Condukting research in medicine

Condukting research in medicine
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.