PRC Ethical Research Practices & Compliance 3

Question 1

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

Accepted Answer

The Common Rule (45 CFR 46)

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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.

Question 3

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

Accepted Answer

Exempt review

Answer

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

Question 4

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

Accepted Answer

Executing a data use agreement and providing de-identified data

Answer

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

Question 5

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

Accepted Answer

Fair distribution of research burdens and benefits across population groups

Answer

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

(PRC) Professional Researcher Certification Practice Test

(PRC) Professional Researcher Certification Practice Test

PRC Ethical Research Practices & Compliance 3