Ethics, Professionalism and Leadership in Health Informatics Flashcards

Which set lists the three core ethical principles of the Belmont Report?

Answer: Respect for persons, beneficence, justice

The Belmont Report (1979) set out respect for persons, beneficence, and justice as the basis for ethics in human subjects research.

Which federal regulation, known as the Common Rule, governs most federally funded human subjects research in the US?

Answer: 45 CFR Part 46

The Common Rule is codified at 45 CFR Part 46, Subpart A.

A researcher wants to run a retrospective EHR chart review of 50,000 patients, and contacting each patient is impracticable. What may the IRB grant?

Answer: A waiver or alteration of informed consent if the research is minimal risk

IRBs may waive consent when the research is minimal risk, could not practicably be done without the waiver, and the waiver does not hurt subjects' rights and welfare.

Under HIPAA, what must be in place before a covered entity shares a limited data set for research?

Answer: A data use agreement with the recipient

A limited data set may be disclosed for research, public health, or operations only under a data use agreement.

Which two methods does the HIPAA Privacy Rule recognize for de-identifying PHI?

Answer: Safe Harbor and Expert Determination

HIPAA de-identification is met either by removing 18 specified identifiers (Safe Harbor) or by a qualified expert's statistical determination.

An informatician is asked to review a vendor product while holding stock options in that vendor. What is the most appropriate professional action?

Answer: Disclose the conflict of interest and recuse from the decision if required

Professional codes require disclosing financial conflicts and managing them, often by recusal.

A health system plans to sell de-identified EHR data to a commercial analytics firm. Which ethical concern is most often raised even when HIPAA is fully met?

Answer: Re-identification risk and lack of patient awareness or benefit sharing

Legal de-identification does not remove re-identification risk or the questions of transparency and trust around commercial secondary use.