Clinical

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Submitted By MOMO32
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The Regulations for Protecting Research Subjects (the Common Rule) state that when reviewing protocols, IRBs must determine that there are adequate provisions for protecting the privacy of subjects and to maintaining the confidentiality of data.
The Common Rule is just one document that directs researchers to consider privacy and confidentiality when conducting research. The guidelines of the American Anthropological Association, the Oral History Association, the American Psychological Association, and the American Sociological Association identify protecting privacy and ensuring confidentiality as key components of respecting the safety and dignity of research subjects.
This module will define privacy and confidentiality and discuss their application in various research settings. It will also discuss applicable laws, other than the Common Rule.
Learning Objectives
By the end of this module, you should be able to:
• Distinguish between privacy and confidentiality
• Identify privacy risks associated with study designs
• Identify a range of procedures for ensuring confidentiality
• Identify relevant laws regarding collection of private information
• Identify laws that limit the ability to ensure confidentiality
Definitions
According to the IRB Guidebook, published by the Office for Human Research Protections, privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.
Thus it follows that privacy, a right, can be violated. Confidentiality, an agreement, can be breached.…...

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