A quick search of the internet reveals that sites often wonder who is able to serve as the Principal Investigator of a study. Does the PI have to have a medical license or can non-physicians (PhDs, DOs, PsyDs, DPT) also serve as the PI?
What does the FDA say?
- 21 CFR 812.43 (a): A sponsor shall select investigators qualified by training and experience to investigate the device.
- 21 CFR 312.53 (a): A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.
- FDA has no written guidance on whether a non-MD can serve as PI.
So, the FDA does not regulate whether the PI has to be a MD.
How about Good Clinical Practice? GCP does seem to suggest a higher standard. Although not specifically requiring a medical degree, GCP talks about medical decisions and qualified physicians.
- ICH GCP 4.1.1: The investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial.
- ICH GCP 2.7: The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- ICH GCP 4.3.1: A qualified physician, who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical decisions.
Since investigator selection is the responsibility of the Sponsor, it is ultimately their decision. However, it is dependent on the type of study. Typically for IND studies, if the PI is a non-MD there is a MD listed on the 1572 to perform any medical decisions (diagnosis, distribution of medication). If the device study is an implantable device, the PI will always be a surgeon with experience in the study indication. But, if the device is non-implantable and let’s say is used for physical therapy patients with neck pain- the PI may be a DPT or PhD as the PI would be qualified by education, training and experience.
We would love to hear your thoughts. Have you ever had a Sponsor not allow a non-physician serve as the PI? Have you had a non-physician PI and medical oversight from a sub-investigator?
Photo Credit: Horia Varlan