Introduction to Experimental Medicine

MEDN69631 Introduction to Experimental Medicine 15 Semester 1 Postgraduate Taught Level 6 Benjamin Parker Unit coordinator School of Medical Sciences 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 7.5 The Introduction to Experimental Medicine module is a 15 credit, interactive blended learning course which provides students with an overview of issues related to conducting EM research. This area of research is broad and the aim of this module is to give students a generic introduction to the concepts, practical issues, and challenges that researchers may experience when conducting EM research.This module will cover basic concepts, ethical and regulatory considerations, study design, statistical methods, protocol development, and challenges encountered frequently in EM, including recruitment. The teaching will be delivered by clinical researchers active in EM research and will be supported by the Manchester Clinical Research Facilities.The unit will provide teaching to students using a mix of face-face session, interactive workshops and supportive learning opportunities:- Face –to-face sessions will be hosted by the NIHR Manchester Clinical Research Facilities and will be provided by researchers active in EM research, using current and recent studies to illustrate generic EM concepts.- Interactive workshops will be utilised to gain insight into study design, protocol development, and EM challenges, including analysis and recruitment.- Interactive review of CRF infrastructure and how CRFs can enhance EM studies- Interactive PPI/E sessions will facilitate students understanding of how patients and the public can feed into the design and dissemination of EM research.- Published studies will be used by students to develop their critical appraisal skills, and allow group feedback of the challenges and successes in EM research.- Students will also undertake creation of an ethics application, design of patient information sheets, and design of a recruitment strategy.   <div>  The Introduction to Experimental Medicine module is a 15 credit, interactive blended learning course which provides students with an overview of issues related to conducting EM research. This area of research is broad and the aim of this module is to give students a generic introduction to the concepts, practical issues, and challenges that researchers may experience when conducting EM research. This module will cover basic concepts, ethical and regulatory considerations, study design, statistical methods, protocol development, and challenges encountered frequently in EM, including recruitment. The teaching will be delivered by clinical researchers active in EM research and will be supported by the Manchester Clinical Research Facilities. The unit will provide teaching to students using a mix of face-face session, interactive workshops and supportive learning opportunities:  <ul> <li> Face –to-face sessions will be hosted by the NIHR Manchester Clinical Research Facilities and will be provided by researchers active in EM research, using current and recent studies to illustrate generic EM concepts.</li> <li> Interactive workshops will be utilised to gain insight into study design, protocol development, and EM challenges, including analysis and recruitment.</li> <li> Interactive review of CRF infrastructure and how CRFs can enhance EM studies</li> <li> Interactive PPI/E sessions will facilitate students understanding of how patients and the public can feed into the design and dissemination of EM research.</li> <li> Published studies will be used by students to develop their critical appraisal skills, and allow group feedback of the challenges and successes in EM research.</li> <li> Students will also undertake creation of an ethics application, design of patient information sheets, and design of a recruitment strategy.</li> </ul> </div>     <div> The unit aims to: <ol> <li> introduce students to general concepts of experimental medicine (EM) research</li> </ol> - understand the infrastructure and resource available to support EM research- provide students with practical and real world understanding of the regulatory oversight of EM- develop students’ understanding of ethical issues related to EM research, and introduce ethical considerations involved in special scenarios (e.g. children) 2. give students understanding of how to conduct EM research:- develop an EM protocol and define research outcomes- understand methodological issues and how they may be overcome- awareness of clinical research facilities and how they support EM- how to define populations of interest and choose appropriate inclusion/exclusion criteria- understand how to plan data collection and statistical analysis in EM studies 3. provide students with an awareness of challenges in EM research:- recruitment, retention, and healthy control populations- how to develop collaborations- how to translate EM into later phase research- how to integrate public and patient involvement when planning EM studies</div>     <table border="1" cellpadding="0" cellspacing="0"> <tbody> <tr> <td style="width: 158px"> Knowledge and understanding</td> <td style="width: 428px"> <ul> <li> Understand concept of EM and different EM study designs</li> <li> Understand who funds EM and who delivers EM research</li> <li> Understand the role of Clinical Research Facilities, and other EM research infrastructure, in helping deliver EM</li> <li> Understand principles of Good Clinical Practice (GCP) and how they relate to EM research</li> <li> Understand role of ethics committees, sponsors and NHS bodies in overseeing early phase clinical research</li> <li> Understand how GCP and ethical approval apply to special circumstances, including clinical research in children, mental illness, and pregnancy.</li> <li> Understand key statistical concepts in small n EM studies, including sample size calculations, hypothesis testing, and how data should be collected to facilitate statistical analysis</li> <li> Understand importance of collaboration to enable EM research</li> </ul> </td> </tr> <tr> <td style="width: 158px"> Intellectual skills</td> <td style="width: 428px"> <ul> <li> Discuss how EM research applies to the student’s own speciality and career</li> </ul> <ul> <li> Demonstrate importance of PPI/E in design and conduct of EM research</li> <li> Discuss impact of specific challenges in EM and develop a strategy to overcome (including recruitment, population selection, healthy control sampling, retention of participants, and dealing with missing data)</li> </ul> </td> </tr> <tr> <td style="width: 158px"> Practical skills</td> <td style="width: 428px"> <ul> <li> Apply new knowledge to development of research protocol and ethical application</li> <li> Critically appraise and discuss published EM research to enhance understanding of key issues and challenges</li> </ul> </td> </tr> <tr> <td style="width: 158px"> Transferable skills and personal qualities</td> <td style="width: 428px"> <ul> <li> Working collaboratively across professions</li> <li> Appreciation of research timelines and managing multiple deadlines and stakeholders to deliver a successful EM study</li> <li> Development of organisational, critical appraisal, presentation and statistical skills.</li> </ul> </td> </tr> </tbody> </table>   2 Written assignment (inc essay) 60% 7 Oral assessment/presentation 40% Feedback on assessed work is given to students via Turnitin. MRes Experimental Medicine MRes Exp Med (Cancer) PGDT Taught Component Mandatory MRes Experimental Medicine MRes Exp Med (Respiratory) PGDT Taught Component Mandatory MRes Experimental Medicine MRes Exp Med (Hearing Health) PGDT Taught Component Mandatory MRes Experimental Medicine MRes Exp Med (Dermatology) PGDT Taught Component Mandatory MRes Experimental Medicine MRes Exp Med (Musculoskeletal) PGDT Taught Component Mandatory MRes Experimental Medicine MRes Exp Med (Cancer CRUK) PGDT Taught Component Mandatory MRes Experimental Medicine PT MRes Exp Med (Cancer) PT PGDT Taught Component Mandatory MRes Experimental Medicine PT MRes Exp Med (Respiratory) PT PGDT Taught Component Mandatory MRes Experimental Medicine PT MRes Exp Med (Hearing Hlth) PT PGDT Taught Component Mandatory MRes Experimental Medicine PT MRes Exp Med (Dermatology) PT PGDT Taught Component Mandatory MRes Experimental Medicine PT MRes Exp Med (Musculoskel) PT PGDT Taught Component Mandatory N 0 0 0