CITI Training(2024 Latest Update)100% Correct(Rated A+)

3 criteria of unanticipated problems - ANSWER 1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the research plan-related documents, such as the IRB-approved research plan and informed consent document; and (b) the characteristics of the subject population being studied; 2. Related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and 3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. adverse event - ANSWER Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. Belmont Report covers - ANSWER (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings 3 basic ethical principles - ANSWER 1. Respect for Persons 2. Beneficence 3. Justice