CRS Ethical Standards & Compliance 3 — Questions and Answers
Question 1: A researcher conducting a focus group on domestic violence wants to protect participants from mandatory reporting obligations. The appropriate federal protection to seek is:
- IRB waiver of documentation
- Certificate of Confidentiality (Correct answer)
- FOIA exemption
- HIPAA waiver of authorization
Correct answer: Certificate of Confidentiality
A Certificate of Confidentiality issued by NIH protects researchers from being compelled to disclose identifiable research data in legal proceedings.
Question 2: Which situation best describes a conflict of interest in research?
- A researcher disagrees with a peer reviewer's critique
- A researcher holds stock in a company whose drug they are independently testing (Correct answer)
- A researcher receives a grant from a government agency
- A researcher collaborates with a competitor institution
Correct answer: A researcher holds stock in a company whose drug they are independently testing
Holding financial interest in an entity whose product is being tested creates a conflict of interest that could bias study design or reporting.
Question 3: In qualitative research, a participant asks that their specific quote be removed from a published case study. An ethical researcher should:
- Decline because consent was given at enrollment
- Remove the quote to honor the participant's ongoing right to withdraw (Correct answer)
- Check with the IRB before responding
- Anonymize the quote and retain it without telling the participant
Correct answer: Remove the quote to honor the participant's ongoing right to withdraw
Participants retain the right to withdraw their data at any time, and researchers should honor requests to remove identifiable contributions.
Question 4: The COPE (Committee on Publication Ethics) guidelines primarily address ethical standards in which domain?
- Human subjects protection in clinical trials
- Research data storage and cybersecurity
- Academic publishing, authorship, and peer review (Correct answer)
- Institutional conflict of interest management
Correct answer: Academic publishing, authorship, and peer review
COPE provides guidelines and flowcharts for editors and authors on publication ethics, authorship disputes, and peer review integrity.
Question 5: A researcher studying opioid use disorder wants to waive written informed consent to avoid creating a paper trail linking participants to drug use. This waiver request is:
- Invalid because written consent is always required
- Potentially justified under criteria allowing waiver of documentation when consent could harm participants (Correct answer)
- Only permissible for exempt research
- Automatically granted for any sensitive topic
Correct answer: Potentially justified under criteria allowing waiver of documentation when consent could harm participants
IRBs may waive documentation of consent when the signed form would be the only record linking subjects to sensitive research, creating risk if discovered.
Question 6: Which federal regulation specifically governs the ethical conduct of research involving human subjects at institutions receiving federal funding?
- 21 CFR Part 11
- 45 CFR Part 46 (The Common Rule) (Correct answer)
- 29 CFR Part 1910
- 40 CFR Part 136
Correct answer: 45 CFR Part 46 (The Common Rule)
45 CFR Part 46, known as the Common Rule, is the primary federal regulation protecting human research subjects at federally funded institutions.
Question 7: A researcher fabricates data points to fill in gaps from a failed measurement instrument. This constitutes:
- Acceptable data interpolation if statistically justified
- Research misconduct (falsification/fabrication) (Correct answer)
- A protocol deviation requiring IRB amendment
- Imputation, which is a standard statistical technique
Correct answer: Research misconduct (falsification/fabrication)
Inventing data points constitutes fabrication, a form of research misconduct under federal and institutional definitions.
CRS Ethical Standards & Compliance 3
A researcher conducting a focus group on domestic violence wants to protect participants from mandatory reporting obligations.
The appropriate federal protection to seek is: