Tissue Banking Overview: Washington University Medical Center
Tissue Banking Overview: Washington University Medical Center
Tissue Banking Overview: Washington University Medical Center
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8/21/2012<br />
WUMC Biobanking 2011<br />
Regulatory Requirements<br />
• For biospecimen procurement, risks are mainly breach of confidentiality.<br />
• HIPAA: (45 CFR Parts 160 and 164) Conditions under which PHI may be<br />
used or disclosed by Covered Entities for research purposes:<br />
• “Safe Harbor” method: Lists 18 specific types of data elements that<br />
must be removed; de-identified data does not constitute PHI and<br />
therefore can be freely disclosed.<br />
• Statistical method.<br />
• The “limited data set”: Requires removal of 16 elements and an<br />
agreement to be executed limiting the use of the data<br />
• Requirements of individual institutions / IRBs<br />
• FDA Rule for Human Subjects Research (21 CFR Part 50)<br />
• State law<br />
• Intellectual Property / Materials Transfer / Legal Requirements<br />
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