The purpose of this University of Wisconsin-Madison Institutional Biosafety Committee (IBC) policy is to define roles, responsibilities, and requirements of a Principal Investigator (PI) on a biosafety protocol.
The IBC defines a PI for biological safety protocols as University of Wisconsin-Madison tenure track faculty, Research Professors (all levels), or academic staff that have been granted Permanent PI Status.
Circumstances may occur where a UW-Madison researcher that does not fall into one of the above categories or a researcher from an external entity may request to be a PI for the purposes of the biological safety protocol. This is requested of the IBC by filling out the "Request for Principal Investigator (PI) Status" form and submitting it to the IBC. These requests are subject to IBC approval. These persons may include (but are not limited to):
The completion and approval of the form by the IBC pertains solely to the ability to serve as Principal Investigator on a biosafety protocol. Although the same form may be used to apply for PI status on Institutional Review Board (IRB), Animal Care and Use Committee (ACUC), and Stem Cell Research Oversight (SCRO) protocols, approval of PI status on a biosafety protocol by the IBC does not confer PI status for IRB, ACUC, and/or SCRO protocols; approval for these must be granted by the relevant oversight committee(s). Submission of the form to the IBC does not replace the formal campus designation process to serve as a Principal Investigator on an extramural grant proposal, nor does it confer any of the benefits of campus-designated PI status.
The IBC may set additional conditions or determine that an individual cannot serve as PI on a biosafety protocol, even if the individual otherwise meets the criteria in this policy, if the committee determines the individual’s ability to fulfill the roles and responsibilities of a PI may be compromised due to existing circumstances. Examples may include lack of appropriate expertise or physical location that is not in proximity to where the research will be conducted.
Roles and responsibilities of PIs are defined by the UW-Madison IBC, NIH Guidelines, and other applicable regulations or local, state, and federal guidelines. The PI shall sign and adhere to the assurance statement for their research conducted within the UW-Madison IBC’s oversight.
The UW-Madison Researchers’ Biosafety Manual, UW-Madison, Office of Biological Safety, current version.
U.S. Department of Health and Human Services, National Institutes of Health (NIH) - NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, current version.
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) - Biosafety in Microbiological and Biomedical Laboratories (BMBL), current version.
11-04-2015, 06-01-2016, 06-01-2018, 06-02-2021