Ethical Principles Flashcards
(4 cards)
1
Q
What are the three components of the Belmont Report?
A
A. Respect for Persons
(Individuals should be treated as autonomous agents capable of making decisions concerning their own actions and well-being
B. Beneficence
(Do No Harm, Risk/Benefit Assessment)
C. Justice
(Research subjects should not be selected out of convenience sampling)
2
Q
What are the three elements of Informed Consent?
A
A. Information
(Participants should be provided with enough information to make informed decisions)
B. Comprehension
(Ensuring the information is presented in a clear concise manner for participants)
C. Voluntariness
(Participants are free to choose whether or not to participate)
3
Q
What are the 10 points of the Nuremberg Code?
A
- Participant’s voluntary consent is essential.
- Results should be fruitful, beneficial to society, and unobtainable by other means.
- Results should come from animal experimentation and knowledge of the natural history of the disease, so the anticipated results justify the experiment.
- The research must avoid unnecessary physical and mental suffering and injury.
- Death/disabling injury cannot be a foreseeable consequence of research.
- Benefits must outweigh risks.
- Participants can withdraw if they wish.
- Study must use proper facilities to protect the subject from harm.
- Study must be conducted by scientifically qualified individuals.
- Researchers must be prepared to stop the study if the participants die or become disabled as a result of participation.
4
Q
What is the Declaration of Helsinki?
A
- A statement of ethical principles for medical research involving human subjects; addressed primarily to physicians but is encouraged to be used by all who are involved in medical research involving human subjects.
- Stresses the importance of establishing an IRB/IEC (Institutional Review Board/Individual Ethics Committee)
