Nursing Progress article on research ethics approval.




	A short guide to research ethics approval Maggie Tarling Abstract: tips for making an application for approval of a ressearch project. 2 references. Content. Introduction. Tips for making a research ethics application. In summary. References. Back to Nursing Progress contents. Back to Issue 5 contents list. Introduction Whenever you conduct research either as part of a degree course or evaluating practice you will need ethical approval before you start. The Department of Health issued guidelines on the structure and remit of local research ethics committees.(1) The research ethics committees' task is to advise any NHS body on the ethics of proposed research projects which involve human subjects. These committees have a mix of medical, nursing and lay members who vet all applications made to them. The local research ethics committee for the Royal Hospitals Trust is the East London and City Health Authority (ELCHA) research ethics committee. The committee meets every month and reviews all applications made to them from the area covered by ELCHA, including the community trusts. Given the many problems that researchers have had with multicentre research over many different health authorities, Multicentre Research Ethics Committees (MREC) have been set up.(2) Application should be made to these committees, in the first instance if a study involves more than five sites. Back to contents Tips for making a research ethics application The application process is time consuming especially if you have never done one before. It is therefore important to establish whether you need to make an application (see table 1). Ethics committees do not consider audit studies unless you plan to give a questionnaire to patients or relatives. The ELCHA research ethics committee handle certain protocols differently. Nursing studies which are primarily questionnaire based or observational in design are processed differently from clinical trials. It is important to establish into which category your study design fits. Table 1: Research protocols which require ethics committee approval Clinical drug trials involving patients Clinical drug trials involving healthy volunteers Asking patients, their relatives, or staff to till in a questionnaire Interviewing patients, their relatives or staff Taking blood from a patient or healthy volunteer Research on specimens or tissues/organs Research carried out for part of an academic course e.g. degree Research involving patient notes Research carried out by another organisation on hospital premises Undertaking an observational study Having established which sort of design you have and which sort of application to make the next step is to obtain an application form from the research ethics committee and then not to panic. The application form looks quite daunting at first. These forms where designed primarily for clinical trials, however for the majority of nursing studies a significant part of the form does not apply. The form comes as a floppy disk so completing it is quite simple. Back to contents Making an application involves writing a short literature review with an annotated bibliography. You will also need to describe how you will conduct your study and how you will protect the rights of patients. Outline what sort of written information you are going to provide to patients or relevant others. This may seem a time consuming task. However, it is not time wasted. If you complete this task thoroughly you have got the structure of your introduction and methodology written before you have started. Making an application is also an advantage in that you need to have a very clear idea of what you want to do and why. This process can be very good for clarifying your thoughts before you actually get out there and make a start. It may seem obvious but it is most important to read and follow the instructions given with the application. Ensure that you complete all aspects of the form. If any question is not relevant you should very briefly state why. You need to make sure that you make the correct number of copies and that you hand in the application in time for the committee meeting. Deadlines for ELCHA research ethics committee are usually three weeks before the relevant committee meeting. The ELCHA research ethics committee periodically update their application forms, therefore it is important that you have completed the correct version. If you do not adhere to these requirements the application is sent straight back and will not be considered until you resubmit. Given that the committee only meets once a month this could put another one - two months onto the process for getting approval. Back to contents It is worth considering the information that you will give to patients. The written information sheets are the one constant reason that ethical approval is postponed or not given. Getting this right is extremely difficult. You must give patients or others enough information that will allow them to make an informed decision as to whether to consent or not. It is important that the information is clear and written in plain English. Abbreviations or medical jargon should not be used. It is useful to give your information sheet to a friend or relative who has no medical or nursing background and see if they understand the information. The information should cover the potential risks or benefits to consenting and what potential inconveniences the patient may suffer as a result of participating. It is also important to assure patients about confidentiality and if others will have access to their records, who these individuals will be. The other issue that may cause problems if you do not address this in advance is the issue of access. It is extremely important that you indicate how you will get access to your patients or others. This means that you will need to approach the relevant key personnel in the area you wish to work in. Even though you may be conducting a nursing research study you will need to speak to the relevant consultant about including their patients in your study. This is a useful exercise anyway to ensure that you will not clash with other personnel conducting research. Back to contents In summary Be sure about what you want to do and why. Contact ELCHA research ethics committee early to find out about the deadlines for each meeting. Give yourself about two months to gain approval. Make sure you have the most up-to-date version of the application form. Read and follow the instructions for completing the form. Check that you are making the correct application, i.e. is your study an observational one or are you manipulating treatments patients will receive. Ensure that you have made sufficient copies of the form. Ensure that you have used plain English when completing the form. If you are at all unsure as to whether you need ethical approval it is always safer to approach the research ethics committee before you start. They will be very happy to give guidance. They will also give guidance on more general ethical issues relating to research. Back to contents References 1. Department of Health. Local Research Ethics Committees. DoH 1991:HSG (91) 5, August. 2. Department of Health. Ethics Committees review of multicentre research: Establishment of multicentre research ethics committees. DoH 1997: HSG (97) 23, May. Nursing Progress: Issue 5: January 1999. Copyright: Nursing Progress, Royal Hospitals NHS Trust. Back to Nursing Progress contents. Back to Issue 5 contents list. Back to Top Last updated by DEB on 30/4/02

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