Exam 3 -Bioethics Flashcards
What is bioethics
The study of ethical issues emerging from advances in biology and medicine.
It is moral discernment as it relates to medical policy and practice. It includes the study of our moral choices relating to medical and biological research
Concern ethic questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy
What is the history of modern human subjects research and the development of human reach regulations
For now writing in NOTEBOOK refer to notes or write in later
What is the importance of declaration of Helsinki?
Doctors duty to protect the life, health, privacy, and dignity of patient
Research protocol must be reviewed by an independent committee (ORB/IEC)
Benefit > Risk ; study must be stopped if risks outweigh benefits
Patients must volunteer for research and give consent
Assent must be obtained from minors if capable of assent
What is the Belmont report?
Established ethical principles and guidelines for protection of human subjects. Also made a distinction as to what the IRB needs to review
Clinical Practice = interventions designed solely to enhance the well being of the individual and will have a reasonable election of success
Research = activity designed to test a hypothesis and that contributes or develop less to generalized knowledge
Three fundamental ethical principles :
Respect for Persons: autonomy of individuals and persons with diminished autonomy are entitled to protection
Beneficence: Do no harm and maximize benefit and minimize the risks
Justices: Benefits and Risks must be distributed equally
What is the IRB
“Institutional review board”
Formally reviews and monitors biomedical research involving research involving humans
under oversight of the FDA
Must be registered with the FDA and regularly inspected by FDA
Purpose to review informed consent,assure the rights and welfare of subjects are protected
Risks to individual should be outweighed by benefit to society
What is informed consent?
Consent is written document that must be explained to the subjects prior to start of their participation in study
Subject must sign
Process includes written explanation, verbal explanation time for questions, information on risk/benefits, ensure subject understands what they are agreeing to, continuing to provide information as needed as the study progresses
Cannot be done over phone, but can be done by sending written document to a legally authorized representative and consent by phone
Subject must show that they understand the information that they are being given
Consent and participation must confidential
Typically research is de-identified whenever possible
When research on children or other vulnerable populations, a guardian must be present and sign the consent form for them
Must be in language understandable to the subject
What is respect for persons
Autonomy of individuals.
Persons with diminished autonomy are entitled to protection
What is beneficence
Do no harm.
Maximize the benefit and minimize the risks
What is justice
Benefits and risks must be distributed equally
