Nuremberg Code of ethical research conduct, 1948
In response to the horrific experiments conducted on prisoners by
Nazi & Japanese physicians.
Declaration of Helsinki (1964)
•A set of rules for human experimentation by the medical community
•It is morally binding to physicians and should override national and
state laws
•Some important guidelines
•Independent review committees
,Informed consent
,Risks should not exceed benefits
Parts of Belmont Report
1) Respect for Persons
2) Justice
3) Beneficence
Respect for Persons
- persons with diminished autonomy are entitled to protection
Informed consent
-Participation is voluntary and subjects can withdraw at anytime
participants must be informed of :
-purpose of the research
-any foreseeable risks of harm
-description of what they are expected to do
Beneficence
1) do not harm
2) maximize possible benefits and minimize possible harm
Justice
1) benefits and burdens of research are equitably distributed
2) subject populations are not chosen because of convenience
Institutional review board
8 criteria must be satisfied for approval:
•Risks must be minimized
•Favorable risk/benefit ratio
•Safe data collection
•Equitable subject selection (no discrimination)
•Vulnerable individuals must be safeguarded
•Free (no coercion) & informed consent must be sought
•Informed consent must be documented
•Confidentiality & privacy must be maintained
Who is a confederate?
A member of
the research team that
pretends to be a
participant.
Debriefing
Equitable selection
Those who take the risks should be
those that receive the benefits.
Safeguarding special populations
Institutional Animal Care and Use Committee
Animals need to be treated humanely. •low Pain/stress •Surgery •Trained researchers •Lab inspections •Veterinarians available
Replication crisis
solutions: