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Ethical Research Practice

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

Institutional Review Board

Institutional Review Boards (IRB) became part of federal regulations when Congress was searching for a practical way to protect human research subjects in the many thousands of institutions that receive federal funding. Rather than establish a gigantic agency with nation wide policing powers, it was decided to require that each organization become responsible for enforcing the federal requirements internally. This is how IRBs became a part of every institution that does federally funded research.

Under federal regulations, any institution engaged in federally-supported human subjects research must commit itself in writing to the protection of those subjects. This written commitment is called an Assurance of Compliance and is filed with the Office for Human Research Protections of the U.S. Department of Health and Human Services. The federal regulations are intended to implement the basic ethical principles governing the conduct of human research. No one should be involved in human research at any level without being familiar with these ethical principles.

 Any organization that has an IRB makes a commitment to review all research involving human subjects through their IRB, even if the research is not funded by a federal agency.

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