Austria Secondary and Future Use Consent Requirements

Separate the main trial from optional future use

Mandatory where future use is optional. The participant must be able to decide on the optional future use without losing the ability to participate in the main clinical trial. Use clear yes or no choices where AustrianEthics requires them.

Do not combine all future research into one undefined permission. Identify the data or samples, intended research purpose and consequences of the participant's decision.

Optional genetic investigations also require a separate consent form under current AustrianEthics guidance.

Future use of biological samples

Conditional. If residual samples from the main study or additional samples will be retained for future research, the participant information must describe the future-research plan.

AustrianEthics Guidance Version 4 cites section 2d(3) of the Austrian Research Organisation Act and requires the research field to be restricted. The field can be framed, for example, as biomedical research or human medicine and health sciences and should be narrowed further to a specialty or product class where possible. Avoid unrestricted wording such as “any future research.”

The participant information should state:

• which residual or additional samples will be stored
• whether extra samples are collected solely for future research
• where the samples will be stored
• how long they will be stored
• who or which function is responsible for storage and destruction
• that consent can be withdrawn while the relevant pseudonymised samples remain identifiable for destruction

The guidance also notes that renewed consent is generally required when the intended future purpose is not compatible with the original purpose and no other separate legal basis applies.

Pseudonymised samples and destruction

Mandatory. AustrianEthics states that participants have an indispensable right to request destruction of pseudonymised biological samples.

Explain how that request can be made and which samples it covers. The process should be operationally possible while the sample remains pseudonymised and linkable through the controlled code.

Planned anonymisation of samples

Conditional and optional. If remaining research samples will be anonymised, explain what anonymisation means, what data remain linked to the sample, the implications for participant rights and the planned use of the anonymised material.

AustrianEthics requires the participant to be able to refuse anonymisation without losing main-trial participation and recommends a separate yes or no choice. Once a sample is anonymised so that it can no longer be linked back to the participant through the trial coding system, the participant cannot practically demand destruction of that specific material. The consent text must explain that consequence before the optional decision is made.

The Austrian guidance also cautions that genetic characteristics can complicate claims of absolute anonymity. Avoid overpromising that biological material can never be re-identified in any technical sense.

Secondary use of trial data for new technologies

Conditional. AustrianEthics Guidance Version 4 specifically addresses reuse of pseudonymised data originally collected for the clinical trial to develop new technologies such as artificial intelligence or machine learning.

Where this is planned, add a separate, understandable subsection at the end of the data-protection passage or use a separate information and consent document. Explain the secondary purpose or development goal. If a commercial company performs the processing, state the commercial nature of the activity.

The participant must be able to consent or refuse the secondary use while still participating in the clinical trial. AustrianEthics requires a corresponding yes or no option in the consent form.

Other secondary data use

The current Version 4 section described above is explicit for new-technology development. Do not automatically treat it as a blanket authorization for every other future data use. Define each proposed secondary purpose and check whether it is compatible with the original purpose or requires a separate consent or other valid legal basis.

Section 41 of the Austrian Medicines Act requires explicit written information about the purpose and scope of personal-data processing for the trial. Any secondary-use wording should be consistent with the mandatory Austrian sample data-protection passage rather than replacing it.

Withdrawal and the relationship to main-study participation

The main clinical trial, future sample use and secondary technology-development use should be treated as distinct decisions when the latter activities are optional. Refusing an optional future-use choice must not exclude the participant from the main trial.

For samples, explain destruction rights before anonymisation. For secondary data use, state the applicable withdrawal mechanism and consequences based on the specific processing plan and legal basis rather than promising deletion that cannot lawfully or technically be delivered.

For full withdrawal from the clinical trial itself, AustrianEthics Guidance Version 4 states that new study-purpose data collection through study visits, follow-up visits or re-contact should stop, while CTR safety-reporting obligations remain unaffected.

CTIS and Part II document placement

The Part II biological-sample compliance document belongs in CTIS Section S when samples are collected, used or stored. Optional future-use participant information and consent belongs with the relevant Section L participant materials.

The national GDPR compliance statement belongs in the Part II data-protection area, while participant-facing privacy and optional secondary-use choices remain in the ICF set. The Austria Part II document checklist explains the full upload structure.