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

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...

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...

Research in Public Elementary and Secondary Schools – SBE Questions and Answers Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? Directory information. Schools may disclose, without consent, directory information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students that ...

Research in Public Elementary and Secondary Schools – SBE Latest 2023 Graded A+ Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? Directory information. Schools may disclose, without consent, directory information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students that ...

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 ...

CRA Exam Practice 93 Questions with Verified Answers Who uses eBRAP for proposal submissions - CORRECT ANSWER DOD SD-272- federal cash transaction report - CORRECT ANSWER 1 grant/cooperative agreement ASAP Automated Standard Application for Payments - CORRECT ANSWER a secure, web-based all electronic payment and information application that allows federal agencies to choose from three payment models to fit their financial needs and streamline operations at no charge to federal agencies...

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...

What is an orphan drug program? - ANSWER-FDA program that provides development of drugs for rare diseases Nuremburg Code - ANSWER-set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment - ANSWER-Amendment to Food Drug and Cosmetic Act that requires informed consent for experimental drugs Adverse Event - ANSWER-any unfavorable or unintended event associated with a research study Assent - ANSWER-a child's affirmative agreement to participate i...

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...

SOCRA - CCRP (high level) Questions and Answers 2023 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. ...