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

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Belmont Report - Guiding principles for Human Research
Right for Autonomy
1.
Beneficence
2.
Justice (equal chance, unbias)
3.
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)
-
1.
Research study question has value
2.
Study conducted honestly
3.
Reported accurately and promptly
4.
Assessments of benefits vs risk
5.
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
6.
HSREB - health science research ethics board
-
Vulnerable groups
Children
1.
Edward Jenner - 1790, injected 2 boys with cowpox to see if they were vaccinated against
smallpox
Mentally challenged children institution as hepatitis research
History
-
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
risk
Risk
-
Women
2.
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)
Motivations
-
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
Sponsorship
-
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
benefits
-
Nontherapeutic research - research on volunteers for general knowledge
-
Lecture 9 Ethics
April-22-12
9:02 AM
clinical pharm Page 1
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