PM-138 Intro to Humans in Research PDF

PM-138 Skills for Medical Scientists Humans in Research Dr Siân-Eleri Owens Learning outcomes History of human involvement in research Describe different types of clinical trials and human involvement in research Outline the phases of clinical trials Understand the ethical issues around u...

PM-138 Skills for Medical Scientists Humans in Research Dr Siân-Eleri Owens Learning outcomes History of human involvement in research Describe different types of clinical trials and human involvement in research Outline the phases of clinical trials Understand the ethical issues around use of humans in research and why we have these standards Outline the Nuremburg Code and Declaration of Helsinki, and their role in protecting research  What is research? Dictionary definition: systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions; investigate systematically. (Bio)Medical research Basic research (also called bench science or bench research) applied research, or translational research conducted to aid and support the development of knowledge in the field of medicine. Clinical research: Branch of healthcare science that determines the safety and effectiveness (efficacy) of: medications devices, diagnostic products treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Why do we have research? Research question Must be specific to test a specific hypothesis Question that ‘matters’ Scientific / health related bases & relevance Avoid fishing exercises Gathering of data to find a question  Observational ‘studies’: Participants are assessed for biomedical or health-related outcomes. May receive diagnostic, therapeutic and standard care interventions but are not assigned to specific groups by the investigator. Interventional ‘trials’: Participants are assigned to specific groups, by investigators, to receive one or more (or no) interventions so that they may be assessed for biomedical or health-related outcomes evaluated.  Research studies Drug Design & Discovery Preclinical: Phase 0: Phase 1: Usually in vitro.