Ancillary Data and Specimen Consent Section
SPIRIT 2025 item 32b addresses additional consent provisions for collection and use of participant data and biological specimens in ancillary studies when applicable. Only include provisions that apply to the protocol. Consent choices, withdrawal possibilities, storage, data protection, and secondary-use rules depend on jurisdiction, ethics approval, identifiability, and the ancillary research plan.
An Ancillary Data and Specimen Consent section explains whether extra consent is needed for ancillary use of participant data or biological specimens and how that consent, collection, storage, sharing, and withdrawal scope will be handled.
Key details
Important caveats
Scope Boundary
Only include provisions that apply to the protocol. Consent choices, withdrawal possibilities, storage, data protection, and secondary-use rules depend on jurisdiction, ethics approval, identifiability, and the ancillary research plan.
Further guidance
Content
Describe how consent will be obtained for specified or unspecified ancillary studies and, when relevant, how the associated data or specimens will be collected, stored, shared, and governed.
Purpose
Separate consent for ancillary research from the main-trial consent so future or additional uses are transparent.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- SPIRIT 2025 statement: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 reporting guideline for the minimum content of randomized-trial protocols, including amendments and protocol transparency.
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 explanation and elaboration for trial protocols, including trial monitoring and data monitoring committee roles and reporting structure.