human subjects in research

Question 1

purpose of the IRB

Answer 1

protect the rights and welfare of human subjects in research

Question 2

nuremberg code (3)

Answer 2

voluntary consent is necessary, experiment should yield fruitful results that are unattainable by other methods, subject can stop at any point

Question 3

declaration of Helsinki (2)

Answer 3

subjects must be volunteers and informed participants

Question 4

belmont report (3)

Answer 4

respect for persons, beneficence, justice

Question 5

a study cannot be ethically sound—

Answer 5

unless it is scientifically sound

Question 6

“research”

Answer 6

investigation to contribute to generalizable knowledge

Question 7

human subject (2)

Answer 7

obtains data or identifiable private information

Question 8

5 levels of IRB review

Answer 8

evaluation for research 
evaluation for involvement of human subjects
exempt
expedited
convened (full) board

Question 9

3 types of vulnerable populations

Answer 9

prisoners
women/fetuses
minors

Question 10

all approvals must be obtained:

Answer 10

before starting the study

Question 11

rule of 7s for assent

Answer 11

0-7: no role in decision
7-14: given input
14+ make decision