What is an IRB?
An Institutional Review Board (IRB) is an administrative group established
to protect the rights and welfare of human research subjects recruited
to participate in medical research activities. An IRB provides ethical
and safety oversight for medical research.
The federal regulations mandating research oversight by IRBs originally
grew out of ethical and legal lessons learned, in part, from the Nuremberg
Trials following World War II and the Tuskegee Experiment that ended
in 1972. These regulations help to ensure that people participating in
research can do so safety and with full informed consent. They are based
on three key ethical principles:
Respect for Persons: Requires full informed consent
by research participants. Informed consent requires that research participants
have full information on the study's risks and benefits, that researchers
confirm participants fully comprehend those risks and benefits, and that
participation is voluntary. Subjects must be given sufficient information
on which to decide whether or not to participate, including the research
procedures, their purposes, anticipated risks and benefits, alternative
procedures when therapy is involved, and a statement offering the subject
the opportunity to ask questions and to withdraw at any time from the
research.
Beneficence: The principle of beneficence - maximizing
benefit while minimizing risk - requires that researchers protect individual
subjects against risk of harm. All possible harms should be considered,
including physical or psychological pain or injury, social harm, loss
of privacy, and economic harm through loss of job if health information
is publicly disclosed. The societal benefits that might be gained from
the research should also be considered.
Justice: The principle of justice mandates that the
selection of research subjects must be the result of fair selection procedures
and must also result in fair selection outcomes.
All research supported or conducted by federal governmental agencies,
such as the National Institutes of Health (NIH), is required to have
IRB oversight. Medical institutions that receive federal funding are
also required to have such oversight. The IRB has the authority to approve,
require modifications in, or disapprove all aspects of clinical research.
The IRB makes its decisions to approve research independently of the
organization within which it is established.
The Pine Street Foundation has independent IRBs review all of its research
activities, including the recently launched Pine
Street Survival Study. The Pine Street Foundation has also established
an internal IRB, which exists to review research for outside investigators
specifically studying complementary and alternative medicines.
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