IRB

3. What is an IRB and it's purpose?

An Institutional Review Board (IRB) is charged with protecting the rights and we
lfare of people involved in research.
The IRB reviews plans for research involving human subjects. Institutions that
accept research funding from the federal
government must have an IRB to review all research involving human subjects (eve
n if a given research project does not involve federal funds).
The Food and Drug Administration and the Office for Human Research Protections (
OHRP) (part of the National Institutes of Health)
set the guidelines and regulations governing human subjects research and IRBs.
The definition of research involving human subjects is broad. The IRB must revi
ew research that involves the following areas, among others:
Medical and administrative record data.
Research that uses leftover tissues.
Health services research.
Survey research.
Behavioral research.
Biomedical and other clinical research.
Purpose of the Instituional Review Board
The New Hanover Regional Medical Center (NHRMC) Institutional Review Board (IRB)
is stablished under the authority of the Food and Drug
Administration for the purpose of protecting the rights and welfare of human res
earch subjects recruited to participate in research activities
conducted under the auspices of NHRMC. The IRB is intended to protect the rights
and welfare of subjects by reviewing clinical investigations
regulated by the FDA under sections 505, 507, and 520 of the Federal Food, Drug
and Cosmetic Act. In addition, the IRB will review all clinical
investigations that support applications for research or marketing permits for p
roducts regulated by the FDA, including food and color additives,
drugs for human use, medical devices for human use, biological products for huma
n use and electronic products.
Why Does an IRB Review and Approve Research?
Review of research involving human subjects is required by federal law. Federal
laws and regulations regarding research on human subjects have
specific requirements for IRB and study administration.
The federal requirement for review of research by human subjects committee stems
directly from previously conducted unethical research experiences
like the Tuskegee Study. The Tuskegee Study was a federally funded study. In i
t, a large number of poor African-American men with syphilis were
studied for several decades to determine the natural history of untreated syphil
is. The diagnosis of syphilis was made before treatments for syphilis
were available. But the men were not offered treatment with penicillin even aft
er it became available. Worse, the men were not told they were subjects
in a research study. Many men in the study died of the complications of syphili
s.
When this breach of ethics became publicly known in the middle of the 1970s, the
federal government decided to put in place legal requirements for
an external process for review and approval of research done using federal funds
. The federal government also decided to require that all institutions

accepting federal research funds review all research done in that institution by
the same procedures.
Responsibilities Of The Institutional Review Board
The NHRMC IRB operates under the principles of The Belmont Report. The Belmont R
eport exists because of the unfortunate history of unethical research
conducted on human subjects. It clearly explains the three principals that are t
he main tools that all IRB members should use to evaluate the ethics of
specific research proposals. Respect for Persons is the first principle which ma
ndates that subjects voluntarily consent to participate in research,
that they are adequately and thoroughly informed about the research and what is
required, and that their privacy and confidentiality are protected.
Beneficence is the second principle which mandates the risks of research are jus
tified by potential benefits to the individual or society and that those
risks are minimized. Justice is the third and final principle which mandates the
equitable distribution of risks and benefits among those who may benefit
from the research, meaning that one subset of a population should not take on al
l the burden of risk and reap all of the rewards; risks and rewards should
be applicable and available to all subsets of a community.