Considerations for Analysis of Existing Data or Biospecimens
The NIDCR Clinical Terms of Award (CToA) policy applies to all grants and cooperative agreements conducting human subjects research. This includes studies that will enroll human subjects to collect new data and studies that use previously collected data or specimens that can still be linked to living individuals. The NIDCR CToA policy provides information regarding the documents to provide to your NIDCR Program Official, as well as other expectations before starting your study.
Considerations for studies providing analysis of existing data or specimens include assessing whether the currently proposed research is compatible with what subjects agreed to in the original study’s consent document, how and where the data will be stored, and what security measures are in place to protect access.