Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee.

Several frameworks assist research ethics committees (RECs) in risk assessment of medical studies. However, little is known about how researchers describe risks of the procedures in study protocols and participant information sheets. We examined 349 study protocols and participant information sheets submitted to an REC and evaluated the risk assessments performed for 1,510 study procedures. Risks had been assessed for 399 (26%) procedures in study protocols and for 425 (28%) procedures in participant information sheets. Physical risks were assessed six times more frequently than psychological risks. Risks of medical procedures are not always detailed in study protocols or participant information sheets. Risk descriptions of procedures believed to be familiar to potential participants may be omitted.