First edition of Ethics Matters@Waterloo
It is our pleasure to present, Ethics Matters@Waterloo, the first research ethics newsletter. Please share this newsletter with members of your research teams. We appreciate your feedback. Comments or suggestions can be sent to ohrac@uwaterloo.ca
In this issue
- A message from the ethics committees
- What's new?
- Compliance reminders
- Website refresh
- Office of Research Ethics statistics
- Research Ethics committees
- Responsible conduct of research training available
A message from the ethics committees
It's been a very busy year! Here are a few highlights:
- 2,916 files were reviewed in 2012, up from 2,181 in 2006 (a 34% increase).
- Requests for ethics clearance of modifications have increased substantially - 72% since 2006.
- Since 2006, 97% of new applications (on average) have been reviewed through a delegation process and 3% go to full committee.
- New applications reviewed in 2011 - 2012 represented $6.6 million in annual animal research funding and $16.5 million in annual human research funding.
- The complexity of research ethics applications has increased since 2006 to include clinical trials, multi-site sponsored research involving new technologies and new privacy and consent issues. The increased complexity may be due to innovative procedures and equipment and an increase in multi-jurisdictional applications.
Changes to key personnel during the last year include:
- Dr. Maureen Nummelin was appointed Director, Office of Research Ethics (ORE), in June 2012, replacing Dr. Susan Sykes.
- Dr. Jonathan Fugelsang succeeded Dr. Richard Staines as Chair of the Human Research Ethics Committee (HREC) in November 2012. Membership on the Clinical Research Ethics Committee (CREC) expanded to include Dr. Richard Staines to represent Kinesiology in November 2012
- Dr. Russell Tupling succeeded Dr. Niels Bols in January 2012 as Chair of the Animal Care Committee (ACC).
- Dr. Andrea Edginton, will succeed Dr. John Flanagan as Chair of CREC, effective September 2013. Dr. Flanagan was the inaugural Chair of CREC and played a key role in its start up activities. We thank him for his significant contributions and unflagging commitment to ethical research.
The responsibility of these three committees, together with the ORE, is to ensure any research conducted by university faculty, students, and staff involving humans and/or animals complies with an ever-changing roster of national and international guidelines and statutes. This compliance oversight is required to ensure that Waterloo researchers continue to receive Tri-council funding and ensure that all research on humans and animals is conducted according to the highest ethical standards.
In 2013, the three committees and the ORE will continue to work toward:
- streamlining processes
- clarifying compliance obligations
- ensuring that ethical review is focused on areas of real risk
- improving researchers' familiarity with the Responsible Conduct of Research obligations, and
- developing a method to allow for broader and more pro-active input into ethics review policy and guideline development.
We look forward to working together with you to help you meet all of your compliance obligations.
What's New?
Several
new
initiatives
have
been
launched
to
continue
the
university’s
ongoing
efforts
to
streamline
the
ethical
review
process
and
address
common concerns
heard
from
researchers.
They
include:
Reduced
paper
Researchers
no
longer
need
to
submit
two
copies
(or
up
to
16
for
committee
review)
of
their
ethics
application.
Effective
July
2012,
one
signed
hard
copy
will
suffice.
Reduced
review
cycle
time
The
ORE
continues
to
develop
guidelines
to
help
researchers
better
interpret
various
agency,
legislative,
and
governmental
requirements,
as
well
as
providing
hyperlink
explanations
within
the
applications
to
reduce
iterations.
By
helping
researchers
understand
the
ethical
issues
associated
with
various
protocols,
we
expect
the
cycle
time
will
be
compressed.
We
continue
to
review
feedback
to
ensure
it
focuses
on
ethical
issues
rather
than
editorial
comments
or
minor
items.
Guidelines
to
clarify
requirements
For
many
researchers,
the
ethical
review
process
can
feel
like
a
"black
box."
However,
there
are
fairly
predictable
issues
which
ethics
review
committees
are
mandated
to
look
for
depending
on
the
type
of
human
research.
In
an
effort
to
improve
transparency
and
speed
up
the
ethics
review
process,
the
ORE/HREC/CREC
have
developed
a
series
of
guidelines
in
order
to
identify
common
ethical
issues
and
provide
possible
solutions:
- What Requires Ethical Review? (Coming soon!)
- How Do I Ensure Data Security and Confidentiality?
- What Special Issues Exist When I Use Equipment to Collect Biomedical Data?
- What Do I Need to Consider When Establishing a Biobank or Biorepository?
- How Can I Use Crowdsourcing to Recruit Participants?
- Are There Special Considerations When Conducting Off Campus Research?
- What Are the Special Ethical Considerations When Reviewing Course or Honour's Projects?
- Can I Conduct Research in Classes Using Students as Participants?
- How can I Use Partial Disclosure and Deception in Research?
- How Can I Ensure I Comply With Ontario's Controlled Acts Legislation?
- What Research is Conducted Under the Auspices of Waterloo?
Opportunity
for
harmonized
review
with
Wilfrid
Laurier
University
The ORE
is
working
jointly
with
the
Research
Ethics
Board
(REB)
at
Wilfrid
Laurier
University
(WLU)
on
a
pilot
project
for
simultaneous
review
of
collaborative
research.
Once
complete,
it’s
expected
this
agreement
may
be
used
as
a
model
to
negotiate
agreements
with
other
institutions.
Project
Management
Assistance
for
Clinical
Trials
To
help
streamline
the
time-consuming
administrative
project
management
issues
that
researchers
face,
a
Multi-site
Clinical
Trial
Agreement
has
been
created that
can
be
used
for
clinical
trials
when
the
University
of
Waterloo
is
the
sponsor.
As
of
July
2013,
the
CITI
Canada standard
operating
procedures are
available
for biomedical
and
clinical
researchers to
incorporate
directly
into
their
protocols.
These
are available
to
Waterloo
researchers
upon
specific
request.
These
generic
SOPs cover
common
clinical
trial
requirements
(e.g.,
data
management)
and
have
been
approved
"as
is"
by
Health
Canada.
Good
Clinical
Practice
Training
Researchers
required
to
complete
Good
Clinical
Practice
Training
as
part
of
clinical
trial
research
are
now
able
to
do
so
through
the
university.
Effective
July
2013,
CITI
Canada
provides
this
training
so
Waterloo
researchers
can
demonstrate
competency.
CITI
Canada
training
will
be accessed
through
the
ORE
website
and
includes:
- Good Clinical Practice
- Responsible Conduct of Research (RCR)
- Biomedical Research Ethics
- Social and Behavioral Research
- Transportation of Dangerous Goods TDG/IATA
Information about how to register can be found on the ORE website.
Compliance reminders
-
Have
you
taken
CORE
(the
Course
on
Research
Ethics)?
The
tutorial
outlines
the
second
edition
of
the
Tri-Council
Policy
Statement
on
the
Ethical
Conduct
for
Research
involving
humans
(TCPS2).This
tutorial
is
a
newer
version
than
the
tutorial
released
in
2010
and
is
mandatory
for
all
University
of
Waterloo
researchers.
-
Researchers
at
all
institutions
who
receive
tri-agency
funding
will
be
required
to
implement
the
Tri-Agency
Framework:
Responsible
Conduct
of
Research.
A
Tri-agency online
tutorial
is
expected
in
the
fall,
however,
an
online
tutorial
is
currently
available
through
CITI
Canada.
-
If you’re
conducting
clinical
research,
you’ll
need
to
be
aware
of
(and should
read
about):
- Canada’s Strategy for Patient-Oriented Research which outlines a vision and 10-year plan to improve health outcomes of Canadians and enhance patient care through research.
- Good Clinical Practice, a set of standards implemented internationally and focused on the ethical and scientific quality of the design, conduct, recording, and reporting of clinical trials that involve humans.
- Clinical Trials Ontario is a new organization that has been established through the Ministry of Research and Innovation to provide a streamlined approach to conducting multi-centre clinical trials while ensuring the highest ethical standards for patient safety.
Website refresh
Our website is undergoing a refresh. Watch its progress on the Office of Research Ethics (ORE) site.
Office of Research Ethics Statistics
In 2012, 2916 research ethics applications and event forms were submitted. Of all new applications, 3% were reviewed by a Research Ethics Committee.
Over a third of new human ethics applications in 2012 were from the Faculty or Arts, predominantly from the department of Psychology. Applied Health Sciences (AHS) was second with 170 followed by Environment with 138.
61% of new human applications in 2012 were for faculty, PhD, or postdoctoral projects.
Research Ethics Committees
Human Research Ethics Committee (HREC)
The Human Research Ethics Committee (HREC) reviews applications that involve sensitive or invasive procedures and/or populations that could be considered vulnerable or potentially vulnerable in relation to the research question.
The committee consists of representatives across four faculties including Arts, AHS, Environment, and Mathematics. Their expertise includes qualitative research, statistics, clinical psychology, law, and medicine. There are two community representatives and two student representatives as well as ORE representation.
Clinical Research Ethics Committee (CREC)
This committee reviews applications involving drugs, natural health products, or medical devices, clinical trials, and/or procedures involving controlled acts (e.g., blood draws, ultrasound, etc.)
The CREC consists of representatives from two faculties - AHS and Science. Committee expertise includes medicine, law, ethics, and neuroscience. There is one community representative as well as ORE representation.
Animal Care Committee (ACC)
The ACC consists of representatives from AHS, Mathematics, and Science. Committee expertise includes a veterinarian, animal health technicians, a graduate student, and two community members as well as ORE representation.
Responsible conduct of research training available
Do you supervise graduate students with whom you collaborate on research projects? Do you want to be able to demonstrate you've been "duly diligent" if a member of your research team is found to have committed research misconduct?
If so, you may wish to have members of your research team complete the new free, online training on "Responsible Conduct of Research." We think this training is particularly valuable for those who are new to research.
If you have feedback, comments, or topics for future issues, we would like to hear from you at ohrac@uwaterloo.ca.
Copyright
©
2013
University
of
Waterloo
-
Office
of
Research
Ethics,
All
rights
reserved.