[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: 16CFR1028.111]



[Page 114-115]

 

                     TITLE 16--COMMERCIAL PRACTICES

 

             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION

 

PART 1028_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Sec. 1028.111  Criteria for IRB approval of research.



    (a) In order to approve research covered by this policy the IRB 

shall determine that all of the following requirements are satisfied:

    (1) Risks to subjects are minimized:

    (i) By using procedures which are consistent with sound research 

design and which do not unnecessarily expose subjects to risk, and

    (ii) Whenever appropriate, by using procedures already being 

performed on the subjects for diagnostic or treatment purposes.

    (2) Risks to subjects are reasonable in relation to anticipated 

benefits, if any, to subjects, and the importance of the knowledge that 

may reasonably be expected to result. In evaluating risks and benefits, 

the IRB should consider only those risks and benefits that may result 

from the research (as distinguished from risks and benefits of therapies 

subjects would receive even if not participating in the research). The 

IRB should not consider possible long-range effects of applying 

knowledge gained in the research (for example, the possible effects of 

the research on public policy) as among those research risks that fall 

within the purview of its responsibility.

    (3) Selection of subjects is equitable. In making this assessment 

the IRB should take into account the purposes



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of the research and the setting in which the research will be conducted 

and should be particularly cognizant of the special problems of research 

involving vulnerable populations, such as children, prisoners, pregnant 

women, mentally disabled persons, or economically or educationally 

disadvantaged persons.

    (4) Informed consent will be sought from each prospective subject or 

the subject's legally authorized representative, in accordance with, and 

to the extent required by Sec. 1028.116.

    (5) Informed consent will be appropriately documented, in accordance 

with, and to the extent required by Sec. 1028.117.

    (6) When appropriate, the research plan makes adequate provision for 

monitoring the data collected to ensure the safety of subjects.

    (7) When appropriate, there are adequate provisions to protect the 

privacy of subjects and to maintain the confidentiality of data.

    (b) When some or all of the subjects are likely to be vulnerable to 

coercion or undue influence, such as children, prisoners, pregnant 

women, mentally disabled persons, or economically or educationally 

disadvantaged persons, additional safeguards have been included in the 

study to protect the rights and welfare of these subjects.