Generation Victorian (GenV) aims to create large, parallel whole-of-state birth and parent cohorts for discovery and interventional research. GenV is open to all babies born in Victoria, Australia, and their parents over two years from mid-2021. Follow up blends study-collected, study-enhanced and linked data and biosamples. GenV is designed to address physical and mental health, and social issues experienced during pregnancy and childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults.

Learn more about GenV at genv.org.au/for-researchers/



The GenV cohort design comprises four elements:

  1. Consent soon after birth to follow the child and parent/s indefinitely until study end or withdrawal
  2. Retrospective and prospective linkage to clinical and administrative datasets
  3. Universal and clinical biosamples
  4. GenV-collected demographic, risk, geographic and outcomes data that are not available via linked datasets or biosamples. Because of GenV’s size and whole-of-state dispersal, this requires a high-throughput digital platform capable of capturing wide-ranging psychosocial, phenotypic and functional outcomes

 

 

GenV proposes to recruit for two full years from 2021 in all of Victoria’s birthing hospitals, in which collectively around 75-80,000 babies are born each year. All children born in Victoria during the recruitment period whose parents/guardians have decisional capacity, and their parents, are eligible to take part. Participants who leave Victoria may continue to take part via linked and contributed data, and families may join GenV who move into Victoria later and have children born within the recruitment period. Data and samples will be available to all researchers internationally, under the Five Safes[1] (safe people, projects, settings, data, outputs) and FAIR[2] principles.


[1] Desai, T., Ritchie, F., and Welpton, R. (2016). Five Safes: designing data access for research

[2] Wilkinson, M.D., Dumontier, M., Aalbersberg, I.J.J., et al. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Scientific data, 3: 160018-160018. doi:10.1038/sdata.2016.18
(Addendum Wilkinson, M.D., Dumontier, M., Jan Aalbersberg, I., et al. (2019). Addendum: The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data, 6(1): 6. doi:10.1038/s41597-019-0009-6)

Study Summary
Study name Generation Victoria
Study abbreviation GenV
Current principal investigator/s Professor Melissa Wake: Scientific & Cohort ​Director
Professor Richard Saffery: Deputy Scientific Director (BioSciences)​
Professor Sharon Goldfeld: Deputy Scientific Director (Equity and Knowledge Translation)​
Ms Natasha Zaritski: Platform & Operations Director​
Current project manager/s Dino Asproloupos: Program Manager
Joan Leong: Bio Discovery Stream Lead
William Siero: Cohort 2020s Stream Lead
Dr Yanhong Jessika Hu: Solutions Hub Co-Lead (Epidemiology)
Naomi Schwarz: Solutions Hub Co-Lead (Knowledge Translation and Engagement)
Kerri McAllen: Data Innovation Stream Lead
Primary Institution Murdoch Children’s Research Institute
Collaborating Institution/s Royal Children’s Hospital
The University of Melbourne, Department of Paediatrics
The Victorian Government
Cross-sectoral coalition of partners – see:
https://genv.org.au/about-genv/supporters-and-partners/
https://genv.org.au/for-researchers/working-groups/
Major funding sources Paul Ramsay Foundation (PRF)
The Victorian Government
Murdoch Children’s Research Institute
Royal Children’s Hospital Foundation
Study website genv.org.au/
www.mcri.edu.au/genv
Are data available to others outside study team? In the future, yes. GenV is committed to Open Science and equal access to data, working within the FAIR and Five Safes principles and ethical and legal requirements to protect participants. Data access processes and platforms will be finalised by 2023. Once an application is approved (under existing or additional Human Research Ethics Committee approvals as needed), the applicants will be able to access GenV data in a safe and secure manner. The timing of release will depend on the complexity of the data, and usually after all participants have completed a given ‘sweep’ or ‘wave’. Each wave of GenV data collection will likely take two years from first to last participant to collect measures that are predicated on age milestones.
Study focus (e.g. social development) GenV is conceptualised as very large birth and parent cohorts, open to all babies born in the state of Victoria over a two-year period and their parents. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical and mental health and social issues experienced during childhood, as well as childhood and adult antecedents of health or disease during ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of all children and adults.
Sampling frame All babies born in Victoria in a two-year period and their parents.
Study type (e.g. randomised control trial, cohort, case-control) Longitudinal cohorts of children from birth and parents. GenV is also being designed to support/embed other research designs such as registries, trials, health services, place-based and geospatial research.
Year commenced Vanguard: 2020
Cohort 2020s: 2021
Ongoing recruitment? Yes
Intergenerational (e.g. offspring)? Yes
Imaging (e.g. fMRI, ultrasound, retinal photograph)? Being scoped
Linkage (e.g. BioGrid, VPDC, NAPLAN, Medicare)? Data linkage is expected in the future. We will regularly update the GenV, figshare and LifeCourse websites as this progresses.
Biosamples (e.g. buccal, blood, hair)? Yes.

GenV collects a buccal swab/saliva sample from the baby and each parent at the recruitment visit.

Families can consent to GenV accessing each baby’s Newborn Blood Spot screen (also known as NBS or Guthrie card).

Excess sample left over from routinely collected pregnancy samples can enter GenV’s biostore with consent. These include Maternal Serum Screen (MSS) or Non-invasive Prenatal Test (NIPT), booking bloods, 24-28 week bloods, 36 week bloods & Group B streptococcus (GBS) swab.

Other samples are expected in the future. We will regularly update the GenV, figshare and LifeCourse websites as this progresses.

Ethics approvals or requirements (e.g. specific, extended, unspecified, other)? Unspecified consent covers analyses that aim to benefit human health and wellbeing. Additional consent may sometimes be sought for specific research or substudies.

GenV is putting Site Specific Agreements (SSAs) in place with all hospital recruitment sites.

Principal Investigators

Professor Melissa Wake: Scientific & Cohort Director
Professor Richard Saffery: Deputy Scientific Director (BioSciences)
Professor Sharon Goldfeld: Deputy Scientific Director (Equity and Knowledge Translation)
Natasha Zaritski: Platform & Operations Director

Project Managers

Dino Asproloupos: Program Manager
Joan Leong: Bio Discovery Manager
William Siero: Cohort 2020s Manager
Dr Yanhong Jessika Hu: Solutions Hub Co-Lead (Epidemiology)
Naomi Schwarz: Solutions Hub Co-Lead (Knowledge Translation and Engagement)
Kerri McAllen: Data Innovation Manager

Study Contact

GenVHQ@mcri.edu.au

Postal Address

GenV
Murdoch Children’s Research Institute
The Royal Children’s Hospital, Flemington Road
Parkville VIC 3052

Australia