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CITI training Social and Behavioral focus 100% Accurate!!

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Your informed consent form must describe _______. - ANSWER All foreseeable risks and discomforts. Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. - ANSWER - Protecting the rights and welfare of human subjects - Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. - Reviewing subject recruitment materials and strategies. A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review? - ANSWER Determination for Exemption A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review? - ANSWER Not Human Subjects Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. - ANSWER - Faculty Advisor/Research Mentor- IRB Office In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________. - ANSWER The common rule Identify one way faculty researchers can possibly avoid undue influence of student subjects? - ANSWER Avoid recruiting their own students in the research A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review? - ANSWER Convened Review An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of

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Uploaded on
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