Certification for IRB Professionals (CIP) Exam Complete Q&A 2023.

Certification for IRB Professionals (CIP) Exam Complete Q&A 2023. According to the Belmont Report, respect for persons usually demands that subjects... According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - A poorly designed protocol is considered unethical because... - When should an IRB suspend or terminate approval of research? - A quorum for a convened IRB meeting requires the presence of... - What is required in research involving no more than minimal risk with children? - Federal regulations require each IRB to have written procedures for... - What are the 3 ethical principles discussed in the Belmont Report? - An example of how the Principle of Beneficence can be applied to a study employing human subjects? - The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation of which study? What is an example of how the principle of beneficence is applied to a study involving human subjects? - Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - Which study is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? - The Belmont Principle of beneficence requires that... - A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? - . How long is an investigator required to keep consent documents, IRB correspondence, and research records? According to federal regulations, when can the IRB use expedited review on a new, proposed study? Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: - A therapist at 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: - Provide potential subjects with information at the appropriate reading comprehension level. Data are made anonymous by... 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)? - The Right of Subject Privacy - The Right of Subject Confidentiality - 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? - longitudinal study - Example of Economic Vulnerability Which is an example of a situation where deferential vulnerability might be a factor? - Deferential Vulnerability - Which is true of inducements in research? - Example of Medical Vulnerability - The most important ethical concerns related to conflicts of interest in research are: - Current NIH rules require investigators to disclose details regarding financial conflicts of interest to: - The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold: - A financial conflict of interest could involve - Conflict of Interest - Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections: -