by Rose Rohloff
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.
The 1974 Research Act was created in entirety from the Belmont report, and put into place to prevent the Government, it agencies or representatives, military and private companies, from violating an individual's freedom: by forcing, tricking or coercing persons for research, testing and administration of unknown injections/materials, and experimental procedures. This law was enacted after a century long track record of precedence including, and not limited to, the following:
Demonstrated lack of Respect for Persons and their protections in violation of 1974 law.
1- Autonomous agents, individuals capable of deliberation about personal goals and of acting under the direction of such deliberation. The Government and companies have to give weight to autonomous persons' considered opinions and choices, and cannot obstruct their actions and judgments, nor deny individual freedom to act on considered judgments, and cannot withhold information necessary to make a considered judgment. Necessary information includes - but not limited to - all medical opinions by established, industry experts, health status, the necessary assessments, labs, with close monitoring of physical lab and test follow ups of each and every autonomous persons as part of clinical research and testing, along with full documentation of testing, efficacy, use of chimera for research and testing, any and all conceivable side effects, and interactions of conditions.
2- persons with diminished autonomy are entitled to added protections.
Violators to the law have been marketing to the most vulnerable, including the immature and the incapacitated who were in need of extra, added protections, even to the point of excluding them from any injections or procedures which may harm them; violating added safety precautions for children, elderly, or those with diminished capacity.
Informed consent - must include full disclosure of ALL contents to be injected, any and ALL possible side effects (which can be several pages long), how those persons are individually to be closely monitored, safety guidelines, and above all the right to say no before or at any time, and full reporting of all individuals regarding their safety monitoring/labs/assessments, and any and all side effects. By promoting COVID shots all still under clinical trial/research, and coercing with careers/jobs, inability to travel, etc. in order to take the shots, this law is being violated through: lack of informed consent, lack of protections of autonomous persons, and/or illegally acting as IRSB board members marketing to those not autonomous and capable of self-determination, with higher standards of protection to be invoked, and assuming the role for their safety.
The maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others.
An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.
Undue influence also includes offers of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable as in the case of targeting children, persons with limited capacity, and elderly with elements of mental defect, or instilling fear.
Short term morbidity and mortality cases from the shots are well reported and known, such as death, myocarditis along with spontaneous cardiac arrest with no warning, debilitating neurological conditions, etc. And, there is no means yet to determine mid and long term effects because Phase I trials have not been competed, let alone Phase II and III - which is vital information in order to determine informed consent.
Injustice has been performed with companies and government representatives, by involving vulnerable subjects, including the young, those unable to fully comprehend with all necessary information, and scaring parents with compromised capacity for free consent. In addition to lack of individual, tightly scheduled, continual monitoring and follow ups, autopsies of all persons involved in this trial participation should be conducted for reporting by the pharmaceuticals companies for any and all persons who received the shots, as well as labs determining efficacy and detriments (as examples, antigen creation, D-dimer, Pulse Cardiac and Troponin Tests) for all those who were coerced or unduly influenced to participate in research.
This law was created to protect people from government abuse through experimentation. The government cannot arbitrarily dismiss components, create resolutions or stipulations to supersede the law, as to invalidate its protection of individuals from them, including, but not limited to Health and Human Services (HHS) Center for Disease Control (CDC), Food and Drug Administration (FDA), National Institute for Health (NIH), etc. and pharmaceutical companies, etc.
Persons have been illegally acting as members of, or bypassing, IRSB safety review and monitoring of each and every person receiving injections, with open undue influence and coercion, to participate in Covid injections. Coercion has been especially directed to the diminished autonomous, children and elderly, through TV ads, library recordings, verbal encouragement, schools or other public venues acting as government agents, and/or clinical researcher recruiting participants, and/or illegally as untrained IRSB member who is not following up to ensure safety of the people they recruited, coerced or used undue influence.
Overall lack of informed consent has become too often common practice across the healthcare industry, including people being given consent forms hours or minutes prior to surgery; no alternative treatments or lifestyle-nutrition changes prior to medications begin prescribed, and undue influence to intubate or perform surgery on patients in lieu of alternative treatments.
Why have $MM/$BB EMRs?
by Rose Rohloff
The 2009 HITECH Act and the Center for Medicare Medicaid Services’ (CMS) Meaningful Use regulations caused a massive spend for electronic medical records (EMRs), the push for interoperability, as the solution to healthcare quality. However, EMRs are not solutions - along with massive IT overhead spend with decreasing quality - because in a high percent of instances, nurses and doctors don’t even read them.
A 40-year old mother went to the doctor after treating herself holistically for some laryngitis, stuffy nose, congested sinus, with continued symptoms after five days. After an exam, the doctor stated, “I am not going to give you antibiotics. You do not have a fever; your lungs sound clear. It looks like a little virus with severe allergies. I recommend an antihistamine.” The patient told him, “Thank you for not putting me on antibiotics when they are not needed, that makes me happy.” He responded, “I am glad you are glad.”
He then said something and the patient responded, “I have MS.” He responded, “Oh wait, you have Multiple Sclerosis?”
This story is sadly too often the new normal, numerous instances of patients and their caregivers stating issues of diagnosing with medication prescription, or misdiagnosis; the doctor or nurse having no idea of pre-existing conditions or a full list of medications currently being taken, a lack of care coordination or care planning because the time was not taken to simply read the chart (whether written or electronic), and ensuring a comprehensive history followed by the necessary physical assessment.
No physician or nurse should walk in to care for a patient without first having read the patient’s record, knowing all current information, the last visit/healthcare encounter, chronic conditions/comorbidities, and all medications; then, asking for updates of changes. Unfortunately, even without having to decipher poor handwriting, being able to read clean typed text, clinicians are not simply reading the basics of information they should before doing any diagnosis, planning and care, or prescribing of medications.
There are pitfalls with IVF that are not discussed. And, this business end of reproduction is more often than not cash only. There are virtually ZERO long term studies regarding what effect-impact freezing, and a host of other ‘things’, that are done to the egg, or sperm, or the embryos that have (or could have) on the child that is produced. This 'miracle of modern medicine' could be good ... or just OK ... or it could be very, very bad. Science has rubbed the lamp and we cannot put the genie back in the bottle. After counseling many women in my career, the great emotional toil let alone the finances are not discussed. The ethical check is also missing regarding instances of doctors using their own sperm such as the Indiana doctor who in 2016 used his own sperm at least 50 times.
As the character Dr. Ian Malcom (played by Jeff Goldblum) said in the 1993 movie Jurassic Park, “Your scientists were so preoccupied with whether they could (create life) that they didn’t stop to think if they should.” by Karen F., (Ret) RN, NP OB & Palliative Care
by Rose Rohloff
As a 35-year healthcare veteran, I am a firm believer of cross-pollinating successful processes from other industries into the healthcare industry, for positive transformation. Delivering quality care will continue to be complex and challenging, with the need to leverage solutions that work. And SEAL teams are a proven efficient and effective success in the military.
By rebranding PC teams and the team process, expanding with additional SEAL successful methods and approaches, we can create the Healthcare version of SEALs (sea, air, land), as APAC Teams (acute, post-acute, and community) - expanding the process to operate in every environment versus only in facilities, for enhancing the quality of care of high risk patients versus limiting to end-of-life cases.
The following chart displays characteristics of SEALs, obtained from several former SEAL, special operation personnel, and military officers; with several of the attributes emulating characteristics regarding the successful palliative care (PC) team process.
Within the industry, PC is still aligned or mistaken with hospice, as demonstrated in the following two scenarios. Recently, a viral video was circulated and applauded, Australian paramedics fulfill dying woman’s wish to go to the beach, telling the story of a Hervey Bay crew transporting a patient to the palliative care unit, but she wished she could, “Just be at the beach” instead, and so the crew drove to the beach to provide her peace, based on her wishes of quality of life. This story is lovely regarding true care of a patient. Additionally, in April of this year I attended the Becker’s Hospital Conference in Chicago with the top leaders in healthcare, with a wonderful presentation about business analytics regarding palliative care, end-of-life. Both stories demonstrate clearly that palliative care is still being confused with hospice, or limited to a specific unit definition, instead of the effective use of the team process use with complex and/or chronic conditions.
However, what is it continuing to do to their brains having more medications and anesthesia, while it may not be improving their actual quality of life?” With APAC team coverage, a non-end-of-life case can be reviewed with a sound plan of care based on the desired quality of life for the patient and family. The PC coverage in the community has been focused on cancer patients, with a high focus on children. With the demonstrated cost savings and positive outcomes with The value of palliative care teams (HFMA, March 2013), the community coverage can be successful for individuals with multiple comorbidities, such as diabetes with congestion heart failure and hypertension; as well as elderly who are being targeted when ‘sundowning’ with fraud scams, or confused with medication regime, and those with family living in other states who are their primary support system/durable power of attorney. It is daunting, emotionally and financially, for the families of high-risk consumers to search out the various interdisciplinary resources such as dieticians, social workers, case managers, pharmacists, nurse practitioners, and spiritual counselors.
APAC teams would also address the necessary information gathering for determining the real issues of consumers, for example, who needs dietary changes or removal of drugs with side effects before being prescribed new medications by physicians, causing even more side effects or noncompliance, and self medicating or opiate abuse.
PC teams can be expanded to APAC teams utilizing the successful palliative care process across the care and health continuum, eliminating the end-of-life association, and differentiating from the terminally ill care of hospice. Just as SEALs operate in every environment (air, sea and land), APAC teams can be an extension of PC teams to be the quick, nimble action teams in all settings, especially the community, for patients with complex and chronic conditions.
by Rose Rohloff
Sleep apnea affects about 18 million people. This condition is linked as a major contributor to atrial fibrillation as well as multiple other health issues. Individuals have previously had to go to sleep centers for diagnosis, which is time consuming, and people generally do not sleep well in a foreign environment. "The Mayo Foundation for Medical Education and Research (Mayo Clinic) has purchased the WatchPAT device, an FDA-approved sleep apnea home testing device developed by Israeli medical diagnostics company Itamar Medica." nocamels -- Israeli innovation News
WatchPAT is an FDA-approved portable diagnostic device that uniquely uses finger based physiology and innovative technology to enable simple and accurate Obstructive Sleep Apnea (OSA) testing while avoiding the complexity and discomfort associated with traditional air-flow based systems.
Theranos - many lessons learned but the main important lesson has not been talked about
by Rose Rohloff
Learned lessons from the devaluation and closing of Theranos labs and blood testing centers include the lack of transparency, the need for thoroughly vetting new innovation, the requirement to understand the market, the need to support vision with qualified proof of concept, as well as deficient oversight and due diligence, to name a few. One lesson of success, however, has been overlooked – the model that was established. [read more]
The healthcare industry has used perioperative morbidity and mortality reviews (M&Ms) for blunt evaluations, to continuously improve the understanding of and performance in surgical intervention. Since the industry touts Population Health and Patient Engagement as top initiatives, health systems can use the successful process of M&Ms to perform Population Health and Patient Engagement reviews (P&Ps) of individual cases, for ensuring quality care processes. [read more]
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