Ethics of medical research Flashcards
How does the scientific method provide scientific evidence to improve health care?
By providing knowledge and info on the usefulness and effectiveness of diagnostic, therapeutic and preventive procedures
What does biomedical research contribute to?
It contributes to increase our understanding of the etiology, pathophysiology and risk factors of diseases
What is biomedical research?
It’s the careful, meticulous, systematic, diligent inquiry or examination of current knowledge, undertaken to establish facts or principles
What is the aim of researchers by developing biomedical research?
Researchers strive to better understand the causes of disease, expand knowledge to discover better ways to prevent ill health, and to develop beneficial medications, and procedures to diagnose, treat and cure diseases and conditions that cause illness and death.
Biomedical research should be considered
A moral obligation for all physicians and health professionals.
What does ethical biomedical research encompasses?
The attainment of moral aims or purpose
The application of morally acceptable means to obtain them
Scientific rigor characteristics as a condition
It is a necessary condition but not a sufficient one; not all what is scientifically feasible may be acceptable from an ethical standpoint.
When did documental ethical guidelines develop?
In the mid-twentieth century, after a series of well-publicized ethical breaches and war crimes.
Ethical breaches and war crimes that lead to the development of documented ethical guidelines
World War II: Nazi scientists launched a series of studies designed to test the limits of human exposure to the elements with the final aim of better preparing German soldiers —> Nüremberg Code (1947)
1932: U.S. Public Health Service started the “Tuskegee Study”, an experiment on black men in the late stages of syphilis
What did the Tuskegee Syphilis Study lead to?
U.S. Congress passed the National Research Act in 1974
What did the National Research Arch create?
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
What did the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research consider?
- The boundaries between biomedical and behavioral research and the accepted and routine practice of medicine
- The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects
- The establishment of appropriate guidelines for the selection of human subjects for participation in such research
- The nature and definition of informed consent in various research settings
The work of the National Commission led to
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
When was the Belmont Report published?
In 1979
What does the Belmont Report state?
“persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well being”
What did the Belmont Report summarize and define?
The basic ethical principles of respect, justice and beneficence, thereby representing the origins of modern research ethics.
Basic ethical principles
Principle of autonomy
Principle of justice
Principle of beneficence
What does the principle of autonomy recognize?
The rights of individuals to self-determination
The respect for persons incorporates at least 2 ethical convictions
Individuals should be treated as autonomous agents
Persons with diminished autonomy are entitled to protection
What does respect autonomy mean?
To give weight to the person’s autonomous considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others
Capacity of self-determination
Not every human being is capable of self-determination.
This capacity matures during an individual’s life, while some individuals lose it wholly or in part as a consequence of illness, mental disability, or circumstances that severely restrict liberty
What does the respect for persons demand?
That subjects enter into the research voluntarily and with an adequate info (informed consent)
What does the principle of justice refer to?
It refers to the ethical obligation of fairness and equality in health resources and treatment
The conception of justice is especially relevant to
Protect vulnerable groups:
- It should be determined whether some classes are being systematically selected simply because of their easy availability, compromised position or manipulability
- When research leads to the development of therapeutic devices and procedures, these do not provide advantages only to those who can afford them
- Research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research
