[Code of Federal Regulations] [Title 34, Volume 1] [Revised as of July 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 34CFR97.119] [Page 291] TITLE 34--EDUCATION PART 97--PROTECTION OF HUMAN SUBJECTS--Table of Contents Subpart A--Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) Sec. 97.119 Research undertaken without the intention of involving human subjects. In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted, by the institution, to the department or agency, and final approval given to the proposed change by the department or agency. (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v- 1(b))