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PHMD 5250 Exam 2 Questions And Answers
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PHMD 5250 Exam 2 Questions And Answers...
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PHMD 5250 Exam 2 Questions And AnswersWhat event in history led to the modern era of human subject protection? - ANSWER
Nuremberg Trial
what event in history led to the requirement of informed consent? - ANSWER
thalidomide tragedy
what event in history led to the creation of the National Commission for the protection of
human subjects of research and the belmont report? - ANSWER tuskegee study
what are the 3 basic principles of the belmont report? explain each - ANSWER 1)
respect for persons: individuals should be treated at autonomous agents, individuals
with diminished autonomy are entitled to increased protection, informed consent
2) beneficence: first, do no harm, second, maximize possible benefits and minimize risk,
study designed properly
3) justice: fairness in distribution, risks and benefits must be spread equally across
population, selection of research subjects
what are the 3 steps of the informed consent process? - ANSWER 1) information
2) comprehension
3) voluntary
human subject protection regulations are based on the ethical principles of __________ -
ANSWER the belmont report
what are the 3 principles of the Common Rule? - ANSWER 1) review of research by IRB
2) informed consent
3) institutional assurances of compliance
,what are the 4 main tasks of an IRB? - ANSWER 1) approve, disapprove or modify
research
2) conduct continuing review
3) observe and verify changes
4) suspend or terminate approval
IRB membership requirements - ANSWER - at least 5 members
- various backgrounds
- one not a scientist
- one not affiliated with institution
- can review specific types of research it oversees
- know community where it takes place
- researchers may not review their own research
what is the drug approval process? - ANSWER - pre clinical studies
- IND
- application
what are the 4 phases of clinical research - ANSWER 1) phase I: determine dose range,
healthy volunteer, safety and toxicity
2) phase II: patients have disease or condition, evaluates safety and efficacy
3) phase III: larger groups, treatment vs. placebo
4) phase IV: post marketing surveillance
NDA submitted after phase III
what are the 2 areas for finances for research? - ANSWER 1) funding at the institution
, 2) insurance/participant responsibilities
who oversees proper receipt, handling, storage, blinding and accountability of
investigational drugs? - ANSWER investigational drug service
what are the 3 main FDA requirements for investigational drug storage? - ANSWER 1)
secure location, limited access
2) comply with study protocol or instructions on drug label
3) administer drug only to subjects under personal supervision
what allows pharmacists to sit for board certification and allows PGY1 residents to
apply to PGY2 residencies? - ANSWER ASHP accreditation
what type of pharmacist performs these tasks: inpatient or outpatient, work with nurses
and providers, review labs, verify orders, etc. - ANSWER clinical pharmacist
what type of pharmacist performs these tasks: work with providers in the workroom
assisting with dosing, answering drug questions, orders, independent and joint visits,
order and titrate meds, review labs - ANSWER clinical pharmacy specialists
- learned skill
- adapting principles to circumstances
- process that focuses on making organizational changes
- art of mobilizing others to want to struggle for shared aspirations - ANSWER leadership
what are the 6 skills that leaders share? - ANSWER 1) clear, guiding vision
2) passion
3) integrity
4) trust
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