Safety

While clinical trials are important to the advancement of science and innovation, if they cannot be conducted safely they should not be conducted at all. Everyone at the University of Utah involved in the research process (from the principal investigator to the hospital administration) believes the safety of research volunteers is paramount.

The safety process begins right after an idea for a clinical trial is conceived. It can take years of scientific and ethical scrutiny from the FDA, the IRB, and other organization-specific processes before a trial will ever be studied with volunteers. The main criteria for safety is judged by minimal risk and risk-to-benefit.

Minimal Risk

According to the US Department of Health and Human Services: “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”. This means, if a study is minimal risk, a volunteer should not experience any pain or discomfort found outside of their daily routine or routine tests. If a study does not meet this criteria it is considered "greater than minimal risk."

Greater than minimal risk studies vary widely in their implementation and are best understood by speaking with the principal investigator and reading over the informed consent document. These studies can be very important for improving medical emergency care. If a patient arrives at an ER, it is possible the best treatment option for them is a new procedure still being studied. In this scenario, minimal risk is not an option because it is not encountered in the routine of daily life.

Director & Associate Vice President for Research Integrity

Erin Rothwell, PhD
Phone: 801-581-5407
Email: erin.rothwell@nurs.utah.edu

Contact Us

Director:
Sadie Gabler
Phone: 801-581-3803
Email: participant.advocate@hsc.utah.edu