II

IV.17

 

 

Privacy and Confidentiality

 

 

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Objective

This Policy describes the processes by which privacy and confidentiality will be evaluated by the University of Texas Health Science Center at Houston (UTHSC-H) Committee for the Protection of Human Subjects (CPHS).

 

Policy/Procedure

I.      The CPHS shall determine that, when appropriate, there are adequate provisions to protect the privacy of research subjects.

 

A.   CPHS will review information regarding plans to protect the privacy of subjects.

B.    CPHS will systematically and rigorously consider privacy protections.

 

 

II.    The CPHS shall determine that, when appropriate, there are adequate provisions to maintain the confidentiality of data.

 

A.   CPHS will review information regarding plans to protect the confidentiality of data.

B.    CPHS will systematically and rigorously consider confidentiality protections.

C.    For repository activities, CPHS will make determinations concerning the regulatory status and appropriate use of stored biologic samples.

 

 

Applicable Regulations and Guidelines

21CFR 56(http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html )

45CFR 46 http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html )

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