These are trials that the Investigator at HHS or another non-industry institution has developed a protocol for. Often these trials are funded publicly through funding agencies such as CIHR. They may also be funded by industry, but industry has not designed any aspect of the study and is not sponsoring the study.
Currently there is no overhead rate applied to Investigator-initiated trials at HHS.
When conducting an Investigator-initiated trial, the Investigator becomes the Sponsor of the trial. There is additional information that Investigators need when commencing this type of clinical trial. Links to more information and contacts can be found below: