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Perspective from a REC chair in Europe<\/span><\/span><\/span><\/span><\/span><\/h2>\n\n
David Shaw - Maastricht University <\/span><\/span><\/span><\/span><\/span><\/h3>\n\n
<\/p>\n\n
So, a research ethics committee is designed to protect participants in research from potential harms that research can pose to them, and those harms can be physical harms, and includes everything all the way down to simply wasting the time and inconveniencing participants. So, scientists and doctors and other researchers write applications, send them to the research ethics committee, and then the research ethics committee has a meeting in which they discuss these applications.<\/span><\/span><\/span><\/span><\/p>\n\n
Very often they have to contact the applicants to ask for information that should have been included in the application but perhaps wasn't and we spend a lot of time doing that. But once all the information is provided, we can normally approve research fairly easily.<\/span><\/span><\/span><\/span><\/p>\n\n
Common issues include, as I said, wasting participants' time including too many participants and sometimes a failure to consider important ethical issues that haven't occurred to researchers. So sometimes they will say there are no ethical sensitivities in this research even though the research<\/span><\/span><\/span><\/span><\/p>\n\n
involves, for example, drug use among teenagers, which is which is obviously a very sensitive topic.<\/span><\/span><\/span><\/span><\/p>\n\n
<\/p>\n\n
Another issue is the consent procedures for research. So, it's not just that the ethics committee has to be happy with what the researchers are doing, we also have to be happy with the information that's<\/span><\/span><\/span><\/span><\/p>\n\n
being given to participants and of course that has to correspond very closely to the information we are giving. So really there shouldn't be any mismatch between the materials sent to the REC, the research ethics committee and to the participants. So, if we find information in the protocol that's not being disclosed to participants that can obviously be an important issue.<\/span><\/span><\/span><\/span><\/p>\n\n
Protecting participants is our main concern but we also flag up other kind of compliance concerns<\/span><\/span><\/span><\/span><\/p>\n\n
like data protection and data management and they have to have a clear plan for that as well. And last but not least scientists sometimes don't like it but if there's a flaw in their methodology we will also point that out as well because if there's no risk to participants, but if the research can't answer the research question it would be unethical for that research to proceed.<\/span><\/span><\/span><\/span><\/p>\n\n
<\/p>\n\n
At my committee, we are at the Faculty of Health, Medicine and Life Sciences at my university. And so it's often research, not hard medical research involving clinical trials and so on, but softer medical research, which isn't technically under the legislation, not human subjects research. So, it might involve patients, but not invasive procedures in patients. Quite often qualitative interviews and surveys with patients or people living in care homes or other institutions.<\/span><\/span><\/span><\/span><\/p>\n\n
So that's on the more medical side. We also get lots of academic applications, again, looking at stakeholders\u2019 views, patient views, views of the public on important medical and scientific issues. And we also review lots of student projects, which are sometimes PhD students.<\/span><\/span><\/span><\/span><\/p>\n\n
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And our committee also operates a series of licenses for courses such as like the master's in public health. So, we issue a license that covers certain projects. And so the course coordinators have their own ethics assessors who can review internally. But anything that goes beyond the conditions for which we've issued the license, the application will get bounced up to our committee.<\/span><\/span><\/span><\/span><\/p>\n\n
So, we are normally dealing with most applications are fairly straightforward, but there are just some vulnerable populations involved, such as quite often school children and people with dementia and other difficulties living in care homes. So, it's a very wide gamut of applications that we can receive.<\/span><\/span><\/span><\/span><\/p>\n\n
As Chair of an Ethics Committee, you have to get through the applications and in our case the two hours that you have available. Sometimes it's a meeting, at a quieter time of the year, we might only have six or seven applications, busier times, it could be as many as 20 applications. And unless you're lucky and they're straightforward, you can't get through all those in a meeting. So, the role of the chair is to, although I'm chairing the discussion, I also read every application, so I've got an idea about what the primary reviewers of each application are going to say. And I coordinate between them and I sometimes have to be quite efficient, some would say brutal, in stopping discussion about interesting but not particularly relevant points in an application. And focusing on the main things that we need to do to decide what we're going to say to the applicants. And so that's during the meeting.<\/span><\/span><\/span><\/span><\/p>\n\n
<\/p>\n\n
The other main thing is after that I receive the minutes of the meeting from our administrator and I then have to formalise those in letters to applicants. And last but not least, in order to speed things up<\/span><\/span><\/span><\/span><\/p>\n\n
because we only have a meeting once a month; at least twice a month we also have chair action letters that I have to write and send out so that applicants don't have to wait for the next meeting for us to<\/span><\/span><\/span><\/span><\/p>\n\n
re-review their project. We'll virtually review re-submissions twice during the month, so I then have to<\/span><\/span><\/span><\/span><\/p>\n\n
write letters for those as well, and send those out too.<\/span><\/span><\/span><\/span><\/p>\n\n
We hardly ever reject an application. Quite often we have to suggest quite major changes to design and recruitment, or even who's doing the research, because sometimes it can be quite a risky, brave methodology, which is fine if it's a professor, but not if it's a bachelor's student, as you sometimes see in some cases. So as long as the changes are made and we have all the information that we want and we're satisfied with the responses, we will approve the application. There are, I don't think we've ever<\/span><\/span><\/span><\/span><\/p>\n\n
rejected one outright, but sometimes researchers withdraw an application because we say, you would need to do this, this, and this. We're not trying to be difficult, but that is just the standards of which we operate. And sometimes they would just rethink, they wouldn't normally drop the project, but they would rework it in a major way. So, it's very rare that we would reject an application, although quite common, that it might have to go through two or even three rounds of revisions. But again, that's not normally because we are requesting more changes. It's because we're just still trying to get clarity, because quite often researchers have all the information, but they're so close to it, they think of it as obvious, and they don't share it in the way that we need to know what's going to be done.<\/span><\/span><\/span><\/span><\/p>\n\n
<\/p>\n\n
One key thing the ethics committee does is to encourage researchers to use their moral imagination. And what that means is not simply to think from a scientist's perspective but think of all the things that a participant might have to go through as part of a research project, not necessarily painful things, but things that could go wrong, and things that could make someone feel different. So, it's not just mapping the eventualities. It's thinking about the possible ethical effects of all of the things they have planned in their project, not in isolation, but in combination, because two things might happen that they haven't anticipated. So, it's anticipating all the things that could happen to participants and their ethical effects.<\/span><\/span><\/span><\/span><\/p>\n\n
And that's how you use your moral imagination.<\/span><\/span><\/span><\/span><\/p>\n"},"library":"H5P.AdvancedText 1.1","metadata":{"contentType":"Text","license":"U","title":"Untitled Text"},"subContentId":"754b293e-d4af-4d84-b4a4-e6db8a2728e6"},"title":"Interview Transcript"}],"hTag":"h2"}

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REC Chair Interview