Page 288 - Encyclopedia of Nursing Research

InSTITUTIonaL ReVIeW BoaRD anD InFoRMeD ConSenT n 255

review. The Institutional Review Board research subjects to no apparent risks, then
(IRB) procedures are part of the regulations the research activities are exempt from IRB
for the Protection of Human Subjects of review. In Table 4, a list of research activities I
Biomedical Research (Title 45, Code of Federal exempt from review is displayed.
Regulations [CFR] 46, Subpart a). This code
was revised and expanded in 1978, 1983, (2) Expedited review (45, CFR 46.110). This type
1991, 2001, and 2009. In 1991, these guidelines of review is undertaken when the reviewers
were adopted, as a common core of regula- ascertain that the research will have only a
tions governing human subjects’ research, by minimal risk to research subjects. Under
all federal agencies and departments. These 46.303 of the code, minimal risk is defined as
core regulations (45, CFR 46) became known “the probability and magnitude of physical or
as the common rule, because the regulations psychological harm that is normally encoun-
were common to federal entities conducting tered in the daily lives, or in the routine med-
research on human subjects. ical, dental, or psychological examination of
each IRB should have a minimum of five healthy persons” (45, CFR 46.303).
members with varying backgrounds and also, expedited review may be con-
diversity to ensure adequate review of the ducted when there are minor changes in
research usually conducted at the institution previously approved research protocols.
(45, CFR 46.107). Members must be qualified expedited reviews may be conducted by the
with pertinent experience and expertise to IRB chairperson or by one or two experi-
ensure the protection of research subjects. enced reviewers designated by the chairper-
The diversity of the members, including son from the IRB members. These reviewers
race, gender, and ethnicity, is another consid- may exercise all of the authorities of the IRB,
eration in the makeup of the IRB. IRBs that except that the reviewers may not disap-
are regularly reviewing research protocols prove the research. a complete review of the
involving vulnerable populations, such as research protocol is necessary prior to disap-
children, prisoners, and pregnant women, proval of the research.
should consider having IRB members expe-
rienced with these vulnerable subjects (3) Complete review (45, CFR 108; 45, CFR
involved in the review. IRBs must have male 46.109). all studies with greater than min-
and female members coming from more than imal risks must have a complete review
one profession. one member of the IRB must by the IRB. The IRB must ensure that spe-
be from the scientific area, one from a non- cific requirements are met to approve the
scientific area, and at least one not affiliated research. These requirements include
with the institution. When additional exper- ensuring that the risks to research subjects
tise is required for a particular review, the are minimized and are reasonable in rela-
IRB may invite additional individuals to par- tion to the anticipated benefits. Informed
ticipate in the review. These individuals are consent must be obtained and documented.
nonvoting. a data-monitoring plan to ensure research
There are three levels of IRB review: subject’s safety and adequate protections
(1) exempt from review, (2) expedited review, to ensure the privacy and confidentiality
and (3) complete review. The IRB chairper- of subjects and data are in place. Complete
son or IRB decide on the type of review review is conducted at IRB meetings with
warranted for individual studies. the majority of the IRB members present,
including at least one whose primary con-
(1) Exempt from review (45, CFR 46.101b). cern is nonscientific. The majority of the IRB
When human subjects are involved in spe- members must approve the research for it to
cific categories of research exposing the be approved.