Condukting research in medicine

2. Decide if the research project requires research governance approval
Research governance requires that research does not commit Trusts to unexpected expense either by funding the research out of clinical budgets or by exposing the Trust to unexpected risk. Details on the local application process will be available on the relevant intranet site. Close liaison with the department makes the process easier and any unforeseen issues may be identified before submission for ethical approval. Also, these departments act as a resource to help students and they should not be afraid of asking for help.
3. Decide if the research project requires ethical approval
Research requires NHS research ethics approval if the research participants (patients or staff) are selected because of their relationship with the NHS or because it uses any NHS resource. In addition, the human tissue act 2004 requires that any genetic studies on human tissue need ethical approval from a recognised NRES (Cooke, 2007) ethics committee.
4. Ensure that sponsorship is in place
In NHS terms the sponsor is the organisation taking professional responsibility for the researcher. For a student research project, this usually lies with the University.
5. Register with NRES and complete an online application form for the project
This step is not to be rushed; the form is lengthy, moreover it is an “intelligent form”, particularly the screening page (towards the beginning of the form) where if you answer a question incorrectly, not only will the form be confusing, but you may be locked out of relevant pages later on. Members of ethics committees are very familiar with these forms, and will therefore most certainly be aware of what you should have filled in and will often pick up internal contradiction.
6. Submit to the local NHS Trust research governance committee to obtain research governance approval
Some ethics committees require scientific peer review/critique of the research project as part of the application process. Thus, obtaining research governance approval can generate this scientific critique and is often advised by Trusts themselves.
7. Book the application for ethical review
Only book when all the documents required for an application to be processed are in hand. A checklist generated at the start of the NRES form enables one to know what these are. If any documents are missing, the Research Ethics Committee (REC) will automatically withdraw your application and you will be required to resubmit with the correct information at the next available meeting.

General tips for success

In order to commence the project on time, formulate a time plan. As a general rule of thumb, allow a month for research governance approval. The REC is allowed 60 days from when it accepts an application to decide on the outcome. This is committee time, not overall time, thus, the clock stops each time they write with queries. It is sensible to assume a minimum of four months will elapse before you start. This is most useful when working on relatively short research degrees / projects, where time is of the essence.
Once the application is booked at a REC, the accompanying paperwork must be submitted within 4 days. RECs only accept original signatures on the NRES form and covering letters, although any other documents can be photocopies. Therefore before booking, it is essential that all the individuals needed to sign the NRES form are available. If in doubt, committees have contact numbers, and it may be worth ringing to confirm what is exactly required in order to submit a valid application.
Although it is not essential to attend the REC meeting, you are strongly advised to do so. Similarly, supervisors are also advised to it be present with the student at the REC meeting. The presence of the student’s supervisor at the meeting eases nerves, as many have already been through the process. The meeting itself usually lasts for 20-30 minutes. The committee will have already read the application and discussed it prior to inviting the researchers into the room. Questions usually arise as a result of lack of understanding of paperwork so it is helpful to have a copy of all research documents for quick reference. It is important to give honest and clear answers while looking confident. In student projects, students should always attempt the questions first, but if they stumble there is no harm in passing it over to their supervisor. Supervisors may also feel they need to clarify any points raised by their students. Common sense should prevail, in that both the student’s and supervisor’s responses should be similar in context; any obvious contradictions will be noted and may count against the application.
Remember that research ethics committees are not there to prevent research taking place; their role is to facilitate good research, and, by and large, they wish to work with applicants to ensure that this happens. The committee has 10 days to respond to the applicants. Few projects (less than 10%) get outright approval at this stage; the vast majority get approval subject to some changes. The committee will list a series of points they wish applicants to address. These should all be answered; it is most convenient if you copy the letter as your reply with your response to each point as a paragraph immediately following the committee question. Changes made in any accompanying documents should be tracked and the version numbers changed. These revised documents should be re-submitted with an official response letter. If you wish for your research to take place rapidly, then you should reply to letters as quickly as possible.
Tips for Medical Students Undertaking Research in the NHS
The above process applies to all NHS research; however as a medical student we present some additional tips for undertaking successful research in the NHS.
Ensure a clear understanding of the research that is proposed and what it entails for study participants. In our first application it was apparent from the response of the committee that we failed to make it clear what we were doing as part of the research. It should be made explicitly clear in the application form what the study entails for its participants as a result of taking part in this research, that differs from normal practice were they not to agree to take part in the study. Ethics committees are only concerned with the additional elements.
The wording used within the documents needs to be well thought. Throughout our first application, we had not made it apparent that the medication the participants received was routine management and would therefore take place regardless of them taking part in our study. The use of “a trial of medication” led to a serious misunderstanding, in that the committee interpreted the research as a clinical trial. Generally speaking, few ethics committees feel comfortable approving student research projects composing of drug trials, therefore it is best to avoid such types of studies in the first place.
There are many documents to submit as part of an application and invariably the content is repetitive. However, they address different parts of the process; the protocol is for specialists in the field, the PIS address the potential study participants, and the NRES form addresses the REC. There is a requirement for consistency of content and use of appropriate language in all documents. In our first application, the PIS was detailed and somewhat unnecessarily complicated and the REC felt it was not obvious exactly what the study participants would be letting themselves in for. We addressed this in our second application so as to make explicit at the start what potential study participants would be engaged in if they took part; however the committee felt the PIS was, this time, not “user-friendly” and required additional line spacing. It is obvious from our experiences that RECs place great emphasis on a high-quality PIS. Therefore spend time perfecting the PIS. Ask a lay person to read it through and check the PIS is particularly comprehensible to them. Also remember to include your contact details as the researchers of the study in the PIS as this highlights that participants have the chance to contact you if they have any queries regarding the study.
Typical medical students will not be able to complete the NRES form in one sitting; we found completion of about 5 questions per day preserved sanity. The completed form should make sense to a lay person with correct language, spelling and grammar. Consequently, it may be useful to ask a lay person to read through the completed form. It is also advisable to go through the questions with your supervisor and any academics from the medical school / teaching hospital, who have a special interest in research ethics. The value of such individuals cannot be under-estimated and adding their “fresh brain” often helps identify some of the obvious errors. Furthermore, they may be able to predict questions the REC are likely to raise and suggest answers. If such questions are asked, a well-thought-out answer always looks slick, confirming that the candidates have considered ethical issues when preparing the application.
Maintaining a good relationship with your supervisors is imperative. They are vital for attending the REC meeting and for the project itself to be executed; they will also be the first line of contact for any queries in relation to the research. Admiration must be given to all supervisors, who take time out to help medical students’ needs. Ensuring supervisors are happy ultimately ensures a happy ending to the research too.