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Ethical Research Practice
Institutional Review Board
IRB Review Criteria

Informed Consent
--Capacity to Consent
--Freedom from Coercion
--Risks & Benefits
--Informed Consent Document
--Informed Consent Delivery
--Waiver of Informed Consent
--Quiz

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

Capacity to Consent

The participant should have legal capacity to consent, excluding those with diminished mental capacity, comatose patients or children. Under certain circumstances legal guardians may give permission for those in their care to participate. If the subject is a minor, the parent or legal guardian should be fully educated about the study as well as the minor.

The Institutional Review Board examines these situations extremely carefully to protect the rights of vulnerable populations. Any suspicion of coercion or manipulation of vulnerable populations will result in denial of research rights and possible disciplinary action. The Willowbrook Study and the Fernald radiation experiments are examples of studies that improperly used mentally retarded children and adults without informed consent. More information about these studies is available on the Historic Research page.

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