human subjects research Flashcards

What's on the cards

1. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
2. The Belmont principle of beneficence requires that:
3. A medical record is an example of:
4. An example cited in the Belmont Report stated that "during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?
5. A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:
6. A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?
7. 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?
8. According to federal regulations, when may the IRB use the expedited review process for a new, proposed study?
9. Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
10. Which of the following concerns is related to the Belmont principle of justice?
11. Identify the groups that are given additional protections in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D.
12. Which statement best describes the purpose and role of an IRB?
13. A student is conducting a research project that involves using a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?
14. A master's degree candidate needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stocks and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?
15. Which statement best describes information that must be included in a consent form?
16. A study proposing to involve pregnant adolescents who are detained in a juvenile detention center would only be allowed if:
17. True or false: research involving prisoners requires both specific IRB membership and a determination by the HHS Secretary that the proposed research falls within the permissible research categories.
18. True or false: after informed consent for a research study is given, a research participant must complete the study.
19. In order to participate in research, children must:
20. True or false: if a researcher determines that his/her study poses no more than minimal risk as defined in 45 CFR 46, there is no need for the protocol to have IRB review and approval.
21. True or false: risks to research participants must be completely eliminated for the study to be considered ethical.
22. 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.
23. True or false: requirements specific to informed consent for prisoners include adequate assurance that parole boards do not consider a prisoner's participation in making decisions regarding parole.
24. Why might an individual have diminished autonomy?
25. True or false: according to the regulations, to be approvable, research participation must provide a tangible benefit to the individual research subjects.
26. True or false: the concept of individual justice implies that it is acceptable for investigators to offer potentially beneficial research only to favored patients while selecting undesirable persons for riskier research.
27. A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:
28. According to the federal regulations, research is eligible for exemption if:
29. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
30. As part of the consent process, the federal regulations require researchers to:
31. According to Subpart D, research with children may be eligible for exemption under Category 2 when:
32. The provisions of Subpart D of the HHS regulations, Additional Protections for Children Involved as Subjects in Research, apply to:
33. A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. Under 45 CFR 46, this unanticipated problem must be reported to the IRB in which timeframe?
34. The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
35. Belmont Report: which three basic ethical principles does the report identify as particularly relevant to research involving human subjects? A. Autonomy, nonmaleficence and fidelity B. Respect for persons, beneficence and justice C. Confidentiality, consent and compensation D. Privacy, equity and scientific integrity
36. Belmont Report: the three basic principles are applied to the conduct of research through which three applications? A. IRB review, continuing review and record keeping B. Recruitment, enrollment and debriefing C. Informed consent, risk/benefit assessment and the selection of subjects D. Registration, assurance and reporting
37. Belmont Report: what does the term 'research' designate?
38. Belmont Report: how does the report define 'practice', as distinct from research?
39. True or false: under the Belmont Report, a procedure that is new or untested is automatically research because it is experimental.
40. Belmont Report: if an activity contains any element of research, what does the report say should happen?
41. Belmont Report: the principle of respect for persons incorporates which two ethical convictions?
42. Belmont Report: how does the report describe an autonomous person? A. Any adult who has signed a consent form B. An individual capable of deliberation about personal goals and of acting under the direction of such deliberation C. A person who is not institutionalized D. A person who has no legally authorized representative
43. Belmont Report: why does the report say respect for persons may require protecting prisoners who volunteer for research?
44. Belmont Report: what two general rules express the obligation of beneficence?
45. True or false: the Belmont Report treats beneficence as acts of kindness or charity that go beyond strict obligation.
46. Belmont Report: 'Who ought to receive the benefits of research and bear its burdens?' is a question of which principle? A. Respect for persons B. Beneficence C. Justice D. Fidelity
47. Belmont Report: list the five widely accepted formulations of just ways to distribute burdens and benefits.
48. Belmont Report: what injustice does the report identify in the Tuskegee syphilis study?
49. Belmont Report: justice demands scrutiny of whether some classes of subjects are being systematically selected for which improper reasons?
50. Belmont Report: the consent process can be analyzed as containing which three elements? A. Information, comprehension and voluntariness B. Disclosure, signature and witness C. Notice, choice and access D. Recruitment, screening and enrollment
51. Belmont Report: the report finds the disclosure standards used in medical practice insufficient for research subjects. What standard does it suggest may be proposed instead?
52. Belmont Report: incomplete disclosure is justified only if which three conditions are clear?
53. True or false: under the Belmont Report, information about risks may be withheld when doing so is needed to secure subjects' cooperation.
54. Belmont Report: which describes coercion? A. An offer of an excessive or improper reward to obtain compliance B. An overt threat of harm intentionally presented by one person to another in order to obtain compliance C. Any payment to research subjects D. A consent form that is too long
55. Belmont Report: how does undue influence differ from coercion?
56. True or false: under the Belmont Report, an inducement that would ordinarily be acceptable can become an undue influence if the subject is especially vulnerable.
57. Belmont Report: the moral requirement that informed consent be obtained is derived primarily from which principle? A. Justice B. Beneficence C. Respect for persons D. Scientific validity
58. Belmont Report: the requirement that research be justified by a favorable risk/benefit assessment bears a close relation to which principle?
59. Belmont Report: which kinds of harm does the report list as the most likely types of risk for an IRB to consider?
60. True or false: under the Belmont Report, brutal or inhumane treatment of subjects can be justified if the expected benefits to society are large enough.
61. Belmont Report: at which two levels is justice relevant to the selection of research subjects? A. Federal and state B. Social and individual C. Institutional and departmental D. Scientific and nonscientific
62. Belmont Report: what does the report say institutionalized persons, already burdened by their condition, should be protected against?
63. Belmont Report: the National Research Act (Pub. L. 93-348), which created the National Commission that wrote the report, was signed into law on what date? A. December 10, 1948 B. July 12, 1974 C. April 18, 1979 D. June 18, 1991
64. 45 CFR 46: a human subject is a living individual about whom an investigator conducting research does which of the following?
65. 45 CFR 46: private information includes information about behavior that occurs in what kind of context?
66. 45 CFR 46: which statement matches the regulatory definition of minimal risk? A. No risk of any kind to subjects B. Risk no greater than that approved by the sponsor C. The probability and magnitude of harm or discomfort are not greater in and of themselves than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests D. Risk that the subject has agreed to in writing
67. 45 CFR 46: how does the Common Rule define 'research'?
68. 45 CFR 46: which of these is listed among the activities deemed not to be research for purposes of the rule? A. A randomized drug trial B. Scholarly and journalistic activities such as oral history, journalism, biography and historical scholarship C. A survey designed to contribute to generalizable knowledge D. Secondary research with identifiable biospecimens
69. 45 CFR 46: how is a 'clinical trial' defined?
70. 45 CFR 46: who is a 'legally authorized representative'?
71. 45 CFR 46: what is the minimum number of members an IRB must have? A. Three B. Five C. Seven D. Nine
72. 45 CFR 46: an IRB must include at least one member whose primary concerns are in scientific areas and at least one member of what other kind?
73. 45 CFR 46: what must be true of the IRB member often called the unaffiliated member?
74. True or false: under 45 CFR 46, an IRB member with a conflicting interest in a project may take part in its initial review as long as the member discloses the conflict.
75. 45 CFR 46: an IRB may invite individuals with competence in special areas to help review complex issues. May those individuals vote?
76. 45 CFR 46: except when expedited review is used, what must be present at a convened IRB meeting for research to be reviewed, and what vote approves it?
77. 45 CFR 46: if an IRB decides to disapprove a research activity, what must its written notification include?
78. 45 CFR 46: when continuing review is required, how often must the IRB conduct it at minimum? A. Every 3 years B. Every 2 years C. At intervals appropriate to the degree of risk, not less than once per year D. Only when the protocol changes
79. True or false: under the 2018 Requirements of 45 CFR 46, every study approved by an IRB must undergo continuing review at least once a year.
80. 45 CFR 46: who may carry out an expedited review?
81. 45 CFR 46: which IRB authority may expedited reviewers NOT exercise? A. Approving the research B. Requiring modifications C. Disapproving the research D. Reviewing minor changes
82. 45 CFR 46: under the criteria for IRB approval, risks to subjects must be reasonable in relation to what?
83. True or false: under 45 CFR 46, in evaluating risks and benefits an IRB should weigh possible long-range effects of applying the knowledge gained in the research, such as effects on public policy.
84. Which IRB approval criterion in 45 CFR 46.111 most directly carries out the Belmont Report's principle of justice?
85. True or false: under 45 CFR 46, institutional officials may approve research that has not been approved by an IRB.
86. 45 CFR 46: on what grounds may an IRB suspend or terminate approval of research?
87. 45 CFR 46: for cooperative research, what does the single IRB requirement say about institutions located in the United States?
88. 45 CFR 46: how long must records required by the policy, including records relating to conducted research, be retained? A. 1 year after IRB approval B. At least 3 years, and for conducted research at least 3 years after completion of the research C. 7 years after publication D. Indefinitely
89. 45 CFR 46: before involving a human subject in covered research, what must an investigator obtain?
90. 45 CFR 46: under what circumstances may an investigator seek informed consent?
91. 45 CFR 46: the Common Rule requires prospective subjects to receive the information that whom would want to have to make an informed decision about whether to participate? A. The investigator B. The sponsor C. A reasonable person D. The IRB chairperson
92. 45 CFR 46: with what must informed consent begin (other than broad consent)?
93. 45 CFR 46: which of these may NOT appear in an informed consent? A. A description of reasonably foreseeable risks B. Exculpatory language through which the subject is made to waive or appear to waive any legal rights C. A statement that participation is voluntary D. Whom to contact about research-related injury
94. 45 CFR 46: what must the basic elements of informed consent say about risks, and about voluntary participation?
95. 45 CFR 46: for research involving more than minimal risk, what must the consent explain about injury?
96. 45 CFR 46: name two of the additional elements of informed consent that are provided when appropriate.
97. 45 CFR 46: broad consent may be obtained in lieu of study-specific informed consent only with respect to what?
98. 45 CFR 46: which is NOT one of the findings an IRB must make to waive or alter informed consent under the general waiver provision? A. The research involves no more than minimal risk to the subjects B. The research could not practicably be carried out without the waiver or alteration C. Subjects will be paid for their participation D. The waiver or alteration will not adversely affect the rights and welfare of the subjects
99. 45 CFR 46: for a clinical trial conducted or supported by a Federal department or agency, what must be posted on a publicly available Federal Web site?
100. 45 CFR 46: unless documentation is waived, how must informed consent be documented, and who receives a copy?
101. 45 CFR 46: an IRB may waive the requirement for a signed consent form in which situation? A. The investigator is short on time B. The only record linking the subject and the research would be the consent form and the principal risk would be potential harm from a breach of confidentiality C. The sponsor requests it D. The study enrolls more than 1,000 subjects
102. True or false: under 45 CFR 46.104, the exemption categories generally apply to research involving prisoners under subpart C.
103. 45 CFR 46.104: research in established or commonly accepted educational settings is exempt when it specifically involves normal educational practices meeting what condition?
104. 45 CFR 46.104: which of these is one of the listed exemption categories? A. Phase 1 drug trials B. Taste and food quality evaluation and consumer acceptance studies C. Research with prisoners as the target population D. Any study that pays subjects
105. True or false: under 45 CFR 46 subpart B, investigators may offer payment to encourage termination of a pregnancy if the IRB approves.
106. 45 CFR 46 subpart C: what two special composition requirements apply to an IRB reviewing research involving prisoners?
107. 45 CFR 46 subpart D: who are 'children'?
108. 45 CFR 46 subpart D: what is the difference between 'permission' and 'assent'? A. They mean the same thing B. Permission is the agreement of parent(s) or guardian to the child's participation; assent is the child's own affirmative agreement C. Permission is given by the IRB; assent by the investigator D. Assent is only required for adults
109. 45 CFR 46.405: research with children involving greater than minimal risk but presenting the prospect of direct benefit may be approved only if the IRB finds what about the risk?
110. 45 CFR 46.406: for research with children involving greater than minimal risk and no prospect of direct benefit, how large may the risk be? A. Any level the IRB accepts B. A minor increase over minimal risk C. No more than minimal risk D. Moderate risk with parental permission
111. 45 CFR 46 subpart D: for research approved under 46.406 or 46.407, when may permission from just one parent suffice?
112. 45 CFR 46 subpart E: how often must an IRB renew its registration with OHRP, and when does registration become effective?

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