by Srimathy Vijayan, Mark Wilkinson and Paul Worth^[1], School of Medicine, Health Policy and Practice, University of East Anglia

 

Abstract

Medical practice should be generated using robust research, otherwise known as evidence-based practice. It is therefore important that medical students understand the process of research from the initial concept through to the analysis of its output. Herewith we present a concise overview of initiating a research project within the NHS, UK. We then use our experiences of applying for research ethical approval for our student research project as a basis to provide some further tips for success. We hope this will be of particular interest to academics supervising and partaking in student research projects and indeed to students themselves. Despite the difficulties that become apparent in obtaining the necessary approvals required to commence research within the NHS, the long term skills and knowledge gained from undergoing the process are valuable.

Keywords: Research ethics, NHS ethical approval, medical student research

 

Introduction

Modern-day medical practice should be based on strong evidence (Fisher et al., 2007) underpinned by high-quality research. This allows doctors, with the involvement of their patients, to make optimum patient care decisions. Undertaking research itself enhances one’s career profile (Thomas, 2004), and in an increasingly competitive world, doctors who have done something beyond the usual requirements do stand out (Gao et al., 2007). It is therefore important that medical students understand the process of research from the initial concept through to the analysis of its output, and it is not surprising that most modern-day medical curricula incorporate such a message. In fact, 16 of 32 medical school prospectuses on the internet mention research teaching; of these, 10 make participation compulsory (Wilkinson, 2006).

The necessity for rigorous appraisal of all research in the NHS from scientific credibility to ethical acceptability has led to the commonly held view that gaining approval to carry out research within the NHS system is over-regulated, making it tiresome, tedious and time-consuming (Beales, 2004; Henderson, 2007). Some authors have suggested that the outcome is so variable as to be almost a game of chance (Glasziou et al., 2004). For this reason wiser students may choose to conduct research projects that take the form of audit, which are absolved from these bureaucratic requirements. However, their braver colleagues who undertake original research need NHS research governance and ethics approval. More guidance through this process can be found on the National Research Ethics Service (NRES) website (http://www.nres.npsa.nhs.uk/).

Background and Project outline

Srimathy Vijayan is a medical student currently undertaking clinical research supervised by Paul Worth. Their research project involves using a validated scale and motor assessment tests to assess clinical response to a routine medication in patients.

 

Application Process and Outcomes

Our first application was submitted to a Research Ethics Committee (REC). After a lengthy appointment at the committee, we received an unfavourable opinion (outright rejection). From the letter, we realised that we had not made our research intent clear. We used the points raised in the letter to re-write a new application for our study ensuring we had addressed all the issues without changing our actual study per se. We then re-submitted to the next available meeting of a Type 3 committee; the outcome was an approval subject to minor modifications.

Aims and objectives

In the following extract, we use our experiences of applying for research ethical approval for our student research project as a basis to provide some tips for success.

 

How to Approach Gaining Approval for a Study within the NHS

The following chronological steps provide a brief overview of the process:

1. Draft a protocol which clearly defines what the research entails and prepare/draft any additional required documents for the study

Clearly define a research hypothesis and how research subjects will be selected. It should be very apparent in the protocol what is routine practice and what is part of your research. The protocol should also highlight the way in which the results of the study will be disseminated, and thus the likely benefits of the research to the community. Copies of additional documents including questionnaires, participant information sheets (PIS), GP/consultant letters and consent forms should be included and prepared in the same manner. Do bear in mind that these documents should be printed on hospital or institutional paper as this adds credibility and authenticity.

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.

 

Specific Tips Regarding Ethical Approval

An understanding of the REC’s role and responsibilities improves the chance of successfully completing the application process. Do keep in mind that the minority of ethics committee members are medical professionals; and even these members are unlikely to have specialist knowledge of your field of research. Therefore it is advisable to write everything in simple language, with short sentences and to get it checked over by a lay person. The simpler it is, the more likely it will be understood and less likely it is rejected.

The RECs consider each research project on an individual basis, assessing the following:

1. The justification of the research, i.e. is it worth carrying out on participants?
2. The methodology of the research and whether it has been well thought out?
3. Is the research something that a medical student can do in the given time period?
4. Are there appropriate supervision measures for students?
5. Will the research give rise to benefit for the community from which the participants are derived from?
6. The impact the research has on participants, above that of their normal care.
7. The risk of and likelihood of distress to participants?
8. The participant’s ability to take part and the reality that the research will be able to recruit?

Research ethics is a complex topic, yet there is a fundamental question behind it. The bottom line is to ensure the risk to the safety and welfare of participants is minimised and justified by the potential outcome of the study, and if an application can demonstrate this to the REC, there is no reason why ethical approval should not be granted.

 

Conclusion

Despite the application process being a period of intense stress, pressure and tension for medical students, which is often made worse by lack of understanding, students exposed to research are able to develop generic skills very early on in their career, and such skills are likely to be valuable for their future.

 

Practice Points

Medical students need to:

• Have a good understanding of the research, including what it entails for study participants, why it is important and how it will benefit the wider community;
• Allow time and help in filling out the NRES form;
• Ensure consistency in all the documents submitted for ethical review;
• Be able to predict and anticipate any ethical points in your study and prepare potential answers for them;
• Develop good organisational and time-management skills to plan well in advance research;
• Be able to accept when things go wrong, to move on from it, and re-attempt;
• Have a good relationship with supervisors and other academics in medical school / teaching hospital;
• Have commitment, motivation and desire to succeed in research.

Academics supporting medical students undertaking research should try to:

• Offer clear guidance for students undertaking research;
• Allocate time at regular intervals to check progress of research applications;
• Ensure regular liaison with the student’s clinical supervisor to ensure they are part of the team;
• If they can, put students in contact with former REC members;
• Support and encourage students who are struggling.

 

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Notes

[1] Srimathy Vijayan is currently a Foundation Year one doctor. As a 5^th year medical student, she undertook an intercalated year of study to obtain a Masters in Health care research (MRes). She has developed a keen interest in neurology, and is currently involved in a prospective, double-sited research study investigating groups of patients with parkinsonism.

Mark Wilkinson is Consultant Pathologist at Norfolk and Norwich University Hospital and Honorary Senior Lecturer, University of East Anglia. He is current Chair of Institute of Health REC UEA, previously Chair Great Yarmouth and Waveney LREC, Vice Chair Eastern MREC. His interest is in the teaching of research design and ethics.

Paul Worth is Consultant Neurologist at Norfolk and Norwich University Hospital and Honorary Senior Lecturer, University of East Anglia. Qualifying at Oxford University, he trained at the National Hospital for Neurology and Neurosurgery, St Mary’s and Atkinson Morley’s Hospitals in London. His special clinical interest is Parkinson’s disease and related disorders.

 

References

Beales, I. L. (2004), ‘Ethics review in research: Role of ethics committee review is interpreted widely’, BMJ, 328, 710

Cooke, E. (2007), ‘Unpacking the Human Tissue Act 2004’, Research Ethics Review, 3 (1), 61-63

Fisher, C. G. and K. B. Wood (2007), ‘Introduction to and techniques of evidence-based medicine’, Spine, 1, (32)(19 Suppl), S66-72

Gao, A. and P. I. Murray (2007), ‘Going for the third degree’, BMJ Career Focus, 335, 181

Glasziou, P. and I. Chalmers (2004), ‘Ethics Review Roulette: What can we learn’, BMJ, 328, 121-22

Henderson, M. (2007) ‘Constant policing of our research makes us look sinister, say scientists‘, The Times. 25 October 2007, http://www.timesonline.co.uk/tol/news/uk/science/article2733452.ece (Accessed on 10/07/2008)

Thomas E. (2004), ‘The future of clinical research – an outside-in view’, Clin Med, 4 (2), 169-72

Wilkinson, M. (2007), Personal internet search of all UK medical school prospectuses, 10 September 2007

To cite this paper please use the following details: Vijayan, S., Wilkinson, M. and Worth, P (2009), ‘Conducting Research within the NHS: A Guide for Medical Students and a Closer Look into the Ethical Approval Process', Reinvention: a Journal of Undergraduate Research, Volume 2, Issue 2, http://www.warwick.ac.uk/go/reinventionjournal/issues/volume2issue2/vijayan Date accessed [insert date]. If you cite this article or use it in any teaching or other related activities please let us know by e-mailing us at Reinventionjournal@warwick.ac.uk