The Role of the Surgical DRC
Departments, Divisions or Institutes are responsible for establishing an explicit and formal scientific review process that evaluates the scientific merit and potential risks of each protocol before that protocol is submitted to the Human Research Ethics Committee. The Committee retains the authority to examine a study’s scientific design to determine its impact on the safety and well-being of potential participants.
Scientific quality is improved when study objectives and methods are clearly thought through and described. A well-written protocol facilitates high quality science and is an invaluable tool as investigators develop and conduct their studies. A protocol is the formal design or detailed action plan of a study. The protocol explains what will be done, when, how, where and why.
The research question and methodology must be presented in enough detail to permit evaluation of the scientific merit of the study.