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