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IC in special populations

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Hello,

Although the basic principles of obtaining informed consent transcend therapeutic areas and vulnerable patient populations, significant differences must be considered when research designs include individuals at increased risk. Special attention must be given to meeting the needs of vulnerable populations such as children, the critically ill, or the mentally impaired.

People who may be considered vulnerable in clinical research

• Children

• Economically disadvantaged

• Educationally disadvantaged/illiterate

• Employees

• Physically impaired

• Life-threatening condition/seriously debilitating illness

• Mentally disabled/cognitively impaired

• Nursing home residents

• Pregnant women

• Prisoners

• University students

(Source: -Tyler: Informed Consent, Confidentiality, and Subject Rights. Proceedings of the American Thoracic Society vol 4 2007, 189-193. DOI: 10.1513/pats.200701-008GC. www.atsjournals.org)

Dr. Smita

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