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Exposé

The exposé in medicine and health sciences.

The study design is key here. A good research question with a weak design will not result in a good thesis, and a sample size that is too small cannot be rectified later on.

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The short answer

The research proposal outlines the research question, study design, population, sample size, data collection tools, analysis and timeline. This includes details on ethics approval and data protection. Anyone working with patient data should plan the lead time for ethics committee approval, authorisations and recruitment as a separate phase.

The components

The structure follows the logic of study planning. Anyone who can address the points in this order has a sound research proposal.

Background and research gap, substantiated by the current state of the literature.
Research question and hypotheses, clearly operationalised and testable.
Study design: cross-sectional, cohort, intervention, qualitative or mixed methods.
Study population, inclusion and exclusion criteria, recruitment strategy with a realistic source.
Sample size planning with justification; for quantitative designs, including a power analysis.
Data collection instruments and analysis methods, including the handling of missing values.
Ethics and data protection: relevant committee, consent, pseudonymisation, storage, retention periods.
Timetable and feasibility, with a specified lead time for approvals.

Clarify ethics and data protection at an early stage

Ethics committees meet according to a fixed schedule. An incomplete application therefore costs not just a few days, but an entire round of meetings. Enquire at an early stage about deadlines, required documentation and who is responsible: the university, the professional body or the institution.

The data protection plan must also be in place before the first data collection takes place. Clarify where data is stored, who has access to it, how it is pseudonymised and when it is deleted. Where data relates to your own employer, written authorisation is also required, including clarification of what may be published.

Key considerations

Number of cases
“Underestimated”

An under-sampled study generates effort without producing reliable results. Planning belongs in the research proposal, not in the analysis.

Recruitment
“Access not secured”

Anyone recruiting through an institution needs their written confirmation before the plan is finalised. Verbal commitments do not survive staff changes.

Ethical considerations
“Meeting dates”

Committees meet according to schedule. Treat the lead-up as a separate phase, not merely a formality.

Tools
‘Not validated’

Self-designed questionnaires without validation weaken any findings. First check whether an established instrument exists.

For non-medical professions

The same methodological standards apply in nursing science, public health, healthcare research and health economics. The difference lies in the faculty, the degree level and the entry requirements, not in the level of rigour.

A common mistake is to make one’s own institution’s quality project the subject of the study. The question must be generalisable; otherwise, it remains merely an evaluation, however well executed it may be.

Frequently asked questions

Further enquiries.

Do I need an ethics committee approval for the proposal?+

No, but the proposal must demonstrate that you know how to obtain one and have factored in the necessary lead time.

How do I plan the sample size?+

Through a well-founded estimate of the expected effect and the chosen analysis method. It’s worth seeking statistical advice at an early stage.

Can I work retrospectively?+

Yes, provided the data quality allows it and data protection and access issues have been clarified. This saves a considerable amount of time on recruitment.

How long should the proposal be?+

Usually 5 to 12 pages. The design section can be detailed, whilst the rest should be concise.

What should be borne in mind regarding data from the employer?+

Written authorisation, a data protection policy and clarity on what may be published.

Do I have to use an established tool?+

If one exists, yes. Developing your own tools requires validation, which often doubles the effort involved.

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