Pharmacology 4350A/B Lecture Notes - Lecture 9: Theralizumab

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Belmont Report - Guiding principles for Human Research
Right for Autonomy
Justice (equal chance, unbias)
Clinical Equipoise - Honest Genuine uncertainty of the drug in question and comparator drug going into
clinical trial
PHIPA - personal health information protection act (privacy disclosure)
Research study question has value
Study conducted honestly
Reported accurately and promptly
Assessments of benefits vs risk
Clarify risks and discomfort + identify potential benefits + explain alternative treatments +
what happens during injury + contacts + voluntary participation and may leave anytime
Specific consent + Tiered consent + general permission + presumed consent
Informed consent
HSREB - health science research ethics board
Vulnerable groups
Edward Jenner - 1790, injected 2 boys with cowpox to see if they were vaccinated against
Mentally challenged children institution as hepatitis research
Child with intellectual age > 7
Unable to give informed consent (proxy consent)
Must be minimal risk (not greater than everyday risk) + greater benefits compensates for increase
More unethical to give treatment without evidence + men/women are diff
Excluded from trials until 90s
Negative pregnancy results + usage of birth control
Included in trial when
Healthy volunteers
Money + altruism
TGN1412 (provided money + food + entertainment)
Drug dose starts small + increments of reasonable amount + try and include patients with no
current effective treatment + fully educated with informed consent + will not accept due to
incentives when they would reject normally due to risk
TCPS2 (regulation)
Research ethics board reviews incentives
Reimburse expenses
Compensate for time + appreciation
Good payment whent
Experimenter is paid
Amount that volunteer can't refuse
Increase pay to compensate for increase risk
Bad payment
Payment incentives (NO CONCENSUS RULE/LAW)
Clinical trials to meet health regulations rather than for academia knowledge purpose
Pharmaceutical companies is the top funder for clinical trials
Poor selection of control/comparator
Analysis bias
Studies found pharma companies that fund studies are more likely to have favourable outcomes +
less ADR report
Personalized medicine
Black woman cervical cancer line used without consent (HeLa cells)
Indian tribe consent to give blood for diabetes research but also used for other research
Genetic Exceptionalism - anything that is genetically related involve exceptional ethical issues
UNETHICAL if genetic information of the child were disclosed to parents
Therapeutic research - research involving subjects with a specific disorder and the study may provide
Nontherapeutic research - research on volunteers for general knowledge
Lecture 9 Ethics
9:02 AM
clinical pharm Page 1
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