Intro Flashcards
What does autonomy mean?
The right to self-determination
What is beneficence?
The duty to protect research subjects from harm and to assess potential risks and possible benefits to ensure the benefits are greater than the risk.
What is justice?
Requires the selection of research subjects to be fair.
What is respect for persons mean?
Treating patients as independent persons who are capable of making decisions in their own best interest.
What is informed consent?
Right to be informed and right to voluntary participation.
Who is responsible for providing the education, expectations, and answer questions with patients concerning certain treatments?
HCP like physicians.
Can nurses receive informed consent from a patient that is not alert and unable to comprehend?
NO! Patient must be alert and able to comprehend.
how long can it take for a new drug to be approved from FDA?
about 12 years.
What are the steps of FDA’s Drug Approval Process?
1) Drug discovery (3-5 years)
2) Phase 1 Test drug for safety in small group of people (1 ear)
3) Phase 2 Test drug in medium group of people (2 years)
4) Phase 3 Confirm safety and drug effectiveness in very large group (3 years)
5) FDA application Submit data
6) Phase 4 Approved for Sale and Test for long term effects.
What is the Food and Drug Act of 1906?
First law to regulate drugs, prohibits sale of misbranded and adulterated drugs ( does not address effectiveness or safety)
What is the 1912 Sherley Amendment?
Prohibits false therapeutic claims on drug labels.
What is 1938 Federal Food, Drug, and Cosmetic Act?
FDA ensures drugs are safe prior to marketing, requires labeling with ASE
What is 1970 Comprehensive Drug Abuse Prevention and Control Act?
Schedule of Controlled Substances.
True or False? In a civil court, a nurse can be prosecuted for giving the wrong drug or dosage, omitting a drug does or giving the drug by the wrong route?
True.
