Ethical Principles and Human Subjects Regulations in Research, Exams of Nursing

Download Ethical Principles and Human Subjects Regulations in Research and more Exams Nursing in PDF only on Docsity! NIH 1 / 8 1. The Belmont Report is sig- nificant because 2. A study proposing to in- volve pregnant adolescents who are detained in a juve- nile detention center would only be allowed if 3. An "autonomous person" is someone who: 4. 45 CFR 46 requires Feder- al Departments and Agen- cies to rely solely on IRBs to evaluate risks to subjects, protection against =these risks, potential ben- efits of the research and the importance of the knowl- edge to be gained. 5. What are the three ethi- cal principles that constitute the basis for the HHS Hu- man Subjects Regulations (45 CFR 46)? 6. An institutionally designat- ed authority, other than the investigator, should deter- mine that proposed studies are exempt from regulatory requirements. It articulated ethical principles that formed the basis for the HHS Human Subjects Regula- tions. The requirements of Subparts A, B, C, and D are met. Understands the risks and benefits of his or her participation and is able to make a volun- tary decision if adequate information is provid- ed. False Respect for Persons, Beneficence, Justice True NIH 2 / 8 7. False NIH 5 / 8 20. Which of the following is TRUE regarding applica- tions for NIH-funded re- search overseas? 21. In localities where commu- nity consent is the norm, 22. Which subpart(s) of the 45 CFR 46 is/are sometimes re- ferred to as The Common Rule? 23. Identify the most influential event that led to the HHS Policy for Protection of Hu- man Research Subjects: 24. Which entity has regulato- ry authority for the protec- tion of human subjects for PHS- funded research? 25. The three fundamental prin- ciple of Informed consent are 26. If informed consent informa- tion is presented orally, it must be documented using a short form that states that all of the required elements were presented orally. 27. Which of the following most accurately describes clini- cal equipoise: Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies In addition to the cultural norm, individual in- formed consent is required Subpart A which describes the required pro- tections for all human subjects Syphilis Study at Tuskegee OHRP Voluntariness, Comprehension, Disclosure True Scientific uncertainty that one study interven- tion is superior to another. 28. False NIH 6 / 8 Risks to research partici- pants must be completely eliminated for the study to be considered ethical. 29. What is an appropriate method for maintaining con- fidentiality of private infor- mation obtained from hu- man subjects? 30. Social justice and individual justice are different and dis- tinct, yet compatible, con- cepts 31. Children must be included in all NIH-supported human subjects research unless: 32. A study proposing to in- volve pregnant adolescents who are detained in a juve- nile detention center would only be allowed if: 33. Which subpart(s) of the 45 CFR 46 is/are sometimes re- ferred to as The Common Rule : 34. All research that involves interaction or intervention with humans or human sam- ples/data, whether they are alive or dead, is human sub- jects research. 35. Requirements specific to in- formed consent for prison- 1. Keeping data in a password-protected data- base 2. Storing images in a secured cabinet 3. Coding data or specimens and keeping the key to the code in a separate, locked drawer True There are scientific and ethical reasons to ex- clude them The requirements of Subparts A, B, C, and D are met. Subpart A which describes the required pro- tections for all human subjects False True NIH 7 / 8 ers include adequate assur- ance that parole boards do not consider a prisoner?s participation in making deci- sions regarding parole. 36. One of the requirements of informed consent is that subjects must be told whether they are eligible to receive compensation if they are injured as a result of their participation in the research 37. For research involving preg- nant women, participation requires: 38. Why might an individual have diminished autonomy? 39. According to the regula- tions, to be approvable, re- search participation must provide a tangible benefit to the individual research sub- jects. 40. There must be equipoise in order to justify conducting a clinical trial. 41. The concept of individual justice implies that it is ac- ceptable for investigators to offer potentially beneficial research only to favored pa- True Consideration of risks and potential benefits for the fetus and the pregnant woman. 1. They are a neonate. 2. They are incarcerated or involuntarily con- fined. 3. They are unconscious. False True False