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Maintaining trust

Research and audit

Key points

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.

Definition of research

D37

Research is a systematic activity that:

attempts to answer a clearly defined question
employs systematic and rigorous methods
leads to generalisable and new knowledge.²⁹⁷

References

²⁹⁷ Health Research Authority (2020) UK policy framework for health and social care research [Accessed 20 Nov 2020]

Ethical research

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:

university ethics committees
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.

References

²⁹⁸ General Optical Council (2016) Standards of Practice for Optometrists and Dispensing Opticians [Accessed 20 Nov 2020]
²⁹⁹ Health Research Authoriry. Research Ethics Service and Research Ethics Committees [Accessed 20 Nov 2020]

NHS National Data Opt-out

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.

References

³⁰⁰ NHS. Choose if data from your health records is shared for research and planning [Accessed 20 Nov 2020]
³⁰¹ NHS Digital. National data opt-out [Accessed 20 Nov 2020]

College research misconduct

D48

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 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
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 fabricate or 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
you should avoid duplicate publication of material in multiple journals to ensure transparency for literature reviews and a robust evidence base.

References

³⁰²All Trials campaign [Accessed 20 Nov 2020]

Definition of audit

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.

Audit principles

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: