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Ethics stop dodgy experiments but there’s too much red tape

Incoming! But did he need to jump though all those hoops? Wolfsavard

Researchers and other similar species working within academia are ethical human beings. But actual standards are needed to ensure nobody is exposed to harm in our search for answers.

Without these standards we risk a repeat of studies like the Milgram Experiment. This was developed by Stanley Milgram in the wake of the trial of the German Nazi war criminal Adolf Eichmann in the 1960s. The experiment tested participants’ willingness to obey authority figures, by delivering what they believed to be painful or even lethal electrical shocks to other people in the name of science. Those receiving the shocks were in fact actors. The study aimed to test whether humans were prone to following orders, however horrible they were. Milgram showed that participants were likely to follow the order to shock, despite listening to people experiencing serious distress.

The experiment suffered from many methodological shortcomings, which compromised the quality of the research itself. Most importantly, however, it raised numerous ethical questions regarding the extreme emotional stress that people were exposed to.

The Milgram Experiment.

Similar questions were also raised about the Monster Study, a psychological investigation into stuttering by Mary Tudor and her mentor Wendell Johnson in the US in the 1930s. A group of 22 orphaned children were split into two groups. Half of them were given positive praise for their fluency of speech. The other half were belittled for errors. The results of the study were never officially published, but Tudor and Johnson were able to induce stuttering in children with normal speech.

While such methods would not be used today, both of these studies highlight the why ethics processes are important and necessary. It’s now rather common to hear researchers referring to “filling in an ethics application”, “seeking ethical approval”, “going through ethical review” or “submitting to an ethics committee”.

In England, there are several ethics committees that review applications and issue favourable opinions. These include the NHS Research Ethics Committees; the Gene Therapy Advisory Committee; the Social Care REC; the Ministry of Defence REC; and other Higher Education Institution RECs). If research is being conducted on NHS organisation premises, with NHS patients or staff, then there’s an extra requirement to seek approval from a local NHS Research & Development (R&D) office too.

Different types of research

But although these processes are necessary in principle, not all research is the same. And the hoops that some researchers have to jump through may unnecessarily impede the work and the time to do it.

I’m a clinical researcher with a psychological mixed methods background and a member of an ethics committee. I’m currently conducting qualitative research. This often involves in-depth face-to-face, phone or online interviews with individuals with mental health problems who have the capacity to consent to take part. Interviews are usually about specific experiences that may have limited their potential. And because their content may be upsetting, I make sure that there are systems in place to guarantee that participants are supported both during the interview and once this is complete. Their data are treated in confidence and are accessed only by individuals who have ethical clearance.

It’s a far cry from the potentially higher-risk studies. I’m not conducting a clinical trial; or intervening with people’s genetic code; or testing the effectiveness of a new drug dose. I “simply” have a chat through which I try to understand people’s experiences and potentially help others too.

For such a chat, I have had to apply for independent reviews, university ethics, NHS ethics, and R&D approvals. In my role, and in addition to my professional qualifications, I’m expected to be appropriately trained in good clinical practice and information governance. But nothing seems to be enough to equip me with the sufficient knowledge, expertise, tools, stamina, resources, ability or even patience to deal with processes that aren’t relevant to the type of research that I and many of my colleagues are currently conducting.

What we have to do

Based on my experience so far, when a chat of this sort is to take place, this is what is needed:

To do list.

In this example, a research proposal is reviewed within a research team (or by a student supervisor), by an independent academic or review board, by the study sponsor, by the NHS local office, and by an R&D office. This obviously takes time, and a funded project “simply” going through required ethics procedures may take anything between six to eight months.

At a time when everyone, including academic institutions, the NHS, researchers and sponsors, are feeling the economic pinch it’s important that we simplify these ethical review and approval processes for research that just doesn’t require the same level of ethical oversight as other potentially high-risk studies; ensuring rigour but avoiding unnecessary repetitions.

In Homer’s epic poem the Odyssey, Odysseus return to his home of Ithaca takes 10 years. It’s a far cry from the everyday ins and outs of qualitative research, but I don’t see why getting an approval letter from an ethics committee is like a modern-day academic trip to Ithaca. For some, at least, the journey should be a lot shorter.

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