This Guidance does not change what you must do under the law.

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.³¹⁰

You must make the care and safety of the patient your first and continuing concern. All research should be conducted: 

1. lawfully, 
2. with honesty and integrity, 
3. under appropriate clinical governance arrangements, 
4. in accordance with codes of good practice.³¹¹ 

If you undertake research on people or animals, you must: 

1. ensure it is based on a protocol:  
   1. that minimises any foreseeable risk
   2. where the anticipated benefits outweigh the foreseeable risks
   3. that is free from discrimination at all stages of research, particularly for recruitment
   4. developed in accordance with good practice guidance from relevant research organisations, professional bodies and government
2. seek ethical approval, where appropriate, using the relevant research ethics approval process before conducting research
3. make sure the safety, dignity and well-being of the participants take precedence over all study aims 
4. make and keep clear, accurate and legible records.

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.³¹²

If your research involves even one NHS patient or record, you should apply for ethical approval using the appropriate NHS approval system:

1. Research involving NHS patients in England or Wales should be approved using the HRA Approval system
2. Research involving NHS patients in Scotland and Northern Ireland should be approved using the appropriate NHS/HSC permissions process for that nation.

University research will be subject to the ethics processes in place at the individual institution.

You must work within the relevant legislation; see Useful information and links section below.

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. However, there may be specific circumstances where you do not need to obtain consent to use health data for research:

1. using anonymised health information 
   1. you may render confidential information anonymous without breaching duty of confidentiality 
   2. anonymised information refers to data without any patient identifiers (de-identified data) 
   3. you should ensure that the practice data usage policy includes reference to processing personal information for research purposes to comply with data protection legislation 
   4. patients must be given a choice as to whether or not their anonymised information is used for research and planning. 
2. anonymous information can then be used in health research. There are two main scenarios where this is likely to apply: 
   1. adding anonymous information into a database to support public health surveillance and clinical decision making. The establishment of this database does not need ethical approval but should be managed under local clinical governance arrangements. Any research using this database does not need ethical approval. This data would be anonymous to a researcher, and can be used for research without ethical approval 
   2. adding anonymous information into a study specific database for an individual research project. The establishment of this database requires ethical approval, even though the data is anonymous to the researcher.  
3. where patient information is being used for research, this should be included in your data protection policy.  
   1. how patient information is used should be visible in the practice. This may be through leaflets, posters or websites, but proportionate and appropriate to the circumstances 
   2. your data protection policy should be available upon request 

See Health Research Authority. Guidance for using patient data [Accessed 1 Nov 2023] 

You must maintain confidentiality.

You must act with honesty and integrity when designing, supervising or carrying out research and when publishing any data or reports.

You must give patients a choice as to whether or not their information is used for research and planning. ^{313, 314}

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.³¹⁵
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.

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.

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.

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.³¹⁶ 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.³¹⁷

You should identify and agree with other practice staff, as appropriate, the audit:

1. purpose
2. scope
3. topic
4. criteria or standards.

You should use an audit to measure the level of performance in your practice.

You should use the results of your audit to inform changes and improvements in your practice.

You should review any changes made on a regular basis.