- Research
- 07/01/2020
Ethical testing aims to protect test subjects
In advance of starting, TU/e research involving test subjects or recognizable data taken from individuals must undergo ethical testing. This requirement came into effect on January 1st, having previously applied only to medical research. The Ethical Review Board (ERB) has worked hard to prepare the ground; it wants the new testing regime to be sound - while at the same time its members see this development as a joint learning process. “Suppose that within two years we find ourselves simply rubber-stamping projects because TU/e staff are familiar with all the considerations involved in dealing with their test subjects in an ethical manner. That would be the ideal scenario,” says ERB president Anthonie Meijers.
“Our primary aim is to protect test subjects,” Anthonie Meijers emphasizes, formerly a longstanding ethics professor at TU/e. For the rest, the work of the committee, which was set up at TU/e in 2019, has plenty to offer scientists in the way of benefits, the president contends. “Increasingly, when they are placing an article with a journal or making a grant application, they are asked for the opinion of an ethical testing committee.”
As well as assessing the university's non-medical research projects, the ERB members will also become the go-to people at TU/e for questions on research ethics, and will help with the drafting of sections on ethics in, say, grant applications. From now on, any non-medical research involving test subjects or recognizable data taken from individuals must gain the ERB's approval before data collection can start. Medical research in the Netherlands has long been subject to statutory ethical testing, conducted by a recognized medical ethical testing committee, the METC. TU/e also assists its staff taking this route - via Susan Hommerson, coordinator of medical & medical device research.
Balance
TU/e is the last of the Dutch universities to set up such as committee, i.e. university wide, tells Meijers. Until now, only in the Human-Technology Interaction group of the Department of IE&IS have the ethics of research been tested by a committee - because here they have a long history of working with test subjects. With TU/e researchers increasingly involving people in their research, and grant providers increasingly requiring approval, the time was ripe to set up a university-wide ethical committee here at our university.
The key question in TU/e's ethical testing is this: ‘Is there a reasonable balance between the expected benefits of the research and the hardship experienced by the test subjects? Important aspects in this regard are the protection of weaker groups and persons and the preservation of their human dignity’ - to use the working group's own words.
While this approach - including a checklist - provides guidance, Meijers and ERB secretary Jolanda Habraken emphasize that it will be necessary to examine on a case-by-case basis ‘what the scientific benefit is and what the test subjects are being exposed to’ and whether the research methodology is sound.
The ERB has defined various levels of testing. At level 1 are the applications involving minimal risk to test subjects. ERB secretary Jolanda Habraken explains: “This is the case when completely anonymous data are collected and there is no question of vulnerable target groups or sensitive topics. By the last, we mean, for example, interviews with children or where the questions concern a particular religious belief. In this case, an accelerated procedure exists involving approval from within the department."
At level 3 the research studies are more complex and the consideration of the full committee is required. “Think of Atlas as a living lab or of the research involving Helmond as a smart city”, says Meijers. Level 2 lies in between and applies to research that is in many ways similar to research that has previously gained approval.
Meijers says that the assessment is a joint learning process. “It is our wish - and something we are working towards - that within two years all TU/e researchers will know what is expected of them and when they need to contact us. It would be nice if by then rubber-stamping is all that is required. This isn't supposed to become another hoop that researchers have to jump through. We are here to help them.”
In any event, the (central) ethical committee will handle all applications. This comprises members of every department who reach joint decisions about the application. Meijers: “In principle we aim to achieve consensus within the committee. If that's missing, we first seek external advice. If that doesn't resolve things, a two-thirds majority of the committee members breaks the impasse. But I expect that to happen rarely.”
Meijers and Habraken do not expect to see many applications rejected, but it may well be that a proposal needs a number of revisions.“The other day I had a research proposal in which test subjects were asked all kinds of questions that were not relevant to the research objective. So those questions have to be omitted,” says Habraken by way of illustration.
Bundles
Habraken and Meijers find it hard to estimate how many applications will be handled in a year. “I know they have about six hundred in Delft, so for us three hundred would be a reasonable estimate. We want to assess the applications as efficiently as possible. The majority can be dealt with within a department. In addition, we'll aim to assess research projects whenever possible as ‘bundles’,” says Meijers. An average of four to six weeks will be needed before the committee, which meets once a month, can make a decision about a research proposal at level 3, says Habraken.
Similarly, student projects involving test subjects will need to be seen by the ethical committee - but in most cases the applicant will be the lecturer involved. Student factions Groep-één|ESR and DAS have previously had concerns about the consequences of ethical testing in TU/e's education. Their greatest concern was that students' work would be delayed. This matter has been discussed by the University Council. On the advice of the student fractions, the ERB will cluster applications whenever possible with a view to granting a swift approval.
More information about the work of the ERB is posted online.
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