45 cfr 46 subpart b - Study guides, Class notes & Summaries

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 laid out principles for PHYSICIANS to follow. First significant eff...

Practice Questions for SOCRA exam questions and answers already graded A+| Updated & Verified | 2024 Which of the following is a disclosure of financial interests form? - Which of the following is a certification of financial interest form? - If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - Investigational New Drug Application In the to...

45 CFR 46 Subpart A "Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C Additional protection for prison...

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...

45 CFR 46 Subpart A - Correct Answer-"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B - Correct Answer-Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C - Correct...

The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - European Union, Japan and United States What organizations are represented in the ICH Steering Committee? - Australia, Canada, the Nordic countries and the World Health Organization (WHO), European Union, Japan, and the United States What ethical standards are the ICH Documents based on? - Declaration of Helsinki What is the status of ICH in U...

Introduction Revelations in the early 1970s about egregious medical experiments provided the impetus for developing federal standards for protecting human research subjects; however, a close reading of the regulations at 45 CFR 46 will find mention of research methods and topics of inquiry relevant to researchers in the social and behavioral sciences, as well as education and the humanities. Methods mentioned include surveys, interviews, focus groups, participant observation, observations of pu...

45 CFR 46 Subpart A - Correct Answer-"Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. 45 CFR 46 Subpart B - Correct Answer-Additional protections for pregnant women, human fetuses, and neonates (46.200) 45 CFR 46 Subpart C - Correct...

NIH Training Questions - With Verified Answers, Graded A A "systematic investigation designed to develop or contribute to generalizable knowledge" may include: A. Evaluation B. Research Development C. Testing D. All of the above True or False: Communities may grant emergency waivers of informed consent for research involving pregnant women in the community who are in active labor and call Emergency Medical Services. False True or False: Requirements specific to informed consent for prisoners ...

SOCRA Practice 1 questions and answers latest 2023 True or False The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing. False. A treatment protocol is sponsored by a sponsor, while a treatment IND (Investigational New Drug) is sponsored by a licensed medical practitioner who becomes a sponsored investigator. 21 CRF 312.35 True or False Investigators are responsible for periodically requesting updates regarding new information gleaned by a ...