The PI is responsible for all aspects of IRB-approved research including the responsibility for the oversight of all staff to whom tasks are delegated and for the fiscal management of the research. To serve as a PI for a non-exempt, human subjects research protocol at CHOP an individual must be qualified under the eligibility requirements enumerated below.
The principal investigator of a non-exempt human subjects research study must meet all of the following:
- Employed at CHOP or have an appointment as a member of the CHOP medical staff;
- Have an appointment or position that meets one or more of the following:
- Professor, Associate Professor or Assistant Professor at the University of Pennsylvania;
- MD with appointment as an Instructor appointment at the University of Pennsylvania or at CHOP;
- MD or PhD (in a scientific field) at the CHOP Research Institute; individuals in this category must work in a clinically-related field;
- PharmD or Masters-prepared clinician (nurse, pharmacist, audiologist, respiratory therapist, nutritionist) with training or experience in the conduct of clinical research.
As part of each new protocol submission, the department chair, division director or director of the PI's reporting unit must attest that the individual is qualified by training and experience to serve as a principal investigator proving oversight for the proposed research and for the required clinical procedures.
Unless they have previously served as the PI of a non-exempt human subjects research study at CHOP, individuals who are trainees, including Fellows, Residents, Masters or Doctoral Candidates, or Postdoctoral Researchers may not serve as the PI. Trainees may serve as a lead investigator or co-investigator under the supervision of an individual qualified to serve as a PI but may not serve as a Principal Investigator.
Individuals not qualified to serve as a PI at CHOP include:
- Non-Penn faculty;
- Residents, fellows and other trainees including Masters level and PhD students doing research for a thesis;
- RNs, therapists or technicians who do not hold an advanced degree that includes research training;
- Individuals without a permanent CHOP appointment such as non-traditional personnel (NTPs) or Penn faculty without a CHOP appointment.