Dr. R. Kirk Jonas
Chair, Institutional Review Board
Ms. Carolyn Strong, CIM,CRA
rjonas@richmond.edu
strongcd@jmu.edu
University of Richmond
Research Compliance Coordinator
James Madison University
October 12, 2012
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Clearly establishing areas of responsibility.
Getting the academic community to know that the
IRB exists and has an important role.
Ensuring that the research community understands
what human subjects research is
Educating the community on subject protection.
Developing a service-oriented board.
Launching a website as de facto SOP.
Developing an FWA (with the Common Rule).
Records Management.
Champions and advocates.
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Establish who will do what.
◦ Who is going to do the work? (receive and
distribute proposals; schedule meetings; prepare
notices of action; prepare/maintain website and
SOP, maintain files, etc.)
◦ Who is going to make decisions? (on expedited
reviews, exemptions, training, policies, etc.)
◦ Who is the ultimate authority? The higher the
better, e.g. the University President as the IRB
Signatory Authority for an FWA.
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The President is the Signatory
authority
The Chair and the IRB
Administrator are the same
person (Jonas, one 30 hour
person; used to have an
assistant)
PI’s rarely attend meetings;
the Chair clarifies issues on
behalf of the PI; invite PI’s
where necessary
Subcommittees used to
review some conditions of
approval
University of Richmond
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The Interim Provost and
Vice-President for
Academic Affairs is the
Signatory Authority
For administration: one
full-time person (Carolyn),
two part-time persons, and
one student
Chair is a faculty member
doing service
Every PI is invited and
strongly encouraged to
attend
James Madison
University
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Chair makes the
exempt determination
and handles the
administration on it as
well.
Workflow varies a great
deal
There is no backup
Use of downtime
University of Richmond
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Staff processes
exemptions and sends
to Chair
Workflow varies a great
deal
Administrator has a
backup
Use of downtime
James Madison
University
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Ensure that academic leaders understand the role
of an IRB
Tell faculty and student groups about IRB; discuss
one on one with key persons
Lay out benefits of an IRB: protection of subjects,
best practice, education, etc.
Lay out the risks of human subject research:
subject harm, harm to researchers, inappropriate
distribution of information, institutional damage,
etc.
Ensure that university community understands the
authority of the IRB; that the IRB has the “final say”
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Human subject research is generally research
involving living human beings, including collection
of information about people.
Two major categories of human subject research
are biomedical research and behavioral/social
science research.
Most human subject research at smaller colleges
and universities falls under the category of
behavioral/ social science research, often from the
collection of information from and about
individuals through the use of surveys and
interviews.
Students do research and can publish “globally.”
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Since 2009,UR has
had 2,400 users
Since 2012, JMU
has had over 4,500
users
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Enroll in CITI or develop shortcuts to free
educational programs for researchers.
◦ (CITI is about $2,500 per year and provides
training in many areas, such as RCR, Conflict of
Interest, etc.)
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National Institutes of Health (NIH) offers a
free training module
Develop in-house training for faculty
groups, research classes, and others.
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While the IRB necessarily exercises
compliance and regulatory functions, it can
also serve the university community and its
researchers.
Develop protocols and templates to help
guide researchers through the process.
Invite researchers to board meetings for
complex proposals.
Build capital for when the board needs to
firmly enforce regulations and procedures.
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The IRB has the authority to:
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Approve
Require modifications prior to approval
Table
Disapprove all research activities including
proposed changes in previously approved human
subject research
The IRB’s decision is FINAL.
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Establishing an IRB is an iterative activity.
A website can serve as a “test site” for
procedures while an SOP is being developed.
A website can provide temporary
documentation of institution-specific IRB
policies.
FAQs can be used later as part of an SOP.
Use OHRP and other links, but try to provide
plain language to explain their relevance.
The final policy guide must be OHRP compliant.
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http://irb.richmond.edu/
http://www.jmu.edu/sponspr
og/irb/irbmission.html
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IRB Overview
Submitting Proposals
Research Training
Requirements
Policies and Resources
Contact
FAQ’s
Submit a Proposal
IRB News
University of Richmond
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IRB Mission Statement
Protocol Submission
Procedure
Training
Policy
FAQ’s
Forms
IRB Committee &
Meeting Schedule
IRB Feedback
James Madison
University
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Developing an Federalwide Assurance agreement is a
good way to provide an IRB with needed legitimacy and
authority. (Registering an IRB and obtaining an FWA are
related but separate processes.)
The FWA Signatory Official should be a very high
ranking person. At UR it is the University President.
The IRB Chair reports directly to the Provost.
At some point an institution will likely want to apply the
Common Rule to all research involving human subjects.
The UR IRB Chair and IRB administrator are the same
person.
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As a recipient of federal funds for research, JMU is
required to have an IRB that meets federal
requirements to review research protocols involving
human subjects and to evaluate both risk and
protection against risk for those subjects.
JMU is required to register with the Federal Office of
Human Research Protections (OHRP) through a
process called Federal Wide Assurance.
In this Assurance, JMU is given the option to
designate whether the University and the IRB will
follow federal regulations for only federally funded
research or for all research.
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IRB activity generates records that must be
maintained for at least three years after the
completion of the research, IAW §46.115
IRB records.
Records may be maintained in electronic
form.
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Developing a system for maintaining
records is key.
◦ Keep it simple: PI Name, Research Title, Date of
Submission, Date of Action
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Keep in mind records that may have other
retention requirements (i.e. grant funded
research)
Weed records that you are no longer
required to maintain.
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IRBs must make decisions.
Decisions can result in unhappy people.
Develop champions and advocates of the
IRB.
◦ IRB members (establish regular meetings; provide
lunch if possible)
◦ Research-active faculty members
◦ Administrators who will support the function.
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Meet regularly with champions and
advocates.
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Researchers don’t want their research
activities to harm subjects.
The university doesn’t want research by
members of the university community to
harm subjects.
A determination by the IRB does not free a
researcher of responsibility. The
researchers – whether faculty, staff
members, or students – must know that
they retain primary responsibility for the
protection of subjects.
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