Institutional Review Board Overview
The cornerstone of protection for human research participants
is an independent Institutional Review Board (IRB). The purpose of the IRB
is to review research activities at an institution with the focus of protecting
the rights and welfare of human subjects recruited to participate in those
research activities. The IRB is authorized to approve, require changes, or
disapprove all research activities that it reviews. Officials at an institution
may disapprove a project that has been approved by an IRB, however, they may
not approve research that has been disapproved by the IRB.
Institutions may have their own IRB, may use the IRB of a cooperating agency,
or may use a commercial IRB. In some cases more than one IRB may exist at
an organization, based on the amount and variety of research. Often separate
IRBs review clinical/biomedical research, and social/behavioral research.
Specific areas of concern to the IRB are informed consent, measuring the risks
and benefits of the proposed research, and recruitment of subjects for research.
These are described in the introduction of the HSS' IRB Guidebook:
First, subjects must be given sufficient
information on which to decide whether or not to participate, including the
research procedures, their purposes, risks and anticipated benefits, alternative
procedures (where therapy is involved), and a statement offering the subject
the opportunity to ask questions and to withdraw at any time from the research.
Second, subjects must be able to comprehend the information that is given
to them. The presentation of information must be adapted to the subject's
capacity to understand it. Finally, consent to participate must be voluntarily
given. The conditions under which an agreement to participate is made must
be free from coercion and undue influence. IRBs should be especially sensitive
to these factors when particularly vulnerable subjects are involved.
Closely related to the principle of beneficence (maximizing anticipated benefits
and minimizing possible risks of harm), risk/benefit assessments "are
concerned with the probabilities and magnitudes of possible harms and anticipated
benefits."
With respect to their status as individuals, subjects should not be selected
either because they are favored by the researcher or because they are held
in disdain (e.g., involving "undesirable" persons in risky research).
From the Introduction to the IRB Guidebook available on the OHRP Website.
Most
recent revision: January 23, 2008 |
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