STP Research, Development & Innovation 5 — Questions and Answers
Question 1: A laboratory scientist wants to assess reproducibility of a new assay by having multiple analysts run the same samples on different days. Which component of analytical validation does this evaluate?
- Analytical sensitivity
- Within-run imprecision
- Between-run (intermediate) imprecision (Correct answer)
- Analytical specificity
Correct answer: Between-run (intermediate) imprecision
Between-run or intermediate imprecision measures variability across different analysts, days, or instruments, reflecting real-world reproducibility.
Question 2: Under the Declaration of Helsinki, what is required when potentially vulnerable individuals are enrolled in research?
- Their participation must be prohibited in all circumstances
- They may only be enrolled if the research addresses the health needs of their group and cannot be done in a non-vulnerable population (Correct answer)
- Verbal consent alone is sufficient
- Institutional Review Board (IRB) approval is not required for observational studies involving them
Correct answer: They may only be enrolled if the research addresses the health needs of their group and cannot be done in a non-vulnerable population
Helsinki paragraph 20 states vulnerable populations should only be included when the research responds to their needs and cannot be done otherwise.
Question 3: In health technology assessment (HTA), the incremental cost-effectiveness ratio (ICER) is compared against a willingness-to-pay threshold. In England, what is NICE's general threshold range per QALY gained?
- £5,000–£10,000 per QALY
- £20,000–£30,000 per QALY (Correct answer)
- £50,000–£75,000 per QALY
- £100,000–£150,000 per QALY
Correct answer: £20,000–£30,000 per QALY
NICE generally considers technologies cost-effective at an ICER of £20,000–£30,000 per QALY, with flexibility up to £50,000 for end-of-life treatments.
Question 4: Which study design is most appropriate for estimating the prevalence of a disease in a population at a single point in time?
- Cohort study
- Case-control study
- Cross-sectional study (Correct answer)
- Randomised controlled trial
Correct answer: Cross-sectional study
A cross-sectional study measures both exposure and outcome simultaneously in a defined population, making it ideal for prevalence estimation.
Question 5: A scientist co-invents a diagnostic tool while employed by an NHS Trust. Who typically owns the intellectual property rights to this invention?
- The individual scientist as co-inventor
- The NHS Trust as the employer (Correct answer)
- The Department of Health and Social Care
- NICE, as the national regulatory body
Correct answer: The NHS Trust as the employer
Under UK law, inventions made by employees in the course of their normal duties belong to the employer, in this case the NHS Trust.
Question 6: Which framework provides a structured approach to evaluating evidence for clinical guideline recommendations, using categories such as HIGH, MODERATE, LOW, and VERY LOW?
- CONSORT
- PRISMA
- GRADE (Grading of Recommendations Assessment, Development and Evaluation) (Correct answer)
- STROBE
Correct answer: GRADE (Grading of Recommendations Assessment, Development and Evaluation)
GRADE rates the quality of evidence across outcomes, enabling guideline panels to make transparent recommendations based on evidence certainty.
Question 7: In an NHS innovation pathway, which organisation manages the Academic Health Science Network (AHSN) programme to accelerate the adoption of proven innovations?
- NHS England / NHS Improvement (Correct answer)
- The Medicines and Healthcare products Regulatory Agency (MHRA)
- NICE
- Health Research Authority (HRA)
Correct answer: NHS England / NHS Improvement
NHS England oversees the AHSN Network, which is commissioned to spread innovation and best practice across the health and care system in defined regions.
STP Research, Development & Innovation 5
A laboratory scientist wants to assess reproducibility of a new assay by having multiple analysts run the same samples on different days.
Which component of analytical validation does this evaluate?