BB2025 Chap.1 Research Questions and Study Ethics
Research Questions and Study Ethics
Begin with the decision the evidence should change
A useful research question names a population, an exposure or intervention, an outcome and a time point. Those elements determine what must be observed before any statistical procedure can be selected. A conceptual model then makes the proposed links visible and identifies variables that could create an alternative explanation.
The purpose is not to decorate a proposal. It is to expose which variables need baseline measurement, which direction of influence is being claimed and where confounding could enter.
Ethical quality and scientific quality meet
A design that cannot answer its question exposes participants to burden without producing interpretable knowledge.
Ethical planning therefore reaches recruitment, eligibility, measurement load, privacy, retention and the justification for comparison conditions. Consent concerns the decision to participate; confidentiality concerns the protection of entrusted information.
A defensible proposal explains why each procedure is scientifically necessary and how foreseeable burden is reduced.
Three sentences with different jobs
The aim states what will be examined. The hypothesis states a pattern that observations could contradict. The analysis claim states what the chosen comparison supports after assumptions and uncertainty are considered.
Keeping them separate prevents a descriptive objective from turning silently into a causal conclusion.
What this chapter covers
- 01
Population, exposure, outcome and time
- 02
Conceptual models and directional paths
- 03
Confounding as an alternative explanation
- 04
Operational definitions and measurable variables
- 05
Research aims, questions and hypotheses
- 06
Consent, privacy and confidentiality
- 07
Scientific value and participant burden
- 08
Causal language and evidence limits
Worked example · free
Repair a broad rehabilitation question
- 2Specify the eligible population and intervention.
- 3Add the comparison, outcome and time point.
- 3Name a variable that could influence exposure and outcome.
Key terms
- Research Question
- A precise statement of the population, variables, comparison and outcome that a study is designed to answer.
- Conceptual Model
- An explicit representation of proposed relationships among exposures, outcomes and competing explanatory variables.
- Operational Definition
- The rule that turns an abstract construct into an observable and reproducible measurement.
- Confounding
- Distortion created when a common cause influences both the exposure and the outcome.
- Informed Consent
- A voluntary participation decision made with adequate information, understanding and capacity.
- Confidentiality
- The procedures used to protect information entrusted to the research team from unauthorised disclosure.
Research Questions and Study Ethics FAQ
How narrow should a research question be?
It should be narrow enough that the population, exposure or intervention, comparison, outcome and time point can all be stated without placeholders. A good check is whether the question already implies what observations must be collected. If several incompatible designs could answer it, the wording probably still contains more than one research problem.
Why draw a conceptual model before choosing variables?
The model distinguishes variables that represent the main question from variables that offer competing explanations. That prevents automatic adjustment for every available field and helps identify measurements needed before exposure. It also reveals mediators and colliders that may be harmed by careless adjustment, so the later statistical model follows the scientific logic.
Is ethics approval separate from research design?
Administrative approval is a separate process, but ethical quality is built into the design. Unnecessary measurements add burden, selective recruitment can distribute benefits unfairly, and a study unable to answer its question wastes participant contribution. Recruitment, consent, privacy, comparison conditions and data retention should therefore be justified alongside the scientific method.
Exam move
Take one clinical problem and write five lines: target population, exposure or intervention, comparison, outcome with time, and strongest alternative explanation. Draw arrows among them, then ask what observation could challenge each arrow. Repeat with a survey and an experiment so the difference between measured exposure and assigned intervention becomes automatic.
For every ethical issue, connect it to a method decision: recruitment to selection, measurement burden to missingness, privacy to data handling and comparison conditions to clinical equipoise. Once the model is stable, convert each box into a variable plan that gives the construct, instrument, timing and scoring direction. Mark every unobserved concept in a different colour.
Decide whether it should be measured, acknowledged as a limitation or removed from the claim. Finally, read the participant information against the actual plan and check that collection, reuse and retention are described consistently. End by rewriting the conclusion with the weakest verb the proposed observations genuinely support.
If that version feels disappointing, improve the comparison or measurement rather than strengthening the wording. Keep a claim ladder beside the diagram: description, association, prediction and causation. For each rung, name the extra design evidence required to move upward. This makes overclaiming a visible mismatch rather than a vague writing problem.
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