500
There are 3 areas of composition of the IRB/IEC who collectively have the qualifications and experience to review and evlauate the science, medical aspects, and ethics of the proposed trial. The three areas are:
What are:
1) Consists of at least 5 members
2) One member whose primary area of interest in in a nonscientific area
3) At least one member who is independent of the institution/trial site.