Do I need ethics and research governance approval to use GenV data or biosamples?

Yes. Ethics approval is required for all research involving GenV data and/or biosamples, and it is your responsibility to obtain the necessary approvals.

Depending on the nature of your proposal, GenV may offer a review pathway through its own governance processes, or you may need to obtain approval from a Human Research Ethics Committee (HREC).

For further information, please refer to the User Guide - Data and Biosample Access and GenV Lower Risk Review Pathway.

Do I still need to meet my organisation's ethics and governance requirements?

Yes. Any review or approval provided by GenV does not replace your organisation's own ethics, governance, legal, or institutional requirements. Ensuring these requirements are met remains your responsibility and that of your organisation.

What does GenV consent cover?

GenV participants provide consent for the collection and use of information about themselves and their child, including access to relevant routinely collected records and, where applicable, biosamples.

Participants may also choose to provide a saliva sample and consent to genetic analyses being conducted on their samples. Consent includes the sharing of approved data and biosamples with approved users for ethically approved research.

Participants also consent to being recontacted by GenV and to receiving invitations to participate in future GenV-related research studies.

For further information, please refer to the GenV Protocol Paper, and the Parent/Guardian Information Statement.

Can I contact GenV participants directly?

Generally, no. You must not attempt to identify or contact individuals represented in GenV data.

Direct participant contact is only permitted as part of a GenV collaborative study and requires appropriate approvals and governance arrangements.

Will I have access to identifiable participant information?

Generally, no. Access is usually limited to de-identified data.

You must not attempt to identify participants or report information in a way that could reasonably identify an individual or family.

Access to more identifiable information may be considered in limited circumstances where there is a strong justification and additional governance, security, and approval requirements are met.