Nuremberg Study guides, Revision notes & Summaries

Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - respect for persons, beneficence, justice Application of Respect for Persons - informed consent (autonomy, choose for themselves) Application of Beneficence - risk/benefit analysis Application of Justice - appropriate selection of patients (equality) Language Level ICF - 6th-8th grade 8 basic elements of ICF - 1. purpose, duration, and procedu...

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

Nuremberg Laws correct answer: Anti Semitic (hatred) laws against Jews, originated by the Nazi Government in 1935 Purpose of Nuremberg Laws correct answer: based on the belief of scientific racism. Separate Jews from Germans (Aryans) Deprived Jews of German citizenship 1933 correct answer: After Nazi came to power during_____, attack on jews increased. Defined As Jew correct answer: had three or four racially full Jewish grandparents belonged to a Jewish religious community anyo...

CITI Training, Modules 1-24 (Biomedical Research) Questions and Answers (2023/2024) With Complete Solution. 1. 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 au...

Belmont Report was created as part of? Correct Answer: The national Research Act of 1974. Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA regulations made? Correct Answer: 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? Correct Answer: 1996 What is the National Research Act? Correct Answer: ...

This document consists of a summary of the course Clinical Development and Clinical Trials (AM_1180).

CCRP SoCRA Exam Latest Update Rated A 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subpa...

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

Who was tried in the Nuremburg Military Tribunals and why? - Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? - After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948. What historical docume...

CITI –Social & Behavioral Research Questions and Answers Already Passed What procedures must be described in an agreement called an "assurance of compliance" with OHRP? Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional poli...

PNR 415 EXAM LATEST UPDATE GRADED A+ CNO Entry to Practice Competencies Conceptual framework Patient Acuity Self regulation CNO Conflict Resolution Resolution approaches Techniques Values clarification Conflict prevention and management What is mediation? Provinces decide how much money to spend on health services, where to deliver these services, where to locate hospitals, and how many doctors are needed. federal in the Yukon, Nunavut, and the Northwest Territories and of Aboriginal people...