“A discussion about the throttling of clinical knowledge exchange by well meaning but ill-informed ethics committees is a topic for another paper.” Goble et al., Accelerating scientistsā knowledge turns
Gareth Beale andĀ Steve HitchcockĀ have been piloting a proposed study of three-dimensional data practices through institutional ethics clearance. Here they recount the experience so that others who are new to such processes – probably most of us – can save time, and some pain, and devote more energy to the study at hand.
Mesolithic stone tool captured in 3D by CT scanning. The growing importance of image and 3D data in all areas of research require us to think deeply about how we treat these data.
So you want to find out how researchers at your institution generate and manage data. No problem. Set up a survey targetted at a well specified group. It will be fair and rigorous, the contributed information will be handled carefully to ensure anonymity of data soĀ it won’t give secrets away or embarrass anyone. By the end we will have learned something that will shape our approach to data management and that we will share with the world by publishing the findings. Easy, done it before.
Well, things may not be quite as straightforward as you think. Current regulations require that all research, regardless of its nature, must be reviewed by an institutional ethics committee. Where humans are the subjects of the study this process can be lengthy and intricate. The need to guard against dubious research practice is a matter of great concern to all researchers. However, this post will argue that the system of ethics governance can cause delays and obstructions which threaten to hamper small ethically non-contentious research projects.
It’s not hard to imagine ethically dubious research practices. If you were the subject of a medical trial, say, you would want to know there was proper oversight to ensure full ethics compliance. In our particular case we are investigating practices in capturing and managing image and 3D data, beginning with 3D images. That does not immediately suggest big ethical dilemmas, but you might be surprised.
First, we are going to defend the ethics procedures here at the University of Southampton, even though hearts sank when we realised we would have to discover and learn this process. We have been helped through the process by numerous people intimately familiar with it. Once you understand the system it works well, and the process is logical andĀ rigorous, from an ethics perspective. All submissions have been handled promptly, and responses are not obviously ‘ill-informed’. So what can go wrong?
- It can extend the timescale of your survey substantially. It might be first-time syndrome in our case, but the process has taken from mid-July and has just been approved. At Southampton there are online forms and six Word document templates to complete, so plenty of scope to take some wrong directions.
- You can end up committing yourself to an unworkable design or plan for your survey.
- You can tie yourself in knots over issues such as anonymity and confidentiality, to the extent thatĀ your capacity to publish data may be restricted, and unless you are careful, you can forget about open data.
- After the project has ended and staff may have moved on, you may find no one is authorised to access the data. So much for data verification.
How do we deal with the problems presented here? First, realise that this ethics process is here to stay, so we need to get used to it. In that case we need to treat ethics as integral to the study and not an additional hurdle to be jumped and then forgotten. That means starting with the design and planning of the study, rather than with the ethics process. The design will inform the ethics. In that way you will get consistency and hope to avoid unintended commitments in the ethics submissions that will later restrict your study.
However simple you think your study may be, the ethics process will present you with unexpected questions and tricky dilemmas, particularly when it comes to data dissemination, which is at the heart of research data management. Tackle these honestly, and try to envisage the longer-term consequences. Often the simplest approach to ethics may to limit and restrict studies, effectively to promise to do nothing with the data beyond your project or group. Ethics submission templates and questions may even be designed to lead you in this direction – easier to comply than confront these issues, especially if the ethics process is simply something you want to clear or avoid. Resist the temptation. Publication and open data are still possible and consistent with ethics clearanceĀ if you respect and present in your design the ethical principles of treating your subjects fairly.
There remains the issue of responsibility for confidential data. Survey results will typically contain some data that will remain confidential, notably identities of the subjects and how these might be linked to their contributions to the survey. It is important to remember that someone will have to be responsible for ensuring continued confidentiality as long as these data exist somewhere. As projects invariably come to an end and project staff may move on, this may not be as simple as it seems. Responsibility needs named individuals, and the means to authorise the passing of this responsibility to someone else. This is another process that projects will have to delegate effectively at conclusion, but first any studies subject to ethics approval have to specify names and a procedure that will enable this to happen.
The process of gaining ethical clearance to proceed with research is rigorous and has the capacity to shine a light on areas of your research that may not have seemed to be ethically significant when writing the proposal. However, the process is also time-consuming and perhaps unnecessarily complex where ethically uncontroversial projects are concerned.
We do not doubt that ethics clearance will ‘throttle’ some studies as Goble et al. suggest. Those studies with more difficult ethical issues to confront will find some ethics committees intractable, or researchers may be unwilling or unable to make the necessary compromises. Studies may be lost through the simple expedient of losing too much time on ethics clearance. We may have been lucky – we can still proceed despite the delay.
It’s not only the big issues that cost big time. Failure to align your marks perfectly in columns or rows of anĀ MS Word tableĀ can cost you one extra round of the reviewing process, and a few more days. As can declaring that audio recordings will be made of interviews with subjects (a legitimate ethics issue, clearly), but failing to specify which medium (tape/digital/minidisc, etc.) will be usedĀ to record (less obviously a major ethics risk). Those extra days and rounds add up, as the documents circulate again between author, supervisor and reviewer. Don’t even think about going away!
As for our actual study, the investigation into 3D data portends some fascinating insights into a technology that is growing rapidly and is already sparking popular imagination:
Is this a common experience? Have others had similar experiences when confronting ethics processes for their research data surveys? Or are we at the precipice of change in the way we perform standard research surveys involving other people.
We were at once reassured, surprised and frustrated by our experiences with University of Southampton ethics governance. It was reassuring to observe the degree of attention that our research was receiving and heartening to receive detailed comments on how our research could be modified in order to conform to ethics guidelines. It would be worrying if research were not checked in this way. We were surprised by the complexity and intricate nature of the process to which our research was subjected, particularly given its relatively uncontroversial nature. The timescale over which the whole process took place was frustrating.
If ethics procedures are to be modified perhaps it should be to simplify and speed up the process, especially for those studies that might be quickly classified, through the process, as low risk. At Southampton there is such a classification, but that did not save us from an extended process.
Until that happens, or until all ethics submitters become more familiar and competent with the process, our experience may save others new to the process some time, and pain, so they have more energy to focus on their study.