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Research That Will Involve Human Subjects in the Future

Certain types of applications for grants, cooperative agreements, or contracts are submitted to HHS departments or agencies 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 when selection of specific projects is the institution's responsibility; research training grants in which 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) or (i), 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 this policy, and certification submitted by the institution, to the department or agency. (sec. 46.118)

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