 Welcome to our webinar. This is the first in a series of three webinars hosted by Ann's. My name is Kate LeMay and I work in the Canberra Office of Ann's and I have a history that I was a pharmacist and then I worked in medical research and now I am at Ann's as a research data specialist and I work with our programs and information services where we are dealing with sensitive data and in particular health and medical data. So as I said this is our first webinar in the series that we are 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 and the third webinar is the week after on the 23rd of May about ethics, legal issues and data sharing. So I just wanted to quickly introduce a few concepts to everyone about Ann's because some people this might be the first time that you've come into contact with us. So we're an NCRIS facility funded by the federal government and we work to make Australia's research data assets more valuable for researchers, research institutions and the nation. So just 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 and 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 is from research funded by them being required to be shared and 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. And 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. So the last thing that I would like to point out to you before I hand over to our speakers is that ANS has quite a suite of resources for medical and health data and this slide is one of the handouts that's in go-to webinar so feel free to download it and have a look but it's basically pointing you to our sensitive data homepage where you can go and explore all of these resources that are related to medical and health data. So now I'd like to introduce our three speakers. Firstly, Whimming Boone is a senior research scientist in the research translation and policy branch of NHMRC and he provides scientific and policy advice towards NHMRC strategic projects and peer review. Previous to that, he was the research director at the Heart Foundation and a research fellow at Monash and the Flory Institute. Whimming also has Jeremy Canner in the room with him who will be speaking a little bit after Whimming and 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. And Whimming and Jeremy are both in Melbourne and we've also got Peter Odinger also in Melbourne who's a senior journal publishing manager at Wiley and 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 the Australia and the Middle East such as Lonely Planet, Explorer Publishing and The Age. So I'm going to hand over to Whimming now and Whimming is going to speak about the NHMRC statement on data sharing. Thanks Kate and thanks to AIMS for the invitation. So 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 and the original open access policy mandates that all publications are to be made openly accessible within 12 months of publication. And 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. So it doesn't actually mandate data sharing but rather encourage data sharing in this because the data field is evolving very quickly while the field is maturing and it's also for other aspects of data that actually catch up first and these can be ethics, privacy, technical and quality issues that faces everything that is data related and not to mention the actual skill and knowledge that is required to think through the whole process of data sharing as well. So if you looked at the NHMRC data sharing statement, it actually talks about the use of life cycle thinking when it comes to data and 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 will 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 for fluke forever. And I'm sure many of us have come across a situation where we get to where we needed to go back to some data from years ago and the data is stuck in the lab in the garage somewhere or in a floppy disk with no easy way to access it. And 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. So that's what we're trying to avoid at the same time. So the data sharing statement is aligned with overall government strategy of data sharing and as Kate has mentioned the pre-activity commission just released a report yesterday and we are totally aligned with things that has come from government as well. So all in all sharing of data is about maximizing the benefits from data derived from quite a limited pool of resource and minimizing wastage. And it's also about considering the community and the 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. So it is basically to make the best use of resources coming from public funds and the moral obligation by way of being ethical in the research behavior that we have. So 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 or music. The challenges include privacy of individuals and patients when dealing with health reports, genetic information, overall health information. And other tricky sections include sharing of clinical trials data and in particular non-aggregated data and these are some of the things that we often need to think about when coming up with policies at NHMRC. So now I'll pass you on to my colleague Jeremy Kenner who will talk to you a bit further about this. Good afternoon. The NHMRC is as the peak body or the expert advisory body in Australia for research ethics and research governance issues under the Code of Conduct which we're not going to be discussing today as explicitly. We produce guidelines and one of the most significant one that we produce for research ethics is something called the National Statement on Ethical Conduct in Human Research. So 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 in different populations involved in research and then the establishment operation of HICs 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 biospecimens 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, etc. This document's undergone a full review in between 2004 and 2006, yielding a document in 2007 that is the current document although it's been amended in small in various ways since then. It's now undergoing an ongoing review and we are addressing first one of this section that deals with the various categories of research and additional sections will be reviewed in accordance with priorities that have been set by a virtual consultation with the users of the document. So regarding data the guidance in the national statement really attempts to achieve two core objectives. The first is for researchers to understand and to minimize the risk of the unauthorized use or disclosure of sensitive personal information that they obtain through these research. So it's an awareness raising activity and the second is to ensure the appropriate collection use and sharing of data or information so as to maximize the ethical use of the data and information research and 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 ethically appropriate. So 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 minimize the risk and to maximize the use. The necessary framework for the of the principles including what will be what is phrased in the in-must language and insured language is part of the national statement. It also includes props for consideration by reviewers regarding whether the proposed mechanisms or processes that they wish to use to address or mitigate the risks are adequately protect participants and are ethically acceptable means of maximizing 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 and that is for ethics committees and other reviewers to make assessments based on their own judgment of what is proposed for a specific research project with reference to the national statement and other guidance. Now it's often the case with ethics that these these two core objectives are intention and the national statement and the including the prompts are exist in order to help people address those tensions and mitigate the risk 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 cognizance of the existence of privacy legislation and the general concepts that are part of that and in fact the NIH has responsibility for developing the guidance for researchers with respect to the application of privacy legislation. So this national statement that we've been discussing the section that deals with consideration specific to research measures of fields is in the final stages of revision as we speak. It has been radically reconceptualized 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 and this includes research involving biospecimens, laboratory based research involving biospecimens, human biospecimens, 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 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 and obviously in particular in elements four or 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 in 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 and it's a 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 and so there are 18 questions in this section related to data characteristics and activities that are planned for or with the data and 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. So thank you for the opportunity for NHMRC to contribute to this session today. Okay fabulous we're going to have Peter speak now so thank you so much Wimming and Jeremy for sharing us sharing with us those policies and things that are happening at the NHMRC. Excellent thank you well thanks Kate for that and thanks to Anne's for inviting us to speak in this webinar. I guess firstly I just should say at Wiley we're committed to open science and we believe in it strongly as I guess essentially it's our business disseminating research is our core business. So our open science strategy focuses around five main things and I'll just explain those quickly now and then go into detail on a couple of them later. So 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 licenses as they wish such as Creative Commons etc. Open data well that's the reproducibility and verification of researcher data methodology and reporting standards well 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 licenses as such to our partners and suggest and use various creative common licenses. 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. So thirdly open standards collaborative interoperable and global dissemination standards. So new digital first technology and infrastructure infrastructure helps increase the discoverability of research of course new technology and infrastructure helps to publish journal articles that integrate all major research outputs text images images data and code preserve more of your research activities as part of the scientific record and help other researchers find your work when and when they need it most. Open collaboration well that's a more inclusive and networked research practices so new technologies and pressures on researchers to find new ways to collaborate has seen us as a publishing company investing technology to help you as authors collaborate with peers and create the best possible outcome for your research. So we believe this should help facilitate data sharing text and data mining for easier collaboration between researchers. So through annotations of work through article sharing policies which we support and have at every stage of production a 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 to have open recognition and reward that's integration of researcher identification and evaluation tool so simply that's to increase recognition of authors and their work to create an orchid ID when you submit your paper make that easy to then you can connect you with your research activities maximize and measure the impact of your work through kudos and our metric get credit in the end for your peer review work as well through publons or programs with publons that recognize and reward the contribution of peer reviewers. So through our our journal level data recommendations well that 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 etc so 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. So there's three recommendations that we suggest and that is to encourage data sharing to expect data sharing or to require data sharing the three main ones as you can imagine. So our recommended default position for our society partners is to expect data to be made available it's probably a little stronger than what Wei Ming and Jeremy were talking about before where they encourage so it's really up to each individual journal in society so 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. So then there's data accessibility statements so these are a consistent way that articles can point to the data that informs their results so these statements should be placed within an article to identify where this data is held so it should include how the data can be accessed through a DOI or a link for example what conditions are placed on it you know again is it a Creative Commons license is it a restricting licences so that's really important and 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 that we don't have a clear structure for it and we are working with other bodies to come up with a I guess a simple way and a standardized citation information for the data. So 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 so we have done this in a seamless way through our submission stage so therefore all authors can put their data up on to fixed share at no cost to them and in a seamless way so we don't have a strong view on where the data should be held as I say that's really dependent on journal or discipline but we do suggest and recommend fixed share it's easy for authors who submit their papers to Wiley journals so I'm using this repository it's free can be dealt with at submission stage and is pretty easy and seamless for authors now so I think I've run through my five minutes but that's all right I'll just summarize basically so 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 but ones that are appropriate in their fields and which encourage expect or require authors to make their research data accessible and 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 so thank you 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 you know particularly in the health and medical field improve outcomes for patients and people with you know medical conditions who want better treatment better outcomes so we've run out of time today so thank you very much to our presenters today and thank you to everyone who has called in today