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How to navigate the ethical review of research
  1. Hugh T Davies1,
  2. Bob Phillips2,3,
  3. Jennifer Preston4,
  4. Simon R Stones5
  1. 1 Health Research Authority, London, UK
  2. 2 Department of Paediatric Oncology, Leeds Children’s Hospital, Leeds, UK
  3. 3 Centre for Reviews and Dissemination, University of York, York, UK
  4. 4 National Institute for Health Research, Alder Hey Children’s NHS Foundation Trust, Liverpool, UK
  5. 5 School of Healthcare, University of Leeds, Leeds, UK
  1. Correspondence to Dr Bob Phillips, Centre for Reviews and Dissemination, University of York, York YO10 5DD, UK; bob.phillips{at}doctors.org.uk

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Introduction

Submitting your project for ethical review and the comments or even criticisms that may follow can be irritating or even painful. There are many stories that recite and relive the difficulties some have experienced, but we do not believe it need be so. There may be some eye-rolling at this, but we ask you to delay judgement until you have read the article, a description of how reviewers tend to approach the process and, from this, we propose a practical approach for researchers.

Contents

  1. Do I need to submit my project for review?

  2. What are reviewers trying to do?

  3. What are the reviewers’ likely concerns and questions in this area?

  4. How can I make my project easier to review?

  5. How can I analyse contentious or ‘tricky’ issues?

  6. What should I do when/if I attend review?

  7. What shouldn’t I do?

  8. A checklist.

  9. Lessons from survivors.

  10. Encouragement.

1. Do I need to submit my proposal for review?

Generally if your work is ‘research’, you will need to submit your project. Audit, service evaluation or quality improvement do not require this. Usually it is easy to distinguish these (if it looks like a duck, swims like a duck and quacks like a duck, it IS a duck). But sometimes judgement is needed. In the UK, the Health Research Authority (HRA) provides a leaflet ‘Defining research’, which tries to differentiate audit, research, service evaluation and public health disease management (http://www.hra-decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2017-1.pdf).

If in doubt, it is worth talking to others and your relevant authorities may provide a helpline. Key discriminants for clinical research are: (1) it may change treatment or intervention according to a protocol not by choices made by a healthcare professional, child or young person (CYP) and parent, (2) allocation to treatment may be randomised and (3) patient and/or healthcare professionals may be ‘blinded’ to a treatment. In other types of work, there is: (1) no change in treatment, …

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