The post you’ve all been waiting for with baited breath – the why’s and wherefore’s of the Research Ethics approval process! But seriously, this is a big issue for researchers, participants in research and the general public. If you’ve ever been involved in a research project, you will have been given an information document, and asked to sign a consent form. Somewhere there will be a statement about the study having been approved by this or that Ethics Committee, so what does this really mean?
All research should go through an independent ethical review process. The rigorousness of this process depends on the topic of the research, the commitment being asked of the participants, and who is backing it. So for example, an undergraduate student project, which involves sending round questionnaires to Freshers, asking them about their experience of starting University – that would normally be assessed by an internal ethics committee for the department supporting the study. But even such innocuous sounding research can have serious ethical implications. Perhaps one of the questions asks whether the respondent has experienced depression since coming to University. What if the answer is yes? Does the researcher have a duty to follow up this response? But we can’t expect our final year projects students to start providing counselling services, can we? One likely solution to this kind of dilemma is that the ethics committee would recommend that information about existing Counselling and Student Support Services be enclosed with copies of the questionnaire in the first place.
An even more rigorous ethical review process is required by anyone conducting research within the NHS. Obviously this includes drug trials and investigations of medical procedures, but my own research is also subject to this level of scrutiny. This is because I will be using NHS records to recruit potential participants to the trial. We will be circulating letters to families with a child with autism in the Lothian area, and posting information about the study in the waiting rooms of relevant clinical services. Click-East has therefore been submitted for consideration and approval by a local NHS Research Ethics Committee, or REC.
The REC approval process in fact began as soon as I took up my current post, in April 2010. We completed a 28-page form, along with 21 attached documents. This included copies of anything that will be seen by participants: the text of the recruitment page on this website, for example; and information leaflets for every stage of the trial. There is a detailed protocol which lays out the scientific rationale of the study as well as the process of the trial and a list of every procedure participants are being asked to undertake (even including contact by phone, or filling out a form). Everything is read and sicussed by members of the REC, who will include medical professionals, patient representatives and researchers from various fields.
So what are the REC members looking for? Well, obviously, they want to check that all the participants are being treated appropriately. Participants need to have complete and accurate information about the trial, presented in a form they can easily understand – no jargon, translated copies if need be and so on. For Click-East, we have even created information dcouments for pre-schoolers which are simple picture descriptions of what the trial means for them. With this information, participants are able to give INFORMED consent – they know what they’re being asked to do, and can agree to do it. In the same vein, the REC will make sure that participants aren’t being asked to do anything risky or even to commit too much time or effort to the research.
This is where the committee’s decision becomes more complex. They have to balance the inconvenience to participants against the potential reward. So a study might be asking participants to visit their local hospital say every week, for a year. That seems like a lot, but if the study is investigating a new cancer treatment which looks like it might be effective against a lot of cancers, we could argue that the committment from the participants is a worthwhile investment, both for themselves and the wider population of people with cancer. Another factor that comes in here is scientific rigour. A study might be well thought out and ask very little of participants, but if the science isn’t appropriate it has no value. For example, let’s say you were looking at the effect of drinking caffiene on weight loss. You might ask some people to drink their usual amount of tea and coffee, and others to switch to decaf for a few weeks, and both groups to keep a record of their caffiene intake. Sounds OK. But at the end of the trial period, let’s imagine you don’t weigh anyone, you just ask them if they think they’ve lost weight. Particularly if they know your hypothesis, that weight loss is linked to caffeine intake, you are likely to get some really biased data, because participants tell you what they think you want to hear. So this kind of study might get refused by the REC because it is ethically wrong to run a study which has little or no chance of telling you something interesting at the end.
You’ll be pleased to hear we got our REC approval in January 2011. I remember going along to the committee meeting. One of the questions they wanted to ask me was why I was applying in January 2011, when the trial start date wasn’t until early 2012. I think when I walked in heavily pregnant (I had my baby just 12 days later) they probably worked that one out! Now that I’m backj at work, there have been some inevitable changes to some of the paperwork associated with our trial. In fact, today I have submitted a “notice of substantial amendment” to the REC which, among other things, requests permission to continue this blog once the trial is underway! Crossed fingers!
Not a very festive post, but I hope you have a super Christmas and Hogmanay break and I’ll be back with an update in the New Year.
