Exam 2 - Ethics

Question 1

What are the 3 basic ethical principles?

Answer 1

• RESPECT FOR PERSONS – Right to self-determination/autonomy
• BENEFICENCE- Obligation to do no harm and maximize benefit
• JUSTICE- Treated fairly can not deny benefits

Question 2

Describe some ethical characteristics studies must have

Answer 2

• The design of the experiment must be as sound as possible given any ethical constraints.
• Benefits must be Maximized in Magnitude and Probability of Occurrence
• The risk to the subjects must be reasonable in relation to the anticipated benefits.

Question 3

What is a risk?

Answer 3

A potential harm that a reasonable person, in what the investigator knows or should know to be in the subject’s position, would be likely to consider injurious.

Question 4

What are the 5 categories for risks?

Answer 4

1. Physical
2. Psychological
3. Social
4. Economic
5. Legal

Question 5

What are some examples of physical risks to patients?

Question 6

What are some examples of economic risks to patients?

Question 7

What are some examples of social risks for patients?

Question 8

What are some examples of psychological risks for patients?

Question 9

How are risks minimized?

Answer 9

• Investigator Skill
• Prescreening
• Subject Compliance
• Monitoring
• Termination of Protocol

Risks must be Minimized in Magnitude and Probability
of Occurrence

The inclusion of vulnerable subjects must be strongly justified.

In therapeutic research the risks should be outweighed or balanced primarily by benefits to the subject

In non-therapeutic research the risks should be outweighed or balanced by benefits to the subject and/or by benefits to society

Question 10

What is the difference between therapy vs research?

Answer 10

• “Therapy”refers to interventions designed solely to enhance the well-being of the patient.
• “Research” is an activity designed to test a hypothesis, permit conclusions to be drawn and thereby contribute to knowledge.

Question 11

What are the elements for informed consent?

Answer 11

1. Title of Protocol
2. Invitation to Participate
3. Basis for Subject Selection
4. Overall Purpose of the Study
5. Explanation of Procedures
6. Description of Risks and Discomforts
7. Potential Benefits
8. Alternatives to Participation
9. Financial Obligations
10. Financial Compensation
11. Assurance of Confidentiality
12. In Case of Injury Compensation
13. Subject Withdrawal
14. Offer to Answer Questions
15. Concluding Consent Statement
16. Identification of Investigators