I am using established human cell lines and/or anatomical substances in my project. How do I know what regulatory requirements must be met?
The appendix “Research Involving Human Subjects and Anatomical Substances”, available under the eReceipt TAB “Regulatory and Other Documents”, explains the requirements and documents that must be completed for all research projects that involve human subjects and/or anatomical substances. Protocols using established human cell lines that are maintained in the laboratory and commercially available human cell lines qualify for exemption from the Humans Subjects Protection regulations and are administratively reviewed by the HSRRB. Questions regarding the completion of these documents should be directed to the RCQ human subjects office at 301-619-2165.
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