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Human Subjects

Policies & Guidance

Non-Physician Involvement in Biomedical Research

The following guidance has been adopted by the Human Subjects Office in order to provide guidance for investigators and IRB members regarding the participation of non-physicians in biomedical research. When non-physicians are conducting biomedical research, especially that which involves the use of drugs or devices, the IRBs have raised concerns regarding appropriate training for non-physicians, appropriate control of the drug or device, and appropriate ongoing oversight for adverse events or other problems. The IRBs will continue to assess such situations on a case-by-case basis; however, the following minimum expectations should be met in the absence of extenuating circumstances.

Training of Non-Physicians
When investigators without previous clinical training will conduct biomedical procedures, such as placement of IVs or drawing of blood, the investigators must be appropriately trained to do so. The IRB will expect to see evidence of prior training or certification, or a plan for training, supervision, and monitoring for required skills.

Control and Dispensing of Drugs
When prescription or investigational drugs will be dispensed as part of the study, a licensed healthcare practitioner acting within the scope of his/her practice should conduct an in-person evaluation of all potential subjects prior to dispensing. The licensed healthcare practitioner must provide a formal order for dispensing of the drug/device. The written order should include dispensing instructions and a checklist for ensuring continued eligibility if additional criteria should be confirmed prior to additional medication being dispensed. Dose adjustments shall be evaluated and confirmed by the licensed healthcare practitioner prior to implementation.

Ongoing Oversight for Drug Studies
The research protocol should include a plan for ongoing monitoring and evaluation of adverse events and other potential problems. The plan should include regular review of events by the licensed healthcare practitioner, as well as a list of events that must be communicated to and evaluated by a licensed healthcare practitioner immediately.

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