STP Research, Development & Innovation 4 — Questions and Answers
Question 1: Which phase of the PDSA (Plan-Do-Study-Act) cycle focuses on interpreting the data collected during the 'Do' phase?
- Plan
- Do
- Study (Correct answer)
- Act
Correct answer: Study
The 'Study' phase involves analysing results against predictions, identifying what was learned, and drawing conclusions before deciding on next steps.
Question 2: What term describes intellectual property protection for new inventions that grants the holder exclusive rights to exploit the invention for up to 20 years?
- Copyright
- Trademark
- Patent (Correct answer)
- Trade secret
Correct answer: Patent
A patent grants exclusive commercial rights over a novel, inventive, and industrially applicable invention for up to 20 years from the filing date.
Question 3: In research governance, what is the purpose of a Research Passport in the UK?
- To fund international research travel
- To facilitate honorary contracts allowing researchers to work across NHS organisations (Correct answer)
- To register clinical trials on a public database
- To approve patient consent forms
Correct answer: To facilitate honorary contracts allowing researchers to work across NHS organisations
A Research Passport streamlines the pre-engagement checks required for researchers who need to work with NHS patients, staff, or data across multiple organisations.
Question 4: Which type of error occurs when a researcher incorrectly rejects a true null hypothesis?
- Type I error (false positive) (Correct answer)
- Type II error (false negative)
- Systematic error
- Random error
Correct answer: Type I error (false positive)
A Type I error (α) occurs when the null hypothesis is true but is incorrectly rejected, equivalent to a false positive finding.
Question 5: A new medical device is classified as Class IIb under UK MDR 2002 regulations. What level of conformity assessment is required?
- Self-declaration by the manufacturer only
- Involvement of a UK Approved Body to assess the quality system and/or device design (Correct answer)
- Full pre-market approval by the MHRA alone
- No regulatory approval needed below Class III
Correct answer: Involvement of a UK Approved Body to assess the quality system and/or device design
Class IIb devices require a UK Approved Body to conduct conformity assessment of the quality management system and, typically, the device design.
Question 6: When describing research outputs using the REF (Research Excellence Framework) impact case study format, which element is most critical to demonstrate?
- The number of publications generated
- The reach and significance of the change the research caused beyond academia (Correct answer)
- The grant value awarded to the project
- The journal impact factor of the primary publication
Correct answer: The reach and significance of the change the research caused beyond academia
REF impact case studies must evidence the reach and significance of real-world changes attributable to research conducted in eligible UK institutions.
Question 7: Which concept describes the ethical requirement that research benefits and burdens should be distributed fairly across society, including historically under-represented groups?
- Autonomy
- Beneficence
- Non-maleficence
- Justice (Correct answer)
Correct answer: Justice
Justice requires equitable distribution of research benefits and burdens, ensuring vulnerable or marginalised groups are not unfairly excluded or exploited.
STP Research, Development & Innovation 4
Which phase of the PDSA (Plan-Do-Study-Act) cycle focuses on interpreting the data collected during the 'Do' phase?