[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.111]
[Page 300]
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.
(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]
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