4.1 Ethical and Legal Considerations: A historical Perspective

Question 1

The Nuremberg Code

Answer 1

• This is the code that made informed consent a requirement for medicine
• It however lacked inclusion of safeguards for vulnerable populations

Question 2

1970 - New Federal Guidelines

Answer 2

• Realization that federal guidelines for informed consent were needed

Question 3

1973-1974

Answer 3

1973 - First set of proposed federal guidelines on protection of human subjects was published

1974 - creation of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
- Mission was to protect the rights and welfare of human research participants
- Highlighted principles of respect for person, beneficence, and justice.

Question 4

Belmont Report

Answer 4

• Ethical principles and guidelines for the protection of human subjects of research

Basic Principles

• Respect for person - Recognition of autonomy and protection of those with limited autonomy (children and cognitively impaired). We also must respect persons for prisoners as well.
• Beneficence - Researchers have an obligation to maximize benefits and minimize risks.
• Justice - Fair distribution of benefits and burdens of research. Each person deserves an equal share, according to individual need, effort, societal contributions, merit.

Question 5

Clinical Practice VS Research

Answer 5

Research - Test a hypothesis, permits conclusions to be drawn, continues contributions to general knowledge

Clinical Practice - Diagnosis, preventative treatment, or therapy

Question 6

Informed Consent

Answer 6

3 Elements of Informed Consent
- Information
- Comprehension
- Voluntariness

Investigator Job
- Assess risk and benefits to see if the proposed research is properly designed

Review Committee
- Method of determining if risk is justified.