 Yeah, as you'll have just heard, we've just started recording because we like to make these sessions available after the fact so that people who couldn't make it can hear. So it does mean that if your camera's on or your microphone's on, then you may be captured in the recording. If for whatever reason, you don't want that, you can turn those things off, but we love to be able to see your face if you're happy to potentially show up. So today, I'm actually only doing this very first part, which is acknowledging and celebrating the first Australians on whose traditional lands we meet. Today, I join you from Canberra, the lands of the Ngunnawal and Nambri people. I'd like to pay my respects to their elders, past, present, emerging and those all around Australia. I'm feeling particularly privileged to join you from this land today. I spent the weekend in one of the national parks, and I'm really appreciative of being able to join you from somewhere so beautiful and so peaceful. So thanks for coming along to this meeting of the Sensitive Data Interest Group. I normally chair these meetings, but today, I'm both happy and sad to hand you over to Kylie Black, who I've had a change of role within ARDC, and Kylie is now taking the helm as Sensitive Data Expertise Coordinator. I'm sure that's not your official title, Kylie, but it's the one I've just given you. And so from now on, Kylie will be organising and chairing these meetings, although I will still be lurking in them because they're so interesting. So yeah, I'd just like to thank Kylie and hand over to you. Thanks so much, Nicola, for that handover and intro. And I've got to say, Nicola has left me with some big shoes to fill. So yeah, hopefully we can keep going with the good work and the really interesting topics. And it's fabulous to have your support and the handover and all the links and everything. Yeah, it just makes it so much easier. So yeah, I'm going to do my own acknowledgement of country. I'm here in Perth on the lands of the Wachau Nunga people, where it is nice and cool today, unlike the East Coast. So that doesn't happen very often. So we'll enjoy this cool weather while we've got it. So yeah, I'd like to pay respect to the Elders' past, present and emerging here as well in WI. OK, so Nicola's already mentioned about the privacy and recording. Yeah, we've got the recording happening and I will make it available on the YouTube channel along with the other OSTIC recordings through the ARDC. So yeah, just turn off your video if you don't want to be identified in the recording. So if you are happy to do that, it's nice to see some friendly faces and especially for Lisa when she does her presentation. OK, also, we do have the OSTIC mailing list, which many of you might have seen the post about today's session. If not, you can you're very welcome to subscribe to that mailing list and be notified of future meetings that are happening. We also have a collaborative notes document. I'll put the link in the chat in a sec. And we'll have got notes about our previous meetings, links to all the recordings and there's space in there to add suggestions for future meetings. So lovely to get your ideas on what you'd like to hear about when we meet in future. OK, so now I would like to hand over to our guest speaker today, Dr. Lisa Eckstein. I would like to also give credit to Kristen King, who, as I've said, everybody knows. If you're recommending Lisa to present today, Kristen works with Lisa as part of the Hesanda Project. And I thought that this idea of sharing information about the National Data's Sharing Statement and all the work she's been doing in the informed project will be of interest to this group. So what I might do is I'll stop sharing so Lisa can start. And what we'll do is hopefully we'll have time for some questions and discussion at the end. So if you could just hold your thoughts until the end, we can have a chat afterwards. That's totally fine. If people want to jump in while I'm talking, that's also fine, especially if people have limited time and unable to stay to the end. I may not always see it on the screen, but feel free to treat this quite informally and jump in as needed is fine by me. If it's fine by others. OK, let me start sharing. Lisa. OK, is that working for you? Yeah. OK, perfect. I am Lisa Eckstein, as Kylie has mentioned, and thank you to Christian for bringing me into the loop. I do want to note that I'm really here presenting on behalf of the informed project team. And I do want to acknowledge Sky Nolan, one of our team members who takes the lion's share of the credit for developing the slide pack that is a lot of what I am using. The work, no. Here we go. Given my own acknowledgement of country, I am in Nicoluna, Hobart, on the beautiful land of the Muaninia people. I do want to pay my respect to the Tasmanian Aboriginal community, past and present and emerging. As Kylie mentioned, I have the privilege of directing the CTIQ project and in particular talking to you today about really something that has been CTIQ's flagship project over the last couple of years, which is the informed project. I do hope that many of you have had a chance to download the template and the user guide for some additional context on what I am talking about. All of our template, user guide and portal for feedback is at www.informedpicf.com.au. Please do go there to download and to provide feedback. There one of the things that we have set up is capturing people's email addresses so that we can prompt them for feedback. But some people's email addresses are blocking delivery of the template and user guide. If that is happening to you or has happened to you, feel free to email me or the email address listed up there on the website. And we can just email you a copy of it directly. OK, let me just say something in the chat. OK, thanks, Kylie. Put it in the chat. OK. Beginning question is, who is CTIQ and why on earth would we be doing this project? CTIQ started up in 2018 as an Australian member based organisation. Our founding members were Belbury Limited, the Australian Clinical Trial Alliance, the NHMRC Clinical Trial Centre and the George Institute for Global Research. Once we joined with the benefit of MTP Connect Growth Centre funding, we also brought Medicines Australia and the Medical Technology Association of Australia into our executive committee, which is our main decision making body, so that we had broad representation from across the sector. We also now have about 50 members from across the Australian clinical research sector. And increasingly, I should be saying health and medical research sector, because really now a lot of our members are medical research, but not necessarily clinical research. What we try to do is take on projects that can improve the efficiency, quality and effectiveness of medical research in Australia and develop recommendations for improvement. Our seventh project is the one that I'm going to be talking to you about today, the informed project, which had no small task of seeking to design a concise consumer-centred participant information and consent form for Australian health and medical research. Not an easy task and one that has taken a considerable amount of time. I'll run you through what has been going on in the last couple of years to give you a sense of the lay of the land and also how we came to join forces with Christian and Cassandra to include as part of the informed project a national data sharing statement. So a couple of years ago, we first set up a project team to develop a revised PICF, did some background research on what makes a good PICF, what should we be aspiring to, supplemented that with stakeholder and consumer surveys to find out from both consumers and people working in medical research, what they thought of PICFs they were currently using, what they would like to see in PICFs and then started developing early drafts of what a national consumer-centred participant information and consent form could and should look like. At about that time, Christian and his colleagues got in touch with us to say, we'll look as part of this work, could we have a focus on a national data sharing statement so that we can provide that to her Santa nodes to have a really robust framework for future data sharing to which we said, amazing, let's do this together. And so that has been a really helpful and really constructive part of how the informed project has moved forward. With that in place, we developed an example library, worked up three mock participant information and consent forms based on the template as it was at that point in time to do consumer consultations. And so for those, we used real studies. One was an early phase device trial donated to us from Biotronic. One repurposed kidney drug study from the Australian Kidney Network and one a low-risk social science mental health study provided to us from origin. We did three consumer consultations run by Dr. Tanya Simmons to see what people thought of the mock PICFs, revised the template further based on that feedback and then developed a user guide. In the work that we've done, we've really followed four key principles. Oh, thanks, Christian, for providing that context. The first of these has been involving consumers in the work that we've done. I'll talk a bit about that. I've mentioned it already. Simplifying language and layout, using visual aids and layering information. So in terms of involving consumers, as context, we've had two consumers on the project team from the outset. We got 157 complete responses for the consumer survey that we issued and did the three consumer focus groups. Worth noting for those focus groups, we recruited through an external provider and had them specifically recruit for culturally and educationally diverse backgrounds. Simplifying language and layout, I'll talk about this generally and then I'll talk about it more specifically for the national data sharing statement. Biggest thing we heard particularly from consumers is that many of the PICFs are just really hard to read and navigate. They tend to be very text heavy, very few subheadings and very just hard on the eye to navigate and have a lot of black and white space. So we put a lot of effort into the formatting of what we've developed to try and make it easy for people to navigate. When the team initially started work, there was this idea that we wanted to make the peak really short. So we had this aspirational idea it was gonna be a full page participant information and consent form. What we actually heard from consumers particularly is they didn't mind the length, they didn't mind if it was eight or nine pages as long as it was easy to navigate and they much preferred extra white space even if that meant it ended up longer. Okay, we'll talk a bit about the privacy language that we put in later but just to give you a sense of where we ended up and where we came from, the left here is the privacy language as it ended up in the beta version template. The right is the privacy language that was the starting point from one of the PICFs. We are adapting. What I want you to see is firstly that it's shorter, that it's got bullet points but hopefully you can also see that it hasn't been about losing content. We've tried really hard to keep a robust level of content but to make it easier to navigate and engage with. On that note, we've also put in visual aids. So in the biotronics study that we used it was about a pacemaker. So we included some visuals so people can see what a pacemaker was and where it was going to be inserted. Consumers have told us that they really liked having tables and other sort of visual breakdowns of information. That's also something that we've really worked to include in the template as it's presently being conceptualized and issued. And finally, layering information. Essentially what this means is that there is a main body of the PICF that includes all of the material information that a person would need to know in terms of whether or not to participate in research for any lawyers in the room, the Rogers and Whitaker standard. There also then will be supplementary information for those who want it. And that's particularly pertinent in the privacy and data storage space where for a lot of people they don't want any of the details at all. They're very happy to be told it's going to be stored securely. We're going to comply with Australian privacy standards and that's really the full information that they want. There will be others who are really, really interested in the detail and we recommend that they be provided with supplementary information that provides the level of detail that they want in order to make a decision whether or not to participate. That's some information about the informed project generally. Really happy to talk about any of that in more detail in the Q&A but I wanted some time to talk more specifically with you about the national data sharing statement that was done in partnership with Cassandra, the ARDC. When Christian and I agreed that we would sort of take this forward as a collaboration the first thing we did was establish a project team that had representatives from CTIQ and the informed project team as well as representatives from ARDC and the Cassandra nodes. And this was really done to ensure that what we developed as the national data sharing statement was going to fit with the look and feel of the informed project more generally but also take into account the needs of the Cassandra and ARDC community. And I particularly want to shout out some representatives from PHRN Public Health Research Network who are really invaluable in the work that we did through that project team. There are a few things that we really focused on in developing the national data sharing statement as part of informed. First was really about language modernizing and simplifying it. So first on that list is removing binary distinctions between identifiable and non-identifiable information. While we sort of moved away from it in the research ethics sphere more generally you'll still sometimes see referred to in PICF's de-identified information set up as a binary from personal or identified information. What we did in the national data sharing statement is move away from that binary distinction and instead explain that we were going to be separating information that could easily identify you like your name or your contact information from other information that was going to be kept and retained and used in the study. Related to that we qualified promises of anonymity. So instead of saying we will keep confidential and won't disclose any of your personal information which we just didn't think was a promise that we could keep in the world of big data we said, look, when we share your information we'll take steps to make it difficult for anyone to link the information back to you. This will include, for example, removing information that could easily identify you and of course research teams can modify this language as needed for their research project. We also kept to qualify that there's still going to be a chance that someone could identify you but we're going to make it small but that could happen. So what we're trying to do is provide accurate information to people about the risks that remain and how those risks are going to be ameliorated by the project team. As with the informed project generally we spent a lot of time working on simplifying the language. So on the left there you can see the original language that was included in one of the PICFs we were working from. On the right you can see how we've modified it. Same content, just shorter, more concise, easier to engage with. Okay, when I talk about the informed project I often say that we're trying to simplify the language we're not about making new policy positions. That is sort of true but when you deal with this kind of project you also can't get away from making some policy positions even if they're passive. So I thought it fair to talk to you about the policy positions we grappled with and where we landed for the beta testing version and I hope that in the chat that we have you can add to this. Tell me what you think of where we came to where we might need to refine our thinking some more or perhaps where we landed in the right space. A big discussion in the project team was how much sharing could be allowed to happen through the National Data Sharing Statement based simply on the original consent that a participant provides to participate in the original research project versus what needed an additional specific consent for future use of the data. This was a huge topic of discussion really interested in your thoughts. Where we ended up landing actually ended up a sort of similar position to where Australian genomics landed in their development of a PICF for genomic research. That is that by agreeing to participate in a research project you agree to a level of data sharing without any further consent being needed. That is for aggregated information to be shared so non-unit level data or information that has been anonymized completely. So not just de-identified but anonymized. In our minds that was reasonable to happen regardless of any further consent that a person might give for future data sharing. However, we also agreed as a project team and interested in views on this that for sharing of unit level or personal data that a separate consent should be available for participants to agree or not agree to secondary use of their data. So if anything was going to be shared on a unit level basis simply agreeing to participate in a research project wasn't enough that that secondary use should be the subject of an additional consent, additional check box that a person could consent to or not consent to as they wish. Now it's fair to say that was an unanimous decision of the project team. It was the consensus but it wasn't unanimous. And so I'm really interested in thoughts from this group of people about where that landed. The other policy position that we grappled with was how granular to go in the future data sharing decisions so how many options to provide participants in terms of how their information will be used in the future. We ended up providing two options for the research team. One was quite a broad consent quasi blanket consent similar to what's used currently in many Australian PICS that is for persons who agree to secondary data sharing that can be shared for any future research whether in Australia or overseas whether for a company that is for profit or a nonprofit based on a discretion of the data custodian or research team whoever's gonna be responsible for sharing decisions. However, we also provided an option B if you like that had more granular sharing options with the idea that some research teams or institutions may be able to provide that might have the current capabilities, others won't. Now, I noticed on the chat has that sentence been checked for readability. The bit that's highlighted is guidance for researchers rather than what we expect to be given to participants. So we would anticipate that people would only keep that we will only share information that has been aggregated or joined together. Perhaps we should change that just to be real only share information that has been joined together but there was differing views. All of our informed template was checked for readability. On the whole, it came to somewhere between a grade eight and nine level but the data sharing component of it is a little bit higher than a remainder of it because of the complexity of information. Consumers that we had read it told us it was understandable to them and so that has sort of been our benchmark but also if people have suggestions about how the wording can be changed to convey the same information in a more concise or reader friendly way please do get in touch with us. We are still working on this. We are still trying to refine it and we're still talking to plain language people but if you see any of this language that you think is overly cumbersome and can be made better without losing necessary nuance please tell us that is precisely why we're doing a beta testing release. But yeah, the bit in highlighted says other strategy to ensure anonymization we certainly wouldn't expect those words to be given to consumers we would expect researchers to find the words to explain what they have done to ensure anonymization. Okay, I want to have plenty of time for discussion but a couple of open questions for people to prompt discussion but happy to go to other places. As Christian will recall in all two vivid detail we had multiple discussions as a project team about whether the National Data Sharing Statement should include a qualifier that research projects seeking access to research data will that the data will only be released for secondary research if it has been approved by an HREC or another ethics review body. We ended up taking that sentence out of the National Data Sharing Statement mostly because of international research that there are a number of overseas countries that do not require any level of ethics review of research projects that are using purely de-identified data and we were concerned about precluding those researchers from accessing Australian research data and therefore decided to leave it at the discretion of the data custodian what preconditions they were going to specify for the research data to be released. Again, that was not unanimous in the project team and I'm really interested in views from this group about whether that is the right decision or whether we should include a statement in a National Data Sharing Statement that qualifies the release of research the release of data to research that doesn't have any approval. Also really interested in general discussion on whether we struck the right balance between the autonomy interests of the research participants and scientific benefits from data sharing. So going back to things like the granularity of consent whether it is the right decision to separate out consent to participate in research from consent to secondary use of data. As I mentioned, we had very diverse group very diverse views in a project team on that and really interested in the views of people in this room. Okay, and I see a comment on the chat of using the health literacy editor. We have tested it with several I would have to check with the team if we've tested it with that one. We also have had a plain language consultant from Westmead Children's Hospital who has also reviewed the form a couple of times for readability. I'm going to be checking back in with her again to get another review of the form as we continue to refine it. So I'll be doing that as well but thank you so much Angela for that tool. I'll check with the project team to ensure we've used that. So that's the last of my slides. So I might pass over now so that we can have questions and I can jump back to any slides if people want to jot their memory about any of it. So I'll just jump in for a moment. You're now moving into Q&A and discussion. Consent and ethics we know from long experience is something that people have lots of thoughts about and I have lots of thoughts and feelings and questions and comments about. So I have no doubt that once everyone realises it's time to switch on cameras and start interacting a bit that there'll be questions coming through. I think while you are doing that I'll just point out a couple of things that might be useful. So the template for those of you who haven't had an opportunity to look at it in detail is yet. It's just that it's a template. It's not something that you take off the shelf and use exactly as is. It's something that as a researcher that you need to go through and use as a starting point but then tailor it and configure it to your particular requirements. The intent there and particularly the section that ARDC partnered with CTIQ on this data sharing statement and sorry data and I've just gone out of my head. That's really embarrassing. The point there was to give people a starting point because actually what we heard inside for a bit of quick context for those of you not familiar with the standard big programme being run in the last three and a half years working with universities, research institutions and such around Australia lots of clinical trial lists and a common thing that we're seeing is when it comes to consent what do we put in there? Now there are definitely obviously groups out there that are already doing this have been doing it for some time had their way of doing it but there's no real guidance out there there are a lot of groups that don't know what to do or how to get started. So the template is as much a starting point as anything else and as Lisa was saying there isn't a company and use a guide as well so the template is the thing that you can build your own PCI from then there's some guidance there for you as the researcher to help you tailor that or bring your attention to particular issues. Thanks Chris and that's really helpful and I sometimes spend longer explaining that and didn't today because I wanted to get to the data-sharing bit but a few I guess rules of how we've done it all of the informed template is designed to be adjustable we try to be very clear with people that this is a starting point but it's not intended as a finishing point and so we say in the user guide that you should use this as a guide to talking to your consumer groups about the information that they need where there are words that are highlighted in yellow what that means is those words are for researchers eyes with the idea that researchers should be changing those words to fit the specific needs of their research project and they're usually there because there are going to be so much variation between research projects and research groups that it didn't seem worthwhile developing template language and instead what we want to do is prompt the researcher to think about how to explain their research so for example if a researcher is going to be anonymising information for future use because they have some kind of tech solution where it's going to create interference with the data or something along those lines well they need to explain to their consumers what that looks like in an understandable way similarly we have an included, often with risks we have an included particular language other than tell researchers think about the risks that are material to your research and explain them for really common risks we've provided some example language but again we expect teams to adjust that and one thing we're trying to do is prompt a more active role of researchers in the way that they develop and draft PICFs so that it's not just to check the box process of selecting the different subheadings but really an active process between researchers and their consumer groups in designing a PIC that provides the necessary information now I see a comment on the chat saying release requirements for the jurisdiction country holding the information not only the jurisdiction requirement we need to make sure we're following the national statement privacy laws etc absolutely so one of the things that we did for the national data sharing statement is we sourced a legal review of that to ensure it satisfied Australian privacy laws that was done by the legal firm into Ellison whose life sciences team are a CTIQ member and they were so they've reviewed that for compliance with the national statement again we as a project team have reviewed it for compliance with the national statement in our view but one of the things we're really doing during the beta testing phase is speaking to HREC chairs members, research governance officers and so forth to ensure that they also are convinced that the requirements of the national statement have been met in a satisfactory way and we're really so far it has been overwhelmingly positive but we really want to see during this beta testing phase if there are things that we may have inadvertently missed so that we refine it and add it in before we issue the more final version of the informed template next year so we as a project team have done that review but one of the reasons we released it as a beta testing version rather than a final version was to allow for anything that may have inadvertently slipped between the cracks. Thanks, Lisa. I'm surprised that we're not seeing any questions come through chat or people putting their hand up that Nicolette started. So I'm not from a health and medical background so my research background was in the social sciences so I did have to prepare information and consent forms but I don't know where the template that I was using came from and I suppose I wondered because I don't have this health and medical background so are there existing templates that are available sort of nationwide that people use for health and medical research or is it kind of piecemeal at the moment? A little bit of both. A lot of people use templates available on the National Health and Medical Research Council website that were originally developed by I think on Victorian health that took the lead on a drafting. We're about 20 years old now so they're a little out of date. There's been updates along the way but it's the most commonly used of the templates but it is quite long very, very complex. We're talking reading grade level above grade 13 and I think there's general consensus that there needs to be a change but getting that change happening has been challenging. A lot of research groups have ended up developing their own bespoke PICS that they then adapt for individual research projects and those tend to be held in-house but obviously that is not available often to early career researchers. Those are the most common ones. There are some more specific subject matter ones. The Australian Genomics has prepared one specifically for diagnostic and predictive genetic research that got issued a year or two ago. Yeah, those are the most common ones I'd say. Thanks. I know that when I used to do this stuff back when I was a research manager I don't know where the original concept form came from but as you study you go back to what was used for the last study and update and revise and then it just becomes is it okay to use the word bastardised version and what was probably a okay form so many possible forms to begin with and God knows where it got to. Yeah, and the other thing to add is some ethics committees have also issued template PICS that may or may not be based on the NHMRC templates but sometimes ethics committees will issue their own Bellbury developed their own PICS several years back with a heap of work into it but really inconsistent uptake. So yeah, there's a whole plethora of different ones that get cross contaminated and bastardised in different ways. Okay, a couple of comments here. Outlining risks in the PICS and how many PICS gives too much information about risks which might put people off. Yeah, risk information so in addition to privacy information risk information is probably the most overwritten section of many PICS according to consumers that we've spoken to and researchers that we've spoken to particularly with commercially sponsored research there's often a view that every single risk that could ever possibly eventuate with any degree of likelihood or not any degree of seriousness or not needs to be outlined extensively in a PICS for it to perform essentially an institutional risk management role rather than a informing consumers role. Now that's not necessarily effective. So we know for example for a person to give a valid consent to participate the risk information needs to be provided in a way that is understandable and meaningful to a participant so no matter if all of the information is set out in a 40 page PICS with 10 pages of risk information. If that risk wouldn't be meaningful for a participant it doesn't actually perform a risk mitigation role that might be anticipated so part of what we've tried to do with informed and say look you need to make this information understandable and you need to focus on the risks that are meaningful. So if you're dealing with stage 3 cancer patients telling them all the risks of a blood draw probably is not going to be meaningful. If you're dealing with a stage 3 cancer patient you shouldn't be telling them the risks of standard of care treatment that they're going to be receiving regardless of whether they are in a research project or not. They might get that information from their clinician you might provide a supplementary information but you need to be focusing on the risks that are research risks not clinical risks and that are meaningful research risks and that is something of an education piece I think both the HREX and researchers to come across and as Nicola put in I'd expect providing more information may make it hard for the consumer to see the pieces that are actually important. Absolutely we know that if you put in all of the potential risks of a particular intervention it makes it very very hard to pick out the bits that are most relevant. Now obviously HREX play an incredibly important role here in reviewing the risk information that's been provided and seeing whether it effectively conveys the meaningful risks that a potential participant would need to know and HREX might be different in terms of how much risk information it wants portrayed but we know that consumers are telling us they're saying too much of the risks and also that they're saying not enough of the potential benefits and so it feels unweighted. I'll let Angela jump in because I think she might want to speak to this particular point. Hi Lisa thanks very much for your presentation I just wanted to pick up the issue of ethics review one of your questions from some early feedback that we've been receiving in Sydney it's emerging that researchers who are based inside our health organisations are different from researchers who are based in universities and MRIs in that at least in New South Wales and I suspect in some other jurisdictions the chief executive of the health organisation is actually technically the data custodian rather than the individual researchers and so a lot of especially and this might be for Kristen as well but a lot of the discussions for Cassandra have really been with the researcher and as the holder of the data that might be shared the researcher who seeks the consent the researcher who assesses requests for sharing the researcher who might make decisions around you know yes we will share or no we will share and whatever but it's actually a bit more complicated in terms of governance at least in New South Wales and so your questions around atric review like I just wonder I haven't seen your guide in detail so I don't know whether there's some discussion there about checking in around local requirements for both atric and governance site review yeah no absolutely if people are going if people are going to be accessing administrative datasets there are going to be very specific things that they need to include and very specific requirements for how that information can be shared we've touched on that whether it's enough or not really really happy for feedback on the situation that we have that we try to deal with in the informed template that I was talking to is where a research team is going to be sort of gathering information and making decisions about how to release it but obviously where where the information where decisions about release of the information will always require atric review if you are in a situation where you have an institution that says we will not ever release data about each rank approval 100% put that in 1000% put that in I didn't want to put it in a template to preclude people in other situations who are currently making decisions to release data that doesn't have ethics review particularly where the data is being released to a researcher overseas that has no requirement to get ethics review I was worried about putting something in a template that would preclude valid sharing decisions that are currently happening essentially adding a layer of policy that isn't currently in a policy now I'm really happy to be told we got that wrong if all of the people who we speak to and on this call said no we would never release data for research that doesn't have ethics approval be that overseas research or domestic research super happy to put that into the template as a guide but I didn't want to put that in and preclude sharing situations that are currently a valid part of the ecosystem if that was going to create a burden that there wasn't you know we don't have as least that I know of a requirement in the national statement or a requirement elsewhere in law or regulation that Australian data can only be shared with others if that research has approval from an ethics committee it needs to be that they need that the overseas research has you know satisfied the requirements of the overseas national statement equivalent but things like the common rule will say well for research using data it's exempt so it was one of those situations where I wanted to make sure say a US researcher wanted to access Australian data that that was allowed but if your institution or if your research group has ethical requirements that go above and beyond that 100% out of you okay thank you very much add on to that so just on that very last point about specific institutional requirements that I have been in the situation myself where that exact situation Lisa was talking about where someone from overseas actually also within Australia has requested data and details of your ethics approval and they said our institution or does not require it went back to the HREC for the institution I was working for and they said okay well get them to write that down you know they need to provide that in writing and I guess that's the baronage request so I think it's kind of more complex and definitely in all the consultations that CTIQ ran and those discussions were part of it is clear that not everyone has had that experience or understands that that is sometimes the case so if for those who have not been in that situation it can be a little bit of a shock when research has had ethics approval it's not that clear cut so that's why we've taken the approach here that we have the other comment more broadly that I've made into that is yeah so we've got the I should use the royal plural, CTIQ did a lot of work here, CTIQ have the consent form a template and a user guide and we've mainly been talking about the consent form today and that has one thing that why we were so supportive of this partnership in this project was the consumer focus of this and not to be trite about it but the P and PICF it's about the participant so having that strong consumer focus was crucial here and I think the consent form has done a really good job and obviously there's no perfect here if there are additional tools or things we can use to check language or improve quality further and that's a good thing but I think there's really hit the mark there there is a company document that's the user guide document so that's for the researchers how do I I've got this specific situation maybe I'm within a health service a track that wants me to do things this way or whatever it might be now we've worked with CTIQ as best we can in the time frames and resource allocation that we have to start the appropriate sections in the user guide what will be really valuable if not from the people in this room then maybe your colleagues or others to provide us more feedback on the user guide because I think that's something we could develop a lot more and the starting point for that is hearing from everyone well and maybe it's you don't know the answer you don't know the thing that needs to be put into the user guide but you can present it let us know well I'm in this situation I need guidance around how to do this and we can collect that feedback and over time see what we can do to provide improved guidance yeah absolutely I think as Christian said this is our starting point it's not a finishing point we think that we have taken a really useful step in moving the discussion forward and including some language and ideas that haven't yet been well reflected in a lot of the templates now that's not to say all of the templates there are absolutely some researchers some research groups, some A-trex using really sophisticated understanding some languages but that's not reflected across the board there's going to be one of those areas where there is a huge diversity of experience in the way that people are using data and wanting to share data and being able to take on board that diversity of experiences will be incredibly valuable I'm always just wondering Lisa and it might be too early to say given that it is in beta mode at the moment whether all these changes to the participant consent information have resulted in higher rates of people consenting There's hopefully better understanding and look it's not anything we've been able to do yet it would be amazing if someone had the resources and capability to set up some kind of study within a trial to work out rates of recruitment or the like between using a consent form that is more concise and consumer focused versus what we might think of as the more consent form it's not something that we've attempted to do but I'd love it if someone did but we know from the consumer consultations that people told us that the length of current consent forms and the detail particularly about the risks was off-putting that it made them see risk that wasn't necessarily there and that it felt really unbalanced with the lack of any information about benefits which is often something that ATREX are quite reluctant for understandable reasons to put too much in in the PICS Yeah I think Sarah's got a question Hi I was just wondering what the expected uptake of this new form is obviously there was a need for it but other people who are like yes as soon as it's ready we're going to start using it So some that already have so the Central and I believe Southern Adelaide Local Health Network ATREX have already been implementing it and I believe the Western Sydney ATREX is in the process of implementing it and some research teams are starting to use it. We are having discussions with NMA so the jurisdictions to talk about whether they would be willing to endorse the informed template for their respective jurisdictions and with the NHMRC about whether the NHMRC would be willing to host it on its website and obviously those are things that will hugely impact uptake Those are ongoing discussions, we're receiving some really positive feedback but we also are really keeping an eye on the feedback that we're getting to make sure that we can make any necessarily refinements and updates to it before we get to that point Yeah and I love Nicola's comment there the other thing I'd love to see is satisfaction with consent even if you don't see differences in consent rates I feel more confident about my participation in the study or I didn't regret consenting to participate later on that would be an absolutely amazing piece of research to do and look as I mentioned CTIQ is a relatively small organisation that's a member based organisation we don't have the capacity to really take on large research projects of our own so we'd be really happy to work with any researchers or institutions that are interested in doing pieces of work like that to see if there's ways that we could support that information being obtained Okay well I'm just mindful of the time and Lisa thank you so much for that, that was fantastic I learnt so much, hopefully everybody else on the webinar did as well So you said lots of times that you're really keen to get feedback about all of this Can you do that through the Provide Feedback link on the informed website Please Obviously I'm happy for my email address to be given out, it's on the CTIQ website, really happy for people to email me directly if they would prefer to give feedback via a chat like sometimes it might be that you want to have a chat about things rather than write feedback that's absolutely fine but having any written feedback through the portal just makes it much easier for us to collate and analyse down the track Fantastic Excellent Well does anybody have any burning questions before we wrap it up? Okay well nobody's jumping in so thank you so much again Lisa for your time and sharing all your information Hopefully as well as us learning things, you know you'll be able to benefit from this as well, from the feedback and the discussion and yeah for the Austic people we do have a couple more webinars lined up later this year one's going to be sharing this bit from the Australian Access Federation and in early December we've got Jeremy Kenner from the NHMRC talking about their new statement which is going to come into effect very soon so stay tuned for the information on those on the Austic mailing list I can see there's just a few messages coming through Everyone loved it Lisa of course Okay So you can get in touch with me offline to say the non love bits of it Okay well thanks very much Thanks so much everybody and yeah we'll publish the recording online as well so you can share with anybody who might not have been able to make it today Thanks a lot and have a good day Thanks so much everybody