Ethics Flashcards
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. What are the 3 core principles and 3 core applications
3 Principles = Beneficence, Respect for Persons, and Justice
3 Applications = Informed Consent, Assessment of Risks and Benefits, and Selection of Subjects
What Federal Regulation is based on the Belmont Report, is shared by 15 different dept and agencies, and is the basis for many IRB’s?
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies
Name the 5 principles of the FTC Fair Information Practices
1) Awareness: Consumers should be given notice of an entity’s information practices before any personal information is collected from them
2) Consent: or Prevention information that was obtained for one purpose to be used for another
3) Access: consumer’s ability to view the data collected, but also to verify and contest its accuracy
4) Integrity/Security: Info must be accurate and secure.
5) Enforcement/Redress: The FTC identified three types of enforcement measures: self-regulation by the information collectors or an appointed regulatory body; private remedies that give civil causes of action for individuals whose information has been misused to sue violators; and government enforcement, which can include civil and criminal penalties levied by the government.
What two Tort Law ideas apply to clinical informatics? Describe them.
1) Negligence Theory: Applies to the provision of services by the provider while using the EHR as a tool
2) Strict Product Liability: Harm casued by defective products. (versus Negligence theory–almost no allowance for bad outcomes)
