CHAPTER 4: CULTURAL, LEGAL, AND ETHICAL CONSIDERATIONS Flashcards
bias
any systematic error in a measurement process. one common effort to avoid bias in research studies involves the use of blinded study designs
black box warning
a type of warning that appears in a drug’s prescribing information and is required by the US FOOD AND DRUG ADMINISTRATION (FDA) to alert prescribers of serious adverse events that have occurred with the given drug
blinded investigational drug study
a research design in which the subjects are purposely unaware of whether he substance they are administered is the drug under study or a placebo. This method serves to minimize bias on the part of research subjects in reporting their body’s responses to investigational drugs
controlled substances
any drugs listed on one of the “schedules” of the Controlled Substances Act
culture
the customary beliefs, social forms, and material traits of a racial, religious or social group
double-blinded investigational drug study
a research design in which both the investigator(s) and the subjects are purposely unaware of whether the substance administered to a given subject is the drug under study to a placebo. This method minimizes bias on the part of both the investigator and the subject
drug polymorphism
variation in response to a drug because of a patient’s age, gender, size and/or body composition
ethics
the rules of conduct recognized in respect to a particular class of human actions or a particular group
ethnicity
relating to or characteristics of a human group having racial, religious, language and other traits in common
ethnopharmacology
the study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution and excretion (i.e. pharmacokinetics) as well as the study of genetic variations to drugs (i.e. pharmacogenetics)
expedited drug approval
acceleration of the usual investigational new drug approval process by the FDA and pharmaceutical companies, usually for drugs used to treat life-threatening diseases
health insurance portability and accountability act (HIPPA)
an act that protects health insurance coverage for workers and their families when they change jobs. It also protects patient information. If confidentiality of a patient is breached, severe fines may be imposed
informed consent
written permission obtained from a patient consenting to a specific procedure (e.g. receiving an investigational drug), after the patient has been given information regarding the procedure deemed necessary for him or her to make a sound “informed” decision
investigational new drug (IND)
a drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy
investigational new drug application
an application that must be submitted to the FDA before a drug can be studied in humans