human research lecture Flashcards
What are the two principles that underlie the doctrine of informed consent?
The principles of autonomy and beneficence underlie the doctrine of informed consent in healthcare.
What is the duty of care for a treating practitioner in regards to informed consent?
A treating practitioner has the duty to give the patient enough information, in non-technical language, to allow the patient to understand and to make a meaningful choice among the available treatment options. This includes conveying the diagnosis, the nature and purpose of the proposed procedure or treatment, material risks and consequences of the proposed procedure or treatment, reasonable treatment alternatives/modalities, and the prognosis without treatment/consequences if the patient elects not to have a given treatment or procedure
What is the definition of informed consent in pharmacy?
Informed consent in pharmacy occurs when a patient is given sufficient information to understand the need, reason, use, side effects, and adverse reactions of a medication and decide whether or not to use a prescribed medication. Pharmacists have the duty to educate and ensure that patients are well-informed partners in their own medical care.
What is the percentage of patients who do not use medication as prescribed because they lack information?
Approximately 30% to 50% of patients do not use medication as prescribed because they lack information.
What is the definition of research?
Research is a studious, rigorous inquiry or examination, especially investigation or experimentation aimed at the discovery and interpretation of facts and the revision of accepted theories or laws in the light of new facts, or the practical application of such new or revised theories or laws to better the human condition.
What is one of the first principles of ethical clinical research?
One of the first principles of ethical clinical research is that ethical studies start with good science.
What is biomedical research?
Biomedical research is an organized and systematic way to find answers to questions, involving the translation from basic science to human studies through the application of clinical science and knowledge.
What is the ultimate goal of biomedical research?
The ultimate goal of biomedical research is to prevent, cure, or treat disease and related human conditions and to make the lives of patients better.
What are the determinants of the ethical nature of a clinical trial?
The determinants of the ethical nature of a clinical trial include whether the research is of social or scientific value, whether there is scientific validity, fair subject selection, favorable risk-benefit ratio, subject to independent (peer) review, proper informed consent, and respect for potential and enrolled subjects (respect of person standard).
What is the key question regarding the ethical concerns of clinical research?
The fundamental ethical concern raised by clinical research is whether and when it can be acceptable to expose some individuals to risk and burdens for the benefit of others.
What are some of the ethical dilemmas posed by clinical research?
Clinical research poses many ethical dilemmas from the time of formulation of research hypothesis to the final implementation of the research and its conduct till completion including post research assessment.
What is Eugenics?
Eugenics is a theory of “racial improvement” that aims to improve humans through selective “planned breeding” by eliminating undesirable characteristics and diseases from populations.
What is the basis of Eugenics?
Eugenicists believed in the Mendelian “laws of heritance” which claimed that human qualities like intelligence, mental illness, criminal tendencies, poverty, drug use and other social behaviors were inherited in a simple fashion, and that complex diseases and disorders were solely the outcome of genetic inheritance.
How did Eugenics justify their methods?
Eugenicists believed that methods such as involuntary sterilization, segregation, and social exclusion would rid society of individuals deemed unfit, and used the methods and legitimacy of science to argue for the superiority of white Europeans and the inferiority of non-white people.
Who were the targets of Eugenics?
Eugenics disproportionately targeted Latinxs, Native Americans, African Americans, poor whites, and people with disabilities during the entirety of the 20th century.
What was the American Breeder’s Association?
The American Breeder’s Association was created in 1903 to study eugenics and hosted national conferences on eugenics in 1914, 1915, and 1928. Led to the establishment of the Eugenics Record Offices, which tracked families and their genetic traits.
How were minorities impacted by Eugenics in the US?
Around 20,000 sterilizations occurred in California state mental institutions between 1909 and 1979, with many being forced and performed on minorities. Thirty-three states eventually allowed involuntary sterilization in whomever lawmakers deemed unworthy to procreate.
What was the impact of Eugenics on Native Americans?
According to a 1976 Government Accountability Office-GAO investigation, between 25 and 50 percent of Native Americans were sterilized between 1970 and 1976, with some sterilizations happening without consent during other surgical procedures such as an appendectomy. In some cases, health care for living children was denied unless their mothers agreed to sterilization.
What was the impact of Eugenics on Nazi Germany?
Between 1933 and 1945, the Third Reich implemented a campaign of forced sterilization that claimed at least 400,000 victims. They also used medical experiments involving brutalities, tortures, disabling injury, and death in complete disregard of international conventions, the laws and customs of war, and the general principles of criminal law as derived from the criminal laws of all civilized nations.
What were the consequences of the Nazi medical experiments?
Approximately 200 internees at Dachau were used in experiments involving vacuum chambers that could duplicate the low air pressure and lack of oxygen at altitudes as high as 65,000 feet. About 40% died as a result, some from extended anoxia and others from lungs rupturing from the low pressures in the chamber. These experiments were contrary to “the principles of the law of nations as they result from the usages established among civilized peoples, from the laws of humanity, and from the dictates of public conscience.”
What were some of the unethical practices used in human subject research during WWII?
Some unethical practices used in human subject research during WWII included the infliction of tremendous pain and suffering on human subjects without attempts to relieve it, treatment of gunshot wounds, burns, traumatic amputations, and chemical and biological agent exposures without the use of anesthesia, forcing prisoners to drink poisoned water and breathe noxious gases, and some were even shot with cyanide-tipped bullets or given cyanide capsules.
What was the typical mortality rate among research subjects during WWII?
The typical mortality rate among research subjects during WWII was 25% or more.
What were some of the groups targeted for elimination during WWII?
Some of the groups targeted for elimination during WWII included the Jewish people, the Sinti and Roma, individuals with disabilities, and LGBTQ+ people.
What was the Nuremberg Doctors Trial of 1946?
The Nuremberg Doctors Trial of 1946, also known as the “Trial of the Century” or the “Nazi Doctors Trial,” was an American military tribunal in the case of the USA vs. Karl Brandt et. al. The 23 defendants, including 20 physicians, were charged with murder, torture, and other atrocities committed in the name of medical science.
What was the outcome of the Nuremberg Doctors Trial?
Fifteen of the 23 defendants were found guilty, all but three of whom were physicians. Seven were sentenced to death, and some of the doctors eluded prosecution.
What was the Nuremberg Code?
The Nuremberg Code was a set of standards developed as a result of the Nuremberg Doctors Trial. It served as an ethical yardstick by which the defendants had been measured and guilt determined.
When was the Nuremberg Code developed, and what is its significance?
The Nuremberg Code was developed in August 1947, more than 50 years ago, by American judges sitting in judgment of Nazi doctors accused of conducting murderous and torturous human experiments. It is the most important document in the history of the ethics of medical research and served as a blueprint for today’s principles that ensure the rights of subjects in medical research.
What was the Mississippi Prison Experiment?
A research experiment conducted in 1915 in which prisoners were forced to work in inhumane conditions and exposed to dangerous levels of heat, which led to multiple deaths.
What was the Monster Experiment?
A research experiment conducted in 1939 in which children were subjected to negative feedback and made to believe they had speech impediments, which caused psychological harm.
What were the Refrigeration Experiments on Mental Patients?
A series of experiments conducted in the 1940s in which mental patients were exposed to freezing temperatures to study the effects of hypothermia.
What was the Willowbrook Hepatitis Study?
A study conducted from 1955 to 1970 in which mentally disabled children were deliberately infected with hepatitis, causing harm and controversy.
What was the Brooklyn Jewish Chronic Disease Hospital Cancer Study?
A study conducted in 1962 in which patients with cancer were injected with live cancer cells without their knowledge or consent.
What was the Stanford Prison Experiment?
A study conducted in 1971 in which college students were assigned to play the roles of prisoners and guards in a simulated prison environment, leading to psychological harm and ethical concerns.
What were the U.S. Government Sponsored Radiation Experiments?
A series of experiments conducted between 1944 and 1972 in which human subjects, including children, prisoners, and minorities, were exposed to dangerous levels of radiation
What was the Henrietta Lacks case?
A case in which cells taken from a cancer patient without her knowledge or consent were used for scientific research and commercial gain, raising ethical questions about informed consent and compensation for research subjects.
Do individuals hold property rights to their donated tissue and cells
No, courts have held that individuals do not hold property rights to their donated tissue and cells.
What must subjects be informed of in the consent process for research using their biospecimens?
Subjects must be informed of the possibility that research using their biospecimens could lead to the development of commercial products, and whether the subjects will share in any commercial profits must be made clear in the consent process.
What was the Tuskegee Syphilis Study?
the Tuskegee Syphilis Study was a forty-year clinical study conducted by the U.S. Public Health Service to research the natural progression of untreated syphilis in rural, poor African-American men in Alabama.
When did the Tuskegee Syphilis Study begin and end?
The study began in 1932 and continued until it was terminated on November 16, 1972.
How many men were enrolled in the Tuskegee Syphilis Study?
A total of 600 African American sharecroppers from Macon County, Alabama, were enrolled in the study.
How many of the men enrolled in the study had syphilis?
Of the 600 men enrolled in the study, 399 had previously contracted syphilis before the study began, and 201 did not have the disease
What did the men receive for participating in the study?
The men received free medical care, meals, and free burial insurance for participating in the study.
What was the study’s end-point after it was modified?
The study was modified into a “death as end-point study” after six months.
Why was the Tuskegee Syphilis Study controversial?
the study was controversial for ethical breaches because researchers knowingly failed to treat patients appropriately after validation of penicillin as an effective cure for the disease they were studying. Scientist also prevented participants from accessing syphilis treatment programs available to other residents in the area.
How were the men deceived into thinking they were receiving treatment?
The men were given only vitamins and aspirins to deceive them into thinking they were receiving treatments. They were told they were being treated for “bad blood,” which was a local term for various illnesses that include syphilis, anemia, and fatigue.
Who leaked the revelations of the study failures to the press?
A whistleblower leaked the revelations of the study failures to the press.
