Human Research Ethics Committee (HREC)

Professor Bill Boyd, the former Chair of the Southern Cross University Human Ethics Research Committee (HREC), outlines how HREC and review supports researchers.

Research ethics process and principles is about ensuring that you've got the best quality research that you can plan for. Now we never know how it will work out but we can plan to do research as well as we possibly can, and the research process, ethics process is part of that, if you like, quality control or quality of management, is I think is probably a better term. So it's there to support you, it's there to help you. There are some obligations, which I'll refer to very briefly. But please see this as a supportive facilitative process. So it is about you, it's about your research and the Ethics Committees are here in the university here to support you as researchers to support your students as researchers or learners. By the way we're not talking about ethics in terms of a moral code. I'm not a bishop or a religious, if you like, an ethical sort of leader in that sort of moral sense. We're really actually talking about a set of principles which underlie good practice, good behaviour, and so if you like it's a sort of secular version of morality but it's really not a moral code. So I do have occasional discussions with people puzzling over how a committee or how an individual can actually comment on the morality of a piece of research. And please we're not doing that we're really trying to evaluate a proposal for research against a set of standards, and these are really the standards that at least in the Anglophone world largely we take to be the standards for good behaviour, at a sort of personal and social level.

The usual question, when do we actually need to use it? It's really simple, whenever you're engaging people in some way in you're research, that's what human research is. Now the old traditional one is that we'll have a pile of subjects. These are either anonymous people answering a survey or they're people in a hospital bed that we will want poke things in to test how they respond to medication or to some surgical something or rather. But it's in fact much broader than that, and most of the research here at Southern Cross University tends to be fairly benign. It tends to be social in nature, there's elements of cultural research, there's a little bit of intervention, experimental work, but we're largely engaging people, looking at how they go about their daily lives, how they go about their professional lives, what their views and opinions about things are, how they respond to social stimuli, for example, so it's the breadth width and breadth of social sciences which is really our primary interest. And oddly enough when I go and visit other universities you realise that we, we have this body of expertise and comfort with that arena of research. Other universities find it quite troublesome because they're use to the more experimental end of research.

So any time that we're surveying people, whether that's formal surveys, online or offline, whether it's focus groups, discussions, stopping and talking to people in the street, working with what we might call key informants, specialists who, you know, have a particular role in society and their business as professional people. Any form of engagement is human research. It maybe passive observation and there are lots of ways that can be done. It can be done quite explicitly, you may be embedded in an organisation, you may be taking part in activities, you may be removed from them. Again if you're observing people's behaviour, that's human research.

There is a little bit of experimental work. The psychologists do a lot of perception and psychological experimentation, often using computer programs asking people to respond to particular stimuli and looking at what those responses look like. We have a little bit of clinical trials, especially in the naturopathy area where we're looking at people engaging in trialling supplements. These are often very formalised, very structured experiments that come out of that tradition of clinical experimentation. There's action learning, action research, community engagement, the list can go on, but basically if you're engaging people, that's human research, and you should think about whether you need human research ethics application.

People who are engaged in our research are participants and we have to remember something very, very fundamental, nobody actually needs us. Now that may seem a bit bold to say but most of the public never need to meet an academic in their life. They'll get on happily, they will live their lives and maybe not happily, but they don't need to actually engage us ever. We need them, because our job, part of our job, our job description is to create new knowledge, and how do we do that, we observe the world, we collect data and if we are in the area that involves people, we have to engage people.

We need them for our degrees, for our papers and to complete our projects. But they don't need to ever come in contact with us. We create reasons why it's good for them to do it, and they will, if they involve themselves with us probably get a good feeling, a soft cuddly feeling they're doing us some good, they're engaging something which might be quite interesting. Most research gives almost nothing back to the participants at point of contact. It's actually very hard to find ways of doing that. There are ways of doing it. I have a PhD student now that's doing that quite deliberately looking at the survey design in order to give point of contact feedback, but that's rare, that's very rare. So we need to remember that our participants are there out of the goodness of their hearts. We need to respect that, we need to make sure that we don't do them any harm, that we give them as much positive as we can and we need to look after them and protect them. So that's what the research ethics process does; it partly does is partly asking us to protect our participants.

Now these participants aren't just the people giving us information or sharing information, giving us their stories. They're ourselves, they're our research assistants, they are the people around us, and we often forget that the research we do can affect ourselves as researchers and we've got to look after ourselves. The very basic workplace heath and safety principle, if we are uncomfortable or stressed, if we're at risk, we do not do our job well. So we know that if we come into a place where, and you hear stories of people coming in and they're anxious because they think another colleague's going to say something about them or they're anxious because the lab they are working in is smelly and they're worried about the chemicals, they don't work well. And this applies here if we do research and we're putting ourselves in a risk, we're reducing the quality of our life, we are reducing the quality of our work and ultimately we're reducing the capacity for our research to yield good outcomes.

We have to protect our institution. As I said we are licensed. If we as researchers misbehave, if we do shoddy research, it's a wonderful piece of beat-up for the press, wouldn't they love to have another go at the universities, because look what this one researcher's doing. Very very simple little things. We had, I'll give you a really simple example we had a researcher doing biopsies on dolphins a few years ago now. It's a really simple technique‒little bit of skin they can get , do chemistry and put genetics on them. How do you get them? It's a very simple little dart gun that you use, the dolphin doesn't notice, it falls off in the water, you pull it back with a piece of string and there's a little bit of skin there and they can do their chemistry and biochemistry on it. Unfortunately you don't stand on the main beach of Byron Bay with what looks like a rifle shooting at dolphins. Yes, it's not the smartest thing to do. It's not unethical, it's just dumb. But it caused quite a public response, you can imagine. And it's very easy for us to do that without thinking and hopefully again the ethics approval process helps you think through some of those things. And planning is everything, time spent planning, just thinking what are the trip wires, what are the things we shouldn't do? That one was sorted but you know it wasn't the smartest thing to do. So you can see that the institution, of course that person nobody knows who they are, they are the University, and so the University gets tagged with that slightly unthoughtful act really. Yeah, it's not what we like to be known for.

Ok, the other side of it of course is as you're getting from me, we're facilitating quality research. We're helping you and a great deal of what I do is talk about research long before it comes to the committee. Probably half of my time maybe more actually now, is just talking about research which I love doing and it gives me a little vicarious pleasure to talk about everybody's research. Some of you will know that I tend to work right across the disciplines, so I've got this sort of interest, I get bored easily so I like to hear about other people's research and disciplines I've never heard about. I've worked in the cultural theory end of things, I've worked in the geo sciences, I have a fairly good understanding of research across the board and I just enjoy talking about it. And the more you talk about your research with people the more ideas get matured and you get new ideas and you know that's, talking with people, sitting having a cup of coffee in the corridors and your tearooms, just sort of sounding out ideas is enormously powerful. And we do it in the context of the research ethics principles and what we then end up with and I've watched this over the years, the quality of the applications coming to the committee have been improving. The number of ones we're having to knock back, well we very rarely do, but we have to work further on, and the ones we have to work further with are the ones that haven't been discussed. They've come off, they've been rushed, they've been done without somebody talking with their supervisor. It's quite clear what the pattern is. So discussing it, talking it, take that opportunity and I do a lot of that to help. And the committee will help as well, we may actually send suggestions back. We've got experts there that quite often will stand up and say, look, I'm happy to go have a chat with this person because this is something I know about, we'll be able to help them redesign it so it really works well.

Obligations and guiding documents

Professor Bill Boyd, the former Chair of the Southern Cross University Human Ethics Research Committee (HREC), outlines responsibilities and obligations that researchers and the institution have.

This University is licensed to be a research institution and we get our licence by meeting a number of obligations. We need to have a process in place which we have. We need to have a research ethics committee which we have. We need to require our researchers to apply for research ethics of approval, and they do it through a process which is formalised and acknowledged by the Federal Government. We need to report on that every year and every year I get a letter saying thank you very much for your report, you're meeting all the obligations and we allow you to continue being a research institution. Last year we had an interesting response. We have tried to be as honest as we can and we do acknowledge to them if we have an issue. We had an issue with compliance and they acknowledged that we had issue but they also acknowledged that we were doing something satisfactory about it and yes you can continue being a research institution.

So that's quite a high order obligation and you can see where the groundwork obligations sit with you as academics and as students as, members of the University having an obligation to apply for ethics approval, for us to have a process, a committee that then reviews against the standards and authorises that approval. And when we meet that kind of compliance process as we do then we're allowed as an institution to continue doing our research. It's when we breech that, that we put that at risk. I don't know of any institution in Australia that has been suspended but it is entirely possible. It's more likely that we have an area of research that misbehaves itself for some reason or another and that we are asked to stop conducting that research. That's more likely to happen internally. But it hasn't happened yet so we're all very well behaved.

There are a couple of guiding documents and if you haven't seen the National Statement on the Ethical Conduct of Human Research, your homework tonight is to go and download it. It's a free download, it's easy reading. It gets reviewed periodically. It used to be a five year review of the whole thing. The National Health Medical Research Counsel who manage it, are on a rolling review so when issues have to be updated as, for example, the world of stem cell research is evolving really quickly so the ethical parameters around it are evolving. They'll be updating it so when you need it go in an download the most recent version of it, and what I'd ask you to do if you haven't done so is have a browse through it, read most especially the first couple of chapters because that sets the definitions and it talks about the principles.

Even if you don't ever end up doing a human research ethics application, it's actually a really powerful statement about what makes good research. And if you follow the principles in there you will design your projects and your programs to work as well as they possibly can. We can't guarantee they will work, but you can actually minimise the trip wires that inevitably turn up in research and if we can do that then we're well ahead.

The Australian Code for Responsible Conduct for Research is a somewhat larger document but it's again one that all researchers should know about, should probably have a look through, lots of more detailed advice on lots of areas of how to plan, implement, design, put into practice research in a way which is ethically sound, is practically sound. The bottom line with both of these documents is that what we want to do is to able to ask research that is useful and meaningful, it has merit. We don't want to ask the sort of trivial stuff that the rag trade magazines. You know what's the proportion of men that wear red ties, yeah, not really much worth asking, we don't dust that as scholars, or maybe we do for a cultural theorist, but you know mostly we wouldn't. We need to ask sensible, deep, useful questions that will do something useful for our society. We need to design it in sound and rigorous ways that are recognised by our individual scholarly communities. So within our disciplines what is the methodology that is validated that been shown to be sound and can we design it in a way which will work? And I say to people how do we know it will work, whether to work with the best guess, it will generate data which is sound and sensible and rigorous and in itself is got a reasonably good chance of actually answering our questions with sensible answers. That's as good as we can get.

We have to remember we have a responsibility, a public responsibility, as a public university. Our results however obscure they may sometimes seem and we wonder whether anybody ever reads them, potentially have the capacity to influence public debate, influence public policy and practice. If we are doing teaching and learning research it may be that something that we do will influence the next generation of how school curricular are designed if we get it well, we're going to make a positive contribution. If we get it wrong we have a potentially huge amount of damage. Public policy based on shoddy researcher can be bad public policy. It could be a lot of money, it could be a lot of grief attached to that if we get it wrong.

So this is what this is trying to do, is help you make sure the research you do is as sound and solid, has got as good a chance of actually achieving something sensible at the end. Now what we can't do is actually guarantee it will work. So the defence that I've seen from one PhD student is: Ah, but why have they failed me because you gave me ethics approval, it must be good. Anyway there's a little bit obligation there but those two documents if you haven't seen them get hold of them, be aware of them.