SOCRA - Study Start-Up Content Exam Questions & Answers 100% Correct

Declaration of Helsinki - ANSWER-Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice generally follow the Declaration of Helsinki. 3 Principles Belmont Report - ANSWER-respect for persons (informed consent) beneficence (assess risks and benefits) justice (selection of subjects) Belmont Report - Commission considered: - ANSWER-1) Boundaries btw research and routine practice 2) Role of assessment of risk/benefit criteria in determining appropriateness of research 3) Guidelines for selection of participants 4) Nature and definition of informed consent US Code of Federal Regulation by number - ANSWER-HHS = Title 45... FDA = Title 21... Public Health = Title 42... Common Rule 45 CFR 46 Part A - ANSWER-HHS regulations for the Protection of Human Subjects in research. Investigators who receive federal funding are required to follow the common rule. **Institutions w/ a FWA may agree to apply HHS regulations to all research regardless of funding source Nuremberg Code 1947 - ANSWER-10 ethical standards: 1) voluntary consent 2) research should yield fruitful results for the good of society