Question 1A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted but still require review at the U.S. site by the institution’s IRB. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. If a proposed study qualifies for exemption, federal regulations do require review at the foreign site where it will be conducted. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted, but still require review by the institutional official at the local site.Question 2A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB? Will the researchers have collaborators at the research site abroad? Does the professor speak Spanish fluently? Is the survey more than minimal risk? Does the potential subject population include children?Question 3The age of majority in international research is determined by the Legal drinking age where the research will take place. Laws in the state where the researchers' institution resides. The research sponsor. Laws, customs, and norms in the area in which the research will be conducted.Question 4What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? Ensuring that the consent process does not slow down the recruitment. In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Including a witness signature line on the consent form. Maintaining confidentiality of responses to survey questions.Question 5Which of the following activities constitutes engagement in research? Informing prospective subjects about the availability of research. Obtaining informed consent and conducting research interviews. Providing potential subjects with written information about a study. Obtaining subjects' permission for researchers to contact them.

QuizInstructions: Please provide an answer for all questions. Each question is one point. Click on the Submit button to register your answers. After submitting your answers, the correct answer to each question and an explanation will be displayed. Navigational links to the next module will also be provided.All quiz questions count towards your score. You should answer all questions.Question 1A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted but still require review at the U.S. site by the institution’s IRB. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. If a proposed study qualifies for exemption, federal regulations do require review at the foreign site where it will be conducted. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted, but still require review by the institutional official at the local site.Question 2A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB? Will the researchers have collaborators at the research site abroad? Does the professor speak Spanish fluently? Is the survey more than minimal risk? Does the potential subject population include children?Question 3The age of majority in international research is determined by the Legal drinking age where the research will take place. Laws in the state where the researchers' institution resides. The research sponsor. Laws, customs, and norms in the area in which the research will be conducted.Question 4What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? Ensuring that the consent process does not slow down the recruitment. In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Including a witness signature line on the consent form. Maintaining confidentiality of responses to survey questions.Question 5Which of the following activities constitutes engagement in research? Informing prospective subjects about the availability of research. Obtaining informed consent and conducting research interviews. Providing potential subjects with written information about a study. Obtaining subjects' permission for researchers to contact them.

Question 1A 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? Determination for Exemption Not Human Subjects Convened Review Expedited ReviewQuestion 2Under 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.Select all correct answers. Reviewing subject recruitment materials and strategies. Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. Reviewing manuscripts prior to submission for publication. Protecting the rights and welfare of human subjects. Conducting inquiries into scientific misconduct.Question 3A 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? Convened Review Determination for Exemption Expedited Review Not Human SubjectsQuestion 4In the U.S., the first federal regulations for human subjects research began in 1991 with the codification of the ________. Nuremberg Code Belmont Report Common Rule Declaration of HelsinkiQuestion 5Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply.Select all correct answers. IRB Office Export Control Office Faculty Advisor/Research Mentor The Student Union

According to the federal regulations, research is eligible for exemption, if: The research falls into one of eight categories of research activity described in the regulations. The researcher is experienced in the field of inquiry. Participation in the research will involve ten minutes or less of the subjects' time. All the subjects are adults and the risk is minimal.

Which of the following statements is true regarding the regulations that govern research? International research collaborations involving U.S. funded researchers are not governed by U.S. regulations when the work takes place at a private university. U.S. funded research collaborations are often governed by U.S. regulations no matter where the research takes place. International research is governed by the United Nations instead of any specific country’s regulations. The research of an international graduate student enrolled at a U.S. university is not governed by U.S. regulations unless the student plans to publish the results.

As part of the consent process, the federal regulations require researchers to: