Training and Competency

You are responsible for ensuring that all personnel listed on an IRB application have the appropriate training and experience to perform their assigned duties. When considering whether certain biomedical procedures may be performed in an investigator’s research laboratory, the IRB will take into account the risk level of the procedures as well as applicable training/licensure requirements for individuals to perform certain procedures.

• In some cases, the IRB will allow non-therapeutic/non-diagnostic procedures to be carried out by non-medically licensed personnel provided they have sufficient training. Such procedures may include finger sticks, screening urine pregnancy tests, and pulmonary function testing.
• For more involved and/or more than minimal risk procedures (e.g., blood draw via venipuncture, IV drug infusion), the IRB will likely require the procedures be performed by an appropriately licensed medical professional.

Emergency Procedures

Your protocol or application should include a description of emergency medical procedures that will be implemented to ensure the safety of research participants. Calling 911 may be a sufficient plan if, for example, a participant experiences an accident during an exercise study. Calling 911 alone may not be sufficient, however, if the research procedures are more than minimal risk and the participant experiences, for example, an event that may require surgery or immediate medical intervention. The IRB will consider emergency procedures on case-by-case basis. The IRB expects that emergency procedures requiring more than a 911 call will involve medically licensed/registered personnel, as determined by the level of risk.