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The new research governance culture: its impact on undergraduate research projects
"The Pharmacy degree course includes a significant research project of three to six months duration, but not necessarily with all curriculum time during this period devoted to this activity alone. The student must undertake the project alone or as his/her individual contribution to a team endeavour. The project must address a research question or problem, must involve a critique of research methodology employed and must include an analysis of results generated directly by the student or indirectly by others as primary researchers".(1) For many years it was expected that research involving NHS patients, staff or premises be submitted to the Local Research Ethics Committee.(2) However, because of the non-NHS status of community pharmacy and the fact that much practice research does not affect patient treatment or access patient data, many research projects have run without ethical approval. This has been particularly the case with undergraduate research. However, it is very clear form BPC and HSR/PP conferences that undergraduate work has been an important element advancing pharmacy practice research. Now, the new DOH Research Governance culture requires all health projects to be approved by an appropriate public Research Ethics Committee (not just the university Ethics Committee)(3). Furthermore, the RPSGB has incorporated this requirement into all applications for pharmacy practice research funding from the Sir Hugh Linstead and Galen awards. Until now we have always taken the obligation to obtain ethical committee approval seriously when undertaking commissioned research. However, with undergraduate projects that do not influence treatment or access confidential information we have not obtained approval. We have therefore had to radically rethink our whole strategy. For this study we consulted all the 8 LRECs in our strategic health authority (SHA) asking for advice on how to proceed and setting out the key problems we face - short term projects, often short timescale in set up of project and identification of the student researcher, student learning needs and the feasibility nature of many of our studies. The responses varied from no response to "I am afraid that we will have to review all research". "I fully appreciate the problems you allude to, however...". The presentation will present the results of that survey and then discuss the implications for the advancement of pharmacy practice research. References 1. RPSGB (2002) Accreditation of UK Pharmacy Degree Courses 2. Jesson, J. Pharmacy practice research, ethical issues and local research ethics committees, Int J. Pharm. Pract 1997: 5: 54-6. Presented at the HSRPP Conference 2003, Belfast
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