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Title 6 Part 46 → §46.118

Title 6 → Chapter I → Part 46 → §46.118

Electronic Code of Federal Regulations e-CFR

Title 6 Part 46 → §46.118

e-CFR data is current as of June 21, 2019

Title 6Chapter IPart 46 → §46.118


Title 6: Domestic Security
PART 46—PROTECTION OF HUMAN SUBJECTS


§46.118   Applications and proposals lacking definite plans for involvement of human subjects.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, 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. Except for research waived under §46.101(i) or exempted under §46.104, 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 Federal department or agency component supporting the research.