IRB Fact Sheet
What is an IRB (Institutional Review Board)?
Institutional Review Boards
(IRBs) are committees made up of professionals of varying backgrounds
and
specialties, who are put in charge—by their institutions
(eg, hospital, university) and the federal
government—of assuring that human subjects (people
who agree to participate in a research study) research
is conducted in an ethical manner. In their work, IRBs interpret
and apply rules that have been established by
the government. IRBs do three things:
-
They review research proposals
within their domain to make sure that the benefits to the
subjects are
worthwhile, considering the risks involved in agreeing
to take part in the research.
-
They assure that potential human subjects are fully
informed about the proposed study, before they
volunteer to participate.
-
They assure that the privacy of research
subjects is protected. Specifically, they require that
subject information shared with a third party is de-identified (ie,
personal information is removed from the data, so there is no way
for that party to identify the person/subject that the data came
from).
What is Human Subjects
research?
Human subjects research includes all activities that
meet the definition of research and involve human
subjects, as defined in federal regulations. Relevant definitions
include the following:
Research is defined as a systematic investigation,
including research development, testing and evaluation, designed
to develop or contribute to generalizable knowledge.
Human subject
means a living individual about whom a researcher (professional or
student) obtains either (1) data through intervention or interaction
with the individual, or (2) identifiable private information.
Intervention
includes both physical procedures by which data are gathered (for example,
blood drawing) and
manipulations of the subject or the subject's environment that
are performed for research purposes (for
example asking subjects to wear a green shirt on Fridays). It
includes all communication or interpersonal
contact between researcher and subject.
Private information includes
facts about behavior that occurs in a context in which an individual
can
reasonably expect that no observation or recording is taking
place (for example, a physical exam or
interview), and/or data which have been provided for specific
purposes by an individual and which the
individual can reasonably expect will not be made public (for
example, a medical record). In order to qualify
as private, information must be individually identifiable (ie,
the identity of the subject may readily be
ascertained by the investigator or is associated with the information).
Why
is Human Subjects Review so Important?
Whenever research is performed,
the subject is affected. The researcher or evaluator may not be
fully aware
of the potential for any resulting harm. Human subjects research
guidelines have been developed to allow for
needed research while protecting subjects from harm, physical
or otherwise. The Belmont Report (a
document that provides guidance to IRBs regarding human subjects
protections—see link below) states that
research on humans should always follow three ethical
principles: respect for persons, beneficence, and
justice.
-
Respect for persons means that each person must be allowed
to make his or her own decisions about
participation and that those with diminished decision-making
abilities (such as children) must be
protected.
-
Beneficence refers to the responsibility of the researcher
both to do no harm and to maximize
potential benefits for the subject.
-
Justice requires a fair distribution of burden and benefits.
A balance should exist between
research subjects (and their families), researchers
(and their organization), funders and the society
at large in terms of sharing the burden and benefits of research.
What do I need
to do to submit a research proposal to an IRB?
Each IRB is different in its
specific requirements. To conduct human subjects research,
you must arrange
for review of the planned research by a federally approved IRB.
You will need to contact the IRB you will
work with to learn its requirements and get the forms it requires.
Not-for-profit IRBs are generally affiliated with universities
and research centers. They usually confine their
review to projects that involve faculty and staff for whom their
home institution is responsible when they are
engaged in research. ("Engaged" is a technical term
in the government’s regulations, meaning hands-on
in
the conduct of research.) Each institution/IRB
defines who it is responsible for and will not
review research
applications by engaged researchers that fall out of this definition.
(Often, this is confined to employees of
the institution where the IRB resides.) IRBs affiliated
with Universities/ Hospitals located in Chicago are
listed below. You will need to work with your colleagues at one
of these to ascertain if your proposal is
eligible for its IRB to review.
There are also private (ie, for-profit)
IRBs that can be used by organizations that are not affiliated
with
organizations that have IRBs of their own (see list below).
Whatever
IRB you use, you will need to submit the proposal for review
using forms that are specific to that
IRB. (Often, these come from an Office of Sponsored Programs—OSP—or
similarly named entity.) The forms require you to provide details
about type of research, the engaged researchers,
and budget/funding.
Engaged researchers must document their knowledge of human
research ethics and regulations. This
requirement can generally be fulfilled via an online course that
is available from the National Institutes of
Health entitled Human
Participant Protections Education for Research Teams.
Online Resources
US Department of Health and Human Services (DHHS)
- Research with Human Subjects
US Food and Drug Administration (FDA)
US Department of Health & Human Services
(DHHS)—Office for Civil Rights (OCR)
National Institutes of Health (NIH)
US Department of Education (USDE)
Ethical Codes
Organizations & Educational Tutorials
IRB organizations with University/Hospital affiliation in Chicago.
Click here
for a complete list.
- Chicago
Department of Public Health
- North Park University
Chicago
- Chicago Institute Neurosurgery & Neuroresearch
- Northeastern
Illinois University
- Chicago State University
- Northwestern
University
- Children’s Memorial Hospital
- Ounce
of Prevention Fund
- Cook County Bureau of Health Services
- Our
Lady of the Resurrection Medical Center
- DePaul University
- Resurrection
Medical Center
- John H Stroger Hospital Cook County
- Roosevelt
University
- Heartland Alliance for Human Needs & Human
Rights
- Rush
University Medical Center
- Howard Brown Health Center
- St.
Joseph Hospital
- Illinois College of Optometry
- St.
Mary Nazareth Hospital Center
- Illinois DHS, Office of Alcoholism
and Substance Abuse
- Saint
Xavier University
- Illinois Institute of Technology
- Swedish
Covenant Hospital
- Loyola University Chicago
- Thresholds
- Mercy Hospital
and Medical Center
- University of Chicago
- Mount Sinai
Hospital Medical Center of Chicago
- University
of Illinois at Chicago
- National Opinion Research Center
- Weiss
Memorial Hospital
For-Profit IRBs in Illinois
- AJ Medical Devices Inc.
- Fox
Commercial IRB, Ltd.
- Applied Home Telemedicine, LLC
- Habilitative
Systems, Inc.
- Community Mental Health Council, Inc. (CMHC)
- Stoelting
Co.
- Etymotic Research, Inc.
- Western
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