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Ethics and GCP Flashcards

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

Read the first 6 Ethics and GCP flashcards as text

  1. What is the role of a 'Legally Authorized Representative' (LAR) in clinical research?

    Answer: An individual or body authorized to consent on behalf of a prospective subject who cannot provide their own consent

    An LAR is a person or entity permitted under applicable law to consent on behalf of a prospective subject who lacks decision-making capacity.

  2. Under GCP, what must a sponsor do before initiating a clinical trial at a site?

    Answer: Obtain a signed agreement with the investigator, ensure IRB approval, and verify site readiness

    Before initiating a trial, the sponsor must ensure a signed investigator agreement is in place, IRB approval has been obtained, and the site has been assessed for adequacy.

  3. What is the significance of the Tuskegee Syphilis Study in US research ethics history?

    Answer: It revealed systemic exploitation of vulnerable subjects and led to major regulatory reform including the Belmont Report

    The Tuskegee study's exploitation of Black Americans — withholding known treatment — directly prompted the National Research Act (1974) and the Belmont Report.

  4. In clinical research, what does 'assent' refer to, and when is it required?

    Answer: A child's affirmative agreement to participate in research, required alongside parental/guardian permission

    Assent is the affirmative agreement of a minor or cognitively impaired subject to participate; it is required alongside legally authorized consent from a parent or guardian.

  5. What is the 'therapeutic misconception' in clinical research ethics?

    Answer: When research subjects mistakenly believe the trial's primary purpose is their personal treatment rather than generating generalizable knowledge

    Therapeutic misconception occurs when subjects conflate participating in research with receiving personalized medical treatment, compromising truly voluntary informed consent.

  6. Under GCP, what is the investigator's obligation when a subject withdraws from a study?

    Answer: The investigator must respect the withdrawal and may not coerce continued participation, but may ask about safety follow-up

    GCP requires investigators to respect voluntary withdrawal without coercion; they may inquire about the reason and ask for permission for safety follow-up but cannot compel continued participation.