[Code of Federal Regulations]
[Title 28, Volume 2]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 28CFR46.118]

[Page 24-25]
 
                    TITLE 28--JUDICIAL ADMINISTRATION
 
              CHAPTER I--DEPARTMENT OF JUSTICE (Continued)
 
PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
Sec. 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 departments or

[[Page 25]]

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 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.