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. Author manuscript; available in PMC: 2015 Nov 6.
Published in final edited form as: Rev Recent Clin Trials. 2014;9(4):233–244. doi: 10.2174/1574887110666150127105545

Table 4.

Overview of Applicable Regulations and Policies.

Regulationa Summary
45CFR46 Protects subjects from research – informed consent process
HIPAA Not for research use, guidelines to regulate research use, fights of the subjects participate in research. HIPAA applies if clinical, identifiable data are obtained to create the repository and if these data are used in projects.
FDA It is important to recognize when does it apply. FDA regulations deal with all biomedical inventions that may lead to a product that would need to be patented, for example data that will lead to a new drug or a diagnostic/prognostic biomarkers.
OSHA Guidelines on biosafety issues of handling human samples
a

Sometimes these regulations clash and herein lies many of the difficulties in this area.