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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 HIPAA Safe Harbor method, data are considered de-identified when:

    Answer: All 18 specified identifiers are removed and there is no actual knowledge the remaining data could identify an individual

    Safe Harbor requires removing 18 identifier types and having no actual knowledge of re-identification potential.

  2. A HIPAA limited data set may be disclosed for research only when:

    Answer: The recipient signs a data use agreement

    A limited data set may retain some identifiers like dates and ZIP codes but requires a data use agreement.

  3. Which element must a valid HIPAA research authorization contain?

    Answer: An expiration date or event, or a statement that there is none

    HIPAA authorizations must specify an expiration date or event, and for research 'end of the research study' or 'none' is acceptable.

  4. Who may approve a waiver or alteration of HIPAA authorization for research?

    Answer: An IRB or Privacy Board

    The HIPAA Privacy Rule allows an IRB or Privacy Board to approve a waiver of authorization when criteria are met.

  5. A research assistant pulls a participant's entire medical chart when only lab values are needed for the study. Which HIPAA principle is most at issue?

    Answer: Minimum necessary standard

    The minimum necessary standard limits use of PHI to what is reasonably needed for the purpose.

  6. A laptop containing unencrypted identifiable study data is lost. What should the research assistant do first?

    Answer: Promptly report it to the PI and institutional privacy/IRB office per policy

    Potential breaches must be reported promptly through institutional channels, which determine IRB and HIPAA breach-notification obligations.

  7. A Certificate of Confidentiality primarily protects:

    Answer: Identifiable research information from compelled disclosure in legal proceedings

    Certificates of Confidentiality protect identifiable sensitive research information from forced disclosure, and NIH issues them automatically for covered NIH-funded research.