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Ethical Research Practice
Institutional Review Board

IRB Review Criteria
--Definition of Research
--Is It Research?
--Human Subjects
--Case Study 1
--Case Study 2
--Study Design
--Minimal Risk
--Risks & Benefits
--Confidentiality
--HIPAA
--Subject Selection
--Vulnerable Subjects
--Incentives
--Quiz

Informed Consent
Genetic Testing
Types of Review
Continuation & Final Reports
Serious Adverse Events
Frequently Asked Questions
Conclusion


Study Design

The primary consideration of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects by approving research that is founded on good clinical practice and evidence-based scientific reasoning. The importance of designing research that is based on complete scientific background investigation and consideration of all possible implications for the subjects cannot be underestimated.

A study must minimize the risks of the experiment. Investigators are strongly encouraged to contact Biostatistics & Research Epidemiology at (313) 874-6360 for assistance with research design.

More information from the U.S. Food & Drug Administration regarding good clinical practice can be found on the Federal Regulations page.

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