Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection? PHS Tuskegee Study Stanford Prison Experiment (Zimbardo) Tearoom Trade Study (Humphreys) All of the above None of the above

Question 1Which of the following brought increased public attention to the problems with the IRB system? Death of Research Subject (Jesse Gelsinger) HHS Inspector General Report of 1998 “Shut Downs” by OHRP 1983 Presidential Commission ReportQuestion 2The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners are not a representative sample of the general population Prisoners may not be used to conduct research that only benefits the larger society Prisoners are less educated that the general population and have difficulty understanding research Prisoners are not free to say noQuestion 3Informed consent is considered an application of which Belmont principle? Beneficence Justice Non-maleficence Respect for PersonsQuestion 4Which of the following is included in the Nuremberg Code: Confidentiality of data Voluntary consent Equitable selection of subjects Additional protection for vulnerable subjectsQuestion 5The National Research Act of 1974 Identified guidelines to ensure the ethical conduct of research. Identified the basic ethical principles of human subjects research. Required that all federal agencies have the same regulations governing human subjects research. Established the National Commission.

Question 2The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners are not a representative sample of the general population Prisoners may not be used to conduct research that only benefits the larger society Prisoners are less educated that the general population and have difficulty understanding research Prisoners are not free to say noQuestion 3Informed consent is considered an application of which Belmont principle? Beneficence Justice Non-maleficence Respect for PersonsQuestion 4Which of the following is included in the Nuremberg Code: Confidentiality of data Voluntary consent Equitable selection of subjects Additional protection for vulnerable subjectsQuestion 5The National Research Act of 1974 Identified guidelines to ensure the ethical conduct of research. Identified the basic ethical principles of human subjects research. Required that all federal agencies have the same regulations governing human subjects research. Established the National Commission.

Question 1The National Research Act of 1974 Identified the basic ethical principles of human subjects research. Required that all federal agencies have the same regulations governing human subjects research. Established the National Commission. Identified guidelines to ensure the ethical conduct of research.Question 2Which of the following was the result of the Beecher article? Realization that ethical abuses are not limited to the Nazi regime An identification of basic ethical principles Additional FDA regulations Multiple Congressional hearingsQuestion 3Which of the following is included in the Nuremberg Code: Confidentiality of data Voluntary consent Equitable selection of subjects Additional protection for vulnerable subjectsQuestion 4Issued in 1974, 45 CFR 46 raised to regulatory status: Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act The Nuremberg Code US Public Health Service Policy The 1974 National Research ActQuestion 5The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners are not a representative sample of the general population Prisoners may not be used to conduct research that only benefits the larger society Prisoners are less educated that the general population and have difficulty understanding research Prisoners are not free to say no

Which of the following are the three principles discussed in the Belmont Report? Respect for Persons, Beneficence, Justice IRB Review, Federal Regulations, Declaration of Helsinki Privacy, Confidentiality, Equitable Selection of Subjects Informed Consent, Institutional Assurance, Researcher Responsibility

Question 1According to the federal regulations, which of the following studies meets the definition of research with human subjects? A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the U.S. between 1820-1845 to track the numbers of immigrants from certain ethnic groups. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS. A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. A researcher conducts a linguistic study of comments posted on a local public blog.Question 2A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates’ friends, family members, and business acquaintances. The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB? The IRB will not review this study because it is not research as defined by the federal regulations. The IRB will not review this study because it does not include human subjects as defined by the federal regulations. The IRB will not review this study because it does not involve an investigational new device. The IRB will review this study because it includes human subjects and is considered research.Question 3According to the federal regulations, which of the following studies meets the definition of research with human subjects? A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.Question 4A medical record is an example of: Private behavior Public information Private information Public behaviorQuestion 5According to the federal regulations, which of the following studies meets the definition of research with human subjects? The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided. A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information. A feasibility study for implementing a year-round school program, focusing on economic issues such as facilities utilization and transportation costs.