Ethics and informed consent

Question 1

4 principles of ethics

Answer 1

autonomy, beneficence, nonmaleficence, justice

Question 2

beneficience

Answer 2

principles of doing good, demonstrating kindness, showing compassion, helping others

Question 3

determining factors to scarce resources allocation

Answer 3

age, position in life, patient’s wishes

Question 4

noteworthy historical events

Answer 4

oath of hippocrates, nuremberg code, declaration of helsinki, belmont report

Question 5

nuremberg code

Answer 5

WWII “Doctor’s Trial” focussed on doctors involved in human experiments in concentration camps.

Question 6

declaration of helsinki

Answer 6

surrogate consent by an individual acting in the subject’s best interest

Question 7

organisation must provide for

Answer 7

education in ethical decision making, nurse participation in ethical decision making, on-going monitoring of approved protocols

Question 8

IRB functions

Answer 8

review proposed research studies, approve protocols for research, conduct research oversight

Question 9

ethics and clinical trials

Answer 9

protect, maintain compliance, facilitate research, adherence

Question 10

patient’s rights to refuse treatment

Answer 10

right to refuse medical care, including any non-consensual touching, right to decline all forms of medical intervention

Question 11

informed consent

Answer 11

respect and autonomy, voluntary participation, ongoing communication

Question 12

obtain informed consent based on

Answer 12

nuremberg code, declaration of helsinski, belmont report, ICH GCP, IRB, local law and regulation

Question 13

respect and autonomy

Answer 13

person’s right to make choices, confidentiality

Question 14

beneficience

Answer 14

provide benefits to persons and contribute to their welfare

Question 15

components of informed consent

Answer 15

(mental) capacity, voluntary, consent/information

Question 16

what is capacity

Answer 16

able to understand the information relevant to the decision, retain that information, use or weigh that information as part of the process of making the decision, communication his decision

Question 17

choice of words

Answer 17

non-technical, practical, understandable to the subject/subject’s impartial witness

Question 18

justice

Answer 18

fairness, nothing to waive any release research company from liability of negligience, ensures that risks or benefits of trial is distributed equitably among different groups of the society, preventing exploitation of vulnerable populations

Question 19

explanation of informed consent

Answer 19

trial involves research, purpose of the trial, probability for random assignment, trial procedures to be followed

Question 20

10 essential consent

Answer 20

aims and expected duration, random assignment, responsibilities, potential risks and benefits, disclosure of alternative, confidentiality, compensation, POC, voluntary

Question 21

GCP

Answer 21

international ethical and scientific quality standard for designing, conducting and reporting clinical trials that involve human subjects. assures public that their rights, safety and wellbeing are protected + assure the quality, reliability and the integrity of data collected are credible + provide standards and guidelines for conduct of clinical research