1. Research, Experimentation, & Clinical Trials
Research involving human life
Ethical Principles
Respect for person
Beneficence
And justice

2. Research, Experimentation, & Clinical Trials
Research Studies are designed to
Answer specific questions
About drugs
About device safety
About effectiveness

3. Research, Experimentation, & Clinical Trials
Considerations
Personal Autonomy
Self Determination
“do no harm”

4. Research, Experimentation, & Clinical Trials
The science of medicine, by the very nature of that which it studies, the human body, is often prevented from making progress through direct experimentation. It must resort to necessary tests in laboratories and on animals

5. Research, Experimentation, & Clinical Trials
Progress in patient care cannot happen without research
Nuremberg Code & the Declaration of Helsinki
International code of ethics governing human research & experimentation

6. Nuremberg Code & the Declaration of Helsinki
Set in place after WWII and Nazi medical experiments
Code Requires
Subjects be informed
Know nature of societal benefits
Guidelines for federal regulations

7. Informed Consent Risks & Benefits Alternatives
Proposed treatment protocol
Pt competent to consent
Obtained in written form

8. Experimental Subject’s Bill of Rights
Medical Research & Duty to Warn case

9. FDA Regulate investigational drug clinical trials
Rules to speed up clinical trials
Allow experimental drugs outside of clinical trial if life threatening condition
Manufactures taking trials overseas

10. IRB Institutional Review Board Responsibilities
Initial approval & periodic monitoring
Responsibilities
Protect rights
Ensure protocols
Ensure disclosure
Review & Monitor
Within FDA guidelines

11. Patents Delay Research
Article: “where are the cures”

12. Research, Experimentation, & Clinical Trials
Henrietta Lacks