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

Genetic Testing
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Serious Adverse Events
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Conclusion

Informed Consent

"Informed consent refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of its purpose, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate."

--OHRP Training Course

Participation in research must be voluntary and free of any type of coercion. Subjects can chose to participate, or not to participate and still receive the high quality of care HFHS provides. This aspect of research design and delivery is extremely important in every sense, morally, socially and for legal reasons. Examples of research where no informed consent was obtained include an investigation of sulfonamides on streptococcal infections with a control group that was excluded from drug treatment, the Tuskegee syphilis studies, and investigation of immune responses to live cancer cells in prisoners and terminally ill patients.

The Nuremberg code, developed after public outrage at the unethical research conducted on World War II prisoners of war, outlines three aspects of informed consent: capacity to consent, freedom from coercion and comprehension of risks and benefits. More information is available on the Historic Research page.

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