CITI Modules|2023 LATEST UPDATE|GUARANTEED SUCCESS

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: Persons with diminished autonomy are entitled to protection. Which of the following are the three principles discussed in the Belmont Report? Respect for Persons, Beneficence, Justice Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Determining that the study has a maximization of benefits and a minimization of risks. An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk. This is an unanticipated problem requiring notification to the IRB and FDA Housekeeping employees of the medical center were recruited for a federally funded study of blood pressure, blood count levels, infectious disease history, and job stress. The interviews and blood tests were conducted in a private location not affiliated with the study center. Follow-up interviews were conducted in the same location. The study coordinator stopped at the cafeteria on her way back to the study office after the second study visit for the last three study subjects and lost the three file folders. Records of one subject indicated he had a history of a sexually transmitted disease and another had recently been treated for tuberculosis. The subjects were notified of the loss. Following this event, the IRB approved a protocol change requiring that all records be transmitted electronically to the study office using the medical center's secure network. This is an unanticipated problem and not an adverse event. A Data Safety Monitoring Board report for an investigator-initiated investigational drug study indicates a significantly higher than anticipated rate of an expected adverse event. This event required revision of the informed consent form to disclose the higher rate. A change in the eligibility criteria of the protocol to reduce the risk was implemented. Current subjects would be reconsented. This is an unanticipated problem A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs. This is an unanticipated problem, which resulted in an adverse event. A study requires that each subject be given two study drugs. The first study drug is given on Day 1. A second study drug is given on Day 7 to counteract the toxicity of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone. This is an unanticipated problem that does not include an adverse event A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: Economic vulnerability According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four? Physical control, coercion, undue influence, and manipulation NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was not included as possibly leading to vulnerability? High potential for individual benefit from participating in research When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Is there a power differential between researchers and subjects? Which is true of inducements in research? Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: Situational cognitive vulnerability The National Research Act of 1974 Established the National Commission. Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy Informed consent is considered an application of which Belmont principle? Respect for Persons Which of the following was the result of the Beecher article? Realization that ethical abuses are not limited to the Nazi regime Which of the following is included in the Nuremberg Code: Voluntary consent Which of the following brought increased public attention to the problems with the IRB system? Death of Research Subject (Jesse Gelsinger) The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners may be used to conduct research that only benefits the larger society 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? 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? For a minimum of three years after completion of the study According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: The changes must be immediately implemented for the health and well-being of the subject. IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: Occur at least annually. An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator? Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. The purpose of informed consent is: To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator: The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. A general requirement for the informed consent form is that it may not 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? I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug. A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research? Confidentiality of the individual subject's responses A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research? Breach of confidentiality from the focus group subjects (therapists) Which of the following most accurately describes the risks associated with SBR? Less predictable, more variable, and less treatable than physical harms Which of the following is considered a SBR data collection method? Interviews As part of a research study, a physician plans to review medical records to explore factors related to patients requiring MRI scans of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true? The study is human subject research which is eligible for expedited review.