STP Professional Practice & Ethics 4 — Questions and Answers
Question 1: Which of the following is a key responsibility of a Good Clinical Practice (GCP)-trained investigator?
- Ensuring the trial is completed as quickly as possible
- Protecting the rights, safety, and wellbeing of trial participants (Correct answer)
- Maximising recruitment at any cost
- Minimising paperwork for the sponsor
Correct answer: Protecting the rights, safety, and wellbeing of trial participants
GCP principles place paramount importance on protecting participant rights, safety, and wellbeing throughout the trial.
Question 2: A healthcare scientist suspects a medical device they use is causing patient harm. Under UK regulations, they should:
- Stop using it and say nothing to avoid disruption
- Report it through the MHRA Yellow Card scheme and their institution's incident reporting system (Correct answer)
- Wait for three incidents before reporting
- Report only to the device manufacturer
Correct answer: Report it through the MHRA Yellow Card scheme and their institution's incident reporting system
Adverse incidents involving medical devices must be reported to the MHRA and through internal incident reporting to protect patient safety.
Question 3: What is 'equipoise' in the context of a randomised controlled trial?
- The equal allocation of budget across trial arms
- Genuine uncertainty about which treatment arm is superior, justifying randomisation (Correct answer)
- The balance between recruitment and drop-out rates
- Equality of participant demographics across trial arms
Correct answer: Genuine uncertainty about which treatment arm is superior, justifying randomisation
Clinical equipoise means there is genuine uncertainty in the expert medical community about the comparative merits of interventions, making randomisation ethically justified.
Question 4: In the context of STP professional registration, which body grants HCPC registration to healthcare scientists in the UK?
- The Royal College of Pathologists
- The Health and Care Professions Council (HCPC) (Correct answer)
- NHS England
- The General Medical Council (GMC)
Correct answer: The Health and Care Professions Council (HCPC)
The HCPC is the statutory regulator that grants and maintains registration for healthcare scientists, including those completing the STP.
Question 5: A laboratory scientist obtains results that do not support the hypothesis favoured by the research team. What should they do?
- Exclude the results and repeat the experiment until the expected result is obtained
- Report the results accurately regardless of their alignment with the hypothesis (Correct answer)
- Discuss with the PI and only report if they agree the data is valid
- Delay reporting until further supporting evidence is gathered
Correct answer: Report the results accurately regardless of their alignment with the hypothesis
Scientific integrity requires reporting all results accurately; selective reporting constitutes publication bias and potentially research misconduct.
Question 6: What is the primary ethical concern with 'covert research' in healthcare settings?
- It costs more than conventional research
- It violates participant autonomy by denying them the chance to consent or refuse (Correct answer)
- It produces less reliable data
- It cannot be published in peer-reviewed journals
Correct answer: It violates participant autonomy by denying them the chance to consent or refuse
Covert research is ethically problematic because participants are denied the opportunity to exercise their right to consent or refuse participation.
Question 7: Which of the following best describes 'responsible innovation' in scientific practice?
- Accelerating research as fast as possible to gain competitive advantage
- Anticipating societal impacts, involving stakeholders, and adapting research to be ethically and socially acceptable (Correct answer)
- Keeping new scientific developments secret until patented
- Focusing solely on technical feasibility rather than social implications
Correct answer: Anticipating societal impacts, involving stakeholders, and adapting research to be ethically and socially acceptable
Responsible innovation requires anticipating impacts, inclusive stakeholder engagement, reflexivity, and responsiveness to emerging ethical concerns.
STP Professional Practice & Ethics 4
Which of the following is a key responsibility of a Good Clinical Practice (GCP)-trained investigator?