AHIC Ethics, Professionalism and Leadership in Health Informatics 2

Question 1

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

Accepted Answer

Respect for persons, beneficence, justice

Answer

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

Question 2

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

Accepted Answer

45 CFR Part 46

Answer

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

Question 3

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?

Accepted Answer

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

Answer

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.

Question 4

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

Accepted Answer

A data use agreement with the recipient

Answer

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

Question 5

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

Accepted Answer

Safe Harbor and Expert Determination

Answer

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

(AHIC) AMIA Health Informatics Certification Practice Test

(AHIC) AMIA Health Informatics Certification Practice Test

AHIC Ethics, Professionalism and Leadership in Health Informatics 2