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Download Certification for IRB Professionals (CIP) Exam Complete Questions With Verified and Correc and more Exams Nursing in PDF only on Docsity!
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... enter into research voluntarily & with adequate information Justice research subjects may be put at risk or inconvenienced for insufficient reason 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? When it is not being conducted in accordance with the IRB's requirements a nonscientific member Adequate provisions are made for assent of the child and permission of parent or guardian initial & continuing review of research and for reporting its findings and actions to the investigator and the institution Respect for Persons, Justice, & Beneficence 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? "The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male" potential benefits justify the risks of harm Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. 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 For a minimum of three years after completion of the study The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations The changes must be immediately implemented for the health and well- being of the subject. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will 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 "Taking part in the research is voluntary, but we choose you as a participant, you waive the right to legal redress for any research- related injuries" A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. 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: Data are made anonymous by... The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. Provide potential subjects with information at the appropriate reading comprehension level. Destroying all identifiers connected to the data. Which of the following constitutes both a breach of confidentiality (the © A faculty member makes identifiable research data have been disclosed, data about sexual behavior available counter to the agreement between to researcher and sub Certification for IRB Professionals (CIP) Exam jects) and a violation of subjects’ graduate students, although the privacy (the right of the individuals to subjects were assured that the data be protected against intrusion into would be de-identified. 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 The right of the individuals to be protected against intrusion into their personal lives or affairs Refers to a condition in which the researcher knows the identity of a research subject, but takes steps to protect that identity from being discovered by others. Securing a Certificate of Confidentiality or reduced cost, and he could not otherwise afford it. Which is an example of a situation where deferential vulnerability A physician recruiting his patients might be a factor? This includes individuals who informally subordinate to an authority figure. For example, abuse victims, doctor/patient Certification for IRB Professionals (CIP) Exam relationships, and/or husband/wife relationships are all situations where Deferential Vulnerability one party may feel obligated to follow the advice of another. Inducements constitute an "undue influence” if they alter a potential Which is true of inducements in subject's decision-making processes, research? such that they do not appropriately weigh the risk-benefit relationship of the research. Subjects with a serious illness may Example of Medical Vulnerability be at risk for exploitation since they 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: Receiving stock in a company funding your research. A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of: Subpart B: Pregnant women, human fetuses and neonates;Subpart C: Prisoners; andSubpart D: Children 
