Ethical Research Practices & Compliance Flashcards

Which federal regulation primarily governs the protection of human subjects in research receiving federal funding?

Answer: The Common Rule (45 CFR 46)

The Common Rule (45 CFR 46) is the foundational U.S. regulation establishing IRB oversight and informed consent requirements for federally funded human subjects research.

In online survey research, what distinguishes a 'passive' consent mechanism from an 'active' one?

Answer: Passive consent assumes agreement by proceeding; active consent requires an explicit affirmative action

Active consent requires participants to check a box or sign, while passive consent infers agreement from continued participation — the latter is often insufficient for sensitive research.

A researcher is conducting ethnographic observation in a public shopping mall without approaching individuals. What level of IRB review is typically required?

Answer: Exempt review

Observation of public behavior where individuals cannot reasonably expect privacy typically qualifies for exempt status under 45 CFR 46.104.

Which practice best protects participant confidentiality when sharing data with a third-party analysis firm?

Answer: Executing a data use agreement and providing de-identified data

A formal data use agreement combined with de-identification provides both contractual protection and reduces re-identification risk.

What does the ethical principle of 'justice' in the Belmont Report specifically require of researchers?

Answer: Fair distribution of research burdens and benefits across population groups

Justice requires that no group bears a disproportionate burden of research risks while another group reaps all the benefits.

A market researcher wants to record phone interviews. Under U.S. law, what is the minimum consent requirement in an all-party consent state?

Answer: All parties on the call must be informed and consent to recording

All-party (two-party) consent states require every person on the call to be notified and agree before recording begins.

Which action constitutes a breach of research ethics when reporting client satisfaction findings?

Answer: Cherry-picking only high satisfaction scores to report

Selectively reporting favorable data while omitting unfavorable results misrepresents study findings and constitutes research misconduct.