In 2004 the process for obtaining ethical approval within the NHS was standardised and governance was taken over by the Central Office for Research Ethics Committees (COREC), which is now known as the National Research Ethics Service (NRES). At the time of writing this book there are major changes being piloted for the NHS ethics approval process and there are two which will potentially benefit you as a researcher: the ‘Early Provision of Advice’ and the ‘Fast Track of Studies Considered to Have no Material Ethical Issues’.

The pilot for ‘Early Provision of Advice’ was launched in May 2007 and is a screening process aiming to identify applications which are unlikely to meet the requirements of the REC, such as:

Applications with poor presentation, which are incomplete, or have insufficient technical merit

Studies submitted inappropriately (i.e. outside of the NHS REC’s remit)

Studies which may require further expert review in order for the REC to make a decision

The NRES then provides advice to bring the application up to an appropriate standard suitable for REC review.

The second pilot for ‘Fast Track of Studies Considered to Have no Material Ethical Issues’ commenced in April 2007. This pilot hopes to develop a filter system where all applications are examined by a small trained review team. This team will be able to give fast track approval to those applications deemed to have no material ethical issues and thus do not require review by the full committee. The results of these pilots are expected in early 2008 and may result in alterations to the ethics process.

Unlike the NHS there is not a uniform system for ethical approval throughout the academic community. Each university will have its own particular process, but all will follow the same basic requirements as the NHS system described in the rest of this chapter. The specific procedure and application form will vary so you must obtain local advice.

Confidentiality is a big issue and you will need to include information about how your data will be kept confidential in your ethics application. You will also need to include statements about confidentiality in the patient information sheet. Advice on suitable wording is provided on the NRES website. The ethics requirements are designed to ensure you do not breach the Data Protection Act 1998, which is a set of rules to limit the use of personal information relating to living people.

Your research notes should be kept in a secure location such as a locked department or locked cupboard or filing cabinet. If you are unable to use a secure environment to store your notes with identifying patient details, such as consent form, letters with name, address or hospital number, should be kept separately to the clinical data collection forms, so that the data cannot be linked to the patient.

When creating your database for the analysis do not use the patient’s name or other identifying information. Instead assign each patient a unique study number and use only this. Even though Hospital IT systems are designed to be secure and suitable to contain patient information, it is best practice to use only anonymous data.

It is customary to write to the patient’s GP or consultant to say they are on a trial and to provide relevant information; indeed ethics committees expect you to do this. Make sure this is stated in the information sheet and the consent form, so the patient knows you are going to share their information in this way.

Along with the full application form you will almost certainly have to submit a patient information sheet and consent form. As a general rule written informed consent must be obtained from all research participants. Only in special circumstances are you likely to run research without written consent. To obtain informed consent you will need both a patient information sheet to explain your research and a consent form for the patient to sign. In addition you may need to submit other information to support and clarify your application.

The participants’ information sheet tells the participants what you are going to do, why you are doing it, and what you expect of them. Once you have completed the application form there is a temptation to sigh with relief and quickly put together the participant information. DON’T – this is a very important document that you must get right.

Give yourself plenty of time to do this carefully. Often all the queries and requests for changes from the REC relate to the information provided for participants. There are specific guidelines provided for writing this, since it must contain prescribed information. It will be sent back for changes if all compulsory information is not included. Comprehensive guidelines are given on the NRES website and even if you are using a university REC, these guidelines will be helpful to you.

Ask other researchers for examples of information sheets if you are not sure how to proceed. It can be particularly useful to use the wording from an information sheet that has already been approved, for example when describing the process for taking blood, using genetics information and so on.

The consent form provides the written evidence that you have gained the participants’ explicit informed consent to include them in the research study. This makes it a very important document so I have devoted the whole of Chapter 11 to examining the issue of participant consent.

You will also be required to submit other information to support your application. This will include, as a minimum, a copy of your research protocol and your CV. If you are a student, your supervisor will also need to submit their CV. Other documents that are commonly required include: copies of letters you intend to send to participants or intended participants; copies of any recruitment posters or adverts you wish to use; copies of letters you will send to the patient’s GP or consultant to inform them of this patient’s participation; and any questionnaires or interview schedules that you intend to use.