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Ethical Standards & Compliance 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 Ethical Standards & Compliance flashcards as text

  1. Under the revised Common Rule, broad consent may be used for which of the following?

    Answer: Storage, maintenance, and secondary research use of identifiable private information or biospecimens

    Broad consent (45 CFR 46.116(d)) covers storage and secondary research use of identifiable information and biospecimens, not new interventional studies.

  2. An IRB may waive documentation of informed consent when the only record linking the subject to the research would be the consent form and the principal risk is:

    Answer: Potential harm from a breach of confidentiality

    45 CFR 46.117(c) allows waiving signed consent when the signed form itself is the main confidentiality risk.

  3. When a short-form written consent is used for a non-English-speaking participant, which requirement applies?

    Answer: A witness must be present during the oral presentation

    Federal regulations require a witness to the oral presentation when the short-form method is used.

  4. Which study team member may obtain informed consent from a participant?

    Answer: A trained staff member delegated the task by the PI and approved per IRB requirements

    Consent must be obtained by qualified personnel delegated by the PI and documented on the delegation log as required by the IRB.

  5. Midway through a trial, new safety information emerges that could affect participants' willingness to continue. What should the research assistant expect to happen?

    Answer: Participants are re-consented with an IRB-approved revised consent form

    ICH E6 requires updating consent and informing current subjects of new information relevant to their willingness to continue.

  6. A 'legally authorized representative' (LAR) is best defined as:

    Answer: An individual or body authorized under applicable law to consent on behalf of a prospective subject

    An LAR's authority comes from applicable state or local law, not from relationship alone or from the study team.

  7. In research involving children under 45 CFR 46 Subpart D, assent refers to:

    Answer: A child's affirmative agreement to participate

    Assent is the child's affirmative agreement; mere failure to object is not assent.