[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR56.111]



[Page 298-299]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 56_INSTITUTIONAL REVIEW BOARDS--Table of Contents

 

                 Subpart C_IRB Functions and Operations

 

Sec.  56.111  Criteria for IRB approval of research.



    (a) In order to approve research covered by these regulations 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 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 that 

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 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, 

handicapped, or 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 part 50.



[[Page 299]]



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

with and to the extent required by Sec.  50.27.

    (6) Where appropriate, the research plan makes adequate provision 

for monitoring the data collected to ensure the safety of subjects.

    (7) Where 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, such as children, prisoners, 

pregnant women, handicapped, or mentally disabled persons, or 

economically or educationally disadvantaged persons, are likely to be 

vulnerable to coercion or undue influence additional safeguards have 

been included in the study to protect the rights and welfare of these 

subjects.

    (c) In order to approve research in which some or all of the 

subjects are children, an IRB must determine that all research is in 

compliance with part 50, subpart D of this chapter.



[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 66 

FR 20599, Apr. 24, 2001]