RESEARCH ETHICS 101
“The voluntary consent of the human
subject is absolutely essential.”
- Nuremberg Code 1947
Work of the United States Govt
RESEARCH ETHICS 101
“The voluntary consent of the human
subject is absolutely essential.”
- Nuremberg Code 1947
Or is it . . .
Work of the United States Govt
EXCEPTION FROM INFORMED CONSENT
Exception From Informed Consent
(EFIC) guidelines, also known as Final
Rule, issued by FDA & HHS in 1996
EXCEPTION FROM INFORMED CONSENT
What conditions would make research without
informed consent okay?
EXCEPTION FROM INFORMED CONSENT
• Life-threatening situation
• Available treatments are unproven or unsatisfactory
• Participation holds potential for direct benefit
• Research could not be carried out without waiver
• Community consultation and public disclosure
Biros 1999, Biros 2007
EFIC CONTROVERSIES
• Undermines autonomy
•
Autonomy removed by the patient’s clinical condition, not the research
•
Future patients who may benefit override current participants
•
Burden is on those who choose to opt out
• Therapeutic misconception
• Slippery-slope
PUBLIC ACCESS TO DEFIBRILLATION
• Study of CPR vs. CPR + publically available AED
• Almost twice the survival in AED group
• Established effectiveness of public AEDs
• Direct benefit both to participants and to future
patients
PAD TRIAL INVESTIGATORS 2004
POLYHEME STUDY
•
Phase III RCT of blood substitute for hypotensive trauma patients
• Prehospital (Polyheme vs normal saline) & in-hospital (Polyheme vs blood)
• Increased mortality in Polyheme recipients, primarily from cardiac events
•
Is in-hospital transfusion of blood for hypotensive trauma “unproven or
unsatisfactory treatment”?
•
Manufacturer did not disclose results of prior studies
showing increased risk of heart attack . . . but WSJ did!
APTE 2008, KIPNIS 2006, MCKENNA 2006
POLYHEME STUDY
• 2008 meta-analysis of five blood substitutes (incl. Polyheme)
• Lead author NIH scientist, co-authors from Public Citizen
• 30% increase in overall mortality risk
• Nearly triple the risk of heart attack
• Increased risks could have been recognized in 2000
NATANSON 2008
EXCEPTION FROM INFORMED CONSENT
• Are there enough safeguards?
• Should these studies be
conducted in vulnerable
populations?
• Do you know if you might be a
research subject?