Step 6: obtaining ethical amd Trust approval

Having prepared your research proposal you need to obtain ethical and trust approval.

Ethical practice in research means ensuring your research participants are not exposed to risk as part of your project, protecting their right to anonymity and confidentiality, and that your project has merit.

If you’re planning to replicate a previous study, merit relates to whether there is justification in revisiting the research idea, perhaps by applying the research process to a new setting.

Research governance

Research governance seeks to improve research quality and safeguard the public within the NHS. It involves promoting good practice and enhancing ethical and scientific quality.

Whether or not you need to apply for full ethical approval, you’ll need to negotiate with research governance at the NHS sites where you’re conducting the research.

More information on NHS research governance and how it might affect your study may be found in the NHS Health Research Authority: UK policy framework for health and social care research. It outlines the general principles of good research practice in the NHS.

Research ethics frameworks

There are many research ethics frameworks available but for a basic check of the kind of things they cover, see Economic and Social Research Council framework for research ethics. In summary, their six key principles of ethical research are:

• research should aim to maximise benefit for individuals and society and minimise risk and harm
• the rights and dignity of individuals and groups should be respected
• wherever possible, participation should be voluntary and appropriately informed
• research should be conducted with integrity and transparency
• lines of responsibility and accountability should be clearly defined
• independence of research should be maintained and where conflicts of interest cannot be avoided they should be made explicit

Informed participants and seeking consent

You will need to prepare an information leaflet, sometimes called a participant information sheet, to invite people to take part in your research project.

The purpose of the information leaflet is to explain what taking part in your research will involve so that people can make an informed decision about whether to participate or not.

To ensure your information leaflet is easy to read and understand you’ll want to check its readability score, a number which tells you how easy it is for someone to read your text.

The score is calculated based on the average length of sentences and the length of the words you’ve used. The higher the readability score, the easier your text is to read. It’s generally recommended that information leaflets should aim for a score of 60 or above.

If you are using Word to produce your information sheet, you may check the readability score of your text under the Review menu’s Check accessibility option.

Some believe it’s not ethical to do research, particularly if you’re involving participants, if you don’t go on to disseminate your findings (Step 9). Your intention to publish should be acknowledged in your consent form together with an assurance that any data relating to a participant will be anonymised.

Informed consent is usually demonstrated by the research participant first reading your information sheet and then either completing and returning a questionnaire, which implies consent, or signing your informed consent form.

The following resources will help you prepare your information leaflet and obtain informed consent.

Medical Research Council/NHS Health Research Authority, Consent and participant information guidance. Examples and templates of both information sheets and consent forms. Outline of guiding principles, style and content.

NHS Health Research Authority/Medical Research Council, Informing participants and seeking consent. Joint guidance on preparing information for your research participants to obtain informed consent.

National Institute for Health and Care Research (NIHR), INVOLVE; patient information leaflet / patient information sheet. Overview of the type of content to include in your patient information sheet.

As part of collecting and collating your data (Step 7), signed informed consent forms should be stored in a locked cabinet or on a password protected computer.

Applying for ethical approval

Your research proposal (Step 5), including copies of your information sheet and informed consent form, will need to be submitted to your Trust ethics committee for approval.

Depending on your study design you may also need to apply for ethical approval at a full regional research ethics council meeting.

The Health Research Authority’s Research Ethics Service (RES) convenes regional Research Ethics Councils (REC), to support and enable ethical research in the NHS.

In line with INVOLVE guidance on public involvement, all RECs include five ‘lay’ members who have no professional interest in research and are not registered healthcare professionals. RECs aim to give a decision on research applications within 40 days, though it can take longer; this time needs to be planned for when designing your study (Step 3).

You can get support in ensuring your proposal is ethical from these sites.

Medical Research Council/NHS Health Research Authority: Do I need NHS REC approval? Tool to determine if your study requires NHS REC approval.

NHS Health Education England: Library and Knowledge Services. Contact details for NHS Library Knowledge and Library Services Leads.

NHS Research and Development Forum: National Directory of NHS Research Offices. Contact details for NHS Research and Development Leads.

Suggested reading

Buchanan, E., & Ferguson, S. (2013). Ethics and best practice. In M. J. Grant, B. Sen, & H. Spring (Eds.), Research, evaluation and audit: key steps in demonstrating your value (pp. 65-76). London: Facet Publishing. Overview of why ethics are important, ethical issues in participant selection and consent, anonymity and confidentiality, data storage, informed consent and participant information sheets.

Pickard, A. J. (2013). Ethics in research. In A. J. Pickard (Ed.), Research methods in information (2nd ed.). London: Facet Publishing. How to identify potential ethical issues in your research.