Chapter 1 Flashcards
what are the 3 human research core ethical principles
respect for persons
beneficence
justice
what is respect for persons
- treat as independent
- aware of alternative options available
- autonomy- respect patients right to make decision in their own interest
- can refuse treatments
what treatment can no person refuse
tuberculosis
-any communicable disease cannot refuse because contagious
what is beneficence
duty to protect research subject from harm
analyzing and balancing
what is justice
to be fair
what are the resources that will tell you about a drug
United States Pharmacopeia national formality
the international pharmacopeia
what are drug standards
any drug in the market should meet safety standards and effectiveness
what are federal legislation
attempt to protect the public from drugs that are impure, toxic, ineffective or not tested before public sale.
what are the Food and drug act of 1906
prohibited the sale of misbranded and adulterated drug but did not address drug effectiveness and safety
what is the sherley amendment of 1912
prohibits false therapeutic claims on drug labels
why was the sherley amendment established
because the soothing syrup was advised to treat teething and colic which contained morphine and led to many infant deaths
what is the federal food, drug and cosmetic act of 1938
empowered FDA to ensure drug was safe prior to marketing
drug be labeled accurate
what is the durham-humphrey amendment of 1951
distinguishes between drugs that could be sold with or without prescription by a licensed health care provider s
what is the Kefauver-Harris amendment to the 1938 act of 1962
controls drug safety, required that adverse reactions and contradictions must be labels and included in literature
why was the Kefauver-Harris amendment established
because of the thalidomide tragedy, European patients who took sedative-hyponotic thalidomide during the 1st trimester of pregnancy gave birth to infants with extreme limb deformities
what is the Health insurance portability and accountability act of 1996 (HIPAA)
patients have more control over their health info
privacy of health info
what is the patient protection and affordable care act of 2010
- quality, affordable health care for all americans
- improved quality
- prevention of chronic diseases and improved public health
- improved access to innovative medical therapies
- community living services and supports