Research and audit
- You must make the care and safety of the patient your first and continuing concern.
- You should ensure that you have gained ethical approval for any research you undertake on people or animals.
- You must work within relevant legislation.
- Research is a systematic activity that:
- attempts to answer a clearly defined question
- employs systematic and rigorous methods, and
- leads to generalisable and new knowledge.181
181 Department of Health (2005) Research governance framework for health and social care, Second edition [accessed 27 Aug 2014]
- If you undertake research on people or animals, you should seek ethical approval, where appropriate, using the relevant research ethics approval process.
- In the UK, the routes to ethical approval are:
- university ethics committees, or
- NHS Research Ethics Committees (NHS REC), using the Integrated Research Application System.183
- If your research involves even one NHS patient or record you should apply for ethical approval using the appropriate NHS REC.
- University research will be subject to the ethics processes in place at the individual institution.
- Where you conduct research on people you must get consent from the research subjects before involving them in any research project. For people who are unable to consent you will need to make an additional application.183
182 General Optical Council (2010) Code of conduct [accessed 3 Feb 2013]
183 Integrated Research Application System [accessed 3 Feb 2014]
184 National Research Ethics Service [accessed 27 Aug 2014]
185 NHS Research and Development Forum (2006) Notes on developing procedures within NHS organisations for appropriate authorisation and management of research and related projects.
- You should protect the evidence base for optometry and vision science as follows:
- you should publish data of any trial in humans within one year of the end of the trial. This applies even if the trial appears to have been unsuccessful; publishing all data helps to ensure the evidence base is robust
- you should not enter into contracts that restrict your ability to publish results or provide appropriate access to data; such agreements can prevent researchers from independently publishing unbiased reports of their research
- you must not deliberately falsify data or information
- you must not deliberately misrepresent data. Doing so may lead to untrue or misleading findings which may skew the evidence base
- you must not plagiarise others’ work
- you should declare any interest or connection relevant to the outcome of a research project in all dissemination. This will enable a fair evaluation of any potential conflicts of interest
- you should name all authors involved in a publication before submission of a paper, to ensure transparency, and
- you should avoid duplicate publication of the same material in multiple journals to ensure transparency for literature reviews and a robust evidence base.
- Audit is a test of whether things are being done as they should. It compares current practice with predefined standards. Audit may raise questions that might be answered by further research.186 Examples of things that may be audited in optometric practice are the completeness of clinical records and the outcome of optometric referrals, for example whether feedback is received from the clinician to whom the patient has been referred.
- If you are only using your existing patient record base for the purpose of audit you do not need to get patient consent since they have already given their consent to you creating and retaining their records. You must get patient consent if you are publishing any patient identifiable data.
- Normally audits can be undertaken without the requirement of ethical approval, however, there may be rare instances where the nature of the audit or the local guidelines mean it is necessary to get approval. The chart on Differentiating clinical audit, service evaluation, research and usual practice or surveillance work in public health gives some useful definitions of audit and research.187
- You should identify, and agree with other practice staff as appropriate, the audit:
- topic, and
- criteria or standards.
187 National Research Ethics Service (2009) Defining research [accessed 31 May 2017]
College of Optometrists. How we do research [accessed 3 Feb 2014]
Health Research Authority
Health Research Authority and Medical Research Council. Is my study research? Decision tool [accessed 24 Mar 2014]
NHS Research Scotland
NICE and the Healthcare Commission (2002) Principles for best practice in clinical audit [accessed 10 Feb 2014]
Adults with Incapacity (Scotland) Act 2000
Animals (Scientific Procedures) Act 1986
Data Protection Act 1998
Human Tissue (Scotland) Act 2006
The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) (Amendment) Regulations 2008
Mental Capacity Act 2005