[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: 21CFR56.109]
[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. 56.109 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 these regulations.
(b) An IRB shall require that information given to subjects as part
of informed consent is in accordance with Sec. 50.25. The IRB may
require that information, in addition to that specifically mentioned in
Sec. 50.25, 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 in
accordance with Sec. 50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement
that the subject, or the subject's legally authorized representative,
sign a written consent form if it finds that the research presents no
more than minimal risk of harm to subjects and involves no procedures
for which written consent is normally required outside the research
context; or
[[Page 299]]
(2) The IRB may, for some or all subjects, find that the
requirements in Sec. 50.24 of this chapter for an exception from
informed consent for emergency research are met.
(d) In cases where the documentation requirement is waived under
paragraph (c)(1) of this section, the IRB may require the investigator
to provide subjects with a written statement regarding the research.
(e) 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
decision and give the investigator an opportunity to respond in person
or in writing. For investigations involving an exception to informed
consent under Sec. 50.24 of this chapter, an IRB shall promptly notify
in writing the investigator and the sponsor of the research when an IRB
determines that it cannot approve the research because it does not meet
the criteria in the exception provided under Sec. 50.24(a) of this
chapter or because of other relevant ethical concerns. The written
notification shall include a statement of the reasons for the IRB's
determination.
(f) An IRB shall conduct continuing review of research covered by
these regulations 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.
(g) An IRB shall provide in writing to the sponsor of research
involving an exception to informed consent under Sec. 50.24 of this
chapter a copy of information that has been publicly disclosed under
Sec. 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter. The IRB shall
provide this information to the sponsor promptly so that the sponsor is
aware that such disclosure has occurred. Upon receipt, the sponsor shall
provide copies of the information disclosed to FDA.
(h) When some or all of the subjects in a study are children, an IRB
must determine that the research study is in compliance with part 50,
subpart D of this chapter, at the time of its initial review of the
research. When some or all of the subjects in a study that is ongoing on
April 30, 2001 are children, an IRB must conduct a review of the
research to determine compliance with part 50, subpart D of this
chapter, either at the time of continuing review or, at the discretion
of the IRB, at an earlier date.
[46 FR 8975, Jan. 27, 1981, as amended at 61 FR 51529, Oct. 2, 1996; 66
FR 20599, Apr. 24, 2001]
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