Page 58 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 37

(7) An explanation of whom to contact for answers to pertinent questions about the research and
research subjects’ rights, and whom to contact in the event of a research-related injury to the
subject.
(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or
loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue
participation at any time without penalty or loss of benefits to which the subject is otherwise
entitled.
(b) Additional elements of informed consent. When appropriate, one or more of the following elements
of information shall also be provided to each subject:
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the
embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
(2) Anticipated circumstances under which the subject’s participation may be terminated by the
investigator without regard to the subject’s consent.
(3) Any additional costs to the subject that may result from participation in the research.
(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly
termination of participation by the subject.
(5) A statement that significant new findings developed during the course of the research which may
relate to the subject’s willingness to continue participation will be provided to the subject.
(6) The approximate number of subjects involved in the study.
(c) The informed consent requirements in these regulations are not intended to preempt any applicable
Federal, State, or local laws which require additional information to be disclosed for informed con-
sent to be legally effective.
(d) Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical
care to the extent the physician is permitted to do so under applicable Federal, State, or local law.
Id. § 50.25.

These elements are orally presented to the subject. This is commonly done by the investigator.
The subject then signs the document to verify that the information transmittal has occurred and that
the subject is enrolling of his/her own free will. Some sites even videotape the informed consent ses-
sion as a record showing that the process was followed.
The guardian of this informed consent process is the IRB. In countries other than the United
States, this entity is commonly known as an ethics committee. The IRB is a committee charged with
protecting study subject rights. The IRB is constituted under federal regulations, both FDA regula-
tions (21 C.F.R. pt. 56) for FDA studies and HHS rules for government studies.
FDA rules specify the membership, the purpose, the processes, and the record-keeping of the
IRB. The IRB’s overall charge is to approve human research. Usually an IRB is associated with a
hospital or medical practice. There are also independent IRBs that review and approve research for
hospitals without IRBs or for multiple-site studies.
The FDA requirements for IRB approval of a study are
(a) In order to approve research covered by these regulations the IRB shall determine that all of the fol-
lowing 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 appro-
priate, 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 distin-
guished 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.