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  • 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.
D36
This Guidance does not change what you must do under the law.
D37
Research is a systematic activity that:
  1. attempts to answer a clearly defined question
  2. employs systematic and rigorous methods
  3. leads to generalisable and new knowledge.297
D38
You must make the care and safety of the patient your first and continuing concern.298
D39
If you undertake research on people or animals, you should seek ethical approval, where appropriate, using the relevant research ethics approval process.
D40
In the UK, the routes to ethical approval are:
  1. university ethics committees
  2. The Research Ethics Service, which is part of the Health Research Authority.299
D41
If your research involves even one NHS patient or record you should apply for ethical approval using the HRA Approval system.
D42
University research will be subject to the ethics processes in place at the individual institution.
D43
You must work within the relevant legislation; see Useful information and links section below.
D44
You must get consent from the research participants before involving them in any research project. For people who are unable to consent you will need to make an additional application.
D45
You must maintain confidentiality.
D46
You must act with honesty and integrity when designing, supervising or carrying out research.
D47
You must give patients a choice as to whether or not their information is used for research and planning. 300, 301
See sections on Consent and Confidentiality.
D48
You should protect the evidence base for optometry and vision science as follows:
  1. you should publish data of any trial in humans within one year of completion 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.302
  2. 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
  3. you must not deliberately fabricate or falsify data or information
  4. you must not deliberately misrepresent data. Doing so may lead to untrue or misleading findings which may skew the evidence base
  5. you must not plagiarise others’ work
  6. 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
  7. you should name all authors involved in a publication before submission of a paper, to ensure transparency
  8. you should avoid duplicate publication of material in multiple journals to ensure transparency for literature reviews and a robust evidence base.

References

302 All Trials campaign [Accessed 20 Nov 2020]
D49
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. 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.
D50
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. However, you must get patient consent if you are publishing any patient identifiable data.
D51
Clinical audit projects must conform to appropriate ethical standards. The Health Quality Improvement Partnership has produced a guide to managing ethical issues in clinical audit.303 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, make it 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.304
D52
You should identify and agree with other practice staff, as appropriate, the audit:
  1. purpose
  2. scope
  3. topic
  4. criteria or standards.
D53
You should use an audit to measure the level of performance in your practice.
D54
You should use the results of your audit to inform changes and improvements in your practice.
D55
You should review any changes made on a regular basis.