[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.118]

[Page 119-120]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 46--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
  Subpart A--Basic HHS Policy for Protection of Human Research Subjects
 
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 agencies with the knowledge 
that subjects may be involved within the period of support, but definite 
plans would not

[[Page 120]]

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.