Research population and medical support:
- The CHRU can be utilized by pediatric and adult subjects with diseases manifest in childhood. There is no age limit to study subjects.
- For all studies, a designated physician-investigator must be identified in the protocol as the primary support physician.
- For IRB/WIRB approved studies that do not include a physician-investigator, the medical director of the CHRU (or designee) can serve as the primary medical support. This relationship must be established between the study PI and the CHRU Medical Director prior to use of the CHRU, and must be approved by the CHRU-SRC. This relationship includes a clear plan to contact the primary support physician should medical questions arise during the conduct of the study.
- To minimize the risk that adult patients would require urgent intervention within the CHRU, the unit will only allow studies to be completed in stable study subjects without significant acute illness. Furthermore, all procedures and/or delivery of study agents involving adult patients will be of low to moderate risk (and not high risk, as determined by the Research Subject Advocate review member of the CHRU-OC). Procedures or delivery of study agents that could be of high risk to the adult study subject will NOT be permitted within the CHRU.
- It is highly recommended that for protocols involving adult study subjects, an adult-trained study team physician be identified and available to aid in the assessment, decision process, and transfer of adult patients to adult facilities should emergency conditions develop.