Unit 6: Research ethics - Practice Quiz

1 What is the primary purpose of an Institutional Review Board (IRB)?

2 Which document must researchers typically submit to an IRB before beginning a study with human participants?

3 What is the term for a participant's voluntary agreement to take part in research after being fully informed?

4 In a clinical trial, a placebo is best described as:

5 Which of the following is considered a vulnerable population in research?

6 Why do vulnerable populations require special protection in research?

7 Which group is typically NOT classified as a vulnerable population?

8 In research ethics, a favorable risk-benefit ratio means that:

9 Who is responsible for assessing whether the risks of a study are reasonable in relation to its benefits?

10 Who should generally be listed as an author on a research paper?

11 The unethical practice of listing someone as an author who did not contribute is called:

12 Failing to credit a person who made a major contribution to a study is known as:

13 The ethical principle emphasizing that human subjects must be safeguarded during research is broadly known as:

14 Which historical document helped establish principles for protecting human research subjects?

15 Making up data that was never actually collected is known as:

16 Using another person's words or ideas without proper credit is called:

17 Which type of cloning is aimed at producing a genetically identical individual?

18 A major ethical concern in embryonic stem cell research is:

19 Biological weapons are best defined as agents that use which of the following to cause harm?

20 Euthanasia is best described as:

21 A researcher submits a protocol to enroll healthy adult volunteers in a low-risk survey study. Under standard regulations, the IRB may assign this study to which review category?

22 An IRB reviews a study and finds the consent form adequate but the risk-mitigation plan incomplete. What is the most appropriate IRB action?

23 A placebo-controlled trial is proposed for a condition that already has an effective standard treatment. Why is this design ethically problematic?

24 In a clinical trial, which practice best upholds the principle of informed consent?

25 Which group is generally considered a vulnerable population requiring additional research safeguards?

26 A study seeks to enroll children. What additional consent requirement typically applies compared to studies with competent adults?

27 An IRB evaluates a study where potential harms clearly outweigh anticipated benefits to participants and society. According to the risk-benefit principle, the study should be:

28 Which of the following is the best example of minimizing risk in a research design?

29 A technician ran all the experiments but contributed no intellectual input to the study design, analysis, or writing. Under standard authorship criteria, this person should typically be:

30 Listing a senior scientist as an author solely because of their position, despite no real contribution, is an example of:

31 The concept of human protectionism in research is primarily grounded in which foundational document that emerged after unethical wartime experimentation?

32 Which ethical principle most directly requires researchers to protect participants from harm and maximize their well-being?

33 A researcher reuses large portions of their own previously published text in a new paper without citation. This practice is best described as:

34 Which scenario is the clearest example of data falsification?

35 What is a central ethical objection to reproductive human cloning as opposed to therapeutic cloning?

36 Much of the ethical controversy surrounding embryonic stem cell research centers on which issue?

37 The dual-use dilemma in biological research refers to which situation?

38 Which international agreement specifically prohibits the development and stockpiling of biological weapons?

39 A physician withholds a life-sustaining treatment at a terminally ill, competent patient's explicit request, allowing the natural course of disease. This is best classified as:

40 What key ethical distinction separates active euthanasia from passive euthanasia?

41 A study proposes minimal-risk retrospective analysis of de-identified hospital records. The investigator argues it should be exempt from IRB review. Under the Common Rule, which factor most critically determines whether continuing IRB oversight (expedited vs. exempt) is warranted?

42 In a Phase I oncology trial, participants have advanced disease with no standard options. The therapeutic dose is unknown and toxicity is expected. Which principle best justifies enrollment despite an unfavorable individual risk-benefit ratio?

43 A trial seeks to enroll incarcerated individuals for a study on a chronic disease unrelated to imprisonment. Which condition would most clearly render this ethically permissible under regulations governing prisoner research?

44 A senior lab head provided funding and lab space but did not contribute intellectually to a manuscript's design, analysis, or writing. Per ICMJE criteria, the appropriate action is to:

45 The '14-day rule' historically limits in vitro culture of human embryos. What is the primary developmental rationale underlying this specific threshold?

46 A competent terminally ill patient requests that a physician withdraw a life-sustaining ventilator, knowing death will follow. Ethically and legally, this is most accurately classified as:

47 A placebo-controlled trial is proposed for a new antihypertensive where effective standard treatment already exists. Under the Declaration of Helsinki, using a placebo arm is most defensible only when:

48 A researcher publishes gain-of-function methods that enhance pathogen transmissibility, citing scientific openness. This scenario best illustrates which ethical tension central to 'dual-use research of concern' (DURC)?

49 The Belmont principle of 'respect for persons' has two distinct components. When enrolling a patient with early-stage dementia who has fluctuating capacity, which action best honors both components?

50 An investigator discovers that a co-author fabricated part of a dataset after publication. Which sequence of actions best conforms to responsible conduct of research?

51 During continuing review, an IRB learns of an unanticipated serious adverse event that shifts the risk-benefit balance unfavorably. The IRB's most appropriate immediate authority is to:

52 In international research conducted in a low-income country, offering free healthcare that participants could never otherwise access raises concern about:

53 Induced pluripotent stem cells (iPSCs) are often cited as sidestepping a key ethical objection to embryonic stem cells. Which objection do they primarily circumvent?

54 The doctrine of double effect is invoked to justify palliative sedation that may hasten death. For the doctrine to apply, which condition is essential?

55 An IRB is evaluating a pediatric study with no prospect of direct benefit to child participants. Under the 'minor increase over minimal risk' standard, approval additionally requires that:

56 Two researchers dispute the order of authorship on a collaborative paper where contributions were roughly equal. Which mechanism most appropriately resolves this within accepted publishing norms?

57 The Biological Weapons Convention (BWC) is often criticized for a structural weakness compared to the Chemical Weapons Convention. This weakness is:

58 A trial's data safety monitoring board (DSMB) observes at interim analysis that the experimental arm shows overwhelming benefit exceeding a pre-specified stopping boundary. The ethically indicated action is to:

59 The Tuskegee Syphilis Study is a foundational case in research ethics. Its most egregious violation, which directly shaped later protections, was:

60 A researcher holds equity in the company sponsoring the drug trial they lead. Beyond disclosure, which management strategy most robustly addresses this conflict of interest?