Download HHS Policy: Understanding Human Research Subjects' Protection and more Exams Nursing in PDF only on Docsity! NIH training Questions Week 4 1 / 4 1. B 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 2. C 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, Beneficence, Justice D. Protections for Pregnant Women, Prisoners, Children 3. A Which entity has regulatory authority for the protection of human subjects for PHS-funded research? A. OHRP B. NIH C. Institutions that receive Federal funds D. HHS 4. False True or False: All research that involves interaction or in- tervention with humans or human samples/data, whether they are alive or dead, is human subjects research. 5. True True or False: An institutionally designated authority, oth- er than the investigator, should determine that proposed studies are exempt from regulatory requirements. 6. D Which of the following should be eliminated or minimized in the research design? A. Coercion B. Research risks C. Repeated recruitment of research participants for new protocols D. All of the above 7. D NIH training Questions Week 4 2 / 4 When might human subjects research require investiga- tors to obtain informed consent? A. Investigators must obtain informed consent if the study involves interactions with research participants. B. Investigators must obtain informed consent if the study involves interventions with research participants. C. Investigators must obtain informed consent if the study involves collection of private information from or about research participants. D. All of the above 8. False True or False: After informed consent for a research study is given, a research participant must complete the study. 9. True True or False: In general, informed consent should be a process rather than a one-time event. 10. C In order to participate in research, children must ... A. Provide written informed consent B. Provide written permission C. Provide assent, unless the IRB determines that they are too young D. Sign, or put an "X" on the assent document 11. D For research involving pregnant women, participation re- quires ... A. That women have completed the first trimester. B. That the study be conducted first in men. C. Permission of the father. D. Consideration of risks and potential benefits for the fetus and the pregnant woman. 12. D Why might an individual have diminished autonomy? A. They are a neonate. B. They are incarcerated or involuntarily confined. C. They are unconscious. D. All of the above. 13. False
