Title 40:
Protection of Environment
PART 26PROTECTION OF HUMAN SUBJECTS
Subpart ABasic EPA Policy for Protection of Subjects
in Human Research Conducted or Supported by EPA
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§ 26.118 Applications and proposals lacking
definite plans for involvement of human subjects.
Certain types of applications for grants, cooperative agreements, or
contracts are submitted to 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. These applications need not be reviewed by an IRB before an
award may be made. However, except for research exempted or waived under
§26.101 (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.
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