change a resident's medicine and see how many actually inquire about: dosages, side effects, expected results including cure or control and other effects.

Some people will undoubtedly see this as a "breakthrough" and a "way for those in the last part of life to contribute". In an altruistic world I'd agree. 

Unfortunately, Long Term Care facilities are few and far between that have the medical ability to monitor some experimental research programs.

At the very least, these programs should be fully disclosed to the general public as they involve individuals who are 24/7 influenced and managed by the people who could directly benefit from an experimental study and because there should be no "hidden" parts of Long Term Care that could influence an informed choice.