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Ethical Considerations & Compliance Flashcards

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

Read the first 7 Ethical Considerations & Compliance flashcards as text
  1. A researcher discovers mid-study that a participant is experiencing unexpected adverse effects. What is the FIRST ethical obligation?

    Answer: Protect participant safety and report the finding promptly

    Participant safety always takes precedence; the researcher must act immediately and report the adverse event through proper channels.

  2. Which principle from the Belmont Report addresses the fair distribution of research burdens and benefits across population groups?

    Answer: Justice

    Justice requires that vulnerable populations not be exploited and that research benefits and burdens be distributed equitably.

  3. A researcher has a financial stake in the company whose product is being tested. This situation most directly creates a:

    Answer: Conflict of interest

    A personal financial interest in the outcome of research constitutes a conflict of interest that must be disclosed and managed.

  4. Under 45 CFR 46 (the Common Rule), which of the following studies is EXEMPT from full IRB review?

    Answer: Anonymous surveys about educational practices in standard settings

    Anonymous surveys on educational practices in standard settings qualify for an exemption under 45 CFR 46.104(d)(2).

  5. What does the term 'therapeutic misconception' refer to in research ethics?

    Answer: A participant believing research treatment is individualized clinical care

    Therapeutic misconception occurs when participants fail to understand that research goals differ from individualized clinical treatment.

  6. A sponsor requests that a researcher not publish negative results. Complying with this request would most directly violate which ethical obligation?

    Answer: Scientific integrity and transparency

    Suppressing negative findings undermines scientific integrity and can distort the evidence base, harming future patients and researchers.

  7. Which federal regulation specifically governs the protection of human subjects in research conducted or supported by the U.S. Department of Health and Human Services?

    Answer: 45 CFR Part 46

    45 CFR Part 46, known as the Common Rule, is the primary federal regulation protecting human research subjects under HHS.