Guidance and Resources - Wrexham University

Research in the NHS

The HRA decision tool will help you determine if your study requires approval from an NHS Research Ethics Committee (REC). If NHS REC approval is required, University Research Ethics Approval is not normally needed in addition. More detailed information, including some examples, is available in the document: Does my project require review by a Research Ethics Committee?

HRA Confidentiality Advisory Group (CAG) approval is required for patient identifiable information collected without explicit consent.

When NHS REC approval is not required, you should contact the clinical governance or research and development (R&D) office of the organisation at which the project will be conducted to discuss what other local review arrangements or sources of advice may apply. For example, there may be standard guidelines on the conduct of clinical audit or service evaluation.

When NHS REC approval is not required you will still need to apply for university research ethics approval, you application should detail the relevant permissions you have obtained from the organisation at which your project will be conducted.

If you’re conducting research in an NHS setting you may need a Research Passport. A Research Passport is the mechanism for non-NHS staff to obtain an Honorary Research Contract or Letter of Access (LOA) when they propose to carry out research in the NHS. A research passport may be valid for the duration of a research project for a maximum of three years. Students should be familiar with the University Research Passport Procedure.

Informed Consent

Informed consent is the central act in research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.

Consent should be obtained before the participant enters the research (prospectively), and there must be no undue influence on participants to consent. The minimum requirements for consent to be informed are that the participant understands what the research is and what they are consenting to.

There are two distinct stages to a standard consent process for competent adults:

Stage 1 (giving information): the person reflects on the information given; they are under no pressure to respond to the researcher immediately.

Stage 2 (obtaining consent): the researcher reiterates the terms of the research, often as separate bullet points or clauses; the person agrees to each term (giving explicit consent) before agreeing to take part in the project as a whole. Consent has been obtained.

University templates should be used for Participant Information Sheet and Consent Forms, exceptions can be made where documents need to be tailored to meet the needs of the research population.

Assessing and managing risk

The principal ethical consideration should be to ensure the maximum benefit of the research whilst minimising the risk of actual or potential harm. Research ethics applications should reflect the potential ethical considerations and risks involved in the project. Appropriate mechanisms to manage any potential risks should be in place and submitted as part of your research ethics application. If you feel the project involves minimal risk – for example, an anonymous online questionnaire on a non-sensitive topic – the application form should still contain a reflection on potential risks and an explanation of why you feel the risks are minimal.

All potential risks should be discussed with research participants through the consent process.

Research conducted online

Increasingly, research data is gathered from online discussion groups, blogs, social media and websites. The separation between public domain and private space is becoming increasingly complex. In an age of increasing digitisation, it is important to consider the ethics in research practice online. Researchers should consider the complexity of informed and valid consent when collecting data through online methods.

Guidance: Association of Internet Researchers

Using online platforms to conduct interviews and surveys has also become more prominent in recent years. Wrexham Staff and Students should read the University Research Ethics Committee Guidance for Online Data Collection, before submitting a research ethics application.

Confidentiality and anonymity

The appropriate use and protection of participant data is paramount, and particular attention must be given to ensuring the confidentiality and security of information provided during research. Researchers should only collect the minimum amount of personal data that is necessary for the research project. If there is a potential limit or threat to confidentiality, for example through the use of elite interviews where the interviewees are potentially identifiable, participant should be aware of this limit and provided with the opportunity to review the data they have provided. Wrexham staff and students should be familiar with the University’s Data Protection and Participant Privacy Notices.

Guidance: Information Commissioners Office

Guidance: UK Data Service

Guidance on completing a generic application