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

Download Ethical Principles and Regulations for Human Subjects Research and more Exams Nursing in PDF only on Docsity! NIH Ethics 2 1 / 7 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 7. False NIH Ethics 2 2 / 7 Communities may grant emergency waivers of in- formed consent for research involving pregnant women in the community who are in active labor and call Emer- gency Medical Services. 8. Research involving prison- ers requires both specific IRB membership and ap- proval by OHRP to signify that the proposed research falls within the permissible research categories. 9. When might human sub- jects research require inves- tigators to obtain informed consent? 10. After informed consent for a research study is given, a research participant must complete the study. 11. In general, informed con- sent should be a process rather than a one-time event. 12. In order to participate in re- search, children must: 13. An example of a potential economic risk to a research True A. Investigators must obtain informed consent if the study involves interactions with research participants. B. Investigators must obtain informed con- sent if the study involves interventions with research participants. C. Investigators must obtain informed consent if the study involves collection of private infor- mation from or about research participants. False True Provide assent, unless the IRB determines that they are too young True NIH Ethics 2 5 / 7 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 Ethics 2 6 / 7 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 NIH Ethics 2 7 / 7 tients while selecting unde- sirable persons for riskier research. 42. NIH has specific policies ad- dressing: 43. Excluding children from par- ticipation in research, while well intentioned, may deny children the benefits of par- ticipation and prevent the collection of sufficient data about the possible effects of potentially therapeutic agents in children. 1. Inclusion of children in research 2. Inclusion of women and minorities in re- search 3. Treatment for research subjects in HIV/AIDS antiretroviral studies following completing of trials in developing countries True 44.