Waiver of irb requirement - Study guides, Class notes & Summaries

History and Ethical Principles - SBE CITI Training questions and answers with certified solutions 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 minimization of risks All of the following are true regarding the belmont report except: T...

Biomed refresher 1 CITI Already Verified A+ Research Ethics and Risks of Harm 1. Informed Consent and Questionnaire Risks - Statement about Consent Form: - ️ False - It is not okay to omit potential risks of harm from the quality of life questionnaire in the consent form. - Rationale: - Depending on the nature of the questions posed, significant risks to privacy and confidentiality could arise, making it necessary to inform participants. 2. Research on Domestic Violence and Children ...

CITI 2023 Exam Questions with Correct Answers Privacy, in the health information context, refers to: - Answer-The rules about who can access health information, and under what circumstances. In the U.S., privacy protections for health information come from: - Answer-Federal, state, local, and private certification organizations' requirements With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category do discussions w...

Which of the following is included in the Nuremberg Code: - Answer-voluntary consent The National Research Act of 1974 - Answer-Established the National Commission. Informed consent is considered an application of which Belmont principle? - Answer-Respect for Persons Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer-US Public Health Service Policy Which of the following brought increased public attention to the problems with the IRB system? - Answer-Death of Jesse Gelsinger T...

CCRP SOCRA Exam test preparation Questions and Must have marking scheme Updated version 2024/2025 This form is used for the voluntary reporting of adverse events and product problems: A) 1571 B) 1572 C) 3500 D) 3500A - correct answer C) 3500 Reminder: 3500 is for voluntary; 3500A is for mandatory Each IRB that reviews studies involving children as subjects is covered by: A) 21CFR Part 56, Sub part A B) 21CFR Part 56, Sub part B C) 21CFR Part 50, Sub part C D) 21CFR Part 56, ...

Which of the following was the result of the Beecher article? - ANSWER-Realization that ethical abuses are not limited to the Nazi regime The use of prisoners in research is a concern under the *Belmont principle of Justice* because: - ANSWER-Prisoners may be used to conduct research that only benefits the larger society Issued in 1974, 45 CFR 46 raised to regulatory status: - ANSWER-US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy ...

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: A. Persons with diminished autonomy should only participate in no more than minimal risk research. B. Persons with diminished autonomy should be excluded from research. C. Persons with diminished autonomy are entitled to protection. D. Persons involved in research cannot financially benefit. C. Persons with di...

CITI Training, Modules 1-24 (Biomedical Research) Questions and Answers 2023 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: A. Persons with diminished autonomy should only participate in no more than minimal risk research. B. Persons with diminished autonomy should be excluded from research. C. Persons with diminished autonomy are entitled to protection. D...

Research with Children – SBE Questions and Answers Already Passed A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission? Th...

SBE Refresher 1 - Defining Research with Human Subjects Latest 2023 Graded A IMMUNIDEFICINECY DISORDERS 1. what is ID? WHAT IS IT CHARACTERISTICS? VERSE NEOPLASMS? 2. ID hallmark? 1-characterized by absences ; EXCESS oR UNCONTROLLED 2-enhanced susceptibility to infections -More frequent illness -Common illness that is more severe or lasts longer than normal o Disease due to uncommon pathogens o Disease due to commensal organisms o Disease that fails to respond to otherwise normal treatm...