CH 4

Question 1

Unethical Research

Answer 1

• Scientific misconduct
• Fraud, research protocol violations
• Fabrication, forging of data
• Plagiarism
• Putting subjects at risk without consent

Question 2

Nuremberg Code

Answer 2

Consent process, protection of subjects from harms, balance of benefits and risks in a study

Question 3

Declaration of Helsinki

Answer 3

The differentiation of therapeutic research (beneficial to participants) from non-therapeutic (non-beneficial) research

Question 4

Belmont Report

Answer 4

The first major ethical guide, was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Question 5

Purpose of Institutional Review Board (IRB)

Answer 5

• Protection of rights and welfare
• Voluntary informed consent
• Benefits exceed risks

Question 6

3 Ethnical Principles

Answer 6

o Respect of persons
o Beneficence
o Justice

Question 7

5 Human Rights

Answer 7

o Self-determination
o Privacy
o Anonymity and confidentiality
o Fair selection and treatment
o Protection from discomfort and harm

Question 8

Elements of Informed consent

Answer 8

1. Disclosure– essential info for consent
2. Comprehension of consent info
3. Competence to give consent
4. Voluntary agreement (consent)

Question 9

Persons with Diminished autonomy

Answer 9

• Legally and mentally incompetent subjects
• Neonates and children
• Terminally ill subjects
• People confined to an institution
• Pregnant women and fetuses