IRB
3 principles of Belmont Report
1) Respect for persons 2) Beneficence 3) Justice
IRB standards must meet what 4 standards:
1) ethical research 2) meet federal regulatory requirements 3) meet university requirements 4) meet accreditation standards
human subjects research criteria (definition)
a LIVING INDIVIDUAL about whom an investigator conductive research obtains
Belmont Report: Beneficence
obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm
Belmont Report: respect for persons
recognition of the personal dignity and autonomy of individuals and special protections of those persons with diminished autonomy
Informed Consent
respect for persons (example)
Human subjects research criteria: ______ ______ ______
Identifiable private information
IRB stands for:
Institutional Review Board
Subject selection
Justice (what to pay attention to)
1) submit who, what, when, where, and why of study with special justifications 2) at risk populations (kids, pregnant women, prisoners, elderly) -a) IRB reviews and rejects/accepts/approve with conditions -b) continuing reiview and reports required periodically -c) need to show IRB approval for publication/working with outside agencies
Process for submitting a proposal to IRB
all research involving _____ participants must be approved by an IRB before it may begin
human
The IRB reviews research involving ______ participants to assure their ______ and ______ are protected
human, welfare, rights
Human subjects research criteria: data through ______ or ______ with the individual
intervention, interaction
Risk:benefit ratio
Beneficence (what to pay attention to)
Belmont Report: Justice
fair distribution of the benefits and burdens of research
