Research Ethics Flashcards
1
Q
describe the response to the Tuskegee scandal
A
- the US Congress passed the National Research Act (NRA) in 1974
- 2 impacts on US research practice:
- established the modern IRB system for the review and oversight of human subjects research
- established the National Commission for the Protection of Human Subjects
2
Q
describe the Belmont Report (1978)
A
prompted by the problems with the Tuskegee Study
- 3 fundamental priciples:
- respect for persons
- voluntary informed consent
- proection of vulnerable persons
- privacy and confidentiality is protected
- beneficence
- maximize benefits and minimize harms
- justice
- non-exploitation
- individuals and groups that participate in trials should benefit from participation
- respect for persons
3
Q
list the subparts of the US DHHS “Common Rule”
A
- subpart A
- definitions
- IRBs
- informed consent
- assurances of compliance
- use of federal funds
- subpart B
- research involving pregnant women, fetuses and neonates
- subpart C
- additional duties of IRBs where prisoners are involved in research
- subpart D
- additional protection for children involved as research subjects
- subpart E
- registration of IRBs
4
Q
describe therapeutic misconception
A
- refers to a trial participant’s belief that enrolling in a research study provides a direct benefit for their disease when it may not
- certain groups of research participants are at a particular risk:
- older participants
- participants with poorer health status
- participants will lower levels of education
5
Q
define coercion
A
voluntary informed consent can be undermined if there is “pressure” to participate
6
Q
define inducement
A
- all reasons for participating in research–including altruism–involve inducements:
- payment for time, travel reimbursement, food and refreshments, etc.
- an inducement is undue when it causes a person to assume risks that they would consider to be unacceptable
