Protocol

The protocol or protocol application is institution specific and is developed by the Compliance Committee to take into consideration federally mandated criteria as well as local institutional policies and practices in proposed research and to be able to assess the risk/benefit ratio for the proposed project. As it relates to protecting human participants, the protocol is more specific than the proposal and they may or may not be tied together. At almost all institutions, there is a many to one and a one to many relationship between the protocol and the proposal. (Reference R Amdur and E. Bankert. Institutional Review Board - Management and Function. Boston: Jones and Bartlett Publishers, p. 143.)