[Code of Federal Regulations]

[Title 16, Volume 2]

[Revised as of January 1, 2006]

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

[CITE: 16CFR1028.115]



[Page 115-116]

 

                     TITLE 16--COMMERCIAL PRACTICES

 

             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION

 

PART 1028_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Sec. 1028.115  IRB records.



    (a) An institution, or when appropriate an IRB, shall prepare and 

maintain adequate documentation of IRB activities, including the 

following:

    (1) Copies of all research proposals reviewed, scientific 

evaluations, if any, that accompany the proposals, approved sample 

consent documents, progress reports submitted by investigators, and 

reports of injuries to subjects.

    (2) Minutes of IRB meetings which shall be in sufficient detail to 

show attendance at the meetings; actions taken by the IRB; the vote on 

these actions including the number of members voting for, against, and 

abstaining; the basis for requiring changes in or disapproving research; 

and a written summary of the discussion of controverted issues and their 

resolution.

    (3) Records of continuing review activities.

    (4) Copies of all correspondence between the IRB and the 

investigators.

    (5) A list of IRB members in the same detail as described is Sec. 

1028.103(b)(3).

    (6) Written procedures for the IRB in the same detail as described 

in Sec. Sec. 1028.103(b)(4) and 1028.103(b)(5).

    (7) Statements of significant new findings provided to subjects, as 

required by Sec. 1028.116(b)(5).



[[Page 116]]



    (b) The records required by this policy shall be retained for at 

least 3 years, and records relating to research which is conducted shall 

be retained for at least 3 years after completion of the research. All 

records shall be accessible for inspection and copying by authorized 

representatives of the department or agency at reasonable times and in a 

reasonable manner.



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

0990-0260)



[56 FR 28012, 28019, June 18, 1991, as amended at 70 FR 36328, June 23, 

2005]