Ireland CTIS Secondary-Use Consent Requirements

Separate required and optional use

Identify the data and samples needed for the current protocol. Then place optional storage, future analysis, recontact or unrelated projects in separate consent statements. Refusal must not prevent participation in the main trial unless the use is scientifically necessary and clearly part of that trial.

Do not use one signature to bundle trial participation, optional genetic research, indefinite sample storage and commercial future use.

Define the scope of future research

Irish guidance permits broad consent when it remains specific, explicit and informed within a described disease, health or research area. It is not blanket consent for any future research.

Explain:

• the types of future research and their limits
• the data and sample types retained
• whether genetic, genomic or biomarker analysis may occur
• who may access them, including academic and commercial researchers
• where they will be stored and for how long
• countries or regions to which they may be transferred
• whether data will be coded, pseudonymised or anonymised
• whether commercial products or intellectual property may result
• whether individual findings will be returned
• whether the participant may be recontacted

If the future purpose cannot be described within a meaningful area, plan to recontact participants for new consent.

Later governance and ethics review

Consent given during the trial does not itself approve a future project. State that proposed secondary research will undergo the ethics, scientific, data-protection and institutional review required at that time.

Ireland has no dedicated mandatory national participant-consent template for secondary use. Use a separate trial-specific consent section or form and align it with the NREC data-protection document and the accepted biological-samples compliance template.

Document access controls, release criteria, material or data transfer agreements, oversight and destruction arrangements. Align the consent with the Part II biological-sample compliance form and Irish NREC data statement.

Withdrawal

Explain how a participant can withdraw permission for future use and whom to contact. State what can happen to remaining identifiable or coded material and what cannot be reversed after lawful anonymisation, analysis, publication or transfer into a completed study.

Do not promise removal from backups, safety files or records that must be retained by law. Stop new optional use when withdrawal is effective, subject to the terms approved for work already under way.

Children and adults lacking capacity

For participants enrolled under 16, plan to seek their own consent when they reach 16 if identifiable material remains in use or storage. Explain the transition in the paediatric documents. See the minor consent and assent guide.

A legally designated representative for an adult lacking capacity cannot ordinarily provide the person's explicit consent to health-data processing. A Health Research Consent Declaration cannot authorise unknown future research. Obtain project-specific legal advice and the appropriate consent or declaration route before secondary use. See the limited-capacity guide.

Submission checks

• Current-trial use and secondary use are clearly separated.
• Declining optional use does not affect trial participation or care.
• Broad consent has a defined disease, health or research area.
• Genetic analysis, commercial access and international transfer are explicit.
• Storage duration, governance and access controls are stated.
• Future projects require later review.
• Recontact and return-of-results policies are clear.
• Withdrawal promises are accurate and achievable.
• Re-consent at 16 and limited-capacity constraints are addressed.

Return to the Ireland CTIS Part II guide hub for all national requirements.