NIH Training Questions with complete solutions

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 correct answer: B 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 correct answer: C 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 correct answer: A 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. correct answer: False True or False: An institutionally designated authority, other than the investigator, should determine that proposed studies are exempt from regulatory requirements. correct answer: True 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 correct answer: D When might human subjects research require investigators 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 correct answer: D True or False: After informed consent for a research study is given, a research participant must complete the study. correct answer: False