Question 1 · Ethics and professionalism, Preclinical
Researchers recruit residents of an orphanage into a trial because they are easy to reach, although the scientific question does not require this population. Which requirement for ethical research is not met?
- A. Fair subject selection
- B. Favourable risk-benefit ratio
- C. Social value
- D. Community partnership
- E. Scientific validity
Show the answer and explanation
Answer: A. Fair subject selection
Orphans are a vulnerable population. In fair subject selection the scientific objectives of the study guide inclusion criteria and targeted populations, and convenient (vulnerable) groups should not be targeted.
Why the other options are wrong
- B. Favourable risk-benefit ratio: A favourable risk-benefit ratio means potential benefits are enhanced and risks are identified and minimised.
- C. Social value: Social value requires that ethical clinical research lead to improvements in health or advancement in generalisable knowledge.
- D. Community partnership: Community partnership requires ethical clinical research to involve the community in which it occurs.
- E. Scientific validity: Scientific validity needs an appropriate hypothesis, design, tool, sampling and sample size, and data analysis.
Key point: Convenient vulnerable groups should not be targeted, because scientific objectives should guide who is included.
References
- WMA Declaration of Helsinki: ethical principles for medical research involving human participants, World Medical Association (revision adopted by the 75th General Assembly, October 2024)
- Law No. 214 of 2020 promulgating the law to regulate clinical medical research (English translation), Egyptian Drug Authority
- 45 CFR 46.116: General requirements for informed consent, Legal Information Institute, Cornell Law School (US federal regulation text)