Joann Starks: Good afternoon, everyone. I
am Joann Starks of S-E-D-L or SEDL in Austin,
Texas, and I will be moderating today's
webcast on Ethics in Research: A Science
Lifecycle Approach. The webcast is offered
through the Center on Knowledge Translation
for Disability and Rehabilitation Research,
or KTDRR, which is funded by the National
Institute on Disability and Rehabilitation
Research or NIDRR in the US Department of
Education.
I want to thank my colleague Ann Williams,
our webinar administrator, for her logistical
and technical support for today's webcast.
A reminder that we will ask you to complete
a brief evaluation at the end of today's
webcast.  I'll give more instructions
following the presentation. And, since the
slides are small on your screen, it might
be helpful to download a copy of the presentation
file from the KTDRR's website at www.ktdrr.org.
The Center on KTDRR is working with a number
of national and international partners, and
one of those is the Canadian Institutes of
Health Research (CIHR). You are probably aware
of the fact that CIHR, which is the Government
of Canada's health research investment agency,
was the first to define and embrace the term
knowledge translation or KT. We
are partnering with CIHR's Knowledge Translation
Strategy Unit to learn about the innovative
KT strategies they are continuing to develop
and implement.
This webcast on Ethics is part of a series
of four webcasts that also include: "KT 101:
CIHR's KT Initiatives," "KT and Evidence-informed
Policy Making," and "Patient Engagement in
KT."
Ethics in Research: a scientific lifecycle
approach is intended to introduce investigators
to the ethical issues that might arise at
each step in the research life cycle. The
research life cycle is inspired by Ian Graham's
Knowledge to Action or KTA cycle, and
depicts the process of both Knowledge Generation
and Knowledge Translation, as well as the
infinite and iterative feedback between these
two processes. Within this framework, the
junctures for ethical consideration are presented
along the cycle.
By working through vignettes that deal with
everyday situations in the research environment,
participants are encouraged to critically
examine the narratives against this KTA-Ethics
framework in order to reveal some of the ethical
issues and pitfalls of scientific research
that might not be obvious at first glance.
While ethical concerns such as protection
of research subjects, consent, privacy and
data stewardship are well-known to any researcher
who has submitted a project to a research
ethics board (known in the US as Institutional
Review Board or IRB), the focus here is on
the more subtle and perhaps bigger picture
concerns. Moving beyond mere compliance, investigators
are encouraged to think critically about the
ethical challenges and opportunities that
emerge throughout the research lifecycle.
Joining us today from CIHR are Jessica Mankowski
and Jaime Flamenbaum.
Jessica Mankowski is the Acting Manager of
Knowledge Translation Strategy. She has enjoyed
working over the past decade in the knowledge
translation, capacity building and cross-sector
partnership space. At CIHR, Jessica and the
rest of the Knowledge Translation team work
to support the integration of KT in CIHR's
activities and to build capacity in the health
research community. Jessica also has an active
life outside of work with a number of volunteer
activities.
Our major presenter today is Dr. Jaime Flamenbaum,
a bioethicist currently working as senior
ethics advisor at CIHR. He is leading the
ethics education project, among other activities.
His areas of concentration are: ethics of
disrupting technologies; ethics of trials,
and methodology of health sciences. He has
published on ethics of knowledge translation
and the epistemology of medicine.
Jessica, are you ready to begin?
Jessica Mankowski: Yes. Thank you so much
for that kind introduction, Joan n. What I�ll
do first is provide a little bit of background
information on the Canadian Institutes of
Health Research. If you'd like to know more
about CIHR, I would invite you to check out
the KT 101 website or webcast which will produce
more information about CIHR. CIHR was created
in 2000 and is the Government of Canada's
Health Research Investment Agency. Its mission
is to create new scientific knowledge and
to enable its translation into improved health,
more effective health services and products
and a strengthened Canadian health care system.
There are 13 institutes within CIHR and CIHR
provides leadership and support to health
researchers and trainees across Canada. CIHR
uses a definition of knowledge translation
that has two major parts. The first part describes
knowledge translation as the dynamic and iterative
process that includes synthesis, dissemination
exchange and ethically sound application of
knowledge, to improve the health of Canadians,
provide more effective health services and
products and strengthen the health care system.
Today's webcast will focus specifically
on what that ethically sound application means.
The second part of the definition describes
the process that takes place within a complex
system of interactions between researchers
and knowledge users that may vary in intensity,
complexity and level of engagement, depending
on the nature of the research and the findings
as well as the needs of the particular knowledge
user. I will now turn it over to Jamie for
the rest of the presentation.
Jaime Flamenbaum: Good day. As in the introduction,
it was said that through vignettes we try
to give an ethics lens to the process of knowledge
creation and knowledge to action. The vignette
that was chosen for today's presentation
is one that was published by the Journal of
American Medical Association. I choose particularly
this vignette because it echoes a lot of what
we do on a daily basis. What happens was that
a researcher was requested by a relative to
check the prices of hip replacement that she
was in need. This researcher, just as a favor
to the relative, phoned a series of institutions,
asking for the price and asking for the type
of service that was associated with the price.
The researcher concluded in his paper that
the variability of prices was huge across
the United States and the types of services
that were associated with the value was also
very big. This is, we can say, a research
in health. At the same time, it's what we
do normally when we want to buy a car, a fridge
or when we go to the supermarket and check
for groceries. In fact, we do knowledge creation
at every moment and all moments. There is
absolutely no difference between the research
that we have at hand that it is titled Research
because it was published and our day-to-day
lives.
We are going to take this concept, this idea,
this project of checking how much a hip replacement
costs in the United States and try to understand
it through the Knowledge Creation to Action
Cycle published by Dr. Graham. I want to
call the attention for those that know the
cycle that this is not exactly what Dr. Graham
published. What he published is one single
cycle that circles through knowledge creation
and knowledge translation, superposing one
activity on top of the other. Because of the
didactic problems that we have with that,
because I am going to apply an ethics lens,
if I let everything in one single cycle at
the end, all the labels that I am going to
apply would be very confusing and so for a
didactic purpose, I divided it into two cycles:
knowledge creation and knowledge translation.
It has to be understood that this is only
one single process. If we repeat the process
of buying a car, buying a house, buying groceries
or checking the price of a hip replacement,
every time that we have to proceed again and
check a new price, and check a new process,
we are repeating the whole cycle over and
over again, without going into different cycles
or different contexts. Let's start putting
an ethics lens on top of the knowledge creation
to action cycle. The first thing that we really
do is what we intend to do. What type of knowledge
we intend to create, what we are going to
investigate, what are our needs and what questions
we are trying to answer. This is exactly what
is the research agenda. On a more academic
way of putting that, that's the epistemological
lens. That's how we are going to understand
what we are designing, that's what we are
going to frame whatever we are going to ask,
and more importantly, that's what we are
committed to do. We have a mission. We are
people on a mission that is answer a specific
question. Because we have a mission, we have
an ethics commitment to our mission.
When we go into the cycle of knowledge creation,
the first thing that we are going to do is
to establish partnerships. These partnerships
are our colleagues or the spouse that is going
to use the car or who is going to the supermarket
to do the groceries? We are going to put the
groceries, so our partners. Who is going to
use the service? This is the person that we
are doing the research for. In what level
of equity, in what level of equality of power
these individuals are participating with us?
Are we dictating the norms? Are we being the
boss? Are we being the only voice? Or are
we taking everything that what they are saying
and we are dividing with them results and
responsibilities? Dividing with them or not
dividing with them, we are going to formulate
the question. We are going to establish what
are the context, we are going to frame what
is the theory that we are going to use, what
is methodological issues that we are going
to frame exactly at this point. Then we are
going to discuss what are the resources that
we need, what theory we are going to apply.
Of course, when we are talking about buying
a car and checking the prices or hip replacement,
checking the prices or going to the grocery
store, we are using low key methods or anything.
That's very, almost no difference at this
point of framing questions, if we are talking
about designing something in the realm of
synthetic biology or if we are doing epigenetic
research or anything like that. The frame
and the ethics lens is exactly the same. What
change are the methods that we are going to
use. Our mindset continues there. Then of
course, who is going to pay the bill? Who
is going to drive us to the supermarket? Who
is going to pay the phone bill? Who is going
to pay for the reagents, the lab, the secretary
and everything that we need in the context
of doing research? There is a funding that
is needed and what are our obligations to
these funds? Are these funds public and we
have a commitment to the public? Or are these
funds private and we have a commitment to
the private sector?
So after everything is obtained in terms of
obtaining funds and everything else, researchers
in general, and this is not the case of the
project that I am using as an example - will
have if the research involves human or non-human
subjects to submit the protocol to an Animal
Research Board in the case of non-humans or
to an institutional review board in the United
States, in Canada to a Research Ethics Board.
These boards are responsible for the compliance
of the specific research, the research protocol,
to specific guidance documents that are mandated
by law. Normally the compliance is what concerned
most of the researchers when we talk about
the ethics because it's the most visible
part. That's when we discuss about privacy,
rights, protection of the subject, informed
consent. All issues that have to be addressed
because legislation so dictates. This is the
most visible part of ethics and is related
to compliance ethics. We are here talking
about a more broad ethics that it's related
to how we behave in relation to knowledge
creation.
Once researchers receive the approval, or
in our case, once we have everything done
in terms of collecting the data, because data
can only be collected after the approval by
an IRB or REB, then we are going to analyze
the data that we have. In the case of the
supermarket, is this the best price? In the
case of hip replacement, we have to put a
cost-benefit analysis. We have to see what
are the services that are given in exchange
for the price. Is the higher price really
the best service? Is there a cost-benefit
that justifies sometimes three times the difference
of price? Interpretation of data, to be ethical,
it has to be done in the context of who is
collaborating with us. In the case of the
hip replacement, the person that is going
to receive the hip replacement has a voice
on what is the best choice. When we are going
to buy a car, is not only the best price in
the car but who is going to use the car and
for what. In the case of the supermarket,
it's not only the price but the freshness,
the variation, all the products that we have
to buy for a specific recipe that we want
to do on that day. Then we are going to draw
our conclusions. Based on that collaboration,
based on the information that we receive from
the users, we are going to check the implications
to groups, individuals, populations and everybody
that is involved. Note that the potential
for conflict of interest is huge and when
we talk about research of any case, any type,
conflict of interest is always present. Remember
that conflict of interest can be real but
can be perceived and can be implied. In reality,
it's something that we have always to have
in the back of our mind. If we are designing
a research project, if we are saying what
we are going to do automatically we have a
conflict of interest because we have that
objective in mind. We want to get there.
Then we are going to disseminate our data
and publishing the data. Everybody wants to
be front page of New England Journal of Medicine.
When we want to publish something, we want
to be read by everybody. We want to be thought
about when Nobel awards are being handed out.
We want to be famous, rich and happy. That�s
the objective of making our knowledge, our
discovery, our creation, the product of our
imagination and work to be known by everybody.
Not hiding anything. This is the objective
of what I�m doing here. I am trying to be
famous, I�m trying to be known. There is
a conflict of interest. This is the choice
of how I am doing addressing the issue and
presenting what I am doing. This will bring
us back to knowledge creation again. We have
a result. We discovered the hip replacement,
we discovered what is the best for our relative
in the case of the publication but that�s
a limited answer. If we want to go and interact
again in the context of knowledge creation,
we may want to see how does it compare with
other countries and other services. How one
service compares with the other? What is the
long term results of a higher cost with a
lower cost? This is not included on the first
work. This is something that can appear on
the next direction of the same article.
Jessica Mankowski: Jamie, I have a question
for you about the Knowledge Translation Cycle.
So we just looked at knowledge creation and
where within that cycle do you think that
researchers are most often unaware of the
ethical considerations they could be including
in their work?
Jaime Flamenbaum: There is one side as I said
before that researchers are really, really
aware and they are aware of the responsibilities
that they have to the system, to the funders.
They are very compliant and very cognizant
and very conscious about what they have to
do in the context of compliance. There is
no issues related to submitting to institute
review boards, no discussion about what are
the documents that have to be handed to the
institute review board. However, researchers
in general, today they have very little understanding
of the social responsibility of research.
Researchers don't think in terms that they
are on a context where they serve the whole
society. What they are doing is the result
of the investment of society on them through
donations, to building universities, to supporting
hospitals and research institutes and even
the commercial aspect of it, the fact that
society is the client of pharmaceutical industry
but at the same time they are the shareholders
of the pharmaceutical industry. The social
aspect, the ethical issues that are related
to social responsibility of research, the
researchers do not touch it on a more responsive
way.
Jessica Mankowski: Thank you.
Jaime Flamenbaum: Once a new cycle is created
and reiterated, we are going to abandon for
a few minutes the knowledge creation side
of it and we are going to talk about the knowledge
translation part of it. Knowledge translation
relates not only to translation to other researchers
but translation to the end user. In health
sciences, end user is a very problematic word.
Who is the end user? The clinician? The nurse?
The patient? The society? The institutions?
Who is the end user? This is a very fluid
kind of concept and when we talk about translating
knowledge, we have to have all these focus
in mind because we don't know where the
knowledge is going to be used in the end.
We have to have a knowledge translator. We
have someone that is going to put knowledge
out there to be used and to be applied, review
and select that knowledge. Selection of knowledge
does not mean that we are going with a bias,
say what is to be used, what is not to be
used, but make a fair offering of all the
knowledge that it is and comment on the knowledge
the way it is.
One example of this is Cochrane reports. Cochran
reports do exactly that. They review the knowledge
and allow individuals that are using that
knowledge to select according to some standards.
This is related totally to the theory that
is used. What are the biases because we are
really on a world where positive results are
published everywhere. Negative results are
very, very hard to find. What is the access
to the data, intellectual property and other
issues related to that? Then we have to get
the knowledge and adapt to a context. We are
talking in particular about an issue of costs
in hip replacement. That's what the study
was about. If we tend to expand that study
and think that the same thing would apply
to a coronary bypass in the same institutions,
we are going to be adapting knowledge that
is not there. We are going to be making relations
that are not there. We have to respect the
context, we have to respect the knowledge
that we have.
Again, we have to talk about who is the voice,
who is going to use and how this is going
to be used. Access to information. This is
very important when we talk about published
data related to health. We know that if you
don't have a subscription to most of the
journals, you are not going to have access
to the most recent data. This is one of the
reasons of the movement to open access. Because
when we think about United States, Canada,
UK, France, Germany and Sweden, Netherland,
Norway - maybe I am forgetting one, or another
 Japan. I would guess the problem of not
having access to information is very limited.
Those that are professionals and need the
information, they have access to it. However,
other countries in the world and even countries
in Europe, they do not have access to information
even if the individuals are professional.
If they are not directly linked to the university,
they have no access to the latest published
material. You know how this is important and
this is one of the reasons of open access.
It�s not only related to Canada and the
United States, the fact that we already have
enormous mechanisms to not suffer the lack
of information. Access to information and
knowledge translation imply resource allocation.
If you know something but you don't have
the means to use it, to apply it, the knowledge
has no meaning. In the context of our hip
replacement, if an individual has $60,000.00
for a hip replacement and he wants to go to
a $120,000.00 facility, it's not going to
happen. The resources are not there even if
the service is there, is available. The problem
is regarding resources.
Then we have to monitor the knowledge use.
We created the knowledge. We translated the
knowledge. Is it being used and is it being
used in the context and in the purpose? We
have to know that and we do very little in
terms of monitoring the use of the knowledge.
There are not many techniques, there are not
many ways of doing it and fact is, many scientists,
many individuals that are related with the
creation of knowledge are not really worried
about monitoring how this knowledge is going
to be used. Evaluating is getting the results.
Once the knowledge is used, what happens?
Does it really make a difference? What are
the criteria that we are using to measure
differences? Again, we return to the issue
of conflict of interest because we created
the theory, we gave an idea, we have a research
agenda. We want to prove that it makes a difference.
When we evaluate at the end, if we evaluate
at the end, the issue of conflict of interest
has to be very carefully seen.
Sustainability is a very important issue.
It�s the fact that okay, we discover about
hip replacement costs. Is it important to
continue the research and who is going to
continue the research? Where it's going
to be published. What are the other questions
that we want to make about it? To do that,
we have to build capacity on the questions
that we are asking. We have to give a chance
for people to come into these research areas
and increase them. Create robustness in research
is one of the main objectives of the whole
theory that surrounds knowledge creation and
translation. Some people may not think in
that terms, but one of the concerns of ethics
in research is to protect the research endeavor.
Make it credible, make it transparent, make
it clear so that people will believe in what
science is delivering and will invest in science.
When we talk about continuing KT, when we
talk about continuing knowledge creation,
we are talking about a situation where we
justify science and where we make resources
come into the cycle.
Jessica Mankowski: Jamie, if I can, one more
question for you, in the Knowledge Translation
Cycle, when you speak about in Step seven,
the Ethics of Sustainability, how can researchers
support the Ethics of Sustainability when
they are dependent on funding from an external
source?
Jaime Flamenbaum: We have to go out of what
you think in terms of knowledge creation and
even in terms of ethics. The fact is that
researchers should, they have to not
should. They must inform policy. Researchers
have to learn to talk about what they do to
the real stakeholders. Those are individuals
that are in position of command in institutions
and governments and agencies. They have to
teach science. They have to teach science
in a broad way, what it means and what resources
it needs, but also science in its particularities.
Each and every research agenda. That's the
only way of making it more robust is making
sure that policies in our countries are scientifically-based,
evidence-based policy.
Jessica Mankowski: Thank you so much Jamie.
Joann, over to you.
Joann Starks: I want to thank you both very
much for a really interesting presentation
on ethics in the research lifecycle. Jamie,
you really brought that Knowledge to Action
cycle alive! It's really interesting. I
also want to thank everyone for participating
in today's webcast. Let me ask if either
of our presenters has any final words for
the audience today?
Jessica Mankowski: Thank you for joining us
and we hope to learn more about your work.
You can contact Jamie. His contact information
is on Slide nine.
Jaime Flamenbaum: Thank you very much and
hope to hear from you.
Joann Starks: Well thank you. We hope everyone
found today's session to be informative.
As a reminder, the webcast will be archived
on the KTDRR's website at www.ktdrr.org.
We also have a brief online evaluation form
and would appreciate your input about the
webcast. The link is here on the last page
of the presentation file, and everyone who
registered will also get an email with a link
to the evaluation form.
Once again, a big thank you to our presenters,
Jessica Mankowski and Jaime Flamenbaum, from
the staff at the Center on KTDRR. We also
appreciate the support from NIDRR to carry
out the webcast and other Center activities.
On this final note, I will conclude today's
webcast and invite you to participate in the
others from this series.
