Codes of conducts

Question 1

the nuremberg code

Answer 1

1946

Question 2

prior to WW2

Answer 2

there was no internationally accepted statement of ethical principles governing research with human subjects- Germany and Russia had their own policies

Question 3

sole purpose of the nuremberg trials

Answer 3

prosecuting Nazi war criminals

Question 4

list the ten main points of Nuremberg Code

Answer 4

1. voluntary consent
2. experiment done for the good of society
3. designed and based on the results of animal experimentation
4. avoids suffering
5. no experiment that is thought to cause death or disability
6. degree of risk shouldn’t exceed humanitarian importance
7. adequate facilities
8. should only be conducted by qualified scientist
9. subject can leave experiment at any point
10. scientist should end the experiment if they see a likelihood of injury/ disability.

Question 5

no. 5 no experiment that is thought to cause death or disability- exception

Answer 5

except in those experiments where the experimental physicians also serve as subject

Question 6

the belmont report

Answer 6

1978

Question 7

the belmont report was published in response to

Answer 7

Tuskegee Syphilis Trial (1932-1972)

Question 8

who wrote the belmont report

Answer 8

a panel of experts

Question 9

what does the belmont report propose

Answer 9

three principles that should underly the ethical conduct of research involving human subject

Question 10

three principles underlying the belmont report

Answer 10

1) respect for persons
2) beneficence
3) jutice

Question 11

Belmont: respect for persons

Answer 11

two distinct principles: individuals should be treated as autonomous and individuals with diminished autonomy should be entitled to additional protections.
-informed consent

Question 12

three element son informed consent as defined in Belmont

Answer 12

1) info
2) comprehension
3) voluntariness

Question 13

Belmont: beneficience

Answer 13

the study should have the interests of research participants in mind.. Behind efforts by researchers to minimise risks to participants and maximise benefits to participants and society

Question 14

example of beneficience

Answer 14

when considering research design, the principle of beneficence should cause us to ask if there is another ay we could obtain the same knowledge but with lower risks to participants

Question 15

Belmont: justice

Answer 15

the principles of justice addresses the distribution of the burdens and benefits of research. Mentioning that not one group in society bears the costs of research while another reaps the benefits.

Question 16

issues of justice arise most strongly around

Answer 16

questions about the selection of participants

Question 17

Helsinki declaration

Answer 17

1964

Question 18

Helsinki declaration was

Answer 18

heavily influenced by the Nuremberg Code

Question 19

goal of Helsinki was

Answer 19

to prevent human subjects from being mistreated

Question 20

how many revision and clarifications of Helsinki

Answer 20

6 revisions

2 clarification

Question 21

Helsinki was the first

Answer 21

signify effort by medical community to regulate research

Question 22

helsinki forms the basis for

Answer 22

most subsequent documents

Question 23

who developed Helsinki declaration

Answer 23

WMA

Question 24

WMA

Answer 24

world medical association

Question 25

Basic principle son Helsinki

Answer 25

is respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research, both initially and during the course of the research.

The investigator’s duty is solely to the patient or volunteer, and while there is always a need for research , the subject’s welfare must always take precedence over the interests of science and society , and ethical considerations must always take precedence over laws and regulations.

Question 26

helsinki and vulnerable populations

Answer 26

recognition of the increased vulnerability of individuals and groups calls for special vigilance. It is recognised that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor, then allowance should be considered for surrogate consent by an individual acting in the subject’s best interest, although their consent should still be obtained if at all possible