STP Ethics in Research 2 — Questions and Answers
Question 1: A researcher discovers mid-study that a placebo control group is being harmed by withholding a newly proven effective treatment. What is the ethically required action?
- Continue the study to preserve statistical power
- Stop the trial and offer the effective treatment to all participants (Correct answer)
- Inform only the IRB but continue enrollment
- Reduce the placebo group size but continue
Correct answer: Stop the trial and offer the effective treatment to all participants
The principle of beneficence requires stopping a trial when continuing would harm participants by denying them a proven effective treatment.
Question 2: Which concept refers to the ethical requirement that research risks must be reasonable in relation to anticipated benefits?
- Autonomy
- Justice
- Risk-benefit analysis (Correct answer)
- Nonmaleficence alone
Correct answer: Risk-benefit analysis
Risk-benefit analysis is the formal evaluation ensuring that potential harms to participants are justified by the expected scientific or social benefits.
Question 3: A graduate student is listed as an author on a paper but only washed glassware during the project. This is an example of:
- Contributorship
- Gift authorship (Correct answer)
- Honorary acknowledgment
- Dual publication
Correct answer: Gift authorship
Gift authorship occurs when authorship credit is given without meeting the substantive intellectual contribution criteria established by bodies like ICMJE.
Question 4: Under the Common Rule (45 CFR 46), which category of research qualifies for exemption from full IRB review?
- Studies involving more than minimal risk to prisoners
- Anonymous surveys about sensitive personal behaviors (Correct answer)
- Drug trials in healthy volunteers
- Research involving children with greater than minimal risk
Correct answer: Anonymous surveys about sensitive personal behaviors
Anonymous surveys posing no more than minimal risk typically qualify for exemption under the Common Rule categories.
Question 5: The Tuskegee Syphilis Study is most directly cited as the catalyst for which regulatory development?
- The Declaration of Helsinki
- The National Research Act and Belmont Report (Correct answer)
- ICH-GCP guidelines
- The FDA's Investigational New Drug regulations
Correct answer: The National Research Act and Belmont Report
Public outrage over Tuskegee directly led to the National Research Act of 1974 and ultimately the Belmont Report outlining ethical principles for human research.
Question 6: A researcher shares de-identified patient data with a colleague at another institution without a data use agreement. This primarily violates:
- The principle of justice
- Data governance and HIPAA data sharing requirements (Correct answer)
- Publication ethics only
- Conflict of interest policies
Correct answer: Data governance and HIPAA data sharing requirements
Sharing de-identified data without a data use agreement violates HIPAA's requirements for institutional data governance even when data appear anonymous.
Question 7: Which of the following best describes 'therapeutic misconception' in clinical research?
- A researcher overstating treatment benefits in the consent form
- A participant believing the research is primarily designed for their personal benefit (Correct answer)
- An IRB misunderstanding the therapeutic intent of a protocol
- A sponsor misrepresenting efficacy data to the FDA
Correct answer: A participant believing the research is primarily designed for their personal benefit
Therapeutic misconception occurs when participants conflate the goals of research (generating generalizable knowledge) with the goals of clinical care (optimizing individual treatment).
STP Ethics in Research 2
A researcher discovers mid-study that a placebo control group is being harmed by withholding a newly proven effective treatment.
What is the ethically required action?