ocial-Behavioral-Educational (SBE) Comprehensive: Citi program (all quizzes) Answered all correctly_2023. Informed Consent - SBE (Answered) A therapist at
... [Show More] a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A waiver of the requirement for documentation of informed consent may be granted when: As part of the consent process, the federal regulations require researchers to: CITI Privacy and Confidentiality SBE (answered Quiz) A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? Data are made anonymous by Assessing Risk - SBE (Quiz Answered) If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: The primary purpose of a Certificate of Confidentiality is to: Additional safeguards that may be included in a social and behavioral study may include: A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: Identify the example of when situation and time are key to assessing risk of harm in a research study: Defining Research with Human Subjects - SBE CITI According to the federal regulations, which of the following studies meets the definition of research with human subjects? According to the federal regulations, which of the following studies meets the definition of research with human subjects? According to the federal regulations, which of the following studies meets the definition of research with human subjects? Census data is an example of: According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB? Conflicts of Interest in Human Subjects Research (ID 17464) What is the term for management controls that are built in to a research study (for example, independent data analysis)? When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher's opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial. A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. The NIH is a PHS agency. Therefore, this proposed research is subject to the PHS regulation regarding objectivity in research, which requires researchers to submit COI disclosures no later than the time a proposal is submitted to a PHS funding agency. The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? The PHS regulations about financial conflict of interests require the researcher to disclose significant financial conflicts of interest to the organization. The FDA's regulation governing disclosure of individual COI requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or disclose financial interests of researchers who conducted clinical studies covered by the regulation. An example of an individual financial COI is Conflicts of interest may arise in the peer review process (for example, bias causes a reviewer to respond positively to a manuscript because it involves research or methodology in which the [Show Less]