citi training and belmont report| 531 QUESTIONS| WITH COMPLETE SOLUTION

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Three principles of Belmont Report Correct Answer: Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence Correct Answer: MAXIMIZATION of benefits and MINIMIZATION... of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest Correct Answer: TRUE The Belmont Report Respect for Person Correct Answer: Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent) The Belmont Report defines and delineates... Correct Answer: "Practice" and "Research" The Belmont Report The Principle of Justice Correct Answer: Research benefit and burden distribution and that selection of subjects is fair. T/F The Belmont report describes the necessity to effectively manage conflicts of interest Correct Answer: FALSE Students in Research The history of ethical regulations in human subjects research began with the Correct Answer: Nuremberg Code Nuremberg Code Correct Answer: Human subjects research guidelines and regulations Year of the Nuremberg Code Correct Answer: 1949 Additional resources regarding IRB approval process Correct Answer: Faculty advisor/Research Mentor IRB office Human subjects research websites What element must be included in an informed consent? Correct Answer: All foreseeable risks and discomforts Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB? Correct Answer: If the study qualifies for EXEMPTION Another name for the "Exempt" status Correct Answer: the Common Rule stated in Title 45 Part 46 Subpart A How can faculty researchers avoid coercion of student subjects? Correct Answer: Avoid using their own students in their research Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information. Correct Answer: Exempt Review category 2 Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects. Correct Answer: Full Board Review Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal Correct Answer: Expedited review Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a business Correct Answer: Not Human Subjects Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components) Correct Answer: "1.data through intervention or interaction with the individual 2. identifiable private information" Name the 3 responsibilities the IRB is charged with Correct Answer: 1. Protecting the rights and welfare of human subjects 2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed 3. Reviewing subject recruitment materials and strategies T/F IRB's investigate scientific misconduct Correct Answer: False T/F IRB's do not review manuscripts prior to submission for publication Correct Answer: True DHHS FDA Correct Answer: Depts [Show More]

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