Biomedical Engineering Reference
In-Depth Information
members whose interests are in protecting the rights and welfare of human subjects
in research. In other words, IRB is consists of members who are not influenced
by any political, institutional, professional or market in reviewing and decision-
making of individual research.
While working with animals as participants of research, institutional review
and approval is also necessary. The Institutional Animal Care and Use Committee
(IACUC), part of the IRB in many places, is responsible for providing oversight and
evaluation of the institution's animal care and use program and facilities by ensur-
ing compliance related to the proper care, use, and humane treatment of animals
used in research, testing, and education. Further, if biological materials such as
DNA and proteins that may have the potential to cause adverse effects are utilized,
additional approvals are necessary. Many institutions implement the review proc-
ess through Institutional Biosafety Committees (IBC). The modes of operation of
the IACUC and IBC are similar to IRB and locally set up guidelines to ensure com-
pliance. These committees are responsible for creating a culture that assures the hu-
mane care and use of animals while facilitating their use in research and teaching.
Guiding this process are the federal and state laws, university policies, and ethical
principles, particularly that of
The Belmont Report
.
Investigators prepare and submit research projects and related materials (e.g.,
informed consent documents and investigator brochures) for review to the IRB, ac-
cording to the guidelines set by the IRB. Investigators cannot commence research
involving human subjects until the IRB has approved the study. Researchers must
explain the significance of their actions in the wider scientific and human contexts
as well as think of their actions in terms of future experimental design. Researchers
take the lead in ensuring that the progress of research is both ethical and free from
political intervention as only they can do so. Demonstration of a well-conducted
process not only protects the investigators from exposure to liability, but increases
the patient's autonomy in decisions concerning health and encourages compliance
with treatment.
The IRB meets regularly to review submitted research projects. However, spe-
cial meetings may be called in case of emergency conditions such as timeliness
of reviews, patient safety concerns, and compliance issues. At the meeting, each
research project is reviewed to determine the ethical conduct of research involving
human subjects. The IRB review is to assure, both in advance and by periodic re-
view, that appropriate steps are taken to protect the rights and welfare of humans
participating as subjects in the research. IRBs may approve the research project
without concerns, send clarification questions prior to approval, or reject the re-
search project due to significant concerns regarding ethical standards. If there are
concerns and questions, the investigator addresses those concerns and questions in
writing and submits a revised project for IRB approval. Investigators interested in
performing research are primarily responsible for assuring that research protocols
are planned, conducted in an ethical manner, and consistent with standards estab-
lished by the IRB. If the IRB approves the research project, then the investigator is
notified in writing of the approval decision.
