Transcript webinar-9-5-17-health-and-medical-short-bites

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Webinar: Health and medical short bites #1
Funders and publishers
9 May 2017
Video & slides available from ANDS website
START OF TRANSCRIPT
Kate LeMay: Welcome to our webinar. This is the first in a series of three webinars
hosted by ANDS. My name's Kate LeMay and I work in the Canberra
office of ANDS. I have a history that I was a pharmacist. Then I
worked in medical research, and now I'm at ANDS as a senior
research data specialist. I work with our programs and information
services, where we are dealing with sensitive data and, in particular,
health and medical data.
As I said, this is our first webinar in the series that we're going to be
speaking about funders and publishers in relation to the publication of
health and medical data. Our second webinar is next week, about
storing and publishing health and medical data. The third webinar is
the week after, on 23 May, about ethics, legal issues and data
sharing.
I just wanted to quickly introduce a few concepts to everyone about
ANDS because some people - this might be the first time that you've
come into contact with us. We're an NCRIS facility funded by the
Federal Government. We work to make Australia's research data
assets more valuable for researchers, research institutions and the
nation.

transcript-webinar-9-5-17-health-and-medical-short-bites-170512041624 Page 2 of 12
Just as a bit of a background to why we're talking about sharing health
and medical data, firstly, the Productivity Commission has put out a
report, that just was released yesterday, about data availability and
use. It's a very long report. That’s got the potential to change the data
sharing landscape within Australia.
In addition, there are several international medical research funding
bodies that have got policies about data that is from research funded
by them being required to be shared. There's a lot of researchers
within Australia who are working on collaborative grants with people
from overseas from these funders who are already coming into
contact with these policies where they're needing to share the data
that comes out of these projects.
There's also quite a few journals, both internationally and in Australia,
that are either thinking about or implementing policies around
requiring statements of data availability or for data behind the findings
from that paper to be made available.
The last thing that I would like to point out to you before I hand over to
our speakers is that ANDS has quite a suite of resources for medical
and health data. This is one of the - this slide is one of the handouts
that’s in - go to webinar, so feel free to download it and have a look.
It's basically pointing you to our sensitive data home page where you
can go and explore all of these resources that are related to medical
and health data.
Now I'd like to introduce our three speakers. Firstly, Wee-Ming Boon is
a senior research scientist in the research translation and policy
branch of NHMRC. He provides scientific and policy advice with
NHMRC's strategic projects and peer review. Previous to that he was
a research director at the Heart Foundation and a research fellow at
Monash and the Florey Institute.
Wee-Ming also has Jeremy Kenner in the room with him, who will be
speaking a little bit after Wee-Ming. He's the expert advisor for ethics
at the NHMRC's evidence, advice and governance branch. At

NHMRC he's responsible for and contributes to a broad range of
programs and projects related to health and research ethics, clinical
trials and governance of research, and provides advice internally and
externally on these matters. In his earlier career in the United States
he worked as a teacher, practised law and conducted public education
and research in bioethics. Wee-Ming and Jeremy are both in
Melbourne.
We've also got Peter D'Onghia, also in Melbourne, who's a senior
journal publishing manager at Wiley. He's worked at Wiley for over 10
years in the research team on Health Science and Life Science
journals. He's worked in publishing for over 20 years for various
publishing companies in Australia and the Middle East, such as
Lonely Planet, Explorer Publishing and The Age.
I'm going to hand over to Wee-Ming now. Wee-Ming is going to speak
about the NHMRC's statement on data sharing.
Wee-Ming Boon: Thanks Kate, and thanks to ANDS for the invitation. As you know,
NHMRC is a supporter of open access in general and has an open
access policy for research, supported by NHMRC since 2012. The
original open access policy mandates that all publications are to be
made openly accessible within 12 months of publication.
In recognising that data management and data sharing is a major
benefit to researchers and the community in general, NHMRC has
released a statement encouraging data sharing in 2014. It doesn’t
actually mandate data sharing, but rather encouraged it, the sharing.
That’s because the data field is evolving very quickly, while the field is
maturing, and it's also for other aspects of data to actually catch up
first. These can be ethics, privacy, technical and quality issues, that
faces everything that is data related; not to mention the actual skill
and knowledge that is required to think through the whole process of
data sharing as well.
If you looked at the NHMRC data sharing statement, it actually talks
about the use of life cycle thinking when it comes to data. Life cycle

thinking basically means that data management should be thought
about, even at the planning stages of the project, and not just at the
end as an afterthought; so thinking about how data is actually
managed from the outset more and ensure that the quality of the data
is high and the security and accessibility of the data is managed well
and the life of the data is managed and made available forever.
I'm sure many of us have come across a situation where we get to the
- where we needed to go back to some data from years ago and the
data is stuck in the lab or garage somewhere, or in a floppy disk with
no easy way to access it. I know I've been there, at the end of that
cycle you see there, and not being able to find data at the last minute.
That’s what we're trying to avoid at the same time.
The data sharing statement is aligned with overall Government
strategy of data sharing. As Kate has mentioned, the Productivity
Commission just released a report yesterday. We are totally aligned
with things that has come from Government as well. All in all, sharing
of data is about maximising the benefits from data derived from quite
a limited pool of resource and minimising wastage.
It's also about considering the community and ethical aspects of the
data sharing. I mean as the collectors of data we have the ethical
responsibility to ensure that data is used properly and not wasted. It is
basically to make the best use of resources coming from public funds
and a moral obligation by way of being ethical in the research
behaviour that we have.
Leading on from this, it's worth noting that the challenges faced by
NHMRC and health and medical research in general is quite different
from, say, sharing data in astronomy, engineering and music. The
challenges include privacy of individuals and patients when dealing
with health records, genetic information, overall health information.
Other tricky sections include sharing of clinical trials data and, in
particular, non-aggregated data. These are some of the things that we
often need to think about when coming up with policies at NHMRC.

Now I'll pass you on to my colleague, Jeremy Kenner, who will talk to
you a bit further about this.
Jeremy Kenner: Good afternoon. The NHMRC is - as the peak body - well, the expert
advisor body - in Australia for research ethics and research
competence issues under the code of conduct, which we're not going
to be discussing today explicitly. We produce guidelines. The most
significant one that we produce for research ethics is something called
the National Statement on Ethical Conduct in Human Research.
This document - which has been in existence in one iteration or the
other since 1999, and was preceded by earlier statements - is a bit
unusual on a global stage because it is much shorter and much more
succinct and much more principles based than some of the other
documents, for example, in the United States or Canada, which are
much longer and more detailed.
It's a document that mixes high level guidance with some prescriptive
guidance and some recommendations for best practice. There are
sections of the document - five of them - that cover the various things
that are listed on the slide: the key principles, the main issues of
consent and risk, special considerations for different categories of
research into the populations involved in the research, and then the
establishment operation of [HRECs] and institutional and research
responsibilities.
This document applies to all human research but, importantly, it
applies only to research, and only to that research which involves
human beings or their bio-specimens or data. Other documents cover,
for example, animal research and activities that are not research, but
sometimes have similar ethical issues, such as quality assurance
activities, audit, evaluation et cetera.
This document's undergone a full review between 2004 and 2006
yielding a document in 2007 that is the current document, although it's
been amended in various ways since then. It's now undergoing an
ongoing review, and we are addressing, first, one of the - this section

that deals with the various categories of research. Additional sections
will be reviewed in accordance with priorities that have been set by
virtue of consultation with users of the document.
Regarding data, the guidance in the national statement really attempts
to achieve two core objectives. The first is for researchers to
understand and minimise the risk of the unauthorised use or
disclosure of sensitive personal information that they’ve obtained for
these in research, so it's an awareness raising activity.
The second is to ensure the appropriate collection, use and sharing of
data or information so as to maximise the ethical use of the data and
information in research. This presupposes that it is, in fact, ethically
appropriate to share data to the extent that it's ethically appropriate
and in ways that are appropriate.
In order to do this, in order to achieve these objectives, you need
some principles to guide the consideration of the ethical implications
of the specific research project, and you also need some suggestions
for resolution of the tensions between these two core objectives. That
is, to minimise the risk and to maximise the use.
The necessary framework for the principles - including what is
phrased in must language and in should language - is part of the
national statement. It also includes prompts for consideration by
reviewers regarding whether the proposed mechanisms or processes
that they wish to use to address and mitigate the risks are -
adequately protect participants and are ethically appropriate -
acceptable meanings of maximising the use of the data.
But the national statement doesn’t provide prescriptive directions
regarding which mechanisms or processes to use, except for some
broad exceptions to that. That is for ethics committees and other
reviewers to make assessments based on their own judgement of
what is proposed for a specific research project, with reference to the
national statement and other guidance.

Now, what's often the case with ethics - that these two core
objectives, our intention and the national statement and the - including
the prompts - are - exist in order to help people address those
tensions and mitigate the risks as much as possible.
One of the things that it also doesn’t do is it doesn’t address the legal
aspects of data use with reference to, for example, privacy legislation;
although the ethical guidance in the national statement takes
cognisance of the existence of privacy legislation and the over - the
general concepts that are part of that. In fact, the NHMRC has
responsibility for developing the guidance for researchers with respect
to the application of privacy legislation.
That is the national statement that we've been discussing. The section
that deals with considerations specific to research [unclear] is in the
final stages of revision as we speak. It has been radically
reconceptualised and restructured so that it does not specifically refer
in categories to types of research as its overall structure.
It's redesigned to address the elements of research, which are listed
on the slide here, that are characteristic of most - not all - research
projects, and it then provides very specific guidance for certain kinds
of research that don’t fall into as - the more generally applicable
categories. This includes research involving bio-specimens,
laboratory-based research involving [inaudible] bio-specimens, human
bio-specimens, genomic research, and there’ll be a new chapter
related to something called xenotransplantation research, which have
very specific requirements that don’t apply otherwise.
The rest of the categories of research are all part - all subject to the
guidance in the section generally, with specific comments related to,
for example, clinical research; but they are not separated - it is not
separated out as a separate category for a variety of reasons. In each
of these elements there is guidance on the ethical considerations
related to the use of data; obviously, in particular, in elements four,
five and six. However, each of the elements addresses these issues in

particular. For example, the types of things that need to be notified to
participants and the consent - as part of the consent process.
In addition to the national statement - although this wasn’t specifically
- explicitly on the agenda - there is a national ethics application form -
which is no longer called the national ethics application form - and has
now been replaced by something called the human research ethics
application: HREA.
This document will be of great assistance to researchers in developing
their projects, as well as submitting their proposals. It's a portal, not
just an application form. The key point I wanted to make here was that
there are three sections of this form, one full section of which are
questions related to data and privacy. There are 18 questions in the
section related to data characteristics and activities that are planned
for - or with - the data.
This, of course, references back to the national statement, but
includes considerations and questions that researchers need to
address that go beyond the guidance that’s provided in the national
statement document.
Thank you for the opportunity for NHMRC to contribute to this session
today.
Facilitator: Okay, fabulous. We're going to have Peter speak now. Thank you so
much Wee-Ming and Jeremy for sharing with us those policies and
things that are happening at the NHMRC. Thank you.
Speaker 2: Excellent. Thank you.
Peter D’Onghia: Thanks, Kate, for that, and thanks to ANDS for inviting us to speak in
this webinar. I guess, firstly, I just should say at Wiley we're committed
to open science. We believe in it strongly as, I guess, essentially, it's
our business. Disseminating research is our core business. Our open
science strategy focusses around five main things. I'll just explain
those quickly now and then go into detail on a couple of them later.

Open access - nearly all of our journals offer some sort of open
access through our programs, our open access programs. Clearly, we
help improve the visibility of research and comply with various open
access mandates. Authors, of course, can retain copyright and
choose appropriate licences as they wish, such as creative commons
et cetera.
Open data - well, that’s the reproducibility and verification of research
data methodology and reporting standards. We take this seriously.
Again, we are committed to open data and to improving the openness,
transparency and reproducibility of research. We don’t recommend
any limiting licences as such to our partners, and suggest and use
various creative common licences. We think this protects the long-
term integrity of the research by making the data, methodologies and
reporting standards openly available. It also complies with some
funders who request that data be shared, of course.
Thirdly, open standards, collaborative, interoperable and global
dissemination standards, new digital first technology and infrastructure
helps increase the discoverability of research, of course. New
technology and infrastructure helps to publish journal articles and
integrate all major research outputs, text, images, data and code,
preserve more of your research activities as part of the scientific
record and help other researchers find your work where and when
they need it most.
Open collaboration - that’s a more inclusive and networked research
practices. New technologies and pressures on researchers to find new
ways to collaborate has seen us as a publishing company invest in
technology to help you, as authors, collaborate with peers and create
the best possible outcome for your research. We believe this should
help facilitate data sharing, text and data mining for easy collaboration
between researchers.
Through annotations of work through article sharing policies which we
support and have at every stage of production, of publication and

platform text and data mining as well, we believe work will get out
there more openly and easily.
Finally, of our five main points is to have open recognition and reward.
That’s integration of researcher identification and evaluation tools.
Simply, that’s to increase recognition of authors and their work, to
create an ORCID ID when you submit your paper, make that easy to -
then you can connect you with your research activities, maximise and
measure the impact of your work through Kudos and Altmetric, get
credit in the end for your peer review work as well through Publons or
programs at Publons that recognise and reward the contribution of
peer reviewers.
Through our journal level data recommendations - well, the thing I
really have to say is that we're a partner with societies. We don’t
publish most of our journals on our own. We're partnering with
colleges, societies, associations et cetera. Therefore, we can't make
our partners do anything, so we work and collaborate closely with
them to come up with the best policies and the best
recommendations.
There's three recommendations that we suggest. That is to encourage
data sharing, to expect data sharing or to require data sharing.
They're the three main ones, as you could imagine. Our
recommended default position for our society partners is to [inaudible]
data to be made available. It's probably a little stronger than what
Wee-Ming and Jeremy were talking about before, where they
encourage. It's really up to each individual journal and society.
Generally, many researchers will be more across this than me, but
check what your society wants, what your journal wants, what your
funding body wants.
Then there's data accessibility statements. These are a consistent
way that articles can point to the data that informs their results. These
statements should be placed within an article to identify where this
data is held. It should include how the data can be accessed through

a DOI or a link, for example, what conditions are placed on it. Again, is
it a creative commons licence? Is it a restricting licence? That’s really
important.
Finally, there is the data citation structure, like a journal citation
referencing. This has to be there to ensure consistency. Now,
currently, it's often referenced in different ways. We don’t have a clear
structure for it, and we are working with other bodies to come up with,
I guess, a simple way and a standardised citation information for the
data.
What do we do and how do we make it easier for our authors? The
first thing we do is suggest that you, as an author, choose the best
way that’s for you. If your discipline has a certain place to store the
data, that’s fine. Do it that way. But if you don’t, we have - we suggest
and we recommend the use of fixed share. We have done this in a
seamless way through our submission stage. Therefore, all authors
can put their data up on to fixed share at no cost to them and in a
seamless way.
We don’t have a strong view on where the data should be held, as I
say. That’s really dependant on journal [or] discipline, but we do
suggest and recommend fixed share. It's easy for authors to submit
their papers to Wiley journals. Using this repository is free. It can be
dealt with at submission stage and is pretty easy and seamless for
authors.
I think I've run through my five minutes, but that’s all right. I'll just
summarise basically. Our position on health and medical data is pretty
simple. We strongly support the open science, open data, believe it
will drive faster and more efficient research. We recommend data
policies to our partners, and only recommend ones that are
appropriate in their fields and which encourage, expect or require
authors to make their research data accessible.

Finally, we facilitate this by encouraging authors to use their most
relevant repository or, as I mentioned, we give free and easy access
to the fixed share repository. Thank you.
Facilitator: Thank you very much to all of our presenters who've joined us today. I
hope that this has been able to get the message across to all of our
audience who've called in that there's a movement in the sector, both
from publishers, funders within Australia and internationally, that
everyone is thinking about data, how it supports research, how it helps
reproducibility of research and will improve outcomes for - particularly
in the health and medical field - improve outcomes for patients and
people with medical conditions who want better treatment, better
outcomes.
We've run out of time today. Thank you very much to our presenters
today, and thank you to everyone who has called in today.
END OF TRANSCRIPT

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