Ohrp - Study guides, Class notes & Summaries

CITI Training Quiz Questions with 100% Correct Answers 1. Which of the following are the three principles discussed in the Belmont Report? - Correct Answer ️️ -Respect for Persons, Beneficence, Justice 2. 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: - Correct Answer ️️ -Persons with diminished autonomy are entitled to protection. 3. Which of the...

CITI -Social and Behavioral Research 100% correct!! What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - ANSWER 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 policy. Accord...

Research NIH Training Exam - Questions and Answers Identify the most influential event that led to the HHS Policy for Protection of Human Research Subjects: a. Nuremberg trials b. Syphilis Study at Tuskegee c. Jewish Chronic Disease Hospital Study d. Willowbrook Study What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)? A. Honesty, Trust, Respect B. Informed consent, IRB review, Research Integrity C. Respect for Persons, Beneficenc...

The probability of harm or discomfort...not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations. - Correct answer Minimal RiskRespect for persons, beneficence, and justice - Correct answer The Belmont PrinciplesAn administrative body composed of scientists and nonscientists established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the au...

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - ANSWER-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 professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the resear...

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 policy. According to federal regulations, is review required at the forei...

Module 4: Good Clinical Practice: FDA Regulations, FDA Guidance, and ICHThe Code of Federal Regulations (CFR) - correct answer Codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government, including the FDA. Divided into 50 titles and these are assigned to federal regulatory topics and/or government departments and agencies TITLE 21 FDA Part 200-499 - correct answer Drugs Title 21 FDA Part 600-699 - co...

OHRP Correct Answer Which entity has regulatory authority for the protection of human subjects for PHS-funded research? False Correct Answer True or False: All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research. Subpart A which describes the required protections for all human subjects Correct Answer Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule? False Correct...

1. Which of the following are the three principles discussed in the Belmont Report? - Answer-Respect for Persons, Beneficence, Justice 2. 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: - Answer-Persons with diminished autonomy are entitled to protection. 3. Which of the following is an example of how the principle of beneficence can be applied to a study ...

Informed Consent -Answer A statement that the study involves research. Explanation of purpose of research. Expected duration of subject's participation. Procedures to be followed. Identification of experimental procedures. Reasonably foreseeable risks or discomforts. Benefits to subject or to others expected. Statement describing confidentiality of records identifying the subject. Disclosure of alternative procedures and treatment. Explanation of Compensation for Injury. Who to contact with...