Ethical Issue

Question 1

Consent 8 req elements

Answer 1

statement of research
reasons/forseeable risks
benefits
alternative procedures
how confidentiality will be mgd
compensation for more than min risk
contact names
voluntary/withdraw statement

Question 2

Consent 4 basic elements

Answer 2

understandible lang
no exculpatory lang
no coercion
auth by IRB

Question 3

children consent 3 elements

Answer 3

no more than minimal risk
greater than min but direct benefit
leads to generalizable knowledge

Question 4

Human subj def

Answer 4

living indiv

obtain data through interaction or identifiable PHI in anyway

Question 5

consent may be waived for (4)

Answer 5

discarded tissues
med records
research databases
questionaires/stuff at IRB discretion

Question 6

discarded tissue

Answer 6

collected for clinical reasons
on the shelf
must deidentify

Question 7

when is it not discarded tissue

Answer 7

anything extra must be done then for proecudral reasons (extra vial of blood, extra piece removed)

Question 8

3 points to consider for genetic information

Answer 8

magnitude of threat
accuracy with which data can predict threat
potential to avoid injury

Question 9

genetic info nondiscrim act

Answer 9

Protects against discrim of insurance (premiums/eligibility) and employers

but not life insuracne, disability insurance, or long term care insurance discrimination

Question 10

coercion/undue burden (3)

Answer 10

payment, subject selection (make sure good sample), outcome measures (are risked worth it