Informed consent in patient preference DCE studies
Patient preference studies involving identifiable health data require informed consent that is specific to the research purpose and distinguishable from clinical care consent.
What informed consent in patient preference research requires, how to design consent processes, and common regulatory pitfalls.
Knowledge Base -> Survey Building -> Health
Ben White, 07.07.2026
Consent requirements in patient research
Informed consent for a patient preference survey is not the same as clinical trial consent. It must be specific to the survey research context - what data is collected, how it will be used, who will see it, and what the participant's rights are under the applicable data protection framework.
Generic consent language from clinical research consent forms is not appropriate for survey research. It typically covers different data types, different uses, and different rights. Reusing it without modification is a common compliance failure.
What valid consent requires in online patient surveys
Data protection regulators - ICO, FDA, EMA - treat consent as a specific legal basis for processing personal data. Consent must be freely given, specific, informed, and unambiguous. A consent form that covers 'all future research purposes' does not satisfy the specificity requirement.
For patient advocacy organisations and clinical recruitment channels, the quality of the consent process determines whether they will participate. Organisations with their own ethical governance will review and may reject consent processes that do not meet their standards.
TLDR Quick links
Implementing consent in SurveyEngine
Step 1: Draft the consent form in plain language. Aim for a reading age of 12. Use short sentences and active voice. Avoid legal jargon.
Step 2: Specify exactly what data is collected. List the data elements: health condition, treatment history, demographics, survey responses. Do not include catch-all phrases.
Step 3: Specify how long data is retained and when it is deleted. GDPR requires that retention periods be stated. 'As long as necessary' is not an acceptable retention period statement.
Step 4: Explain the right to withdraw. Participants must be told they can withdraw at any time without giving a reason and without consequence. For online surveys, explain what withdrawal means in practice.
Step 5: Obtain explicit affirmative consent. A pre-ticked checkbox does not constitute consent under GDPR. Consent must be an active choice.
Worked example - consent for FDA patient preference study
A patient preference study in a rare paediatric condition requires parental consent for participants under 16 and assent from the child participant where applicable. The consent process includes: parent consent form reviewed and approved by the ethics committee; child assent form in age-appropriate language; separate data protection notice explaining GDPR rights.
The patient advocacy organisation reviewing the study requires one revision - the retention period is specified as 'as long as needed for research purposes'. This is revised to '5 years from study completion, after which all identifiable data will be deleted'. The revised consent process is approved.
References
FDA (2019). Patient Preference Information guidance.
ICH E6 (R2) Good Clinical Practice Guideline.
Planning a patient preference study? Contact SurveyEngine's health research team to discuss ethics and consent requirements.
Or Contact us at support@surveyengine.com — we're glad to help.