What is a Principal Investigator (PI)?
The PI is the named person who is responsible, under the regulations, for conduct of the research. WIRB prefers that only one investigator be named for this responsibility (Principal Investigator), but will allow a second person upon request (Co-Principal Investigator). Federal Regulations do not recognize Co-Principal Investigators. Therefore, the Board approves the two investigators as if each is THE Investigator and holds each individually responsible for the conduct of the entire study. If there are multiple sub-investigators and/or sites, WIRB may require an explanation as to how the Principal Investigator will personally conduct or oversee the research, as required under 21 CFR 50.3(d), 21 CFR 312.60, and Box 9 of the FDA Form 1572.
