1
Q
Unethical Research
A
- Scientific misconduct
- Fraud, research protocol violations
- Fabrication, forging of data
- Plagiarism
- Putting subjects at risk without consent
2
Q
Nuremberg Code
A
Consent process, protection of subjects from harms, balance of benefits and risks in a study
3
Q
Declaration of Helsinki
A
The differentiation of therapeutic research (beneficial to participants) from non-therapeutic (non-beneficial) research
4
Q
Belmont Report
A
The first major ethical guide, was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
5
Q
Purpose of Institutional Review Board (IRB)
A
- Protection of rights and welfare
- Voluntary informed consent
- Benefits exceed risks
6
Q
3 Ethnical Principles
A
o Respect of persons
o Beneficence
o Justice
7
Q
5 Human Rights
A
o Self-determination o Privacy o Anonymity and confidentiality o Fair selection and treatment o Protection from discomfort and harm
8
Q
Elements of Informed consent
A
- Disclosure– essential info for consent
- Comprehension of consent info
- Competence to give consent
- Voluntary agreement (consent)
9
Q
Persons with Diminished autonomy
A
- Legally and mentally incompetent subjects
- Neonates and children
- Terminally ill subjects
- People confined to an institution
- Pregnant women and fetuses
