PRC Ethical Research Practices & Compliance 3 — Questions and Answers
Question 1: Which federal regulation primarily governs the protection of human subjects in research receiving federal funding?
- HIPAA Privacy Rule
- The Common Rule (45 CFR 46) (Correct answer)
- GDPR
- FTC Act Section 5
Correct 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.
Question 2: In online survey research, what distinguishes a 'passive' consent mechanism from an 'active' one?
- Passive consent uses email; active consent uses web forms
- Passive consent assumes agreement by proceeding; active consent requires an explicit affirmative action (Correct answer)
- Passive consent is for minors; active consent is for adults
- Passive consent skips the IRB review
Correct 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.
Question 3: A researcher is conducting ethnographic observation in a public shopping mall without approaching individuals. What level of IRB review is typically required?
- Full board review
- Expedited review
- Exempt review (Correct answer)
- No documentation needed
Correct answer: Exempt review
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?
- Sharing raw data with a verbal confidentiality agreement
- Executing a data use agreement and providing de-identified data (Correct answer)
- Password-protecting the email attachment
- Having participants sign non-disclosure agreements
Correct 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.
Question 5: What does the ethical principle of 'justice' in the Belmont Report specifically require of researchers?
- Ensuring all participants benefit equally from research findings
- Fair distribution of research burdens and benefits across population groups (Correct answer)
- Obtaining court approval for sensitive studies
- Publishing results in open-access journals
Correct 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.
Question 6: A market researcher wants to record phone interviews. Under U.S. law, what is the minimum consent requirement in an all-party consent state?
- Only the researcher must consent to the recording
- All parties on the call must be informed and consent to recording (Correct answer)
- Written consent is required before the call begins
- Federal law preempts state recording laws for research
Correct 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.
Question 7: Which action constitutes a breach of research ethics when reporting client satisfaction findings?
- Presenting verbatim quotes with participant permission
- Rounding statistical results to the nearest whole percent
- Cherry-picking only high satisfaction scores to report (Correct answer)
- Using confidence intervals to express uncertainty
Correct answer: Cherry-picking only high satisfaction scores to report
Selectively reporting favorable data while omitting unfavorable results misrepresents study findings and constitutes research misconduct.
PRC Ethical Research Practices & Compliance 3
Which federal regulation primarily governs the protection of human subjects in research receiving federal funding?