[Code of Federal Regulations]
[Title 40, Volume 1]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR26.1125]

[Page 321]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
               CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
 
PART 26_PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
Subpart K_Basic Ethical Requirements for Third-Party Human Research for 
 Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing 
                                 Adults
 
Sec.  26.1125  Prior submission of proposed human research for EPA review.

    Any person or institution who intends to conduct or sponsor human 
research covered by Sec.  26.1101(a) shall, after receiving approval 
from all appropriate IRBs, submit to EPA prior to initiating such 
research all information relevant to the proposed research specified by 
Sec.  26.1115(a), and the following additional information, to the 
extent not already included:
    (a) A discussion of:
    (1) The potential risks to human subjects;
    (2) The measures proposed to minimize risks to the human subjects;
    (3) The nature and magnitude of all expected benefits of such 
research, and to whom they would accrue;
    (4) Alternative means of obtaining information comparable to what 
would be collected through the proposed research; and
    (5) The balance of risks and benefits of the proposed research.
    (b) All information for subjects and written informed consent 
agreements as originally provided to the IRB, and as approved by the 
IRB.
    (c) Information about how subjects will be recruited, including any 
advertisements proposed to be used.
    (d) A description of the circumstances and methods proposed for 
presenting information to potential human subjects for the purpose of 
obtaining their informed consent.
    (e) All correspondence between the IRB and the investigators or 
sponsors.
    (f) Official notification to the sponsor or investigator, in 
accordance with the requirements of this subpart, that research 
involving human subjects has been reviewed and approved by an IRB.