E&I can contribute to our client's HRPP through our IRBs’ review. The client is responsible for conduct of the study and providing the remaining functions. No two HRPPs will be the same. Each will reflect E&I plus all of the other functions, many of which may be sub-contracted.
E&I, as a business corporation, is a “public or private entity” as defined in 21 CFR 56 and in the Common Rule (45 CFR 46). E&I's Director of Regulatory Affairs has established an organizational culture in which protection of subjects is paramount. In this culture, the IRB is kept as free from business concerns as possible. E&I provides adequate resources, education, and staff for the IRB and the IRB staff.
All subject interactions are at sites remote from E&I and outside its institutional jurisdiction. Therefore, all HRPP functions must be handled through relationships, education, and assurances. Our expectations are laid out within this website in the relationship, contracts, and other sections.