Research proposal & ethics application

Make the case that the question matters, the method can answer it, and the risks are managed.

Dissertation proposals, funding applications, and IRB / research ethics committee submissions.22 fields

How this document is used well

Reviewers reject proposals for three reasons far more often than for any others: the question is not important, the method cannot answer it, or the risks to participants have not been thought about. Feasibility is the fourth, and it is the one students most often overlook — a beautiful design that cannot recruit is not a design.

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Title this document

Shows why each item is asked

The question

Title*Research question and hypotheses*Why this matters — to patients, to clinicians, or to theory*Background, ending at the specific gap*Patient and public involvement — who with lived experience shaped this, and how

Increasingly required by funders, and it reliably improves the design. Consultation after the protocol is written does not count.

Design and feasibility

Design, and why this design answers this question*Sample, sampling frame, and power*Recruitment — realistically, where will these people come from and how many are there?*

The commonest way a good proposal fails. Base the estimate on a real service’s throughput, not on an assumption.

Measures, and the burden they place on participants*Analysis plan*Timeline and milestones

Ethics

Consent process — including capacity and any coercion in the recruitment setting*Foreseeable risks to participants, and how each is mitigated*Protocol if a participant becomes distressed during assessment*Protocol if a participant discloses suicidal ideation, abuse, or risk to others*

This must be written before recruitment, agreed with a named clinician, and stated in the participant information sheet — you cannot promise confidentiality you will have to break.

What the control arm receives, and what happens if they deteriorate*Data management — storage, anonymisation, retention, sharing, lawful basis*Payments or incentives, and why they are not coerciveDissemination, including to participants

Telling participants what was found is an ethical obligation that is routinely promised and rarely honoured.

Position and interests

Your allegiance — do you have a stake in one result?*How is the design protected against your allegiance?

Independent assessors, a comparator delivered by someone who believes in it, pre-registration, or an independent analyst.

For qualitative work: your position relative to participants, and how it shapes what can be seen

16 required fields outstanding: Title; Research question and hypotheses; Why this matters — to patients, to clinicians, or to theory …

How this document is used well

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