CRS Ethical Standards & Compliance 2 — Questions and Answers
Question 1: A researcher discovers mid-study that the intervention is causing unexpected harm to participants. What is the FIRST required action?
- Document the harm and continue to avoid bias
- Notify the IRB and suspend the harmful component immediately (Correct answer)
- Consult the sponsor before making any changes
- Complete the study and disclose harm in the final report
Correct answer: Notify the IRB and suspend the harmful component immediately
Researchers must stop harmful procedures and notify the IRB immediately when unexpected harm is detected.
Question 2: Which principle of the Belmont Report specifically addresses the fair distribution of research burdens and benefits?
- Respect for persons
- Beneficence
- Justice (Correct answer)
- Non-maleficence
Correct answer: Justice
The Justice principle requires equitable selection of research subjects so that no group bears a disproportionate burden.
Question 3: An online survey collects IP addresses along with sensitive health responses. Under HIPAA, this combination is considered:
- De-identified data safe to publish freely
- Fully protected health information requiring safeguards (Correct answer)
- Anonymous data because no names are collected
- Exempt from HIPAA because surveys are excluded
Correct answer: Fully protected health information requiring safeguards
IP addresses are one of the 18 HIPAA identifiers; pairing them with health data creates protected health information.
Question 4: What does the concept of 'equipoise' require in a randomized controlled trial?
- Equal sample sizes in each arm
- Genuine uncertainty about which treatment is superior (Correct answer)
- Equal funding for each treatment group
- Balanced demographic representation across arms
Correct answer: Genuine uncertainty about which treatment is superior
Equipoise means investigators must have genuine uncertainty about which treatment is better before randomly assigning participants.
Question 5: A graduate student lists their advisor as a co-author on a paper the advisor did not contribute to intellectually. This violates which ethical standard?
- Confidentiality
- Authorship integrity (Correct answer)
- Conflict of interest disclosure
- Data minimization
Correct answer: Authorship integrity
Honorary or gift authorship violates authorship integrity standards, which require all listed authors to have made substantive intellectual contributions.
Question 6: A company funds a clinical trial and retains the right to veto publication of unfavorable results. This arrangement primarily creates a risk of:
- Selection bias in participant recruitment
- Publication bias due to sponsor control (Correct answer)
- Attrition bias from dropout rates
- Measurement bias in data collection
Correct answer: Publication bias due to sponsor control
Sponsor veto rights over publication create publication bias by suppressing negative or unfavorable findings.
Question 7: Under 45 CFR 46, which category of research qualifies for expedited IRB review?
- Research involving prisoners as subjects
- Research involving greater than minimal risk
- Research on existing data with identifiers already removed
- Research presenting no more than minimal risk using specific methods listed in federal regulations (Correct answer)
Correct answer: Research presenting no more than minimal risk using specific methods listed in federal regulations
Expedited review applies to research that presents no more than minimal risk and falls within categories specified in federal regulations.
CRS Ethical Standards & Compliance 2
A researcher discovers mid-study that the intervention is causing unexpected harm to participants.
What is the FIRST required action?