-CITE- 45 CFR Sec. 46.118 -EXPCITE- Title 45 SUBTITLE A PART 46 Subpart A -HEAD- Sec. 46.118 Applications and proposals lacking definite plans for involvement of human subjects. -TEXT- Certain types of applications for grants, cooperative agreements, or contracts are submitted to the Department with the knowledge that subjects may be involved within the period of funding, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants (including bloc grants) where selection of specific projects is the institution's responsibility; research training grants where the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research described in Sec. 46.101(b), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in these regulations, and certification submitted to the Department.