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But is it ethical?

With research having an increasingly higher profile in the profession, physiotherapists need to know how to get trials approved. Louise Hunt looks at how to go about it

With so much emphasis now placed on evidence-based interventions, physiotherapists are becoming increasingly involved in research that can prove their services are crucial to care delivery. This means clinicians and academics have to navigate their way through the somewhat daunting process of getting ethical approval.

However, this should no longer be the protracted and complicated process it once was, says Louise Connell, chair of the Physiotherapy Research Society and research physiotherapist at the University of Salford. An online application process has speeded things up massively, she says.

The National Research Ethics Service took over from the Central Office of Research Ethics Committees earlier this year, and Ms Connell says its website is the best place to start for anyone who thinks they may have to get ethical approval, or favourable ethical opinion, as the service prefers to call it. The final decision on whether to approve a trial will then be taken by the ethics committee of the relevant trust.

Since guidelines were tightened on informed consent, any research that involves NHS patients and clinical staff is likely to need both ethical approval and informed consent, says Ricky Mullis, clinical trials manager and physiotherapist at Keele university. However, information audits or surveys conducted as part of routine practice are likely to be exempt.

His biggest piece of advice is to allow enough time. Even with online applications there are pitfalls, and the best way to avoid approval being held up is to ensure the protocol is watertight from the beginning.

This can be greatly helped, Mr Mullis says, by seeking guidance from study sponsors, who are most likely to be the research governance officers in a trust. They may be able to provide a scientific review on the value of the study, and the safety of patients and staff, before the application is made.

Physios need to be careful how they word their application and not assume there will be another member of their profession on the ethics committee.

Charikleia Sinani, a senior lecturer at Leeds Metropolitan University, has recently successfully gone through the process of obtaining ethical approval. She says: 'It's important to make sure the committee can understand your proposal. They will pay a lot of attention to detail, and might invite you to answer questions about the project.'

The kind of questions physios may face are: the risk and benefits the study presents to patients; how patient confidentiality will be protected; whether consent forms and patient information leaflets are understandable to patients, and how physios will ensure patients and staff are given at least 24 hours notice before taking part in a trial.

Ethics committees will also consider whether conflicts of interest, such as private sponsorship, have been declared and whether they could compromise a trial.

'Physiotherapy research is going to become much more integral to the profession, and it's important not to shy away from it because of the processes involved,' Mr Mullis says.

FURTHER INFORMATION

www.nres.npsa.nhs.uk

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