Clinical Research exam with complete solutions.

Clinical Research Definition A systemic investigation of a specific question or problem that is designed to develop or contribute to generalizable knowledge Characteristics of research Goal-directed, Objective, Sturctured/Organized, Reliable/ Valid Previous Play Next Rewind 10 seconds Move forward 10 seconds Unmute 0:02 / 0:15 Full screen Brainpower Read More Clinical Research involves human being, often considered patient-oriented, conducted in a variety of setting, test therapeutic interventions disease prevention, improving diagnoses, knowledge of disease process leading cure. Basic Research involves tissues, molecules DNA, rats, mice,monkeys, AKA "bench" research, conducted in the lab,earlist stage of developing disease treatment & prevention, developing drugs and biologics to be tested in clinical studies Investigator-initiated research vs. Industry initiated research both may be clinical,both are subjects to the ethical framework and regulations to be reveiwed in this course,generally different in scope, cost and source of funding, primary difference involves role of the Principal Investigator (PI) and who writes the protocol Do No Harm Principle of ethics in research orignatedin ancient Greece with the HIppocratic Oath. Hippocrates The father of modern medicine. Nuremberg Code 1949 have 10 codes that are not laws but codes for the world medical information. Voluntary Consent Declaration of Helsinki 1964 18 basic principles for reseach that holds important place in history. Introduce concept of surrogate descision making,distinguish between therapeutic research and purely investigational research Belmont Report 1979 response to media attention of human research participant abuses. National Research Act passed 1974. healthcare reform act The three principle of Belmont Report Respect for person, Beneficence, Justice. This was a very long document. National research act lead to Belmont research act. Title 45 part 46 Protection of human subject "Common Rule" research conducted in an insititution that has elected to have all of their non-federally supported studies fall under their assurance of compliance FWA