[Code of Federal Regulations]

[Title 28, Volume 2]

[Revised as of July 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 28CFR46.109]



[Page 20-21]

 

                    TITLE 28--JUDICIAL ADMINISTRATION

 

              CHAPTER I--DEPARTMENT OF JUSTICE (CONTINUED)

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Sec. 46.109  IRB review of research.



    (a) An IRB shall review and have authority to approve, require 

modifications in (to secure approval), or disapprove all research 

activities covered by this policy.

    (b) An IRB shall require that information given to subjects as part 

of informed consent is in accordance with Sec. 46.116. The IRB may 

require that information, in addition to that specifically mentioned in 

Sec. 46.116, be given to the subjects when in the IRB's judgment the 

information would meaningfully add to the protection of the rights and 

welfare of subjects.

    (c) An IRB shall require documentation of informed consent or may 

waive documentation in accordance with Sec. 46.117.

    (d) An IRB shall notify investigators and the institution in writing 

of its decision to approve or disapprove the proposed research activity, 

or of modifications required to secure IRB approval of the research 

activity. If the IRB decides to disapprove a research activity, it shall 

include in its written notification a statement of the reasons for its



[[Page 21]]



decision and give the investigator an opportunity to respond in person 

or in writing.

    (e) An IRB shall conduct continuing review of research covered by 

this policy at intervals appropriate to the degree of risk, but not less 

than once per year, and shall have authority to observe or have a third 

party observe the consent process and the research.



(Approved by the Office of Management and Budget under Control Number 

0990-0260)



[56 FR 28012, 28020, June 18, 1991, as amended at 70 FR 36328, June 23, 

2005]