A2-3. Complete the following sentence: “Under TCPS 2, research that relies exclusively on information that is publicly accessible and for which there is no reasonable expectation of privacy _________.” Requires REB review. Is exempt from REB review. May require REB review, depending on the circumstances.

Canadian researchers who plan to recruit participants only from outside Canada are not required to seek REB approval from their institution because the mission of TCPS 2 is to protect Canadian research participants.

Canadian researchers who plan to recruit participants only from outside Canada are not required to seek REB approval from their institution because the mission of TCPS 2 is to protect Canadian research participants. False True

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 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.

A researcher at a Canadian institution eligible to receive Agency funding wishes to determine the frequency of cannabis consumption among high school students in Canada. The researcher will create a website that includes a secure link to a survey for students wishing to participate in the research. For scientific reasons, only students who have already used cannabis will be invited to participate and respond anonymously to the survey (please answer all questions by YES or NO).The REB administrator sees the proposed study as minimal risk research and decides to do a delegated review instead of a full board REB review. Is the REB administrator correct in thinking this is minimal risk research and that delegated review is acceptable in this case? Yes No