DEFINING RESEARCH WITH HUMAN SUBJECTS - SBE|UPDATED&VERIFIED|100% SOLVED|GUARANTEED SUCCESS

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that risks are reasonable in relationship to anticipated benefits. The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? Harvard "Tastes, Ties, and Time (T3)" study ()" study 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? The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. The Belmont principle of beneficence requires that: Potential benefits justify the risks of harm. According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: Justice. According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or: Obtains, uses, studies, analyzes, or generates identifiable private information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression. Census data (the final report as published by the Census Bureau) is an example of: Public information. According to the federal regulations, which of the following studies meets the definition of research with human subjects? 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. A medical record is an example of: Private information. A 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. According to the federal regulations, which of the following studies meets the definition of research with human subjects? An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. According to the federal regulations, which of the following studies meets the definition of research with human subjects? A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. How long is an investigator required to keep consent documents, IRB correspondence, and research records? For a minimum of three years after completion of the study According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: The changes must be immediately implemented for the health and well being of the subject. IRB continuing review of an approved protocol must: Occur at least annually. A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries. A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. A waiver of the requirement for documentation of informed consent may be granted when: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. As part of the consent process, the federal regulations require researchers to: Provide potential subjects with information at the appropriate reading comprehension level. Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.