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What Cooperative Extension Professionals Need to Know
About Institutional Review Boards
Dan Weigel
Area Extension Specialist/Professor
Reno, Nevada
weigeld@unce.unr.edu
Randy Brown
Area Extension Specialist/Associate Professor
Las Vegas, Nevada
brownr@unce.unr.edu
Sally Martin
State Specialist/Professor
University of Nevada, Reno
Human Development and Family Studies
Reno, Nevada
smartin@unr.nevada.edu
University of Nevada Cooperative Extension
Have you ever struggled writing a proposal to your university's Institutional
Review Board (IRB)? If so, you are not alone. Increasingly, Cooperative
Extension professionals are expected to collect, present, or publish
data about community needs, programming effectiveness, and applied research
projects. Often, Extension professionals are gathering information from
or about people, and such research or evaluation projects must be approved
by a university's IRB.
While some Extension professionals may have considerable experience
with IRBs, others may lack understanding or struggle with particular
issues that are involved in the IRB process. This article is the first
in a four-part series designed to help Extension professionals better
understand the purpose and procedures of Institutional Review Boards
(IRBs). We hope to ease the confusion and frustration that can sometimes
accompany the IRB process.
What Is an IRB?
An IRB is a review committee established to help protect the rights
and welfare of human research subjects. The basic purpose of the IRB
is to provide oversight to research that involves collecting data and
information from or about people. The information might involve input
from community members, ranchers and farmers, 4-H'ers, seniors, and so
forth. Basically, the IRB is there to help ensure that when university-affiliated
personnel work with people and collect information from them, it is conducted
in an ethical way.
IRBs are federally mandated committees. Federal regulations specify
that institutions that engage in research, such as universities, must
establish IRBs to oversee research involving human subjects. IRBs are
composed of members from various colleges on campus as well as community
members whose expertise is valuable in the review process. In some cases,
Cooperative Extension personnel serve on the committees. The authors,
who are Extension professionals, have a combined 19 years of experience
serving on IRBs.
How Cooperative Extension and IRBs Interact
Cooperative Extension is part of a university system and therefore falls
under the same research policies and guidelines as other university units.
Typically, if an Extension professional intends to publish or present
the information gathered in the form of journal articles, trade articles,
bulletins, fact sheets, workshops, or presentations, the project should
first be approved by the IRB at the professional's institution. Information
collected with no intent to publish it and used merely to evaluate the
effectiveness of a program is usually not required to be reviewed by
an IRB.
Benefits of Working with IRBs
Despite what can sometime appear as an aggravation, there are advantages
to working with IRBs.
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Typically, going through the IRB process makes for a better project.
An Extension professional can take advantage of the expertise of
a wide variety of researchers who might provide important and useful
suggestions that will improve the quality of information collected.
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Working with an IRB can provide a researcher with confirmation that
he or she is treating participants ethically and responsibly.
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Going through the IRB process also protects the researcher. Having
obtained IRB approval means that the university approves the project.
In case something unforeseen and/or dangerous happens during a project,
as long as the research was proceeding ethically and following the
approved procedures, the IRB and university are responsible rather
than the individual researcher.
What Is Needed to Apply for IRB Approval?
Although IRBs develop their own application forms, there are key elements
common to all committees. It is important to keep in mind that the primary
focus of the IRB review is the protection of human subjects, not the
rigor of the research design, per se. Applications should address the
following elements.
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A brief summary of the rationale or purpose of the research.
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A plan for how participants will be recruited that is not coercive
and that provides participants with enough information to make an
informed and voluntary choice.
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A plan for obtaining informed consent (or assent from minors or
decisionally impaired individuals) from participants before they
agree to become involved in a project.
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A detailed plan for how data is going to be collected, stored, and
analyzed.
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If the research involves an individual participating in a program,
intervention, or some kind of activity that is being evaluated, a
description of the activity.
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An identification and analysis of the risks to people participating
in the research project and of ways that the risks will be minimized.
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An identification of benefits for participants, if any, and for
the field in general.
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An indication of what safeguards are in place to minimize potential
risks and protect people's privacy and confidentiality.
How Can You Help the Process Go Smoothly?
Based on the authors' experiences both serving on IRBs and shepherding
proposals through the process, some steps can help the process go more
smoothly.
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Find out about the specific guidelines and policies of your university's
IRB. IRBs are mandated to have specific policies in place, and most
often these guidelines can be found on IRBs informational Web pages.
Following these guidelines in preparing your protocol can save you
headaches down the road.
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Talk to people who are currently on the committee or recently have
served on it. They should be able to give you some tips on writing
your proposal and on potential red flags to avoid.
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Talk to IRB staff about questions before sending in your final protocol.
Be up front and honest about questions or delicate issues. They usually
prefer this, and their suggestions can save you considerable time
and effort.
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Have someone familiar with the process review your proposal. Another
set of eyes can often spot things you might have missed or areas
that might need more clarification.
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Examine successful protocols, especially those from Cooperative
Extension or applied projects. Ask the IRB staff if they have good
examples; many have example protocols posted on their Web pages.
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Several IRBs have developed Web-based training courses on writing
protocols and conducting ethical research. Completion of these courses
has become a requirement at many institutions before someone can
have a protocol approved.
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Make sure your protocol has addressed all of the necessary elements
specified in the IRB guidelines. Many applications are returned because
of insufficient information and detail.
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Do not assume that members of the IRB understand Extension or community
education or the terminology common to your field. Be sure to use
descriptive language that someone with no previous knowledge of your
work can understand.
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If you intend to evaluate a program, clearly separate the program
from the research/evaluation component. If people can participate
in the program without volunteering for the evaluation component,
clearly explain this option.
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Plan ahead, and be patient. After the initial review, the IRB often
asks for clarification or requests that you make changes in your
protocol that must be submitted before final approval. Many committees
only meet once or twice a month, so be sure to give yourself enough
time to obtain approval before you intend to start collecting data.
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Remember that obtaining IRB approval is a learning process. Each
time you go through the IRB process you will be better prepared for
the next time.
We hope that this article provides some background and explanation about
the IRB process. Future articles in this series will address in greater
detail: recruiting participants and vulnerable audiences, addressing
risks and benefits, and handling informed consent and confidentiality.
This article is online at http://www.joe.org/joe/2004august/tt1.shtml.
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