Denmark CTIS Part II Secondary Use Consent Requirements

Secondary research use of trial data outside the protocol

Conditional. If the trial seeks consent under CTR Article 28(2) for research use of a participant's data outside the purposes and framework of the protocol, VMK requires the participant or representative to be told that this consent can be withdrawn.

The information and consent for that secondary data use must be in a separate consent form from the main trial consent. Do not place an optional secondary-data yes or no decision inside the main trial ICF as if it were part of consent to participation.

The separate data-use consent does not replace the controller's obligations under the GDPR and Danish Data Protection Act.

Optional substudy that is a defined part of the trial

Conditional. and within Part II. An optional substudy involving biological material can still be part of the clinical trial when its research purpose and analyses are sufficiently defined, it is integrated into the trial and it falls within the trial's approved purpose and endpoints.

VMK states that this type of optional substudy is within its approval competence. The main PIS should mention the optional substudy, but the substudy should have its own Participant Information Sheet and Informed Consent Form. Submit those documents in CTIS so they are covered by the Part II approval.

The separate substudy material should explain sample type and amount, purpose, analyses, storage, transfers, possible findings and withdrawal implications.

Surplus material from samples already collected for the trial

Conditional. Denmark has a specific approach when surplus material from trial samples will be stored after trial end for unspecified future research that is not part of the current protocol.

VMK's Part II approval does not approve the unspecified future research itself. The main participant information must nevertheless explain that the surplus material will be stored for future research and state whether the participant can opt out of that storage.

VMK permits a specific opt-out checkbox at the bottom of the main consent form for this purpose. The model is an opt-out from storage, not a separate affirmative yes or no consent to the future research inside the main trial ICF. VMK states that it does not approve other future-research consent boxes on the main trial consent form.

The PIS should state how long the surplus material will be stored. If stored in Denmark, explain that a later research project using it must normally be submitted to an ethics committee and that new participant consent is the default, although the committee can permit research without new consent when the legal conditions for that waiver are met.

If the material will be stored or used abroad for unspecified future research, explain which rules will govern the later research, whether new consent will be obtained, whether an ethics committee or institutional review board will review it, and how GDPR requirements will continue to be met.

Extra biological material collected specifically for unspecified future research

Outside VMK Part II approval when not part of the defined trial. This is different from surplus trial material. If extra samples are collected specifically to store them for future research that is not sufficiently defined as part of the current protocol, VMK states that the activity is outside its approval competence and will not be covered by the Part II approval.

VMK recommends omitting the standalone information and consent documents for that future research from Part II so that they do not incorrectly appear as approved in CTIS.

If such material is nevertheless submitted, VMK requires the information to make clear that collection is voluntary, explain the later research and ethics-review rules, address GDPR and relevant third-country transfers, explain significant-finding issues if genetic analyses are planned, and state that the future-research information and consent material is not approved by VMK.

Withdrawal and relationship to main-study participation

Keep the choices independent where the optional activity is genuinely optional. A participant should be able to refuse an optional substudy or secondary research use without being represented as refusing the main trial unless the protocol and authorised conditions make that activity essential to the trial.

For Article 28(2) secondary data use, tell the participant that the separate consent can be withdrawn.

For surplus biological material, describe the Denmark-specific opt-out and the consequences of exercising it. Do not promise destruction or withdrawal effects that conflict with material already used, legal retention duties or a later research project's lawful processing.

Sharing and international transfer

For data or biological material sent abroad, identify the purpose and destination at the level required by Danish guidance. If personal data are transferred to countries outside the EU or European Economic Area, address Chapter V GDPR compliance.

For material intended for later unspecified research abroad, explain the future ethical review and consent framework rather than simply stating that the sponsor may use samples worldwide.

Significant health findings

If the planned analyses could reasonably produce new significant health findings, the application and PIS need a Danish feedback process. The participant should be told when qualifying findings may be returned. A participant who chooses not to receive such findings should use the separate right-not-to-know form after being informed of the consequences.

This can be particularly relevant to genomic or other broad analyses. The Denmark patient-facing QC checklist provides a final check of the sample, privacy and consent logic. Return to the Denmark CTIS hub for the full guide set.