 Okay, so I'd like to just begin with an acknowledgement of country. So we'd really like to acknowledge and celebrate the first Australians on whose traditional lands we meet and pay my respect to their elders past, present and emerging. For me, I'm over in WA, so on the lands of the Wajapnoonga people. It's beautiful weather here at the moment. Quite frankly, a damn shame to be inside. It'd be much nicer to be outside enjoying it. But we're here to talk about very important things today, ethics and national statements, so we can get outside later and enjoy that. As I mentioned, the meeting will be recorded. So if you don't want to appear, just turn off your video. If you have any questions along the way, Jeremy, would you prefer that people hold questions to the end after you've presented? It depends how desperate they are, whether they're timely based on what I want to say and whether I'll deal with it later. So if you really need to, you know, ask away, I won't probably be checking the chat or anything. So raise your hand or someone else can call, but we'll have time at the end. OK, that's wonderful. Thank you so much. So with that, also, just before we begin, I'll just mention the Osdig mailing list. Remember that it is there as a resource if you want to make the most of the brains trust. We have 277 people on the mailing list at the moment. So if you have some kind of sensitive data related question, feel free to use that mailing list to source information from your colleagues. OK, so I would now like to introduce our guest speaker, Jeremy Kenner, today. So he's the expert advisor for ethics to the NHMRC's Research Quality and Advice branch. At the NHMRC, he's responsible for or contributes to a broad range of programs and projects related to health and research ethics, governance of research and clinical trials and provides advice internally and externally on these matters. Prior to his current role, Jeremy served as ethics coordinator at the Peter McCullum Cancer Centre in Melbourne. Earlier in his career, Jeremy worked as a schoolteacher, practised law and conducted public education and research in bioethics in the United States. His academic background is in anthropology, theology and law. Jeremy hails from Boston and has roots in the Canadian Maritimes, but says he's a loyal Melbourneian. He loves to spend time in Tassie wherever possible. We won't talk about football or cricket. We'll keep it to ethics and national statements today. I would also really like to thank Kristen King for suggesting Jeremy as a presenter today and putting us in touch. So thanks very much for your time today, Jeremy. Really, really appreciate it. And yeah, over to you. Go right ahead. OK, thank you. First things first, can folks see slides? Yes, thank you. OK, good. It's a good thing we're not talking about cricket because I know nothing about it and I have no desire to know anything about it. So there you go. I know, I know. I know. Well, you know, life's full of disappointments. So, OK, as you can tell, I'm not that formal in the way I do things, but there is some fairly dry material to present to just catch you up on where we are. And then we can have some hopefully robust discussion at the end. We'll try and talk fairly quickly to make sure that we do have time at the end. And the slides can be made available if folks want them after the fact. OK, so there's this thing called the national statement on ethical conduct and human research with which you are all familiar. I hope at least in principle. Why isn't this working? It's just delayed. OK, a little bit of a delay. So the National Health Medical Research Council is something that you know we're largely a funding agency, but we do have an advice and guidelines sort of component to what we do. And the national statement is one of the principal documents that we produce. And it is, as you'll see, it is jointly co-authored with the Australian Research Council and Universities Australia. So this is these things are responsible for I will say here. Some people are quite surprised to to understand that the NHMC is not a regulatory agency and thus has no authority to regulate. We produce guidelines. And if you're relying upon us to regulate in the sense of the TGA, for example, well, we can't do that. And that is something that does get in the way sometimes for people because they will expect us to do things that we can't. I'm like teleethics committees that there are, for example, which they often are. Australian Health Ethics Committee is the principal committee. That is the entity that that essentially recommends the guide on any international statement and other ethics guidelines that are then considered at our council and by the CEO. And ultimately, we report the committee and the NHMC report up to the federal minister of health. And that's what AHEC does. And so the national statement is in satisfaction of that second responsibility. Okay, so there was a, it all began in 1966 with a single statement on human experimentation. It evolved into a full document in 1999, which was then fully revised between 2004 and 2006 and published in 2007. It was then updated several times, which I'll show you a slide about. When we do a review of the national statement and revised, determined it needs to be revised, we used expert working groups to do that. And it can be updated to respond to a variety of things. Identified need complaints from folks are saying, look, we just need some guidance about this, that or the other thing. We also have certain priorities that we might be trying to satisfy. And then there could be internationally developments in research ethics or in research that are requiring us science and research requiring us to make changes. We, the public consultation that we do is, is legally required. And the, what we produce has to be approved by AHEC and the council before it can go public. And importantly, it applies to all human research. In the old days, people understood it as applying only to health research. And as the national health and medical research council, you could make the argument that we have no business producing guidelines for non health research, but no one else does. And so it is on behalf of, it is applying applicable to all human research, even though it is under our banner. And I'll say on that point, that the fact that most clinicians consider, we often hear from clinicians complaints that the document is too skewed to non clinical research. And we hear from university non clinical researchers that it's too skewed towards clinical research. We figure we've got the balance about right. Okay, so it's our principal guideline in Australia. It is as principles based. If we were doing a quiz now, I would ask you what the four principles are, but I'm not going to do that. And it's a mixture of guidance, some of which is prescriptive, some of which is more suggestive, and some best practice recommendations. And it's all kind of mixed together. If you want to see which is which, just put in the search term must or should. And you'll see it when you're reading the national statement and you'll be able to detect what's prescriptive and what isn't. Main area is covered is is is set out here. We'll be talking about the last two today. So as I said, it started off in 1966 with some other iterations, finally producing a national statement 1999. And then a full review and then updates since then, such as this. So new chapter in 2015 changes to a completely renewed news. Sorry, section three in 2018 and some other changes to accommodate those. One of the key changes there was had to do with clinical trials. So we'll, we'll, we'll get to that. We then undertook a consultation process for sections four and five of the national statement in 2020. We got a lot of support back for what we've done in section five and a lot of concern about what we've done in section four. So we then chose the lowest hanging fruit and went for revision of section five first and chapter 2.1 along with it, because they were linked. And now we've gone back to do section four. So this is the process that we use, have used for the last five years or four years review process, which will ultimately result in a, an update to the newest version of the national statement, which was published this year will be an update next year to, which will include the changes to section four and some other less significant or wholesale changes to other sections. I might say here that when we receive submissions, as you can see, we receive a roughly a hundred, let's say each time we do this, we can't accommodate all 100 because they don't line up and they're often diametrically opposed. So we have to make some judgments as to what we're going to do, either based on persuasive arguments that are made as part of the submissions or based on what we think is the right way to proceed. So we have to take account of all the submissions, but we don't have to incorporate all of them. And I like to give a little, an anecdote here. When we did the public consultation on section three and in preparation for the publication of that new section in 2018, one of the questions we asked had to do with categories of information, which of course is pertinent to all of you. And we had in the national statement a three tiered approach of identifiable, reidentifiable and non identifiable as categories. And we had that because at the time that the 2007 national statement was being developed in 046, privacy legislation only had two categories, identifiable and deidentifiable. And the problem was deidentifiable was too ambiguous because it included both coded information and information from which all identifiers had been permanently severed, rendering it non identifiable. So the decision was made to veer away from the privacy legislation ordained categories and create our own. So when we were doing this in 2018, we thought we should ask which people thought we should do. Should we stick with the national statement three categories or should we go with the privacy legislation categories, which had been more made and elaborated upon to make them more nuanced in the interim decade or so. And we had 98 submissions and 49 of them said stick with the national statement and 49 of them said go back to the privacy legislation categories. Well, what do you do with that when you have a break like that 50-50, you have to make the call. So first we tried to create new categories that weren't either of those two and then we abandoned that and decided we would go with no categories. And that's what we did. And so if you look at section three, there aren't categories of information. There is a footnote that says we're not using them. You can use them if you want to, but the national statement isn't going to use them. And we talk about the phenomenon of identifiability. And that was strongly influenced by one of the bodies that made a submission to us, the PHRA and WA. And that was their view. And we agreed with that. And so we developed it that way. Okay. So I'll publicate the new national statement, 2023 national statement, which is not an update. It's a new one. And on the first of January, when it becomes effective, 2007 national statement or all its updates will be rescinded and will be a historical document available on the site, but it will not be current. So the 2023 national statement will be the new one. And then it'll be as you'll hear updated again next year. So that includes largely a revised chapter 2.1 on risk and benefit and a revised section five on ethics review and research governance. And so starting with chapter 2.1, the major change here is the risk categories. So, and I apologize to anyone who's heard this shtick before, but the reason that we did this is we started first from asking, okay, the categories that we have, what's the objective basis for those categories? So we did a little survey and discovered that exactly one country in the world uses the term negligible risk research, Australia. Nobody else does. It's not a thing. It's something that we created. And we created it to talk about what's lower than low risk and to support the idea of exemption, potential for exemption research, which as you would know is a very narrow category in the current national statement. And it's expanded in the, in the number one. And so we thought, okay, well, number one, there's no real. Pretty much, which means low and negligible risk. So if you're going to conflate them and bunch them together, well, then why have two categories in the first place? And if you're going to review them the same way, also why have two categories, separate categories. And there's nothing in the national statement that said anything about how to review negligible risk research. So we threw out negligible risk. And we decided to replace it with minimal risk and moderate to high risk. Well, that didn't work because people said, well, what, what about the stuff that's more than minimal but lower than minimum moderate? What's that called? That's low risk. That's three categories. Again, what's the point? So then we went back to basic principles. And we realized that what we were talking about was a continuum of a risk. And these categorical distinction, these points on the line are not entirely arbitrary, but they are not, don't have a strong basis. You could draw, you could, you can make many more points. You could draw lines in different places. So what we're going to do. So we talk about it as a continuum, but of course you can't use a continuum as a reviewer or a researcher to determine what, what, what category you're in and what, what file you're going to use, what pathway you're going to use. So this table that we introduced is essentially a crutch. It's a tool to be more polite. It's a tool for people to use in order to, as a practical matter, enable appropriate considerations with respect to risk, even though really it's all a continuum, right? Or a spectrum if you prefer that word. So there's a continuum here. The important, the important line, I don't know, can you see me drawing this with my cursor? Yeah. The important line is this one, which is, is there a risk of harm or is there no risk of harm? Right. Potential for risk of harm, potential for harm, no potential for harm. That's the distinction. So that's why the basis for the distinction between higher and lower, right? Or no harm. But within that, of course, there are a couple of other categories and really this split here is just because it's aesthetically pleasing to have, if you're going to have two categories over here, to have two categories over here. But we, you know, there's no particular need for you to consider higher risk any differently than greater than low risk. Right. And what is the word significant mean anyway? But that's the way we've decided to do it because it all should be proportionate, of course, all the systems that are used for oversight of research should be proportionate to the level of risk. So if it's really high risk, well, maybe you do need greater oversight and greater scrutiny than for this category here, greater than low. But the main one that people will focus on is this split here between low and minimal. Now the minimal risk category is actually a bit of a finesse because if there's no risk of harm or discomfort, and the only potential is for burden or inconvenience, which are not themselves risk, then it's not really minimal risk. It's really no risk. But you can't have a no risk category on our risk matrix. Right. It's outside the matrix. So we've compromised here and gone with minimal risk. So what we've said here is that folks can introduce as many categories as they like. They can talk about it however they want. This is to assist you in determining where things go. And importantly, how you make that determination is something we've tried to emphasize in the new document. So the process for assessment of risk and review of research need to be separate processes. And any organization needs to think about this and not delegate the assessment process to the committee that's doing the review. The assessment process should come first. There should be some criteria that are used and some process that is used to determine which committee or which process the review will be used for the review of that project. That is a screening process of a sort. So somebody needs to be saying, you know, all greater than low risk projects to the right, all lower risk projects to the left, and some things that may be exempted for review, we're going to have a different process for that as well. But those things need to be before the review process. Asking a committee to consider whether a project has been appropriately allocated to it is too late. Of course, you can do it. But again, the process should occur for it. And you should be clear in organizations what that process is, who's doing it. It should be policy based. Somebody from the outside understands what the process is, as well as people inside an organization. So we've talked about that a fair bit. And the idea that assessment of risk is a shared responsibility. Researchers need to make a preliminary judgment as to what they consider to be the appropriate level of risk in order to determine which form to fill out, in order to determine who to send it to, et cetera. And then somebody within an institution needs to make a judgment as to whether they agree with the researcher's assessment and where to send it. And the review committee needs to ask, do we agree with the institutional assessment that's been made, or do we think that it's actually lower risk or higher risk than it's being presented to us as? So there are three stages. But the critical one, you might argue, is the middle one. That is where the institution makes the decision. I use an institution and organization interchangeably here. Well, the institutional organization makes a judgment as to which review pathway will be appropriate. That also contemplates, of course, that there is more than one review pathway. And so it's incumbent upon any organization or institution to have a non-HREC review pathway for lower risk research. They can have more than one, but they should have at least one. And I have a personal bias towards making it as distinctive from the HRAC process as possible. So not having it be a subcommittee of the HRAC, not having it be just the chair or chair plus one or chair plus executive officer of the HRAC, but having a dedicated, perhaps quite small, group of people, two, three, five, whatever, who have particular expertise in the issues that arise in lower risk research, which are mostly about data and information. So if you don't have so many people on this committee who understand that, you're not getting the appropriate expertise being used for those reviews. And a lot of that expertise is not on HRACs. So if possible, you have a separate process. It can report into the HRAC process, perhaps if you wanted to, or not. It can go straight up through the organization without any interaction with the HRAC at all. And that's a possibility. Certainly universities use departmental models often or lower risk processes that are not a lot, that are not part of their HRAC process and they're distinctive. All right. So I kind of covered that second one. Another thing that we wanted to make sure people understood in the 2018 national statement update in the revision of section three, we intentionally removed the, the statement that all clinical trials research, all clinical trials research and all genetic research or genomic needed to be reviewed by an HRAC. We took it out of the national statement, but no one noticed or very few people noticed. And they kept saying, oh no, we can't do that. We can't review clinical trials as low risk because the national statement doesn't say we can't. So now it does. Now it explicitly says low risk research, including clinical trials, some clinical trial research, right. And so now if appropriate, you can say something is a clinical trial, but that it's low risk and you can review it outside of the HRAC review process in appropriate circumstances. The most of all most frequent example will be what some type of comparative effectiveness research where the risk is very research risk, independent of the risk of any procedures or treatments themselves, but the research risk is either very low or even zero. If you're comparing to two aspects of standard care and the research risk is arguably zero. So even if the treatments themselves are risky, right. And this is this distinction between research risk and the risk that's intrinsic to the activity itself is an important distinction that people need to make. So anyway, you can now do that. So we've made it explicit. Now people can't say it's not there. And I'll just pause here for a minute to just say that if any of you have any legal background, you'd know that there are principles of statutory interpretation. And some one principle is essentially that which is not prohibited is permitted. And another one is that which is not permitted is prohibited. And that's a different way of two different ways of approaching things. So some people approach the national statement and say, if it doesn't explicitly say you can do something, then you can't. And others approach and say, if it doesn't explicitly say you can't do something, then you can. And those are two very different ways of approaching, right. I'm not validating either one. But it's something to think about to consider. All right. I told you about the negative negligible risk thing. The reason that we've retained the other problem with negligible and low risk was that both they depended on the distinction. The low risk was defined as no greater than discomfort. Negligible was no greater than inconvenience. Right. But what's discomfort and what's inconvenience is a little subjective, certainly ambiguous. Not to mention the fact that things that are inconvenient aren't risks. They're just inconvenient. That doesn't make them risks. And so burden or inconvenience are outside the risk profiling. There are things you need to take into account, but in addition to risk, not as risks. And so that's just something to think about. So you need to consider risk, risk and burden, or if you prefer inconvenience, we use both terms because some people like one and some like the other. I'm a fan of burden as opposed to inconvenience personally. Okay. So section five, the first thing we changed is various things to align with what we had done in section 2.1. We also made some additional fairly significant changes, which we'll discuss. On the less significant end, we made modifications to criteria for certain minimum membership categories. In particular, the old layperson category, the lawyer category and the, the pastoral care, let's call it category. And then, and that was largely because we now live in a world that does recognizes at least more than two genders and arguably more than two sexes. And therefore we can't call layman and laywomen, can't say layman and laywomen is appropriate anymore. We also had to, excuse me, in talking about diversity, not talk about gender balance, but rather diversity inclusive of gender and other things as well. And we won't get into what's gender and what's sex here because that's outside the scope of what we're talking about. But there are some language issues. With respect to the laypersons, we also took out the word lay because lay originally existed to differentiate from religious. That's where the word lay comes from. And what we really want is community perspectives. Non-professional perspectives, community perspectives. So that's what we've said. It now says consumer and community perspectives. Two people with consumer and community perspectives. Okay. We added some guidance or about membership of HRC is the concept of membership pools, aspects of diversity and expertise and what can be delegated and what can't and what that means. Jumping down to the bottom one, the inclusion of advice that permitting HRC to remove an HRC. Now we have a list of registered HRCs. The reason for that list is because TGA regulations many, you know, when they were developed a long time ago required that review bodies that approved research that needed to be notified to the TGA had to be notified to the NHMRC. So that was the beginning of the registration scheme and registration obviously extended well beyond the sort of TGA requirements. So that in theory, all committees reviewing research, all HRCs reviewing the search in Australia should be registered. Now they're not, but we don't know which ones aren't because they're not registered. So there could be five committees out there that aren't registered. There could be 50. We would have no way of knowing. As it is, there's roughly 200 that are registered. And then there are about a quarter of those are institutions that are also certified have certified institutional ethics review processes. Just a side note, we don't certify HRCs. We certify institutions. The NMA program certifies HRCs. So it makes it pretty confusing. We don't control the NMA program. It's completely, it's completely jurisdictionally operated and developed and operated. And we don't even have any input. So conflating NMA and NHMRC is always a problem, but it's incorrect. Anyway, we have this list of registered HRCs. Well, what if one of the HRCs is always in nonconformance with a national statement? We can't deregister them, but now we can, because we put it in the national statement. So now the national statement says that we can. So if we had a repeat offender, some HRC that constantly was nonconforming by not having the right membership, for example, or by not filing reports for 10 years, we couldn't theory deregister them. We've never done it, but we could now. Now the two major changes we made apart from the risk levels was one was we opened the door to the possibility of accepting external ethics review, not just outside your institution, not just outside the jurisdiction, but outside of Australia entirely. And the theory there is that for some research projects, not a lot, but some, at least in theory, it could be the case that the review conducted by an external to Australia committee, let's say in the UK or the US, most people say UK, US, Canada, New Zealand, right? Well, except from them, maybe, but not from others. That's a little bit of a, you know, a little bit of an over restriction, perhaps, but maybe not. The EU is probably credible. Certain Asian countries might be credible or reliable. The standard might be reliable, but it's tough to know exactly. So what we're doing here is we're saying, look, we're not saying you should do it. We're not even recommending that you're doing it. We're saying you could, that an institution could decide on a case-by-case basis to accept certain reviews conducted outside of Australia without doing a review within Australia. Now that's part of its research governance responsibility to ensure that there's ethics review that's appropriate, right? But that can be satisfied in lots of ways. Under single ethics review, it can be satisfied by accepting the review of another HRC, not just your own. So if that's true, why not extend it beyond the boundaries of Australia? What's so special about Australian ethics review? Are we really saying that we're that much better than Oxford or Johns Hopkins? That really doesn't make a lot of sense. So people might say, well, there are local issues. Well, I think don't think there are many, but there could be some. Okay, then don't accept the external review then. That's okay. But what about the ones you can? What about the one where there's no sites in Australia? There's just people participating. And the person doing the research is either an Australian located overseas or a non-Australian researcher. In some circumstances, some sort of survey based research, it might be perfectly appropriate to accept a review that's been conducted by a university overseas. What about online research where there is no site? No one actually has jurisdiction over online research based on the participants because the participants are on their computers sitting all over the world, right? So most people say, well, it depends where the researchers are, right? So if it's an Australian researcher, okay, then Australia reviews it. But what if the Australian researcher is sitting in London? Why would Australia have to review it in the first place? So there are circumstances in which this may work. It's going to be a little tricky how to do it. And one of the ways we first said, in accordance with the standard equivalent to the national statement, and people said not, can't do that because how do we make that decision? What are you going to do? Tell us which countries are equivalent and which institutions are equivalent. We're going to have to figure it out ourselves on what are the criteria we're going to use. It didn't make sense. So we made it simpler. We said, look, if a researcher, and this is what it says in the national statement, if a researcher thinks that a project is eligible for this, then they make their case. And it's incumbent upon them to provide evidence of an adequate standard of review that was conducted. And then the institution is required to take account of that evidence, not to agree with the researcher necessarily, but at least consider it, right? If you're in an institution that will even consider this. So that is discretionary, right? So it's a window. That's all it is. It's just a window, and people can or adore. And some institutions will open that door and some won't. And that's the way it is. We can't tell them to do so. We do not have that authority. Moving on. I'll just go over this briefly. The concept of a quorum does not exist in the national statement and never has. Quorum is a feature of many institutions or HRC activity, but it's not mandated or even mentioned in the national statement. What is, is the importance of the minimum members all being present. Or if not present, getting their views into the secretary area or office or whatever sufficiently in advance of the meeting that it can be distributed to all members of the committee and they can consider it at the meeting or before the meeting. After the fact isn't good enough. Only the chair seeing it isn't good enough. Right. That's the way it's supposed to be. But obviously there are emergencies. You're on your way to the meeting and you get in a car accident. Your kids stick at home and you can't attend the meeting. What do you do? Well, when obviously you have to have a pragmatic approach to that. And so you figure out the best way to approach it. Okay, but meanwhile. You've got to be, if you're a minimum member. So if you have a committee of 20 people. And eight of them are the eight minimum members. And, and even meeting eight, those eight show up and the other 12 don't. You have a valid decision. If you have a committee of 20 people. And at any given moment 19 are present, but only seven of them are minimum members. You do not have a valid decision. If you have a committee of 20 people, you don't have to be a minimum member. You don't have to be a minimum member. Quorum is irrelevant to that. So what you call him, if you're going to have a quorum, it needs to be the eight minimal members plus anyone else. That you think needs to be there. So let's say you have a 20 meeting the old 50% plus one. You'd need to have 11 people, but eight of them have to be the minimum members. Right. That's the way it's supposed to work. It's the eight members. Some categories of two people and that we say to for a reason. So a lot, some organizations have misunderstood this and just say, we just need one researcher or one lay person. No, you need both of them. Right. So. Also to correct some deal with some misunderstandings about expertise. You don't have to have all your expertise as committee membership. You can always call off people, other experts from within the institution or from outside the institution. You can even contract with them for reviews and reports. That's your expertise. That's sufficient. As long as your minimum members, of course, are all there. So. I've sort of talked about the rest and then we get to the exemption. Issue. So we have the narrowest in Australia. We have the narrowest criteria for exemption of research in the world. Of anyone who published their criteria. And it wasn't really close. And so much broader criteria in many other countries. So we wanted to expand this. And so we did. And we. It's come out the way it's come out. We had wanted to do some other things which were not favored. And so it is what it is. It's now going to be a matter of interpretation. You know what, what people think falls into the. Necessary. Category in order to enable exemption and what doesn't. Importantly. If research is exempt. It is a decision that is made by an institution. To grant that exemption. It is not per se exempt. It never was. So a researcher can't say my research is exempt. I don't need to submit it. And that's. End of story. No. That's never been the case and it still isn't. The researcher has to say, I believe that my project should be exempt. And then someone says, yes, we agree or no, we don't agree. And if they do do agree. Then there needs to be a record kept that that exemption was granted. Some sort of database could be just an Excel spreadsheet. That just lists the projects that were granted exemption in case there are queries later and in order to enable quality checks within organizations should they do. Someone therefore needs to be empowered to grant that exemption. It could be the executive officer of an HRC. It could be the chair. It could be someone completely outside the HRC scope entirely, but someone needs to be authorized to do that. And that needs to be clear. Okay, dope. One of the things that can't be exempt. Is research involving biospecies. Which is something that in the US is very common. But it's for whatever reason. People within Australia were not prepared to take that step. So it's not exempt. Eligible for exemption. Some consequential changes from the changes that we made to five and other sections. And as I said that principle of removing the automatic link between the type of research. And HRC review and we're now going to expand that to people in research and that. Is part of the section for review. We released the national statement. New national statement on the 4th of July. I'll pause here. Kylie is one o'clock a hard line. Oh, you're probably. I would imagine other people might need to go to other meetings at the top of the hour. That's the only thing to bear in mind. But other than that, not a hard line. Those who can stay a few minutes will probably need them. So. Anyway, people in according to custom be. All our stakeholders are given six months to adjust to the changes and make changes to policy and practice. Educate themselves, etc. Invite people like me to make these presentations. To, you know, clarify matters. There's the human research ethics application form, which needs to align with the national statement. So we've had to revise that a little bit, not much more next year. And that is already now going to be available for researchers to use. The effective date is the 1st of January, as I mentioned. For projects that were. For which applications were were made. In 2023, but are going to be reviewed in 2024. Which national statement you use is up to you. You know, make you just your call about that. We're not mandating one way or the other. And there's some, yeah. We're not doing systematic training. Basically, the training is me coming and talking to people. And we do have some frequently asked questions on the site. We are hoping to do a webinar, but we didn't get our act together this year. So we're going to try and do it next year when section four will, will also be published. So we'll cover both of them at once. I recommend to your attention. Various people in Australia who are developing what are called communities of practice practice to discuss how they're going to implement some of this. And people have some pretty good ideas, but it's not going to be. Something that is provided by NHMC. It would be great if we kind of had a best practice sort of log of some time, but we don't have that yet. And I don't know if we're going to go in that direction. So section four, I'll do this pretty quick. This is what some people call the vulnerable groups section. That term is never used in the national statement, but that's often how people think about it. So we had an approach that we took where we wanted to get rid of the word vulnerability and then we were the other way and embraced it and tried to spend many pages talking about it. And people said this is all correct, but completely useless for researchers and reviewers. Can you please be more practical about how you present this and don't abandon the groups. We need the groups. So even though really vulnerability is something that's part of all human beings, existences and various ways and shapes, forms and various times in their life, that's too woolly for people to use. We need the names of the groups, right? People begged us to retain it. So we did. But one of the things we did is we added a chapter that talked about the issue and we moved the language from vulnerability to the increased risk of harm. The likelihood of experiencing increased risk of harm, that's what creates the vulnerability. What are you vulnerable to and increased risk of harm? So we just jumped over the term vulnerable and talked about increased risk of harm, although we do talk about vulnerability. And then we made another distinction. We said, look, some of this increased risk of harm or vulnerability, if you prefer, comes from certain characteristics that you as an individual or your group might have or certain circumstances in which you find yourself such as ill health or poverty that produce increased risk of harm. But some of it isn't about your characteristics or your circumstances. It's the context of the research itself. And so the first four bullet points there are characteristics and circumstances. The second four are contexts. And that's how we want people to look at it. It's all about increased risk of harm, but it may arise from these different sources, let's say, or it will be a union of both, you know, in a research conducted during a natural disaster, a public health emergency, that's the context. But the reality is that those disasters and emergencies are rendering people at increased risk of harm because they are homeless or they are ill, right? So it mixes together major themes in the reverse section four, which is currently undergoing analysis. The submissions are undergoing analysis. We talk about increased risk of harm instead of vulnerability. There's a shift in emphasis on the importance of inclusion of groups that have traditionally been excluded or underrepresented rather than saying, oh, no, we don't want to harm them therefore we won't include them. We say, no, your responsibility is to come up with a pretty good argument for why you can't include them. What can you do to mitigate the risk? And it's not just about your responsibility, researcher. Figure it out, right? Yes, there's some situations where you can't. But in a lot more than people are willing to accept, you can make it possible. And you are obligated to do so. Distinction, as I said, importantly breaking the automatic link between specific population groups and research on the requirement, as I said, there are now zero of those groups, none of those groups. Any research involving any group of people can, in theory, in appropriate circumstances be considered low risk. And the group that begged us to do this was the Aboriginal and Torres Strait Islander research community said, we can't, we're not allowed to do low risk research in our community. That's ridiculous. Lots of it's low risk. National statement needs to enable that. So we did it. And then we said, well, that applies to everybody. Right. So you can do low risk, in theory, you can do low risk research with any possible group of participants that you can imagine. And so not always. And in most cases, and for some groups, it would be, of course, greater than low risk, but not definitionally. And then we've tried to add some, to build some stronger links between a guidance on Aboriginal and Torres Strait Islander research between the national statement, which is just a sort of, you know, fairly superficial summary and the documents that go deep into what you need to do, such as the AISIS code of ethics and our own Indigenous research ethics guidelines, both of which apply to all human research, not just health research. Okay. We've changed some language in the preamble. We've changed, and the purpose goes to the limit section, change the definition of research to a core of the ARC definition. That's still not really adequate, but it's what we have. We've changed a single paragraph in section one, paragraph 1.2. I don't know if anybody knows which one that is, but it's the peer review thing. If you want about prior peer review, we've tried to make that clearer, although some people think we've made it less clear. Our process, we had a public consultation on section four, the second one for two months. We're analyzing the feedback from that, considering whether we need any further targeted consultation, but we think we won't. And that will mean we might be able to get a revised, finalized version before AHEC in February of next year, and then our council in March. And if we can do that, we'll be able to publish the 2024 version of the national statement in mid-year, and then there'll be another six months for uptake, followed by an effective date, 1 January 25. That's the projected and hoped for outcome of all of this. We will then stop reviewing the national statement for quite some time, because we've pretty much done everything except for the consent chapter. And so we're going to just not do it for a while and let it all settle. And maybe two or three years, four years down the line, we'll have a look and see if we need to do anything more to it. So that's all I've got. Hopefully folks can stay a little bit because two minutes isn't much for questions, but we can start right away. Thanks so much, Jeremy. And thanks again for agreeing to come along and join us. It's really interesting to hear a discussion like that and get some insight into the kind of thinking that the NHMRC does. Really fascinating from my perspective, the balancing of axiology, ontology, practicality, and so on. So yeah, really interesting talk. We are having some people flow out of the meeting at the moment. Understandably, people have to jump into the next thing. Please pop your questions into chat if you have them. Just to get us started, you're talking before about the acceptance of ethics approvals from committees that are overseas. I just raised an interesting idea. I was wondering if there are any initiatives or discussion about international ethical standards, development of those? No, there isn't really, which is a little surprising, you would think. Some people would say that GCP is an international ethics standard. I would object to that characterization. GCP has its place, but for one thing, it's not principally about ethics. And for another, it only applies to a subset of all human research and should not be broadened to apply to all human research, in my view. But there really isn't any, it really aren't any international. There's the Declaration of Helsinki. There's sometimes, some sort of integrity comes out. There's various statements, Montreal and Singapore and all that. But there's nothing like that in ethics. Excuse me. And I think that's partly because some countries do it so differently. What you have to do in the United States is almost all regulated by the federal code of regulations. It's law, essentially an interpretation of law. In the EU, it's law, particularly in France, where everything is reduced to law. But then you have these more guidance-y approaches in Canada and Australia, for example. And Canada has much more elaborate and expanded definitions, I mean, discussions of things. And their tripartite statement is much longer and more detailed. So because everybody does it differently, I think that there's no standards, except if you drill down, you'd find that most of the not just basic principles, but even the ancillary principles and recommendations are pretty much the same. It's just that nobody's ever bothered to try and create this one ring to rule them all sort of approach, which is a good idea. So anybody who wants to try, you know. That's off to them. I'm not seeing questions in chat. Does anyone have, actually, sorry, there we go. What have you got? Here's Kristen. What do you see? Thanks, President. Is there any consideration for updates to research excluded from mutual acceptance arrangements? Okay. Well, that gets us into a world of hurt, really. But first of all, single ethics review is a concept. And as such, what NISOC tried to develop many years ago was a national approach to single ethics review that applied to all research in all sectors. But for a variety of reasons, not the least of which was political and financial, if there's even a difference between those two, it was applied at first exclusively to clinical trial research. And then to human research, but only human research conducted in the publicly funded health sector, public hospitals, basically, right? So private health research and university-based research and community-based research were always out of the loop as part of that program. But that's just one program, one scheme for single ethics review. It doesn't, you know, it's a Venn diagram, right? The circles don't fully overlap. There was single ethics review outside of NMA, always has been. In fact, even before it was in the national statement, there was single ethics review happening. All it took was two institutions saying, yeah, I'll accept your review. So public and private hospitals would accept reviews, or a university in a hospital would have an arrangement, or two universities might have an arrangement. That was single ethics review. And that's been going on for decades, right? Nothing ever prohibited, ever. No law, no guidance ever prohibited. But as a systematic thing or a systemic thing, it arose, you know, about now 20 years ago or so. People started to talk about it and come up with ways of doing it and pilot projects, blah, blah, blah. So now what we have is I would call a failed project to incorporate single ethics review in Australia because it still largely applies to the publicly funded health sector. And everybody else just has to make do and figure it out for themselves. It shouldn't be that way. It should be one system for everything. But this is a wrestling match between the jurisdictional health departments and others who have other agendas. For example, universities. So, and this is continuing. It'll continue with something we're not going to talk about, which is HRAC accreditation. So that's kind of an answer to the question, but single ethics review, people might want to consider being as creative as they can. All it takes is for an institution to say, I'm willing to accept that ethics review as sufficient to satisfy my governance obligations, my oversight responsibilities, whatever. That's all it takes. And it doesn't have to be in accordance with somebody's scheme or program. Thank you. That's a very interesting response. There is another question that just came through in chat, but I might, if it's okay, I myself need to move on to the next thing. I might hand back to... Yeah, sure. I'll take over. Sure. Thanks again, Jeremy. Thank you so much, Kristin. So, yeah, the question that has just come through was from Lisa. Thanks for putting it in, Lisa. So she says, Chapter 5.1 now mentions institutional authorization. Is there any guidance on how this could be implemented following ethics approval? Right. So this, of course, is not at all new. All we did was put in the document a recognition of something that's been around for 15 years, which is that the concept that ethics approval is necessary but not sufficient for a project to go forward. And what really should be happening is that there's some entity that has oversight or governance if you prefer responsibility for the research conducted under its auspices. That institution has to authorize the research. One of the pieces that needs to be in place in order for that to occur is ethics approval, which they might do themselves or might accept them somewhere else, right? This is true of all research, not just HREC-reviewable research, but all research. So some people might be familiar with the site assessment process. That's what informs the institutional authorization. But it's helpful to think of ethics approval as granted by an ethics review body and the green light to go ahead with the research, the authorization is provided by the institution. And it needs to consider resources. It needs to have appropriate contractual arrangements in place. It needs to make sure that its researchers are trained and qualified. It needs to make sure that the people providing the services within that institution are willing to do so for that project. And it needs to make sure that it's been properly ethically reviewed and approved. And that is all governance and that generates an authorization. That's how it's supposed to be. But that's how it's been. Just because lots of people haven't really sort of tweaked to that being the way it actually is, we made it explicit by using that word in the National State. Yeah, absolutely. I have one question and it's sort of getting back to Chapter 3 about and the data part of it. There's that footnote, of course, about the language that's being used about de-identifiable, potentially identifiable, all those different variations. One thing that came to my mind was that there is no mention of the term anonymisation. And of course, I've been reading up on GDPR a bit lately. And how they have different rules for actually anonymised data and being exempt from GDPR compared to de-identified data and all the different ways of doing that. I was wondering if maybe down the track there might be any consideration to addressing anonymised data or is that just kind of included with the minimal risk in the way that this kind of public data is talked about in the statement? Well, I mean, I don't think that the use of terms like anonymised or anonymous or de-identified de-identification, of course, is a process, it's not a thing. Same with re-identification. I would say information isn't re-identifiable or de-identified as a characteristic. It's something that you do to the information. You make it, you know, it's an action or a process. Speaking to experts. I understand it might be different sense. Look, anonymous and anonymised, these are all words that are used to describe something. Are they in essence different because you use different words? It's all about what you're doing to information that might in one might be identifiable if something isn't done to it and then doing stuff to it to reduce or eliminate the possibility that's identifiable. It's all the same thing. Whatever you call it. Anonymous and anonymised are used in the U.S. and Europe or anonymised are used in Europe, but they've never been used in Australia in a formal sense, like in a document, like the ethics guidance or whatever. So we made the decision not to try, we actually played with that, but we made the decision not to try and mimic. We talked about the issue of identifiability and people can use whatever terms they want to describe the issues and what you do about them and how you stratify all this stuff. We didn't want to get into that in part because those words change, the culture changes and then if we're using words that are no longer used, if you prefer anonymised to anonymous but we used anonymous we're out of date already, right? And I can guarantee you that anonymised is not going to be the end of the story. Someone's going to come up with some other distinction or some other term and so we avoided that. So I would say that. But that's been around for five years and people should be pretty familiar with it by now. Yeah, and in fact, Nicholas just added in the chat a really good point. In fact, we often avoid using the term here because it creates an expectation that we feel you'll kind of always be met and there's certainly been instances of anonymised data sets that people have been able to re-identify. So yeah, that's a fantastic point. This is actually, I'd say, this is the heart of the issue is that when these terms and when this legislation was established, people had this idea that you could make something you could permanently sever and you could make things no way anyone on the planet Earth could ever connect this to this. But the world has evolved, things have evolved and we now know that that's rarely true. That if somebody tries hard enough using enough data linkage, they're going to probably be able to identify stuff. So now it's more about is it sort of what sort of effort needs to be made in order to re-identify. And if it's really going to be really hard and somebody probably has to have an ulterior motive that's negative to do it, well, that's one thing. But in the rest of the cases, it's for all practical purposes non-identifiable or anonymous or anonymised or whatever. So anyway. It's kind of like when you read a bit of cryptography and security stuff even if you've got a password that's 32 letters long and punctuation and stuff. It's just a case of how long could it take to crack it. Not that it is completely uncrackable. And it kind of reminds me of whether something is anonymous or de-identified. Yeah. A non-identifiable biospecimen. Yeah. What about the information associated with a biospecimen? Is that, how can, you know, it's it's difficult. It's a difficult thing. Anyway. Excuse me. Fantastic. Well, Jeremy, I'm mindful that we will pass the hour. Nicholas, the lock on your door doesn't make your house impenetrable. It just makes the casual passer-by less likely to open the door. Exactly. You're mitigating, not eliminating risk. Right? So, yeah. That's a perfect way of explaining it. So thank you so, so, so much Jeremy for presenting today and answering all our curly questions. I have loved this chat. I have a major in philosophy and I did a few ethics units along the way. So it's definitely appealing to that part of the brain, which is fantastic. So, yes. Thank you so much again. And yeah, for people who are still around, we will make the recording available. And Jeremy, if you're able to share your slides, there's been a couple of requests from the group for that, which would be fantastic. I'll email them to you presently and as you wish. Thanks so much. And yeah, thanks everyone for attending. And this is our final Ozdig session of the year. So have a fantastic break or festive season, everyone. And we'll catch up in the new year. Thanks. Bye.