Human subject protections - Study guides, Class notes & Summaries

CITI Training Questions with 100% Correct Answers . Three principles of Belmont Report - Correct Answer; Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - Correct Answer; MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - Correct Answer; TRUE The Belmont Report Respect for Person - Correct Answer; Requires that subjects freely choose to participate in research ...

Test Bank For Pharmacology A PatientCentered Nursing Process Approach, 11th Edition by Linda E. McCuistion Chapter 1- 58 | Updated Version 2023-2024. The nurse is using data collected to define a set of interventions to achieve the most desirable outcomes. Which of the following steps is the nurse applying? a. Recognizing cues (assessment) b. Analyze cues & prioritize hypothesis (analysis) c. Generate solutions (planning) d. Take action (nursing interventions) ANS: C When generating solut...

Belmont Report and its principles - Correct answerWhich of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - Correct answer-Determining that the study has a maximization of the benefits and a minimization of risks Which of the following are the three principles discussed in the Belmont Report? - Correct answer-respect for persons, beneficence, justice The Belmont Report's principle of respect for persons incorporates at le...

ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that "the monitor(s), the auditor(s), the IRB/IEC,...

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if needed ...

2024 Newest |CCRP Exam| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days How many members must sit on an IRB? - ANSWER-5 How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research What are the criteria for IRB approval of research? (7) - ANSWER-1. Risks to subjects are minimized 2. Risks are reason...

CIPP/EUniversal Declaration of Human Rights (UDHR) 1948, Art. 12 - correct answers i. First international legal instrument announcing a right to privacy ii. Catalyst for other human rights instruments in Europe. iii. Recognized universal values and traditions of "the inherent dignity and the equal and inalienable rights of all members of the human race in the foundation of freedom, justice, and peace in the world." European Convention on Human Rights (ECHR) 1950, Art. 8 - correct answers ...

CCRP Certification Exam Quiz with Approved Answers | Latest 2023/2024 Year/ description of the Nuremberg Code ️1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. What implications came of the Nuremberg Code? ️Ten elements of human research including voluntary informed consent is absolutely essential. Year and description of the Declaration of Helsinki ️1964- Based on the principles of the Nuremberg code. This declaration l...

CITI Training, Modules 1-24 (Biomedical Research) Questions and Answers Latest 2022 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 protect...

How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Infor...