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Professional Standards and Ethics Flashcards

7 cards from real RA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Professional Standards and Ethics flashcards as text

  1. Which of the following is defined as research misconduct under the federal (PHS) definition?

    Answer: Fabrication, falsification, or plagiarism

    Federal policy (42 CFR Part 93) defines research misconduct as fabrication, falsification, or plagiarism, and excludes honest error or differences of opinion.

  2. A research assistant notices that a coordinator altered a participant's lab values on a case report form to meet eligibility criteria. What type of misconduct is this?

    Answer: Falsification

    Changing or manipulating existing data so the record no longer reflects reality is falsification.

  3. Which Belmont Report principle is most directly applied when an IRB reviews whether the burdens of research are fairly distributed across populations?

    Answer: Justice

    Justice concerns the fair selection of subjects and equitable distribution of research burdens and benefits.

  4. A participant asks a research assistant whether they will personally benefit from joining a Phase I trial. What is the most ethical response?

    Answer: Explain that direct benefit is not expected and the study's main purpose is safety

    Overstating benefit is a form of undue influence; Phase I trials primarily assess safety, so direct benefit should not be promised.

  5. Under ICH E6 Good Clinical Practice, who holds ultimate responsibility for the conduct of a clinical trial at a study site?

    Answer: The principal investigator

    The investigator is responsible for the trial at the site even when tasks are delegated to qualified staff.

  6. A research assistant is asked to perform a task not listed next to their name on the delegation of authority log. What should they do?

    Answer: Decline until the PI documents the delegation and any required training

    Staff should only perform study tasks that the PI has delegated and documented, with appropriate training on file.

  7. Which situation represents a financial conflict of interest that typically must be disclosed?

    Answer: An investigator holds significant equity in the company sponsoring the study

    Significant equity or payments from a sponsor could bias research and must be disclosed and managed per institutional and federal policy.