Page 59 - Biomedical Engineering and Design Handbook Volume 2, Applications

38 MEDICAL DEVICE DESIGN

(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 main-
tain the confidentiality of data.
(b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or men-
tally disabled persons, or economically or educationally disadvantaged persons, are likely to be vul-
nerable 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.
Id. § 56.111.

The IRB review of research involves
(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 con-
sent is normally required outside the research context; or
(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 disap-
prove 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 appro-
priate 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 con-
sent 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.
Id. § 56.109.