Saskia Leinius, one of the past Ethics Managers at the Office of Research, shares tips on considerations researchers should take when applying for ethical clearance.
The first really important top tip is to familiarise yourself with the relative legislation and that's the National Statement. The National Statement, we've got a link on our website which always links to the National Health and Medical Research Centre, who, always, update the National Statement and so you'll always get the most up-to-date version. If you want to download it from our website, it will lead directly to download link on the NHMRC website. And the most important sections to cover for you before you even start your application are the first two sections which cover in section one the values and principles of ethical conduct and then the themes in research ethics like risk, benefit and consent. Section two is divided into three different chapters, which cover risk and benefit then general requirements for consent and then qualifying or wavering conditions for consent. So we do urge you to read through those very conscientiously.
Tip 2 is to know the process and to apply for the correct application. So we've got the two processes - which is the expedited low risk process and the higher risk process which we call NEAF, where you have to fill in the form online and then submit it to us. But if you go through Tip 1, reading through the first two parts of the National Statement that'll help you identify which path to take and which application to submit to us.
Always use the latest form. That's another top tip regarding the process and you can download them via the links we provide.
Then generally, general ethics guidance, so to think critically actually about ethical issues right through from the very, very beginning, from your research question through to your recruitment, your data collection, the writing up of your findings as well as the dissemination thereof. Really consider each of the stages of your project, and think critically about any ethical issues that might arise there.
Some of the key issues to consider there are, privacy and confidentiality, perception of coercion and recruitment, and risk. And these are, of course, you know these are not, it's not an exclusive list, these are just the most common things that we find people, might lack some considerations on.
Tip 4 is to be realistic and declare all risks. But don't say there's no risk, just tell us what the risks are, identify all the risks and be sure that you design your research to minimise the risks and also put processes in place to deal with them. That's really important that you just work around what risks you identify and adapt your research to deal with them.
Just some common errors that I want to just briefly touch on. Never say there's no literature. Something that we have trouble with sometimes at HREC meetings is that researchers communicate in just really posh language and people don't really understand exactly what their methodology is. So just use lay language as if you were talking to your daughter or your cousin or someone who you really want to explain the gist of you're doing. And clearly convey your project's methodology, the aims and objectives and the benefits and risks.
Attach all the necessary supporting documentation. There's information consent forms for example that we have samples for on our website that you can just download and adapt to your research which is really helpful for you. We provide all the links further down to some of the supporting documentation. And really to think about what would we want to see. So if you, for example, involve another institution in your research you will want to communicate to them and maybe get their consent that you can even involve them in the research. So, also letters that might go back and forth between you, advertisements that you might want to put in place to advertise. Anything that you can think of that is related to your research and to communication to participants.
And then of course utilise your mentors, your supervisors, your colleagues and us of course, and we can't say that enough, just give us a ring, we're really happy to help you and even if we personally can't help you we can surely put you in contact with someone that we know can help you along the way.
The first one was to avoid the last minute rush. Allow generous time frames to plan to complete the application and allow for changes requested by HREC, so that you can actually work on those changes. Then check the HREC meeting schedule, which is also something that we've got on our website and the links will be provided further down. And plan well in advance which date you will aim to submit your application to. And again like Louise said, we're always happy, if the date comes and you're like, arrrgh, I'm not ready yet, I need some signatures. Just give us a ring and we can, even if we have already sent out the agenda we will just put it on an agenda and send your application as a late item to members even if it's a week before the meeting. So just talk to us. Make sure that the information for and the care processes for participants are thorough and sound and then ask for help early in the process.
Professor Bill Boyd, the former Chair of the Southern Cross University Human Ethics Research Committee (HREC), goes into detail about the principles HREC refers to in the ethical review process.
The way the National Statements is couched there are four principles ‒ respect, research merit and integrity, justice, beneficence and respect ‒ and then they talk about the risk. The principles very simply, research merit means is this worth doing, so when you're up you're applying in your application you have to validate why this question is worth doing it. How do we do that? As scholars we do it against the literature. There is a literature of authority out there saying here's what we know about this problem, here's what we now need to know, therefore I'm going to ask you, ask these questions. That's all your doing. Now that's the lit review role in applications for grants, same for us in your theses and so forth.
Integrity refers to, oh sorry, also merit may be a pragmatic. And a lot of our researchers and say scholarship of teaching and learning, it may be a link to industry contracts. You know a company is wanting to evaluate their staff development program. That's a really practical research project, that can be the merit that you need, this has been recognised as a need within this company, I've been contracted to do it, therefore, and I need to seek ethics approval to do the things we need to do to achieve that outcome.
Integrity is about the quality of the research methodology and methods. Now there is a critique that we sometimes get is that you as a committee are not authorised to critique my methods. Now strictly we are not a methods committee but the methods that you're proposing give us an indication that you're meeting these principles.
What I mean by that? The methods and methodology used, you've got to demonstrate that those are the authorised, validated methods within your discipline. So we got lots of disciplines in the University. To take a really facile example you wouldn't take a experiential survey and use it in the chemistry lab, that's just not sensible, but there are disciplines which are much closer and your job is to say, in my field this is the kind of inquiry and the kind of methodology that my colleagues use that are published and therefore I am going to use it. And that's your validation that it's appropriate to the questions you ask, in the context that you're doing it. And then you're going to describe the particular methods and how you've constructed them and build them up and again we're looking for internal validity, sensible design. And very often I'll get for example a design that said, this is what is used, this is the tool that's used by people in my field and therefore I'm going to adapt it. Now that's a very good sensible thing. Does it look like it's designed with enough samples, the right kind of participants and so forth, that's the things we'll look for to see that's it's internally coherent. That's what we mean by integrity.
So there is no design, there's no method, which is out of bounds. The only method that doesn't work is the one that's irrelevant to your topic or your discipline, so, and you're going to make a very good case why you might be borrowing from another discipline. The new humanities do that, they do it very powerfully, but that's context relevant.
Justice is about fairness of recruitment, that's the really good indicator. Are the people you're engaging the appropriate people? Do you need key informants. Do you need targeted individuals, is it a population subsample, what is relevant, and have you given them a fair opportunity to be recruited? Is your recruitment strategy, fair and just? And that's the best indicator that you're dealing with justice. It's in there largely due to the rather sorry history of mid twentieth century medical research, which was fundamentally unjust in many of its precepts. And we will look at some of the principles that underlie why you're doing it, so, there maybe for example a research method frame, which is just fundamentally wrong. You know, the classic old one was the notion that, people's skulls somehow represented their intelligence and it was always culturally laden right across the world for a long time. There were assumptions that the shape of a human being's skull would some how tell them something about their cultural behaviour and you know that's something which is now gone out with it, well we hope it's gone out with the ark. But if I saw an application that came in and said well we've going to do some phrenology because that's going to tell us about linguistic connections, we'll say, look, that's just fundamentally wrong, it's unjust, it's been proven not to be appropriate. But mostly justice we're dealing with how you're recruiting your participants.
Beneficence comes back to that benefit to the participants. I talked about that earlier. It's actually on the face of it a very obvious one, but it's actually really hard to demonstrate in most cases. The best most people can do is say, we will do no dis-benefit, we will ensure that our participants are safe, whether safe physically, culturally, emotionally, reputationally and we'll ensure that we do no harm, that old mind trip from the medics, first of all do no harm. Which interestingly keeps being quoted, it's been made up, probably about in the 1890s and claimed to be ascribed to the Greeks, it's quite an interesting little ethical dilemma. But anyhow you can demonstrate, and how do you do that? Well you look at risk. What are the risks? I'll come back to that in a minute. How will you deal with them? What are you asking people to do? We will look at that package of how you're interacting with people and is there a potential for doing them more harm than good? And there certainly shouldn't be.
If all of these are in place the respect principle comes through. We need to respect our participants as I said, they don't need us, full stop. We need to respect that. How do we judge that as a committee? We look at things like, how you will interact with them? Are you asking them all to come into the University. Are you happy to go out to their community centre? Are you talking to them about when would it suit you to meet me? How would you like to do it? Have I given you the opportunity to withdraw? Have I given you informed consent? Do you know what I'm doing? Am I using language that you understand?
There's been a habit and there's still some academics that like to talk in intellectual waffle, this sort of pompous arrogant nonsense that you hear some academics using. If you're talking to a community person or a group of children, you don't talk like that because what you're saying is, I have no respect for you, I'm god almighty and you're just a, you know, you just listen to me and respect me. Well they don't. And we see examples of information sheets that even we don't understand, and we send it straight back and say, pure disrespect, you are insulting these people, and we don't accept that. So we're looking at the language, we're looking at your proposed way of interacting with your participants. The kinds of questions you're asking, the kind of language you're using, and that's a very good mark of respect.
Finally the risk one. The National Statement is really clear about risk. It defines it in very simple ways. There's negligible, low, moderate or high, and we'll come back to their consequences. There's two groups, negligible and low, and moderate and high, and we'll talk about that divide in a minute. They're defined in very simple terms. There's no such thing as risk-free research so don't say to me there is no risks in this research. There will be, there's inevitably, there's risk in just like getting up in the morning, living. But then you'll come back to me and as I have had from a number of researchers, if I tell you what the risks are, you won't let me do this research will you, and I say well actually it's not up to me to let you do it or not. But it's not actually true. If you don't tell me there is risk then I'll come back to you and say, well tell me what the risks are, so silence is very loud.
If there is risk, what I say to everyone is, put it on the table, be really honest, maybe even overstate it if you really worried. Put it there, because once it's out in the open then you can ask the really important questions. You can say is this risk worth having for this research, so the balance of imports and risk. So if it's the next wonder drug for, that's going to cure cancer worldwide, then we might have some fairly high risks to get there but it will be worth it. You might have to make that argument a bit strongly. But it might be an ultimate risk that a patient dies, and that's pretty serious. But you might be able to make the case that says this is worth doing. If it is something perhaps slightly less of an impact, a lower risk, a lot of the research we do is fairly low level social process stuff. We really can't have a high risk, so you try and balance it and the National Statement talks about balance, and reviews that part of the National Statement, not often but on a few occasions to say, we don't accept the balance between the input of this research and the risk that you've prepared to have in there.
So that's one aspect. The second aspect is that then you look at this risk and think now what am I going to do about this? And there's two things you can do. One is you can go back to the design of the research and say, well what am I going to do to minimise this risk, and often it's not rocket science, it's something really simple. It may be dropping a question from your survey. It may be finding a different place to hold your focus groups. It may be just dropping out one little part or modifying one method, and we can all do that, and often that just brings the risk level down, very simple, not rocket science. The other side of the equation is, now the risks are out there what am I going to do in the event that the event actually happens, and it doesn't, actually, most risks don't eventuate. But if they do, what am I going to do to support the participant? You know, to look after them. And there are lots of ways of dealing with that. There are services, there's support mechanisms, there's reporting mechanisms and so forth. But having them on the table allows you to have that discussion, so this is the power of that discussion, being honest, open and we'll never knock something back however high risk it is, if the design wrapped around it, is sensible and is balanced, as simple as that.